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tv   Administration Officials Testify on Efforts to Regulate Fentanyl- Related...  CSPAN  December 5, 2021 3:16am-6:14am EST

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extension will expire at the end of january. the continuing resolution introduced this morning extends the deadline to february 18th. despite this temporary
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scheduling, deaths due to fentanyl-related overdoses have continued to rise even as deaths caused by other drugs have fallen. our subcommittee hearing today is to learn from the administration its recommendations to congress for permanent scheduling of all fentanyl-related substances. the interagency proposal calls for permanently scheduling these drugs under schedule one but with an expedited process to reschedule those that are later found not to be dangerous enough to warrant such regulation. over 100 civil rights groups have expressed concerns about class-wide scheduling because it expands the number of drugs subject to mandatory minimum sentences that contribute to the disproportionate incarceration of racial minorities. to address this concern, mandatory minimums would not apply in most cases involving
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fentanyl-related substances unless there is death or serious bodily harm. and if a substance is later removed from schedule 1, incarcerated individuals could have their sentences reduced or vacated. the proposal would make it easier for researchers to get permission from the federal government to study all schedule one substances. the current restrictions deter many researchers from studying these drugs and removing some of these barriers will help us better understand how to treat addiction. today we will hear from some of the agencies that develop thesis recommendations, including the fda, the national institute on drug abuse, the drug enforcement administration and office of national drug control policy. and we look forward to their insights on how the administration's proposals will help address the over dose
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epidemic. i want all members to know that we invited the department of justice, the doj, to testify but they chose not appear at today's hearing. our staff began conversations with the doj about this hearing in september, last september. and i formally invited them to send a witness november 18th. doj's refusal to testify i find to be troubling. and they offered no legitimate reason. they just declined. their perspective on their own recommendation to congress would have been valuable for us to hear. so now the chair is pleased to recognize the distinguished ranking member of our subcommittee, mr. guthrie, for his opening statement. >> thank you chair eshod for holding this important hearing and thanks for all our witnesses being here today. today we're discuss thought
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permanently combat the trafficking of illicit fentanyl related substances. this committee has a bipartisan history of addressing the growing opioid epidemic. the growing support for the opioid recovery centers act which authorized creation of comprehensive opioid recovery centers throughout the nation. these centers provide evidence based comprehensive care for those with substance use disorders. however i'm frustrated and pleased to see that we're going to move forward with scheduling on february -- through february 18th. but i'm really frustrated that we're failed to come up with and join together to permanently schedule fentanyl analogs. we lost a hundred thousand americans last year to drug overdoses. in my home state of kentucky, overdose deaths increased by 54% between spring 2020 and spring 2021. the kentucky offensive drug control policy described the trend as one of the most critical public health and
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safety issues facing kentucky. additionally, the agency attributed most of the deaths us to ill lis use of fentanyl and fentanyl analogs chsmt the report note was responsible for over 70% of all of commonwealth's drug overdoses in 2020. but these aren't just numbers on a page. there are mother, father, brothers, sisters friends and children. in march of this year a kentucky mother purchased drugs laced with fentanyl and not too long after found her two year old son dead after he reached into her purse while she was napping and ingested the deadly poise p. these tragedies have become too familiar to not just kentuckiens but thousands of americans across the country. healthcare closures have also caused disruption or lengthy delays in care for individuals seeking substance use disorder treatment. these delays have also affected
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those seeking first-time care for substance use disorder and have tragically led to sharp increase in overdoses. i worry about further disruptions in security to workforce shortages exacerbated by federal vaccine mandated. 30% of healthcare workers in hops are unvaccinated cdc found. -- though i am vaccinated and encourage people to do so if they so choose. even worse, president biden's biden disorder -- biden crisis -- border crisis essentially made kentucky and every other state a border state. only 2 mg fentanyl can be a lethal dose. in the u.s. customs and border protection reported almost 4,000 pounds of fentanyl seelzed at the southern are border. statistics show that the agency sees enough fentanyl this past year alone to give every american a lethal dose.
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the biden administration failure addressing the problemen driving the increase in drug overdoses. i have been urging colleagues to permanently schedule fentanyl analogs by supporting the initiative to guarantee help by targeting fentanyl act. and although the administration recently issued a plan to permanently schedule the substance the proposal misses the mark by failing to impose mandatory minimums on fentanyl analog traffickers. by excluding minimum, the proposal effectively incentivizes cartels to continue to develop more variation of fentanyl and ship these deadly substances to our own backyards. given fentanyl and its analogs have contributing to the highest levels of overdays rates the country's ever seen, excluding them from the man tear minimum is disturbing. it is unfortunate the department of justis can't be here today to explain this policy. did the doj refuse to show up to
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today's hearing because they are unable to justify the policies in this proposal? why didn't this administration send their top federal law enforcement agency to share their plan with the american people on how they will get these deadly poisons off our street? i appreciate the chair's strong remarks to that because it is important and disturbing they wouldn't be here. it is their job. i know sometimes it is inconvenient but it is our job for oversight and their job to be here. i will continue to address permanently scheduling fentanyl analogs and give law enforcement the resources needed to fight back against the illicit trafficking of fentanyl and fentanyl-related substances across the united states that are sadly taking the lives of thousands of americans. thank you and i yield back. >> gentlemen yields back. and pleased to recognize now mr. palone for your five minutes for an opening statement.
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>> thank you chairwoman eshud. this crisis is a tragedy taking more than a hundred thousand americans far too soon in the first 12 months of the covid-19 pandemic. for years we worked to combat this crisis. earlier this year as part of the american rescue plan we included $3 billion in funding for the mental health and substance abuse block grant programs aed the substitute abuse and services administration and this is the largest amount of aggregate funding for the programs and goes to critical programs and services for people experiencing substance use disorder. the american rescue plan builds on the work but we obviously must do more. today wore discussing solutions to the overdose issue and what more congress can do end this crisis. sympathetic opioids have been a significant driver of overdose deaths in the united states last
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year, estimated more than half of overdose deaths involving -- primarily illicit fentanyl. availability of illicit fentanyl in the united states dramatically increased and manufacturers have been able to evade regulations by rapidly manufacturing new versions of fentanyl substance unsubject to control. today fentanyl-related substances taemp rarely place --. schedule one is reserved for drug that have no accepted medical use. a high potential for abuse or lack of accepted safety. the current temporary scheduling order subjecting fentanyl-related substances to these strict restrictions is set to expire january 28 of 2022 however the cr we will consider this week and probably today will provide for an extension through february 18th of next
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year. and it is critical congress and this committee work together in a bipartisan fashion with the administration to put in place a long-term solution. in september the biden administration released recommendations to address illicit fentanyl-related substances for prepared by the office of national drug control policy, the department of health and human services and department of justice and i appreciate the witnesses for joining us today. the administration's proposal would create a classified definition of fentanyl-related substances and permanently place them in schedule one. also create a mechanism to expedite rescheduling or descheduling of substances as needed. and i'm pleased the proposal also includes provisions to streamline registration requirements for all schedule one substances aligning schedule one registration requirements more closely with schedule two requirements will help expedite registration for researchers who want to study schedule one substance and hopefully help to
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expand research in this space. as we discuss this proposal it is important to remember this is a set of recommendations. this committee is responsible for crafting the actual legislation that will help dramatically improve the lives of many americans. many ideas and proposals to meet this goal. including strategies of strengthen prevention, treatment, harm reduction and recovery services. >> there is no idea too big or too small to get ahead of this crisis and we must work together to solve it. and finally, i'm -- i wanted to say that am pleased the dea is represented here by its principle deputy administrator and look forward to also working with directly with doj on the administration's proposal so this committee can better understand the intent and rationale behind their policy recommendations related to enforcement. look forward to hearing from the witnesses and madam chair i know this is something you are very
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concerned and having for some time and thank you for having this important hearing today. i yield back. >> chairman yields back. the chair is now pleased to recognize congresswoman kathy mcmorris rodgers. she's the distinguished ranking member of our full committee for her five minutes for an opening statement. >> thank you madam chair. fentanyl and fentanyl-related substances are killing a record number of americans. making sure these deadly poisons are permanently made illegal requires urgent action. lives are on the line. unthinkable amount of fentanyl and its analogs are coming across our border. enough to kill every american seven times over. according to cdc's national center for health statistics, there are over a hundred thousand drug overdoses in the united states from april 2020 to 2021. in my home state of washington the overdose death rate increased by more than 36%.
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it is higher than the national average. all because fentanyl and its many analogs. here is the recent headline in the spokesman review. death and killings rise. report reflects increase in fentanyl over doses. i want to share a story about someone from my community, where in spokane the illicit drug market is completely flooded with fentanyl. ellen had battled addiction and despair since he was a child. recently lost his job, relapsed and unfortunately overdosed on heroin. the paramedics administered narcan to save his life and he woke up in an ambulance. he later learned that the heroin he consumed was laced with fentanyl. he was lucky. he survived. and each time allen uses, he's playing a game of russian roulette with his life because fentanyl and its analogs are everywhere. as this year dea seize ad record number 9.5 million fake prescription pills containing
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lethal amount of fentanyl. more seized so far in 2021 than the previous two years combined with two out of every five pills containing a potentially lethal dose of fentanyl. this is not your typical street drug. this is a weapons grade poison that is killing our children. i learned another story about a young woman in my district named kayla. she and her friend split what they thought was a percocet tablet. that one pill, which was laced with fentanyl, immediately killed them both. they had no chance. for people like allen and kayla, republicans have been trying to permanently place fentanyl-related substances in schedule one. we're hearing from an army of parents every day. parent who is deserve justice because they have lost a child. and they don't want anyone else to experience their pain. the biden administration agrees that we should permanently schedule fentanyl-related
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substance in schedule one. the biden administration recommends also support and more research into innovation and protect dangerous drugs like fentanyl and treat those with substance use disorders. that's where we agree. unfortunately the administration is also trying to treat these deadly poisons differently from fentanyl and other currently scheduled fentanyl analogs. the administration is proposing to exempt the entire class from trafficking mandatory minimums. this would prevent our law enforcement from finding and putting away drug traffickers who are bringing these chemical weapons across the border. for the parents we're fighting for, it would mean criminals who killed their kids could keep trafficking these lethal substitutes with lower repercussions. surely there is bipartisan support to deliver justice for these families. we should be working together to punish those who make, import and distribute these poisons to our children. and help those with substance abuse disorders with treatment and recovery. recovery.
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congress must work together on the support for patient and communities act. in addition to permanently scheduling fentanyl analogues, i stand ready to work to reauthorize key programs at the substance abuse and mental health services administration that expire next year to help get treatment for those who need it. we need to take urgent action on fentanyl analogues. it's too deadly a substance to be weak on traffickers and to those who sell it to our children and our communities. even if congress passes the cr later on today, after february 18th, fentanyl-related substances will be street legal. i remain deeply concerned that we will not take action in time, tying law enforcement's hands in their battle to keep this poison out of our communities and simply kick the can another few months. congress needs to make permanent the fentanyl analog's ban
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immediately along with communities. parents, communities, and our constituents need it. with that i yield. >> the gentlewoman yields back. i would like to advise members that pursuant to committee rules, all members' written opening statements shall be made part of the record. i now would like to introduce our witnesses. mr. kemp chester is the assistant director of the office of national drug control policy in the executive office of the president. welcome to you and thank you for being with us today. dr. nora volkoff is the director of the national institute on drug abuse at the national institutes of health. we can say welcome back. you have graced the witness table several times before, and
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we welcome you back. dr. douglas throckmorton is the deputy director for regulatory programs in the center for drug evaluation and research at the fda. welcome to you and thank you for being with us. and mr. lewis milioni is the principal deputy administrator for the drug enforcement administration, the dea. welcome to you and thank you for being here today. we look forward to the testimonies that you are going to provide to us. you're probably familiar with the light system. it isn't anything complex. you have one minute remaining when the yellow light comes on. and i think everyone knows what red means. so mr. chester, you're now recognized for your five minutes of testimony. and thank you again for being here with us today for this very important hearing. >> chairwoman eshoo, ranking
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member guthrie, members of the subcommittee, thank you for inviting me to testify today. the biden/harris administration approaches america's overdose epidemic with the urgency it demands, through evidence based drug policy that effectively addresses both the public dimension of the problem and the drug trafficking environment facing the united states and the world. at present one of the most complex and comprehensive challenges we face is illicitly manufactured fentanyl, fentanyl analogues and fentanyl related substances or frs. they confound our efforts to reduce opioid-related deaths, are found throughout the country, and are the main driver of the increase in drug poisoning deaths in the united states. in 2020 alone, overdose deaths involving synthetic opioids primarily illicit fentanyl and its analogues increased by 55%. new and emerging frs are being
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manufactured faster than the united states can schedule them individually, necessitating the permanent class-wide scheduling of frs as a whole. recent customs and border protection data show that it may be possible to synthesize as many as 4,800 fentanyl analogues with relatively simple modifications no the base fentanyl molecule. time is of the essence. although scheduling is not sufficient in itself to solve this problem, it is absolutely necessary to control substances yet to be made and yet to be made available in america's communities. we must deter the creation of these new substances and disrupt their flow into the united states in order to allow our historic investments in public health interventions to take hold and make tangible progress. for the past several months, the office of national drug control policy, the department of justice, and the department of health and human services, met regularly to develop
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recommendations for a comprehensive, consensus approach that addresses the complex issues surrounding the scheduling of frs. this process involved input from the congress, public health officials, law enforcement partners, and stakeholder groups. these recommendations would permanently schedule these dangerous substances as a class while ensuring that access for scientific research is not burdensome and civil rights protections are safeguarded. this is a delicate balance and we've sought to provide a responsible and comprehensive approach. the administration recommends the following. first, permanently schedule all unscheduled frs into schedule 1 in accordance with the controlled substances act, the csa. second, for these class scheduled frs, exclude quantity based mandatory penalties normally associated with domestic trafficking of schedule 1 substances. this exemption does not apply however where there is a direct
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link to death or serious bodily injury. third, create a streamlined process overseen by hhs to remove or reschedule any frs found not to have a high potential for abuse as defined in the csa. fourth, ensure a federal court is able to vacate or reduce the sentence of an individual convicted of an offense involving an frs that is subsequently removed or removed from schedule 1. fifth, establish a simplified process to align research registration for all schedule 1 substances including frs more closely with the research registration process for schedule 2 substances. and finally, direct the government accountability office to analyze the implementation of permanent class scheduling of frs including its impact on research, civil rights, and the illicit manufacturing and trafficking of these dangerous substances. these recommendations follow the approach outlined in the administration's first year drug policy priorities which include
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expanding access to evidence-based prevention, treatment, harm reduction, and recovery support services, as well as reduced the supply of illicit drugs. the foundation of these recommendations rests with making our communities healthier and safer without causing unintended harm. they are a critical part of our comprehensive effort to reduce drug use and its negative consequences throughout the nation. on behalf of dr. gupta and the men and women of the office of national drug control policy, i would like to thank you and your congressional colleagues for your leadership and thank our federal partners as well for their close collaboration on this critical issue. i thank you for your time and i look forward to your questions. >> thank you very much. dr. volkow, you have five minutes for your testimony. and we once again welcome you here today. >> good morning.
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chairwoman eshoo, ranking member guthrie and members of the subcommittee, thank you for inviting me to speak with you today. illicitly manufactured fentanyl and fentanyl-related substances are driving the steep rise in overdose deaths in the united states. the latest data show overdose deaths exceeded 100,000 in a year, a staggering figure and the highest number ever recorded in a 12-month period in the united states. overdose deaths involving synthetic opioids increased by 49% during that period. therefore, it is imperative that we reduce trafficking and manufacture of these dangerous substances. however, these should not be done at the expense of criminalizing people who use drugs, an approach that we know does little to deter drug use or alleviate substance abuse
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disorders. instead, an evidence-based approach that prioritizes prevention and treatment of substance use disorders is needed to address the opioid and overdose crisis. in this regard, research on fentanyl-related substances is essential to develop treatment for opioid addiction and overdose, particularly in light of reports that core medications may not be as effective against fentanyl. however, obtaining a dea registration to study fentanyl-related substances and other schedule 1 drugs presents challenges to researchers. even experienced researchers report that obtaining or modifying a dea registration can take many months. the application process is often redundant with reviews needed to obtain a federal grant or an fda
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investigational new drug authorization. establishing the security infrastructure to conduct schedule 1 research, which is expensive, may need to be duplicated for each registrant working within a single department. researchers have also reported a lack of clarity on the registration requirements and variability in their interpretation. these challenges can slow research progress and dissuade investigators from working with schedule 1 substances. that is why the administration's proposal to permanently schedule fentanyl-related substances is critical, because a class-wide scheduling which is based on chemical structure alone bypasses the usual substance by substance analysis of a compound's abuse potential. these will result in the
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permanent placements of thousands of compounds to schedule 1, potentially including substances with little or no ad addictive potential an those that hold promise for treating opioid abuse disorder, pain, and other conditions. equally important is facilitating research on the substances that remain in schedule 1. the administration proposes an alternative registration process for schedule 1 research honored by hhs or va or conducted under an fda ind that more closely alliance with the process for schedule 2 substances, such as methamphetamine and cocaine. it will remove duplicative protocol reviews, expedite the process for modifying current registrations, and still prevent diversion or maintaining the security and inventory controls currently in place.
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the proposal also addresses aspects of the law that researchers report to be confusing, burdensome, or inconsistently applied, as well as to facilitate transparency in the registration review procedures. i am very grateful to our hhs and doj for their support of this important proposal and to the committee for considering it. i am happy to answer any questions you may have. >> thank you very much, doctor. i now am pleased to recognize dr. douglas throckmorton for your five minutes of testimony. thank you again. >> chairwoman eshoo, ranking member guthrie, members of the subcommittee, i'm dr. douglas throckmorton, deputy director for regulatory programs at the center for drug evaluation
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research at the food and drug administration. thank you for the opportunity to appear before you today to discuss the comprehensive approach to the scheduling of fentanyl-related substances developed with the official of national drug control policy, the department of justice, and the department of health and human services, as well as the important role that the fda plays in scheduling illicit subs that pose a danger to public health while also supporting the development of needed new drug therapies. as the committee has heard, new illicit synthetic drugs derived from fentanyl are coming into the u.s. and are being mixed with heroin and other drugs. hhs has a number of critical responsibilities under the act, several of which have been delegated to the fda. given this, fda and dea have
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worked very closely together in the area of controlled substances including opioids, including the work we are here to discuss today related to the appropriate level of control for the fentanyl-related substances that are flooding into our country with tragic results. dea issued a temporary order in 2018 as has been mentioned, controlling the entire frs class. congress has since extended that order and through january 28th, 2022. in 2020, dea asked hhs to make a scheduling recommendation for the entire frs class. following careful evaluation, the fda concluded that such a recommendation was not possible for the frs class for several reasons. first, the class is vast in terms of the number of hypothetically covered substances. second, data on the pharmacological effects and epidemiological data about the
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harms and overdose deaths are available for fewer than 30 members of that frs class. and third, among the individual frs members that we have pharmacological data, fda has identified examples of substances that do not activate the mu opioid receptor. this activation is the primary pharmacology that would lead to opioid-related harms such as those caused by fentanyl, oxycodone and hydrocodone. instead, recognizing the significant public health risk posed by fentanyl-related substances, we have worked closely with our interagency colleagues on a legislative approach that would control the entire class while minimizing the impact of control on research and drug development by providing for a rapid decontrol or recontrol of individual members as appropriate when new data become available. this proposal would provide law enforcement with the tools they need to promptly respond to the traffic and manufacturing of
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illicit frs subs. because not all of them will on in the pharmacology to predict high risk of abuse and risks of injury and in that way do not warrant control as a dangerous schedule 1 substance and because we believe some members of the frs class could have important therapeutic potential. the proposal includes a science-based mechanism to rapidly remove an individual compound from scheduling the most restrictive schedule into schedule 1 if sufficient data emerge that the substance does not share fentanyl's dangerous pharmacological properties. under the streamlined approach for control, hhs would determine if a substance should either be moved to a lower schedule or removed from scheduling altogether. again, focused on an assessment of its pharmacology. this work would focus on the substance's effect on the mu opioid receptor, the receptor responsible for many of the dangerous effects of opioids including sedation and
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respiratory depression. we believe the proposed approach would appropriately balance the pressing need to address the public health risk posed by the illicit use of these substances while also addressing the important need to support scientific research into these substances to develop new therapies and to improve our scientific understanding. we appreciate the combined work of the federal partners to develop this proposal and the willingness of this committee to discuss it here with us today. fda stands ready to do all we can to support this important work on this critical public health issue. i am happy to answer any questions i can. thank you. >> thank you, doctor. and it's a pleasure to recognize mr. louis milioni now for your five minutes of testimony. welcome and thank you again. >> thank you, chairman eshoo, ranking member guthrie and members of the committee. thank you for inviting dea to testify here today. dea's mission is to protect the
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public from the most significant drug threats harming our communities. i've had the privilege of serving as a dea amendment for over 20 years. i've worked in new york city and around the world, investigating sophisticated criminal drug networks that were pushing different drugs into our community, into our country. my dea brothers and sisters and administrator milgrim and i have never seen anything as dangerous as this fentanyl threat. fentanyl is an existential threat to our country. fentanyl is killing countless americans every day in all our communities. it knows no geographic or economic bounds. as a synthetic drug, the supply in different variations of the drug are limitless. who is manufacturing it and pushing this deadly poison into our country? mexican cartels working with criminal chemical companies in china. they're exploiting or opioid
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crisis by manufacturing massive quantities of fentanyl, flooding our country with it, and profiting from the devastation that they leave behind in our communities. dea's fentanyl seizures this year have reached an all-time high. largely because of the temporary class-wide scheduling of fentanyl-related substances. we've already seized 13,000 pounds of fentanyl this year. that's enough fentanyl, as was mentioned earlier, to give every member of the united states population a potentially lethal dose. what is extremely alarming is that mexican cartels and other criminal networks are mixing fentanyl with other drugs like cocaine, meth, and heroin, and also marketing this fentanyl in a new form, fake prescription bills. these pills are filled with deadly fentanyl and pushed on our population by these criminal networks. they're made and marketed to deceive users, often on social
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media platforms, making their target audience think that the fake pills are legitimate prescription medications. but they're not. so far this year dea and our law enforcement partners have seized more than 15 million fake pills. 10 million of these pills were laced with fentanyl. dea's lab testing confirmed that four out of ten of these pills are laced with the potentially lethal dose. as i said earlier, dea's mission is to protect the public. we are laser focused on this threat. in september, we issued our first public safety alert in six years, warning the public about fake pills laced with fentanyl. the prior public safety alert was also dealing with fentanyl. at the same time, we launched a public awareness campaign titled "one pill can kill," trying to get the message to anyone we can reach that just one of these fentanyl-filled fake pills can kill a user. we also did a nationwide
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enforcement surge focused on the fentanyl and counter fit pill threat. over a period of six to eight weeks we took action in all of our dea offices around the country. we seized millions of fake pills, thousands of pounds of fentanyl powder, dozens of guns, and arrested more than 800 drug traffickers. we will be relentless in the work that we have to do to protect the public. the fentanyl threat, as i said earlier, is an existential threat to our country. now more than ever, it is critical that congress permanently schedule fentanyl-related substances as a class to enable dea and our law enforcement partners to seize these substances before they enter the country, and as they are encountered in our communities. dea is also committed to expanding and enhancing research on controlled substances. this is a key pillar of dea's commitment to fighting overdose deaths and a critical part of dea's mission to protect the
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public. we look forward to continued collaboration with the research community and our interagency partners to facilitate access to research and learn more about these substances. we at the dea are committed to doing anything that we can to protect the public from these dangerous drugs that are harming americans and devastating our communities. we look forward to working with congress and our interagency partners to address this threat in our nation's overdose epidemic. i look forward to taking your questions. thank you. >> thank you very much, mr. milione, that's compelling testimony. we'll now move to member questions. and i recognize myself for five minutes to do so. to what dr. throckmorton, since the temporary class-wide scheduling of fentanyl-related substances began in 2018, overdose deaths, and it's
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contained in the testimony as well, have only risen. so tell us why the administration's proposal will succeed where the temporary scheduling hasn't. >> thank you, madam chairwoman. no single solution exists for the problems that confront us around the opioids crisis. so i believe we have to acknowledge, this is one important step among many that we need to take. one reason i believe this is a particularly important step is because of its focus on this class of substances, this class that's causing particular harm. temporary scheduling has been effective. it has helped prevent control of these substances. permanent scheduling will send a strong message that these substances are something that we -- >> even with that temporary scheduling, deaths have risen.
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>> the deaths have risen i believe as a consequence of other influence, other factors that have occurred in the system. >> what are those? >> well, there are other social influences. one, simply the economics of the managers use and abuse of opioids. we've transitioned from a time where prescription opioids, prescription pills, were driving a substantial fraction of the overdose deaths that were experienced to a place,the fentanyl and the fentanyl-related substances are causing a much larger fraction of the overdose deaths. >> i see. >> this change in the complexion of the crisis leads to a need for us to focus particularly in this area. >> i wanted to ask mr. chester and mr. milione what role they play in the epidemic relative to other opioids. >> thank you for the questions.
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dea's main focus is protecting the public. targeting those that are causing the harm and helping those that are harmed. without question, mexican cartels are driving this substance into our country. they're driven by greed. they'll stop at nothing. they're flooding into our communities. as i said earlier where the analysis that we've done, four out of ten of the pills and only a small amount, minuscule amount potentially will take the life of a user. so they're very deadly substances. the cartels are driving them in here, driven by greed, and will stop at nothing. >> dr. volkow, the administration's proposal would make it easier to conduct research on all -- and you mentioned this in your testimony, on all schedule 1 substances, not just fentanyl-related substances. what's the importance of including this broader category of drugs instead of just
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focusing on frs? >> [ inaudible ]. >> turn your microphone on, please. >> thanks very much for the question. to be able to do research is crucial for us to come up with solutions on how to address the problem. in this case, of opioid overdoses, but other substance abuse disorder problems we face as a nation. for example, with the fentanyl overdoses, we're finding difficulty in reversing some of those overdoses and people die despite the fact that they are keeping the locks on. so we need to investigate what are the pharmacological effects of fentanyl that are producing these and for that we need access to these drugs. to be able to get researchers to work with them is crucial and indispensable. >> let me go back to mr. milione. thank you, doctor. are these -- the frs, do they
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come through the u.s. postal system? has dea worked with any of the social media platforms relative to simply not carrying pharmaceuticals, pharmaceutical -- supposed pharmaceutical drugs? tell us more about the reach across other sectors other than what you -- you know, the cartels that are highly responsible for moving this into our country. >> our focus at the dea is on wherever the harm is being caused. we have to work with our interagency partners. we'll work with whoever we can to try to address the threat and reduce that harm. there is no question that the mexican cartels, sourced with chemicals from china, are manufacturing massive amounts and flooding them throughout this country. we work with our state, local, and federal partners
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consistently around the country. we'll need to continue to do that. >> are they carried in the u.s. mail, though? >> trafficking organizations will use every single possible method to get them into the united states and the distribution networks in the united states will use any means necessary to distribute this poison. >> i think you're saying yes. >> any conveyance that's possible, they'll use. >> thank you. the chair now is pleased to recognize mr. guthrie, our ranking member, for his five minutes of questions. >> thank you so much. and i appreciate all of y'all for being here. i'm still stressed that doj chose not to be here. in september i had an opportunity to host law enforcement round tables, kentucky's attorney general daniel cameroon was with us, i think dea had -- dr. gupta, i
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met with him the other day, i know you're not -- mr. chester, i met with dr. gupta the other day, i was encouraged by the enthusiasm he brings to the job and i look forward to fighting the plague against us. the biden administration's recent proposal doesn't impose mandatory minimums for trafficking these deadly substances. there's debate about what we should do about mandatory minimums but eliminating or not applying mandatory minimums to the scheduling of the analogues. does the biden administration have data or other relevant research it can share with members of this committee that suggest excluding mandatory minimums will lead to less fentanyl and fentanyl-related substances on our streets? >> thank you for the question, congressman. number one, the president opposes mandatory minimums and the administration is committed
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to criminal justice reform that eliminates race and income-based disparities. that having been said, in this particular proposal, we're talking about a narrow class of substances that are causing harm in america's communities that are considered part of this proposal, as part of an overall balanced and comprehensive approach that balances the safety of the american people, civil rights, and also researcher access. in terms of criminal justice elements and mandatory minimums, i know the department of justice has submitted a written statement that addresses that. but i would defer to the department of justice on that. >> okay. when you say this deals with a narrow class of substances, this is one that, as we're all talking about, is killing our people with overdoses. it may be a narrow class but it's a substantial plague upon our society. a lethal dose of fentanyl is 2 milligrams compared to 200
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milligrams of a lethal dose of cocaine. the proposal keeps the mandatory minimums or allows them to stay on less potent drugs like cocaine so why would they be to the disparity of the one that's causing the overdoses versus the others, why not address them all? >> right. and so when we're talking about this particular class of suctions, i think it's important to note we have a few things. number one, we have fentanyl itself, the base fentanyl molecule. then we have fentanyl analogues. and an entire category of fentanyl-related substances that have already been scheduled, they've been done the testing, they've already been classified, they've already been scheduled. as we talked about earlier the universe of potential substances is about 4,800 that are chemically possible here and so we have an entire population of substances that have not yet been created but have the potential to be created. and that's what we're talking about in terms of
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fentanyl-related substances in this particular class as a whole. but as i said, when it comes to the criminal justice and it comes to the mandatory minimums, i would have to defer to the department of justice. >> so fentanyl is scheduled but fentanyl analogues, the reason they're being created is because they weren't scheduled, or not permanently scheduled, is my opinion, they're trying to get around that so by excluding these from the mandatory minimums, it seems arbitrary. >> right. so those fentanyl analogues that have been identified and have been placed in schedule 1 or in their procedure place -- >> they create a new regime. what we're talking about -- until we're -- congress make them -- let me switch and go to mr. milione. in your testimony you say we must use every tool available to combat the opioid and the dea
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has seized fentanyl but failed to mention how to keep these drugs out of our communities. does the department of justice believe mandatory minimums are a viable tool in the toolbox that we can use to keep criminals from selling these drugs in our communities and if not why not and what are the alternatives? >> thank you for the question. dea as a law enforcement agency is focused on protecting the public from the greatest harm, the greatest drug threat. there's no question fentanyl is that greatest threat, it's killing americans every day, in every corner of the united states. our focus, our laser focus is on getting these fentanyl substances permanently scheduled so that when we encounter them, we can stop them before they come into the country and we can seize them and take them when we encounter them in our communities. we also need them permanently scheduled so we can dismantle criminal networks that are distributing these drugs in our country. >> but exempting them from the mandatory minimums, does that have an impact? >> dea is a law enforcement agency. we conduct our investigations, we work with our prosecutorial partners and we allow the judges
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to follow the laws that congress have enacted. that is for the judges to determine. >> thank you. i see my time has expired. i wish i had more time. >> we all wish we had more time, there are so many more questions that need to be asked. the chair now recognizes the chairman of our full committee, mr. pallone, for his five minutes of questions. >> thank you, chairwoman eshoo. i just want to ask each of you to focus on the biden administration's frs proposal. there are many that are opposed to classified scheduling of fentanyl-related substances in the proposal the administration has put forward to congress. basically what would each of you say to those who have expressed concerns about why this proposal deserves their support and what happens if the current emergency scheduling order for fentanyl-related substances expires? i would like each of you to spend a minute or so answering that question, if you will. i guess i'll start with mr. milione.
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>> thank you. at dea we're focused on going after those that are causing this terrible harm in the country and helping those that are harmed. fentanyl, without a question, is the most significant drug threat that we're facing. it is much better to be proactive in dealing with this. these drugs are deadly. they are temporarily scheduled. we need to get them permanently scheduled so that when they are -- we can stop them from coming across the border into the united states. we can deal with the mexican cartels that are pushing this into our country and when we encounter these substances into our community we need the authority to be able to seize -- >> my question is, does that administration proposal accomplish that goal? >> we believe that this administration -- the administration's proposal will help us protect the public's safety and health. >> okay. let me go to dr. throckmorton. same question. because there are some that say, you know, that we should be, you know, doing this -- or don't
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like the proposal, that's what i'm asking. >> thank you, sir. the fda supports this proposal in its current form. we believe it achieves that important balance that's mention ed here today already, the balance between placing these products under appropriate control, recognizing their deadly potential while also providing a rapid mechanism, science-based mechanism to support additional research, which, as dr. volkow has said, is necessary. we believe losing control would be -- >> and you think the administration's proposal accomplishes that? >> i think in its entirety, with control of the class within a possibility of rapid decontrol based on further science and research, it does achieve that goal, yes. >> all right. i'll ask dr. volkow the same question, keeping in mind that, you know, we are getting those that say they are opposed to the administration's proposal and
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the class 1 scheduling. >> thanks for the question, because indeed, we have been getting a lot of concerns from scientists, and that's why we are very supportive of these new proposals that will actually allow us not only to address the challenges of doing research on fentanyl and fentanyl analogues or related substances, but also other schedule 1 substances. so in its current form, it actually provides also a mechanism, when it is found that some of these compounds may not have addiction potential or are particularly useful to remove them. and these, let me just give you an example about why this is so important that we do that. naloxone, which is the most effective intervention to save lives, it reverses overdoses, that was schedule 1, because its chemical structure is very similar of that of other opioid drugs like morphine. so being able to remove it now gives us a very powerful -- and
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the provision as proposed will allow us to do that, so it achieves protection and it will help us accelerate research. >> all right. mr. chester, the same thing. the one thing no one has asked -- answered is, what happens if the current emergency scheduling expires? same question, but maybe you can address that too. >> i will, thank you, congressman. so to answer that question, i would say that currently, particularly in the era of synthetic drug use, this is the most dynamic drug trafficking and use environment that we've had in our history. these drugs are particularly deadly. and because they're opioids, first use leads to chronic use very, very quickly, as well as them being deadly in their own right. i would say the drug traffickers are being able to create these drugs faster than they can be scheduled individually. and if we do not follow through
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on this proposal in some form, it will be profoundly dangerous to the american people to allow these drugs to be uncontrolled and essentially legal, for sale and for purchase. and so this proposition along with the more comprehensive approach that the administration is taking that includes prevention, reducing barriers to treatment, harm reduction, as well as reducing the supply of illicit drugs in the united states, we believe is the absolute right approach for the environment that we face. >> thank you. thank you, madam chair. >> the gentleman yields back. the chair is pleased to recognize ms. mcmorris rodgers, ranking member of our full committee, for five minutes of questions. >> thank you, madam chair. dr. volkow, we have received many letters from parents who have lost their children to
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fentanyl. one mother had found her son had passed away. no parent wants their child to take illicit prescription drugs. if a pill is on the street, you should assume it's not one made by the manufacturer in an fda-inspected facility. but i wanted to ask, are there ways to test pills for the presence of fentanyl and is there research going on to find innovative ways to prevent and stop overdoses? it is time that we did our part to permanently make these fentanyl-related substances illegal and schedule 1. i think we're all desperate for some innovation to help arm parents to better protect and educate their children. >> thanks very much for this question. again, this is another example why we need to do research. and indeed, we're doing research that relates to trying to understand how this fentanyl strip test that allows you to actually measure if the drug that has been purchased contains fentanyl or not affect behavior of the users and also do they
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have the sensitivity to detect not just fentanyl or fentanyl-related substances. we're also doing research to improve of the methods of sensitivity so that it's not only a test/no test but can give us an indication of the amount of drug and whether other drugs are concomitantly mixed because what we're seeing more is that more and more people are dying from drug combinations. so indeed there is a lot of interest to understand how to optimally implement testing and what guidelines we can give people so that they can take the most advantage from it. >> okay. thank you. mr. chester, mr. milione, i just wanted to ask, do you agree -- i think you've spoken to this a little bit, but for the record, do you agree that we cannot let fentanyl-related substances become unscheduled? >> yes, ma'am. we agree with that, and that's why we believe this proposal is the right approach. >> we agree with that, yes.
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>> thank you. do you agree that fentanyl-related substances should be permanently placed in schedule 1? >> they should be permanently someplac placed in schedule 1 until the medical community can determine there is merit and where they should fall permanently in the scheduling regime. >> i agree with mr. chester. >> why is it helpful for these compounds to be placed in schedule 1? >> to make them illegal for purchase and sale in the united states until the research community has the ability to determine just exactly whether they're acting in the body and how dangerous they are. >> so that we can protect the public and stop them from -- seize them, stop them from coming in the country, stop them from killing so many americans and seizing them in our communities. >> would you speak to what you -- how you believe this would deter the bringing in and the selling of fentanyl-related substances? >> yes, congresswoman. and what i'll do is kind of answer it in the opposite, right? so what if they're not illegal?
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that individual is incentivized to create these novel substances, sell them on the internet or sell them on social media, or bring them into the united states in order to do this. and so as i spoke to in my oral statement, we must deter the creation of these new substances before they can be created and introduced into our communities. many of these substances, in fact you can argue the vast majority of them are active in the body and potentially dangerous to americans. >> thank you. is there anything you want to add? >> other than our job at the dea is to make america safer but also to investigate the groups that are trafficking in them. having this scheduled gives us that ability and helps us make our country safer. >> thank you. it seems to me that exempting only certain fentanyl from related substances from mandatory minimums will encourage more trafficking in those substances. and i'm worrying that we're
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playing politics with this issue by insisting on pairing scheduling of fentanyl-related substances with lessening the penalties on traffickers and importers of fentanyl-related substances, we're jeopardizing making these substances permanently illegal. we need to act. we need to act now. permanently schedule this fentanyl-related substance and hold traffickers accountable for those substances. it is a matter of life and death. i yield back. >> thank you very much. i don't quite understand the following, and that is the need to study fentanyl-related issues. we already know what fentanyl does. so if -- it's not clear to me. everyone has stated how devastating fentanyl is, and fentanyl-related substances. and yet you're not treating --
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you state that, but the study -- you say the study has to continue in order to keep them or drop them from schedule 1. what is it that we don't know about this drug and its related parts? >> madam chairwoman, i will start and then i will turn it over to the two doctors that i share the table with. these substances have in common their relationship to the base fentanyl molecule or the fentanyl skeleton that we know its activity in the body. this involves substances that have modifications to that base fentanyl skeleton. in some cases, these analogues have already been tested, they've been subjected to testing and we understand their activity in the body. we're talking about a population of substances that have not yet been created and therefore not
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yet been identified, and therefore the testing has not been able to take place. however, they all share that same fentanyl skeleton and that same basic molecular identity. and so that's from a policy perspective, that's how we set the four corners of the substances that we're dealing with. but i would defer to dr. volkow and dr. throckmorton as well. >> yes, and i think you describe it very well. it has to do with the notion that the chemical structure by itself does not necessarily predict what the pharmacological actions of that compound can be. slight modifications, for example, can make the molecule very, very potent, or it can make it inactive. that's why it's important to understand the unique characteristics of the thousands of molecules that can be derived that way. >> you mean there could be a case where fentanyl is okay? is that what you're saying? >> there could be a case where a
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chemical, a drug that has a chemical structure similar to fentanyl will have potential to have health benefits and not be as toxic or addictive as the fentanyl molecule itself, yes. >> madam chairman, let me give you a concrete example of exactly that. so the dea shares the data that they collect on members of the frs class with the fda. our technical staffs talk to each other all of the time. and we've looked at a group of somewhere over 25 frs's and we've studied their pharmacology. among that group, there are members of that class, and one in particular that has no activity to turn on the opioid receptor that we worry about here. in fact it looks like an antagonist, it looks like it would be a blocker of the mu opioid receptor in the way naloxone is a blocker of the mu
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opioid receptor. dr. volkow mentioned reversing the overdose effects of fentanyl. this is a substance that would have a potential for being a treatment for fentanyl. i'm not saying i know that it is. but i'm saying that's what we'll learn as we study these individual compounds, we'll understand if there are some that have no dangerous effects. some could be antagonists, could be new treatments for opioid disorder, new treatments for reversing overdoses. those are the things we need to make certain we don't lose even as we put this entire class under the control it merits given the larger public health need. >> madam chair, if i might, mr. chestner his opening statement said there were 4,800 potential analogues, based on math, and dr. throckmorton told us they've only looked at 25.
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that's why you have to continue research. >> i thank the ranking member for yielding the time. i think i understand it a little better. it is complicated. the chair now is pleased to recognize the gentleman from north carolina, mr. butterfield, for his five minutes of questions. and he's joining us -- >> thank you very much. >> good to see you. >> thank you very much, it's good to see you, madam chair, thank you so very much for recognizing me this morning and certainly thank you for your leadership on the committee. and to the ranking member, i love the spirit of cooperation that i see between you and the chair and just thank you and your colleagues for all the work that you're doing. we have great challenges in front of us, and thank you for your cooperation. madam chair, as we consider legislation to address the opiate crisis, we must pay special attention to communities that have been historically marginalized. and i refer of course to communities of color. recent findings from the nih found that within a subset of
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counties, disproportionately affected by the overdose epidemic, opioid overdose death rates from 2018 to 2019 leveled off across all of our racial groups with the exception of african americans. isn't that strange? among african american individuals, the opioid overdose death rate increased by some 40%. this is tragic and we must take action to address this trend. and as history has shown us, communities of color are also disproportionately punished by drug policies. a report published by the citizen commission this past january found that in 2019, african american individuals composed a greater proportion of fentanyl and fentanyl analog offenders of which over 50% faced a mandatory minimum
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penalty, even though less than 8% were importers or high level suppliers. these staggering statistics are just absolutely a sobering reminder of the stakes held in our discussion today. and that's why it's important that we have a bipartisan approach to this problem. and so, mr. chester, let me ask you, please, the biden -- and thank you not only to mr. chester but to all of our witnesses today. mr. chester, the biden administration has been clear in its intent to address the disproportionate impact that past drug policies have had on communities of color. he said it in the campaign, he's saying it today, from both a justice and a public health perspective. how does the fentanyl-related substances proposal meet that goal? >> thank you, congressman. and for that very reason, that has created the contours of this
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proposal. and so while permanently scheduling this class of substances is what is done on the front end in the interests of public safety, we must also understand that we can't do unintended harm by doing that. so the very reason that you explained is the reason why this proposal looks the way it does, why it's comprehensive, and why we were able to bring together the department of justice and the department of health and human services to make sure that we make all of those considerations. >> let me now talk about criminal penalties. as a former judge, i have particular interest in this. there are concerns among criminal justice and civil rights organizations that this proposal will lead to harsh criminal penalties, even with the inclusion and provisions excluding fentanyl-related substances from quantity-based mandatory minimums. do you agree with that assessment? and if not, can you tell me why?
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>> congressman, as i mentioned before, the president opposes mandatory minimums and the biden/harris administration is committed to criminal justice reform by eliminating race and income-based disparities in our criminal justice system. and that is one of the foundational elements that the administration has used to approach this incredibly complex issue. when it comes to detailed criminal justice matters, i know the department of justice has submitted a statement for the record. but i would defer to the department of justice on those matters, sir. >> thank you. and my final question, mr. chester, what guardrails are in place, what guardrails should be considered to promote racial equity in drug enforcement efforts? >> congressman, i can only speak to the proposal that's here before us today. and guardrails is probably the exact right term. if we were just to simply
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schedule all of these substances as a class, that's the bluntest instrument that we have. rather than do that, we ensured that we also not only consider research provisions but the criminal justice aspects to it as well. and so we were able to provide the tool that our law enforcement community needs in order to be able to protect the community, but at the same time make sure that we were not doing unintended harm. and guardrails is the exact right term for the approach that we used. >> thank you very much, mr. chester. i'll conclude, madam chair, by repeating what you and others have said throughout this hearing. it is absolutely unacceptable that the department of justice is not participating in this conversation. shame on them. i hope we can hear from them very soon. i yield back. >> hear, hear, mr. butterfield. thank you. the chair is now pleased to recognize the gentleman from michigan, former chairman of the
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full committee, mr. upton, for your five minutes of questions. >> thank you, madam chair. i join with everyone here, voicing our disdain for the department of justice not appearing and knowing that they had a number of months to be prepared for this. it's really sad on an important issue like this. i had the privilege of being selected by kevin mccarthy to serve on the white house commission on combating synthetic opioid trafficking. and we've had great meetings. another one is scheduled for this afternoon, in fact. just a couple of weeks ago i was able to send one of my staffers on a commission trip to mexico and the southern border. so i am troubled about the administration's september recommendations on fentanyl-related substances. a time when we're seeing the highest rates ever, 100,000 folks, man, 2020. it's so disturbing that the administration seems to be favoring weakening penalties for drug traffickers who are
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flooding every community with potent and deadly fentanyl analogues. and i don't hesitate to say that everybody here on this panel probably knows someone who is maybe part of that 100,000, and our families. mr. chester, is there concern that the mexican drug cartels are going to take advantage of the loophole by producing fentanyl analogues with arbitrarily lower mandatory minimums for trafficking while continuing to take advantage of our lack of proper enforcement at the southern border? >> thank you for the question, congressman. i would say the first thing is that the men and women at customs and border protection and our law enforcement partners who are at the southwest border do a tremendous job. >> they do, absolutely. >> they absolutely do. >> they're overwhelmed, which is unfortunate. >> and i would also tell you that one of the reasons we need
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this proposal is to do just what you described, and that is to deter the creation of these new substances by making them illegal. and we make them illegal before they've even been tested. and we do that to ensure that drug traffickers know and understand that these are schedule 1 substances. you cannot create a novel substance based upon the fentanyl skeleton and sell it in the united states with impunity. that's not going to happen. and so i think it's critically important that not only mexican drug traffickers but anyone else with a potential to make these substances and push them into the united states understands that these -- this entire universe of 4,800 substances is illegal. >> well, i know that every one of us wants to make sure that we do everything that we can to deter the creation of these new analogues. i mean, there's no question about that. mr. milione, we talked a little bit about numbers.
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4,800 potential analogues. i guess the dea has looked at some -- a couple of dozen. do any of them have a legislate medical use? >> thank you for that question. i would defer that question to dr. throckmorton or dr. volkow. >> okay. let me just follow up with that, because i was going to ask them the same question. for those that may have some legitimate medical use, are all of those in schedule 2? or are any of them in schedule 3 or 4? >> so fentanyl has an approved medical use. it's a component in approved drugs that are on the market and available. it also has a high potential for abuse. and so it is in schedule 2. there are no fentanyl-related substances otherwise in schedule other than in schedule 1. >> mr. milione, in an ondcp press release from september of
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'21 announced the administration's recommendations to congress on reducing illicit fentanyl-related substances states that, and i quote, the justice department reported only eight cases where the frs charges from the time temporary class scheduling was adopted in 2018 through december of '20 of which only a handful even included charges of quantity-driven mandatory minimums, end quote. given the extremely low prevalence of cases involving quantity-driven mandatory minimums and already established statutes to waive mandatory minimums like the safety valve for low level drug offenders and the substantial assistance provision for providing prosecutorial or investigative help to the government, why did the administration release recommendations that would further hamper enforcement of those crimes? >> congressman, my colleagues at the dea, myself, my whole career as a dea agent, we are laser focused on protecting the public from these
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so that we can seize them at the border, investigate them in our country and seize them when we encounter them in our communities. >> my time is expired. thank you, madam chair. >> thank you. the gentleman yield back. a pleasure to recognize the gentlewoman from california, mrs. matsui, for our five minutes of questions. >> thank you, madam chair, and i want to thank you for having this hearing and thank you to the witnesses for joining us today. i along with others am concerned about the rise of street drugs in our districts including pills containing fentanyl. we have to work to fight the opioid epidemic and that includes cutting out how these illicit fentanyl products are getting in our communities and
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get people the treatment they need. when congress passed the riot act of 2008, our intent was to curb online sales of controlled substances while recognizing there is great value in legitimate prescribing of certain medicine. we need the right balance between safety and access. unfortunately, the dna restricted prescribing in person and this has historically limited the people who can access care. they have waived that during the covid public emergency to limit prescribing of prescriptions despite a person's location. i just need a yes or no. has the dna tracked any use since waiving the in-person
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requirement in response to covid-19? >> congresswoman, dea knows the medical treatment is critical to the disorder -- >> yes or no, please. okay. so has the waiver expansion to access to substance -- >> can you repeat the question? >> has the waiver expanded access to substantive services and interventions during the pandemic? >> congresswoman, when we are talking with our interagency partners and have done so, we believe it helps people who are critical and harmed -- >> so you have expanded access, is that correct? >> we have worked with our interagency partners to expand treatment and working with the white house. >> if i may interject there, because we have been monitoring it from the research aspect, and
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yes, it has made it much more accessible for people that are in the justice setting to have access to opioids much more widely. >> the act of 2008 required the dea to require a special registration process to acquire medicine. community health centers and community behavioral health organizations use this process to register as eligible provider sites. to my knowledge, the dea has yet to carry out that directive. when can congress expect the dea to complete a statutory requirement and issue the special registration rules in accordance with the law? >> congresswoman, as i said, we're committed to working with
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the interagency community to command aspect to treatment. i'm not aware of the specific answer to that treatment, but i'm happy to get back to you. >> would you do that, because this addiction crisis has gone on far too long, and it's always been clear to me that congress and dea must come together to meaningfully put an end to the opioid epidemic. now, i want to quickly shift to how the proposal before us today will impact research eligibility. doctor, there has been some question whether the streamlining for research registration would be limited to federal researchers. can you clarify who would be eligible under the provisions included in the administration proposal? would it include private researchers or just federally funded researchers? dr. brokaw?
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>> use your microphone, please. >> sorry. it will include researchers of private organizations and private investors as long as they have an ind with the fda. but if not, it will not include them. >> so we are already able to conduct research on schedule one. this change will allow them to use a new process for other schedule 1 substances such as marijuana? >> the proposal will basically apply for all schedule 1 substances, so it will expedite research on dhc as well as any other substance on schedule 1. >> thank you. i'm particularly interested in eroding existing barriers in our federal law that allow researchers from studying
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schedule 1 substances. i'm grateful our researchers are working to find effective solutions to continue the important work here. i yield back. >> the gentlewoman yields back. the chair is pleased to recognize the gentleman from virginia, mr. griffith, for your five minutes of questions. >> thank you, madam chair. this panel is great, thank you very much for being here. dr. volkow, let me start with you. i believe much more research on fentanyl analogs is necessary. based on what we know now, how do these fentanyl-related substances refer to traditional fentanyl as far as their properties? >> thank you for the question. there has not been as much research in fentanyl analogs, and it has to do with complexities and difficulties of
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doing research on schedule 1 substances. that has deterred researchers, and i'm optimistic this proposal will make it easier so we can get more talent and expand our knowledge. >> i appreciate that, and i will tell you, both ms. matsui, my colleague and others, i've been working to get more research on schedule 1. i have a bill that's already been introduced. this congress has resolution 2405 that does that, so i'm glad to be in agreement with the administration on this issue. i was looking this morning at a bill that addresses many of the administrations requests and concerns that i hope to be introducing soon. so i'm big on that. dr. throckmorton, if i can go to you, and dr. volkow, i wouldn't put the mask back on yet.
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i'm coming back to you. you wrote in testimony that there is at least one of the analogs that may have some potential. could you provide me the name of that one? in your written testimony there was an s on there that may have indicated there were more that didn't have problems. were there others that were inert or didn't function the way others do? >> thank you for the question. first, understand we have only looked at a relatively small number of these compounds, and without being able to give you the exact number, we're sharing information with the dea, looking at them as much as we can. i have a group of scientists focused mostly on that. having said that, within that group, there is more than one compound that does appear to have other effects than activating the opioid receptor. whether it's this one compound i mentioned that appears to have this antagonism effect or other
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compounds that have other effects at other receptors. there is another opioid receptor, for instance, and some compounds -- the major point, the point i want to make is that those exist. the details are important to study, but fundamentally, they illustrate why just putting these all into schedule 1 is not sufficient. we have to do it along with the mechanism for removing these promising substances that have these other effects that are potentially less dangerous so that we don't miss an opportunity to identify a new reversal agent like naloxone or a new treatment for opioid disorder, and this small number of compound illustrate that. >> i appreciate that, and i want to get back to dr. volkow. based on your previous testimony and his testimony, what i'm gathering the administration wants to do and what i want to do, i want you to tell me if i'm on the right path that we're in agreement, is put it all into
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schedule 1 permanently but then have research available even on the schedule 1 substances so we can determine if we've got something that may be helpful and can come back and take it out later if it's inert, it doesn't do the opioid receptor, or if it has some additional value, then allow that to move forward with research as well. is that my understanding, is that correct? >> you're asking a question in terms of the scheduling, and i think that's better sent to the department of justice. >> they're not here, by the way, but go ahead. >> my view on this is, as dr. throckmorton was saying, we have the opportunity to do research and treatment for opioid disorder but another area that has been neglected is better treatments for pain. as you mentioned, there is another opioid receptor, an indicator receptor, that can
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produce an analgesic. so the extent that we can have a compound that binds to it, you can have an analgesic that is not objective. this is why science becomes relevant, and we try to make that knowledge accessible. >> unfortunately, my time is up. i have lots of other questions, and this is a fabulous discussion. thank you very much. thank you, madam chair, for holding the hearing. >> the gentleman yields back. i think we all have many questions, and to our witnesses, we will -- every member, i think, is going to be submitting written questions, detailed written questions to you and look forward to your timely response to them. the chair now has the pleasure of recognizing the gentlewoman from florida, miss castor, for her five minutes of questions. >> thank you, madam chair, and thanks again to our terrific witnesses here today. i really appreciate president biden and the administration's
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forceful and comprehensive strategy to tackle the opioid crisis, especially this deadly fentanyl synthetic opioids flooding into the country. unfortunately, my area, looking at fentanyl, like other parts of the country, we've seen dramatic increase in opioid deaths fueled by synthetic opioids, and i really want to compliment the tampa police department. they have an opioid task force where they brought in working with the dea, fbi, atf and a lot of our nonprofit partners are researchers at the university of south florida. they are criminally pursuing and prosecuting the folks who are perpetuating the abuse, going after the dealers. but what they have advised me is they cannot arrest their way out
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of this. they received a doj grant a few years ago, and after surveying everyone, they really wanted to put more into crisis intervention. you all know that president biden and the democrats in congress earlier in the year passed the rescue plan where we donated historic amounts of money into crisis intervention, mental health, substance use, disorder services. i'd like to know, mr. chester, are those numbers getting out, because we really need them on the street. if my police department and nonprofit community, they say they need more crisis intervention services to save lives, get folks treatment in addition to what they're doing going after folks criminally, what's the status of the american rescue plan dollars getting out to communities like mine? >> yes, congresswoman, thank you very much, and we will provide you an exact accurate answer as
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to what the status of all those dollars are because it would be irresponsible for me to say off the top of my head, so we will let you know for sure. i will also tell you, though, that what you described in the tampa area and hillsboro county is an approach that is taking place nationwide and it's the approach that the administration uses as well. so while you need to have a strong law enforcement component to what we need to do, we also need to stop drug prevention as a whole as a comprehensive approach. one response to this is insufficient in and of itself to be able to do that. i appreciate you mentioning the american rescue plan. that was $4 billion for samsa and nhs to expand substance abuse services which also included another $30 million to support harmful interventions as
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well. i will get you the exact answer on where those dollars are. i would be glad to do that. >> didn't, when dcp and secretary bacera from nhs, have you done a deeper dive on how you support those collaborations? tell us about that. >> yes, congresswoman. ccp and ohs were incredibly close, hand in hand, on all the public health aspects of this. and i think it's important also to remember that, you know, the president's fy '22 budget, it's $41 million applied to this very difficult problem. it's about $670 million above the previous years' enacted
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levels. a lot of that money goes to hhs but a lot of it goes to several other places around the federal government in order to do many of the things we're talking about here today to not only reduce the supply of these drugs in our communities but also the span of public health interventions that are necessary in order to reduce the pull of these drugs across our borders. >> thank you very much. i yield back. >> the gentlewoman yields back. the chair is pleased to recognize the gentleman from florida, mr. bill arokus. >> i'm sorry the drug epidemic continues to worsen across our country. that includes my district in specifically pascal county where 135 people have died from overdose since january, the vast majority involving fentanyl.
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this crisis has led me to call for a roundtable in my district this month where i will be consulting with local leaders, providers and local law enforcement from pasco, pinellas and hillsboro counties. we must continue to be engaged on all levels of government to fight back against this scourge in our communities. mr. chester, in a previous hearing, we've had in this committee, i questioned then-actor director labelle about its relationship with china and the role it plays in preventing the role of entry and selling of fentanyl in its analogs. she mentioned china is channelling much of their fentanyl-related substances and its components through mexico, and, thus, across the border. in fact, the biden administration's justice department, the deputy attorney general, unfortunately, decided not to come here, and, again,
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that is inexcusable. i agree with you, madam chair. the attorney general stated, and i quote, mexico criminal drug networks are mass-producing illicit fentanyl and fentanyl-laced pills using chemicals sourced largely from china and are distributing these pills through u.s. criminal networks. i don't think anybody will dispute that. these fake pills are designed to appear nearly identical to legitimate prescriptions such as oxycontin, percocet, vicodin, aderal and others. they are selling them on the dark web and distributing networks. as a result, these fake pills are widely available, unfortunately -- that's a quote from the assistant attorney
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general. if we've learned anything from the covid pandemic, it's that we should be skeptical of china. the trump administration was very tough on china and the border issues, as you know, and yet the biden administration's proposal fails to address these components. mr. chester, question. mr. chester, can you provide an update on how the administration is engaging not only with mexico but with china directly on its role in proliferating this deadly substance? and can you tell me whether china has been consistently enforcing its laws in this area and what mechanisms do we have to hold china accountable to its commitment to ban the export of fentanyl and its analogs? please, mr. chester. >> yes, congressman, thanks for the question. you have, in your question,
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identified the two fundamental countries involving the flow of drugs into the united states and that's china and mexico. china's role has changed over time, and there was a time pre-2017 when china was the source of fentanyl and fentanyl analogs coming into the united states. it was either rerouted to mexico, or we talked about the postal service before, ordered on the internet and shipped directly through consignment fedex or ups or through the postal service. we approached the chinese government, and this was actually a conversation between the president in december of 2018 and asked the chinese government if they would do just what we're discussing today, and that is to discuss all fentanyl substances as a class. they did that effective in 2019. it had a couple of impacts. the first one was we saw direct from china to the united states shipments of fentanyl and
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analogs go down to essentially zero. but that didn't solve the problem. what happened was a lot of the fentanyl synthesis shifted to mexico with mexican drug trafficking organizations with the raw materials provided by china and a lot of manufacturers got into the precursor business. so the production shifted from china to mexico, but then it was enabled by china. >> i'd like to ask another question, if i may, madam chair. is that all right? >> yes, sir. >> another concern i have is availability of fentanyl-laced drugs online, and you're getting to that. one study involving the fake prescription pill states, and i quote, fentanyl networks are among the world's first digital native drug networks. global internet connectivity has opened a new era of drug distribution by facilitaing to
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consumer enactions and contribute to retail rather than wholesale drug problems through legal drug services. mr. chester, assistant director and demonstrator malone, if you allow them to respond, madam chair. given the drug companies that incentivize them to bury their head in the sand, how are drug companies working with us, if at all, to curtail these sales and what is the information sharing between these companies and law enforcement agencies? >> yes, congressman, i will tell you you've identified a key part of the problem, which is we have many vectors for these drugs to come in the united states, and we have many platforms they can be sold, which includes social media. i'd like to stay within the
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efforts right now, but we can give you a more specific answer that i'd like to provide on more specific answers the administration has taken, but what you provided is a significant component to this threat. >> administrator mileone, if that's allowable, please? >> finish answering the question briefly on the panel. to mr. bilarockus. >> dea is focused on the larger threats to protect the public. i said that throughout the hearing. >> you have. >> it's critical to our mission. >> you have been consistent. >> you mentioned earlier mexico and china. certainly mexican cartels are flooding the country, working with chinese chemical companies -- >> but you're not answering the direct question, with all due respect to you, sir, and that is who are you working with? it's been testified that there are social media platforms and
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such. i think that's what the gentleman is asking. i asked the same question. who is dea working with? can you name any of the companies? is there outreach? if there is, with whom? have you been successful? if not, have they turned you down? maybe the congress needs to do something about that. >> dea is focused wherever the threats are. if the social media platforms and e-commerce platforms are being used, we will focus our investigative efforts there. >> will or have and shall? >> we will continue every day to do that. we will continue every day to do that. >> so you are doing it? >> we are focused wherever the threat is, and if social media platforms are being used or e-commerce platforms are being used or mexican cartels -- >> but they are being used, correct? >> there is no doubt that social media platforms should do more to prevent social media from pushing these platforms into our
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homes. >> madam chair, can i just say the fda does have an active set of ongoing issues on this. we agree it is a very serious threat. we take counterfeit drug sales, especially online drug sales, very seriously, and have taken actions, including discussions since 2018 with some of the internet providers and some of the groups that control access to the internet. the internet service providers, for instance. i'm happy to talk with you more. >> thank you, doctor. the gentleman from florida yields back. a pleasure to recognize the gentleman from maryland, mr. sarbaines, for his five minutes of questions. >> good morning, madam chair. thank you very much for this hearing. obviously this is a very delicate and pretty complicated topic, this one of scheduling fentanyl, because there is a lot
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of obstacles to navigate or issues to address. maryland hasn't escaped the scourge of this pandemic that we're seeing or epidemic, really, of opioid-related deaths. and my constituents are obviously as interested as anyone in how we're going to address this and strike the right balance here. i know that's the effort that's being undertaken by the biden administration with a proposal and attempts to do that. i would like to get a little bit back into the weeds on this, so given the schedule 1 classifying of fentanyl substances, i would like to hear a little more about
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that process. dr. throckmorton, can you lay out for us plainly what the scientific or medical evidence is that's needed to remove or reschedule a substance? >> thank you, congressman. there is two possible answers to that question, so i just want to clarify, are you asking about the frs class proposal that the administration is putting forward, or are you talking about the more general approach that has been historically used to remove a substance or change a scheduling? >> i'm speaking now sort of more generally. what is the kind of scientific reference points that we use when we're removing or scheduling or rescheduling a substance, for that matter? >> so the general process involves eight factors that are laid out in statute, and we, the fda, are obliged to look at each
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one of those factors, and they include things from the pharmacology, the available information about public health injury, deaths, any accepted uses the product might have. we look at all those eight factors and then provide a recommendation to hhs. in this case we would have to conclude that the available data suggests that the compound has no abuse potential based on those full eight factors. which is a considerable amount of data that are needed to be developed. >> so you anticipate a little bit the next question i was going to ask, because under the expedited listing you are asking to reduce the fentanyl items. hhs would only consider one of these eight factors you're mentioning, and i'm curious if you can let us know a little more about which factors would be required to be considered
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when removing a substance from the schedules. just draw that comparison, if you could. >> thank you, congressman, that's a really great question. first, the focus on the one factor, which is the factor related to the pharmacology, comes from the focus of the frs classification as a whole. the idea of placing something in the frs class and putting it into schedule 1 reflects this pharmacology that the drug causes an effect on the opioid receptor. the effects are farm co logical -- pharmacology
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compounds that belong in other places in the schedule. it may still have abuse potential, but we don't yet have all the information, but it is not the substance that has a high substance of abuse and misuse like oxycontin, like fentanyl. so it is decontrolled entirely. it's not that we're ignoring any of the data. we would look at all available data, it's that we're focusing on the same part of the compound effects that led to it being placed in schedule 1 in the first place. >> thank you, it's pretty complicated. that will help us going forward and trying to do something responsible from a legislative standpoint. with that, i yield my time back. >> the chair is pleased to
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recognize the congressman from indiana. >> thank you. i want to thank the chair for holding this very important hearing on fentanyl and drug-related substances. without demand there is no supply, and for many years we've not addressed what the factors are in our country that's creating such a demand for these substances, and we should be able to do that. members of the committee have had a long history of working to help combat substance abuse of opioids, and i believe the country is making some great strides in those efforts. specifically related to fentanyl and its analogs, i don't completely get the connection in the proposal from the administration to the larger discussion of fentanyl-related substances. unfortunately the pandemic has
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created the perfect storm and sent our country backwards in many ways in this battle against drugs. one of the contributors, and i'm a doctor, so this could -- is we halted elective surgeries that allowed patients to have access to medical care which many people were left in pain, bad knees, bad hips, other things, and while i understand the reasoning for a short while, many states waited too long, honestly, to reinstitute these types of treatments. other states now, new york state, for example, has done this because of the omicron variant before we even had a case in the u.s. i think it's problematic. when someone is in pain and can't get the relief they need through medical procedures, it is much more likely for them to turn to opioids to manage their pain, which can obviously lead to abuse. and as has been described, a lot of the prescription drugs that have been prescribed, that's decreasing the use and this illicit is getting higher, and it's still an issue.
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dr. throckmorton, what can congress do better to promote non-opioid treatments, and are they prioritizing other opioid alternatives that patients can use to better control their pain? >> short answer to your second question, absolutely yes. we are doing everything we can to provide alternatives to opioids. we realize there are two forms of alternatives to drugs. they could be drugs that look like opioids but do not have the addiction and overdose potential that many of our opioids do. that's an area of strong importance to us. >> that's why it is important to have a strong procedure in place if we're going to schedule these as a class to make sure if we find one of those that we can get that back to schedule 2 so patients have access, correct?
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>> i could not agree more with you, and we talk regularly about those kinds of products and how we can bring them forward. the second class of products is obviously the ones that are non-opioids that are effective at treating severe pain. we have to acknowledge we don't have a broad armatorium there. we have other medicines that treat pains not as severe, but opioids are uniquely effective in certain places, so we need to do everything we can to understand that science better and identify non-opioid alternatives that will work for those more severe pains, end of life pains and things like that. we have breakthrough designation that we stand ready to extend, priority review, we have other mechanisms. basically we'll do anything we can to help. >> we in congress have also created separate payment structure for a period of time, as you know, for these non-opioid alternatives to
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encourage their use. because the reality is opioids are cheap. so if you have a more expensive non-opioid product that, for example, under a diagnostic related group at a hospital, a drg, that those may not be used if they're going to cost the facility more money because the opioids are so cheap. we've worked on that part of it also to make sure there is reimbursement encouragement to use non-opioid alternatives. mr. chester, so we've talked about the illicit drugs in mexico. how are they getting into the country? they're in mexico, they're being created. how are they getting here? >> congressman -- >> be short because i have a follow-up. >> principally across the southwest border. >> so if we were to work to secure the border better, would that help? >> there are multiple vectors by which they come in. both the southwest border, which is the short answer, but also through the mail system and also
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other -- >> we did some changes in the mail system to allow the dea -- you mail a crate of a thousand little boxes, right, and each one of them has drugs in it, we allow them not to have to open every one of those. i think we did that a number of years ago. >> the most effective thing we can do is our relationship with mechanics to to help deter the drugs themselves. >> do you know with the cartels the amount of money involved? it's difficult to get public officials across our southern border to engage in this process, both because they worry about their own personal security, and honestly, because there is just so much money. i yield back. >> the gentleman yields back. the chair is pleased to recognize the gentleman from vermont, mr. welch, for his five minutes of questions. >> thank you very much, madam chair. this opioid crisis is just so horrifying for so many
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americans, and my colleague, ms. mcmorris rogers, describes those who succumbed to the opioid crisis. it's a death of despair. there are two things about it. we're not talking about the dealers, but we're talking about many of the good americans who find themselves in the grip. one is that we need treatment more than we need prosecution of those folks, my view. secondly, although it's not the topic of this hearing, we need to rebuild our communities, because people who are alone and lonely, who are dealing with covid and don't have any support systems, they often make a mistake thinking an opioid might be that support system that they want. the second thing, where we do have a criminal reliance system,
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there is a criminal system with black and brown americans being prosecuted. just as an example, in vermont the odds of people of color being prosecuted are significantly higher, maybe 14 times as high. so not just the dealers are something we have to be mindful of. mr. milione -- and thank you for your work, by the way. how do we ensure that we are doing work to address the public health crisis while simultaneously making sure we're not exacerbating an already problematic criminal justice system that does have disproportionate impact on people of color? >> thank you, congressman. at the dea, we're very concerned
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about those that are inflicting the harm in our communities, and obviously with something as deadly as fentanyl, that is our primary concern. that is where we're focused on the most significant drug threats. but we're also interested in helping those who are harmed and that's why we expand our interagency treatment and we'll work with our partners to do that. our focus are the biggest drug threats, and that's fentanyl and a close second of methamphetamine, and they're distributing it to all communities across the country. >> on that topic, a lot of us here have seen the benefit of telemedicine, and that's a tool that can be helpful to provide treatment to the individuals, not the ones you're going after in the mexican cartel. and it's really true for those of us who represent rural districts. there's many temporary flexibilities in place right now to allow telemedicine that could
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benefit from being permanent. i want to ask about the telehealth ability to prescribe. earlier this year the ondcp indicated a rule might be coming regarding telemedicine special registration. how do you see dea's progress here in what might be the status of this rule to ensure that patients are getting the care that they need? >> as i said, we're focused on doing whatever we can to help those that are harmed. i know that we're working with our interagency partners on anything consistent with the controlled substances act. i would have to get back to you with some specifics about that. >> your role in that is really important because you've got a dual responsibility. we look to you for really hard and effective law enforcement, but on the other hand, you're making that distinction between where to focus your resources and where to facilitate treatment for people that we want to help, so i thank you for that, and i thank all the
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witnesses. i yield back. >> the gentleman yields back. a pleasure to recognize the gentleman from florida, mr. dunn, for your five minutes of questions, sir. >> thank you very much, madam chair and ranking member guthrie for hosting this hearing today to discuss the enormously important issue of proper scheduling of fentanyl analogs. i fully support the permanent scheduling of fentanyl analogs as schedule 1 substances and i'm proud to cosponsor the fight fentanyl act introduced by my colleagues, congressman chabot and latta. i also propose punishing those responsible for fentanyl products on our streets. the cartels are producing synthetic opioids and they're pouring over our southern border, and they're assisted by chinese chemical companies who are resourcing their precursors.
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a lax punishment for those who found trafficking in these substances will only incentivize the spread of these deadly substances in our communities. i think the biden proposal gets one thing absolutely right, and that is the pertinent scheduling of the fentanyl analogs. i think it fails in its shortsighted decision to exclude fentanyl analogs from minimal sentencing requirements. the fentanyl analogs are literally, as has been said already today, poison on our streets, and a single drug bust in my district, maryland county, earlier this year sees two pounds of fentanyl. two pounds of fentanyl, pure fentanyl, is potentially enough to kill 80 million people. we're talking about wiping out cities here. when it's prescribed as a
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medication, i'm a doctor as well, in a health care setting we administer this in microgram doses. that's one-millionth of a gram. excluding one of the deadliest drugs in the world from the mandatory sentencing is simply irresponsible in my mind and it will surely shift the illicit drug market towards moving more of these analogs in our communities. i think now is not the time and these are not the charges to encourage prosecutorial leniency. the proposal we're reviewing today will empower, organize fentanyl producers, mostly mexican cartels who are getting their precursors from chemical companies in china, and it will just empower them. so mr. milione, quick question. in the dea's 2020 report it determined that china is the primary source of producing these precursors. is that still true?
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>> yes. >> excellent. a factoid. dr. throckmorton, is the dea able -- this is interesting to me, the science of this thing -- to confidently identify the sources, the or engines, if you will, of fentanyl analogs and fentanyl when you seize drugs? >> i think i would defer to the dea on their detection in deciding where these things came from. >> very good. mr. milione? >> can you repeat the question? >> can you confidently determine the origin of a compound, an analog, a fentanyl analog, when you seize it? is there enough chemical analysis that you know the telltale signatures of where it came from. >> the dea labs have a profiling program that looks at all of that. >> thanks so much. mr. milione, again, has the u.s.
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dedicated enough resources to our southern border to adequately empower you to reduce the fentanyl tracking and analog tracking across our southern border? >> we are very concerned with the threat of fentanyl. we're very concerned with what's going on in mexico. every day agents on the southwest border and around the country are investigating these criminal drug networks. >> are there any critical tools you would like us to provide. >> congressman, we can always use more resources. this is a difficult and challenging problem and we can always use more resources. >> let me just say i will vote for this bill. i'm glad we're doing it, but i'm disappointed there is no mention made of the problem we have of sourcing all these drugs across our southern border. with that, madam chair, i yield back. >> dr. dunn yields back. the chair is pleased to recognize the gentleman from california, mr. cardness, for
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his five minutes of questions. >> thank you, madam chair, for this very important issue. when it comes to deaths, they are rising, and we must do what we can do to reduce the sale of fentanyl-related substances. to do this successfully, congress must write overdoses as a public health crisis that it is. because of this i'm concerned that classified scheduling takes the approach of guilty until proven innocent. we would be criminalizing compounds which haven't even been discovered yet. this approach provides hard penalties and restrictions even if a compound proves to be non-harmful. it could be helpful, for example. fentanyl and fentanyl-related substances are in the category of compounds which includes
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diarrhea, parkinson's disease and dementia. i would like to enter the cautionary tale for fentanyl compound. it was presented by a doctor on this topic. she warns that it is likely to have unintended consequences, including severely limiting biomedical research and in the long term adversely impacting public health, end quote. dr. volkow, you think we all agree that the current classification system has made it very difficult for scientists to reassess the scheduling of compounds which may have medicinal properties. for example, we know that compounds in marijuana have
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legitimate and beneficial medical uses despite it being schedule 1. so i'm encouraged to see that efforts are being made to allow researchers to study the effects of various compounds in this proposal. however, i am concerned with the idea of treating entire categories of compounds as a schedule 1 for enforcement purposes but different for research purposes. i think this puts the entire system into question. schedule 1 compounds are, by definition, compounds with no medical use and a high potential for abuse. i'll say that again. schedule 1 compounds are, by definition, compounds with no medical use and a high potential for abuse. in this specific situation, if we don't have the data to support fentanyl-related substances as schedule 1, why is it being related to an entire category and also including
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compounds which haven't even been discovered yet? >> in general, certainly i would be also very much worried about just taking chemical structure as a way of scheduling. but i also recognize that we're really in an emergency situation, and it's not business as usual, and we have never seen so many people dying from overdoses ever, and fentanyl is one of the drivers as well as fentanyl-related compounds. they are highly, highly profitable. they are not going to go away. and we need to actually do everything that we can to make it harder for the manufacturer and dealers to do it. at the same time, we need to also be very conscious that the way we're going to be addressing the crisis, as has been said by the other agencies, is not one intervention. we need to actually provide prevention, treatment, recovery, and that requires research. that's why i'm very supportive of these provisions because it will give us an opportunity to
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make and research simpler and faster on the schedule 1 compounds. we're in an emergency situation. >> yes, it definitely is an emergency situation. i also would like to add to what my colleagues have mentioned about our disappointment that the department of justice is not here. i hope we would have been able to hear from the justice department about supporting this proposal, but i appreciate the feedback of the witnesses that are here today. being that the doj is not here, i want to ask a question of the dea and also nbcp. the bottom line, why is it being recommended we continue the same strategy of criminalizing compounds which clearly isn't working so far? >> i'll take that. thank you for the question.
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fentanyl is killing hundreds of people every day in this country. tens of thousands of people are dying every year. mexican cartels are flooding the country with these substances, working with chemical companies in china and they're profiting off the opioid crisis in our country. our focus is on those who are harming the country and bringing them to justice, but also it's critical for us to have these drugs scheduled so that we can prevent them from coming in and harming our public citizens in our country and also seizing it when we encounter it, as well as dismantling the groups that are profiting off this. >> thank you. my time is expired. i yield back. >> the gentleman yields back. the chair now recognizes the gentleman from georgia, mr. carter, for your five minutes. >> thank you, madam chair. i'm so glad we're having this
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hearing. i thank you for calling this hearing, madam chair, but i'm frustrated. i'm very frustrated. here we are at this hearing and we have a border where fentanyl is pouring across the border, pouring across the border. enough fentanyl was seized that killed 2.1 billion people. enough fentanyl has been seize d at that border, but yet do we have anyone at the border? no. it's ridiculous we're doing this. drug traffickers are murderers, period. drug traffickers are murderers. ask any of the 100,000 family members of the 100,000 people who died this past year as a result of drug overdoses.
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ask them, they'll tell you, they are murderers. until we resolve the situation in our southern border, anything we do is ridiculous. this has got to be addressed. again, if we have to subpoena the department of justice, subpoena the homeland security to get them here to answer these questions. i want to ask you, mr. chester, if there ever was a time to debate mandatory minimum laws, do you believe it should be now with the unmatched lethality of fentanyl-related substances, which are even more lethal than fentanyl itself? >> thank you for your question, congressman, and i want to talk to you from a policy perspective. i'm not an attorney and i'm not part of the department of justice, but i do want to answer your question directly. the first element of that is
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this. what is not included in that exception are fentanyl analogs that have already been identified and are already placed in the scheduling regime of which there have been close to 30 that have been seized and identified by cbp and other partners that we deal with. that's fentanyl, acetyl fentanyl. this provision does not apply. it also does not apply for those substances in which there is death or serious bodily injury. that also does not apply. so what you have is kind of this very narrow substances that have not been identified where this applies. i want to make sure we're clear on that provision. to the method of how we gather these up, it is true these substances have not been tested
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in vitro, that is true. but it is also true, as you state, that this classical set of substances is markedly dangerous for those we have detected and potentially dangerous for those we have yet to detect and have been able to put to testing and that's what's important. >> being a pharmacist, i carried the update of the pharmacy rules in georgia, and every year we would identify the dangerous drugs and include them on there, and every year they would change them just technically, and we would be behind. we were behind before we even started. mr. milione, i'm going to ask you the same question. do you need me to repeat it? >> no, thank you. we're focused every day, obviously, on the threat that we're facing with these drugs. this is an existential threat to the country, the fentanyl substances that are coming in. what is critical for us is the classwide scheduling so we can seize them before they come in and seize them when we encounter
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them. as a law enforcement agency, we will continue to investigate those groups that are harming our communities, and we will do everything we can to get help for those that are being harmed. prosecutors make decisions about charging, judges follow the law, they will sentence. we will continue to investigate and protect the public with all the tools that we have. >> let me ask you something. isn't it true -- i'll ask you, mr. milione -- i'm sorry. >> that's all right. >> isn't it true that the fentanyl and fentanyl variants are so potent that even in low doses, they can be dangerous? so much so that dea agents are warned about touching them. >> fentanyl is an incredibly lethal substance. two grams are potentially dangerous. >> that you can get over the internet, that's the ones you're
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talking about? >> that's correct. >> madam chair, i cannot believe that the department of justice and the department of homeland security are not here. we should subpoena them and make them come here. thank you, madam chair, and i yield back. >> the gentleman yields back. i think when an agency declines to come and testify, they injure their own case. this is the people's house, and we're examining with every legitimacy the administration's proposal. and it's an agency that's key in this, so i think that they hurt themselves by the choices they've made, and i think it's regrettable and it's troubling to me. i think we all feel the same way about it. okay. the chair now recognizes the gentleman from california, dr. ruiz, for your five minutes of questions. >> thank you very much, and thank you for this hearing.
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i'm saddened that we are here yet again to discuss this crisis that continues to sweep our nation, affecting each and every one of our communities. as a physician i treated far too many patients with substance use disorder in the emergency department, many fighting for their lives. just this week i heard from one of my constituents, jennifer from bermuda dunes in my district of california, who tragically lost her son last year. steven loza was just 18 years old and had graduated from high school when he died from fentanyl poisoning. he should have had his whole life ahead of him. unfortunately, this case is not unique. these tragedies cannot continue. we must continue fighting for jennifer, steven, and families across the country who have been afflicted by this crisis and enact policies that help prevent more suffering and unnecessary
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loss of life. earlier this year, the biden-harris administration's office of national drug control policy released their drug policy priorities, which included various bold approaches to reduce overdose deaths. i applied this proactive approach. this overdose epidemic is one of the most important public health issues of our time and requires urgency. mr. chester, i am interested in hearing about the administration's progress on these priorities, and more specifically, what major actions has the administration taken to increase access to evidence-based treatment services since releasing its policies priorities? >> thank you, congressman. i'd like to bring you up to date on a few things. at the administration level, the american rescue plan invested more than $4 billion, and that was tool lou hhs and samsa resources to expand funding als
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million specifically for harm reduction. we know how important that is in saving lives and preventing overdoses. the president's fy '22 budget, $41 billion across the national drug control program, but that's both demand reduction and supply reduction, as well, and that's about $670 million above the fy '22 enacted. we have also designated six new counties as part of the highly successful program. we have also funded the nationwide expansion of the overdose response strategy, which is not only law enforcement, but also brings together critical public health interventions in our communities as well. we met with more than 300 state, local, and tribal leaders from all 50 states and territories to talk about how they could use opioid litigation settlement dollars and focus them in the right place for substance use
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disorders. >> since you mentioned tribes, we know many, like in many other areas of health care, there's marked disparities in access to substance abuse treatment for underserved communities of color, rural communities, and tribes. so what steps has the biden/harris administration taken or is planning to take to close these disparities to access to treatment? >> yes, congressman. i would offer you two things. the first one is there is never a time that we talk about a particular policy that we don't mention state, local, and tribal as well. we understand the unique aspects and the unique needs of the tribal community and the fact that substance use disorder has fallen on our tribal communities in an outsized fashion. two things i can offer. one was, and this is hhs, released practice guidelines for the administration of buprenorphine for treating oud.
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we know there has been expansion of use of buprenorphine over the covid pandemic and that's been incredibly useful in getting more people into treatment, and the other thing we're proud of the fact the dea in working with ondcp lifted a decade-long moratorium on opioid treatment programs that have a mobile component that's critically important for rural and tribal communities to be able to extend treatment in areas that are traditionally underserved. so that's two examples of things that we're very proud of that we have done, just within the last 10 or 11 months. >> thank you, and are these efforts also conducted and these outreach educational efforts also conducted in spanish? >> i can get you the absolute answer on that, but what i can tell you is i just -- let me just talk about the drug-free communities program for a second. because the drug-free communities program is entirely
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local. their motto and they're managed through the office of national drug control policy. their motto is local problems require local solutions, and that is one that i would be glad to provide you some more information on that and it being culturally and linguistically focused because we're very proud of that program and announced $13.2 million in funds just over this past year. >> thank you. i yield back. >> gentleman's time has expired. chair is pleased to recognize the gentleman from pennsylvania, doctor joyce, for five minutes. >> thank you for convening this hearing on what we all recognize as a grave and important matter. we are aware that the expiration date for the current emergency class-wide scheduling order for fentanyl related substances is coming up next january. or now will be likely punted until february.
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congress cannot, i repeat, congress cannot allow this life-saving order to expire, and rather finally needs to pass legislation to permanently schedule fentanyl related substances to empower our brave law enforcement officers to get these deadly drugs off the streets. and to bring the traffickers and the dealers of these poisons to justice. in face of this escalating crisis, i share with the chair and the ranking member's concerns that the dog hasn't even allowed themselves to be present at this important hearing. drug overdoses are killing more americans than ever before, and nearly two-thirds of these deaths are the fault of synthetic opioids like fentanyl and fentanyl related substances. my district in pennsylvania has been hit hard by this crisis over the last two years. every single one of the ten
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counties that i represent has experienced increase, increases in the overdose death rates from 2019 to 2020. over 30% in each and every one of those ten counties. while i am pleased to see the biden administration finally release a plan to permanently schedule these substances, i worry that this plan is misguided and that the changes of the proposed mandatory minimum sentences for these drugs specifically will have the reversed impact and encourage the traffickers, the traffickers that you talked about to us today, to continue to bring these substances into our communities and kill our families and our friends. my first question is for you, mr. millone. is it reasonable to believe that class-wide scheduling would not expand the application of mandatory minimum sentences as some might suggest?
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>> thank you, congressman. our job at the dea is to make sure that we're making our communities safer. and that includes conducting the investigations into those groups that are flooding our country with fentanyl. as i said before, fentanyl is an incredibly dangerous substance. what's critical is those drugs are classified permanently so that we can stop those drugs from coming into the country and seize them and dismantle the networks that we're investigating. >> my next question is for dr. throckmorton. as a physician, i followed with interest the discussion about streamlining the process to remove fentanyl related substances from schedule i based on just one factor, not all eight. does that mean a fentanyl related substance could be removed from schedule i even if there is no medical use? >> short answer is yes. under the current proposal. it would remain in schedule iii
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presumably if the pharmacology anticipated it would have low amount of potential for abuse, would still be controlled under other various aspects of drug development. my agency has a series of controls that we have over drugs that are under study, as new drugs for us. investigational review boards would continue watching them, for instance, but the short answer is, yes, under the current proposal, the focus is on the pharmacology that we anticipate what would cause greatest harm. identifying that pharmacology, and if it exists, that compound stays in schedule i. should not leave the tightest possible controls. >> i agree with that. mr. millone, i think you said sent some important issues to us. you stated these cartels are permeaing our southern border, flooding every community with
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fentanyl related substances, driven by greed, your terms, and stopping at nothing, your terms, and i agree. my question is for you, mr. chester. is it not incredibly dangerous to leave the door open for hypothetical future compounds? why not fix the threat today? wouldn't it be prudent to be on course if there are research exemptions to address those as the research guides us? >> yes. i appreciate your question, doctor. i agree with your characterization of the threat, but nat that we're leaving the door open. the fundamental element of this particular proposal is to gather these substances up and bring them under control. substances not even yet created. i think that's the important aspect of this, that we're permanently scheduling these substances as schedule i, until the research community has the ability to access them and determine their proper place in the scheduling regime. >> i thank you all for being here today. this is informative, and this is
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an important hearing to have. again, i want to state my grave concerns that the department of justice refused to participate in this hearing today. thank you, and i yield. >> thank you, doctor. always a gentleman. the chair is happy to recognize the gentlewoman from michigan, mrs. dingel, for her five minutes of questions. >> thank you, madam chair. i would also like to thank our witnesses for being here today. and just tell you how important this hearing is. most of you know i lost my sister to an opioid drug overdose, but in the last year, also lost a family member from fentanyl. and we all talk about the southern border, but people don't talk about the fact that the canadian border is also very dangerous source, and law enforcement at the time told me about how deadly this is that's coming in, and most of the people that are buying it have
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no idea what's about to happen to them, and it is why this is all so important. as we continue this discussion, and we have these witnesses, the justice department should be here because i do believe the people selling this are murderers. front and center, we need to take that on. it would be good to hear about additional policies the biden administration is proposing. we all recognize that multifaceted problems require multifaceted solutions with over 100,000 deaths in only a year period in this country and almost 3,000 just in michigan, it's important we consider all possible strategies to combat the crisis. mr. chester, could you briefly summarize other avenues the biden administration is pursuing to reduce overdose deaths, particularly those around prevention, treatment, harm reduction, and recovery services? >> yes, congresswoman, thank you very much. the first thing is, you mentioned it, prevention.
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that is preventing drug use before it starts. the second one is reducing barriers and access to treatment. leading to long-term recovery, and some of those we talked about earlier, particularly extending into underserved populations, reducing financial and other barriers to accessing treatment, but the third thing is harm reduction. and i think it's critically important that we remember that harm reduction is a critical part of insuring that individuals are not losing their lives to overdose. and that is not only service programs, fentanyl test strips which i know have been spoken about a lot in the press lately, but also accessed in the lock zone. the lock zone is critically important as a harm reduction intervention to make sure that we can insure that americans do not lose their lives to opioid overdose. thank you. >> let me build on that, mr. chester. a number of states have adopted co-prescribing programs, when a
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doctor pairs an opioid prescription with a prescription of the overdose reversal drug, like naloxone. what control can increased utilization of pro-prescribing programs play in assisting the response to the opioid crisis? >> thank you for the question. i know congressman sarbanes is also a supporter of co-prescribing. what i can tell you is, and specifically about ondcp's role is we look across the span of possible policies, possible interventions, and those that could be extended across the country, that could be useful and co-prescribing is one thing we have looked at and we'll continue to look at. >> if i may interject. i'm sorry, i apologize, but i also think the importance of science in helping us address the crisis should be highlighted
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because the reality is we're faced with a drug that we don't have so much information to optimally reverse overdoses or to optimally treatment, so therefore, the importance, again, of doing clinical research that will allow us to implement policies that are more likely to be effective. ? i think it's very important and i think it was you who spoke earlier is one of my biggest bugaboos is we don't have pain relievers that are not addictive. we need to be investing in more pain reduction medicines. it's a combination of reasons why people are using these drugs, and i do want to say my colleague, french hill, and i are leading legislation preventing overdoses and saving lives act to provide state grants to encourage uptakes of these programs, which have proven effective in helping address the opioid crisis. i was going to ask you all more questions, but i have 30 seconds left. so i won't. i'll yield back. madam chair, but i will have
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additional questions for the panel, especially on what they think we should be considering the policies to reduce overdose deaths. thank you, and i yield back my time. >> the gentlewoman yields back. i think all members are going to be heard from in terms of detailed question to our witnesses because there is so much more to be learned and questions answered. so we'll be doing deep dives on that. the chair is pleased to recognize the gentleman from texas, mr. crenshaw, for five minutes. >> thank you, madam chair. thank you all for being here. it's an important topic. and i think a lot of potential for bipartisan agreement and policy making. i want to start -- i want to try to understand the mandatory minimum policy by the administration and understand what the intent it and get at
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the repercussions. mr. tester, this is for you. the administration supports mandatory minimums in cases where death or serious bodily injury can be directly linked to the fentanyl analog that was trafficked. i understand where we're going with this. you don't want to put people in jail just because they're a drug addict, but you do want to put the drug dealers in jail. the problem is why support this standard rather than a standard that would get at the serious trafficking cases? these are notoriously hard to prove that this overdose was directly linked via intent and the substance to this dealer, having a very hard time prosecuting that. >> thank you for your question, congressman. i'll give you the policy aspect of it, but i would like defer to the department of justice, and i know they submitted a statement for the record on kind of the arcanna of it as well, but i will tell you, you asked the question i we were coming from, and i want to make sure we're clear. i would make a different distinction than the one you made between the trafficker and
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actually the user and make a distinction actually among, upon the substance itself. you mentioned fentanyl analogs. those fentanyl analogs that have been identified and tested, those are schedule i, they have been placed in the scheduling regime. that's not what we're talking about. what we're talking about is we have gathered up an entire class of substances, uncreated, that within that class of substance, there may be substances that either have medical merit or are not the least bit harmful. they're not any more harmful than water. the question is what do you do with those particular cases where an individual has been convicted of a substance that is only within schedule i by virtue of its class scheduling. that's why that particular guardrail was put in. >> okay, and maybe if doj was here, we would ask them what we could do to make it easier to prosecute drug dealers with bad intent that are dealing fentanyl that is killing people.
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i mean, just going to simplify what we're trying to get at, and this seems to get in the way of it. on a separate note, the administration talks about harm reduction as a method to deal with this crisis. san francisco, philadelphia, new york city, they're promoting harm reduction programs. they had great success in mitigating opioid abuse. more so than cities that have just cracked down harder on illegal drug use. and what does the literature say on safe injection sites? are these workable solutions or not? >> i can get you an exact answer on the kind of the science behind safe injection sites, and in fact, i could turn it over to the doctor. in broader terms when it comes to harm reduction, it's saving people's lives and preventing them from overdosing to drugs. that's kind of one element. the second element of that is it is the first step on the road, hopefully, to treatment leading to long-term recovery. that is ultimately the goal, but
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when it comes to the science behind safe injection sites, dr. volkow, if you would like to add something? >> we have done research in other countries but not in the united states. from that research, it has mitigated some of the adverse effects of drug use, including hiv, hepatitis c, and overdoses, but we need to test this in our country. >> i understand. thank you for being here. thank you for your answers. i do want to point out something, when it comes to the opioid crisis and 100,000 deaths in the past year, we can talk about mandatory minimums, we can talk about harm reduction, and these things are very important to talk about. but we wouldn't have to be talking about those things if there was no fentanyl in the system in the first place. now, we're lucky in a sense because we know where it's coming from. chinese, chinese supplies the chemicals, and the mexican drug cartels are pushing it across our southern border. i say we're lucky to know that
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because it allows us to focus on something. it allows us to focus on the source of the problem, which is an open southern border, where drug cartels are simultaneously shoving hundreds of people at a time across the border to tie up border patrol, meanwhile, border patrol is not actually patrolling the border, and the drug cartels can put their drugs through the gaps in our border. and then they come here, and we seize hundreds and hundreds of pounds of fentanyl, which can kill tens of millions of americans. we seize that on a regular basis. i would like to submit for the record from operation lone star these statistics from texas specifically. and i yield back. thank you. >> gentleman yields back. chair recognizes the gentlewoman from new hampshire, ms. custer, for your five minutes of questions. are you there? ms. custer? going, going, gone.
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the chair recognizes the gentlewoman from illinois -- >> i'm right here. >> are you there? >> i'm right here. i apologize. >> okay. you're recognized. >> i'm so sorry. i apologize. thank you so much. delighted to be here today to discuss the administration's recommendations on combatting the fentanyl overdose epidemic and i want to submit for the record a letter from over 150 advocacy groups and public health professionals in support of bipartisan legislation that i have introduced with congresswoman blunt rochester to address the fentanyl overdose crisis. it's called the stop fentanyl act. and i hope our colleagues on both sides of the aisle will join us. in new hampshire, we saw very early on the devastation of this addiction epidemic. what began in the doctor's office with overprescribing pain medication evolved into a full blown opioid epidemic that could literally be tracked along our
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highway map. communities hooked on pills, they were prescribed by doctors, were inundated with less costly alternative, first heroin, and now other drugs and substances. today, this epidemic continues to evolve with stronger, more dangerous syntheticopeioids like fentanyl and fentanyl related substances, and what makes this even more concerning is that oftentimes these lethal synthetic opioids are laced into other drugs, unbeknownst to the person struggling with addiction. since coming to congress, i have worked tirelessly with my colleagues on the bipartisan addiction and mental health task force and on this committee to help those with substance use disorder. but our work continues. as many have already pointed out just the past year, over 100,000 americans have died of drug overdose, but that number does not begin to capture the many other overdoses that have occurred during the pandemic.
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i want to turn my attention to a comprehensive, holistic approach to ending this epidemic. one that invests in public health treatment, in prevention, and in support for those battling with substance use disorders. i want to focus on the interagency working group examining and developing its recommendations on scheduling fentanyl. as policymakers, one of the challenges in keeping up with the pace of the overdose epidemic is working with lagging data, from different sources, that's not integrated in a readily available way. and we have focused on this in the stop fentanyl act. mr. chester, the covid pandemic has shown the value in realtime data. we know the number of deaths the next day, yet we wait months for overdose data and critical information on this synthetic
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opioids. how can we better access data in both public safety and public health? >> thank you, congresswoman, for the question. we agree, data is the key to understanding the environment the best that we can, understanding where our vulnerabilities are in being able to come up with policies in order to close those vulnerabilities. we are better than we used to be in data, particularly the national center for health statistics, within cdc, now has the provisional data which we get on a quarterly basis and is much faster than the data that we got before previously, and that's been very important. the second thing that we do is we stay very much in touch with our state, local, and tribal partners who can feed us bottoms up data, although you can't extrapolate it across the country, it gives us a sense for our understanding of what the environment is, and the third one is to listen to the congress. and the congress over the years
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has been clear about what it's looking for in terms of this particular legislative proposal and that was helpful in allowing the departments of justice and hhs to be able to shape what you have -- what we have here. but we don't disagree with the fact that we have some gaps on data, and it's an area that we need to work pretty heavily. >> okay. thank you. i'm going to ask this last question with mr. chester and dr. throckmorton, a key priority of mine and the administration is increasing resources for harm reduction. can you tell us what more can we done at the fda perspective to make naloxone more accessible? >> i can start off and then i'll turn it over to dr. throckmorton. we know that naloxone is incredibly effective at preventing overdoses and saving lives. and that increasing naloxone
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availability across the country is one of the critical elements of harm reduction under the first year priorities under the biden/harris administration. but i'll turn it over to doug. >> thank you very much. i could not agree more. one of the fda's highest priorities is expanding the formulations, the available types of naloxone that people can make use of. just recently, we approved a higher dose formulation of naloxone to make available for people that might use it. we believe we have recently started, we have continued -- >> i have to give your response for the record. my time is well up and i'll yield up. >> happy to, ma'am. thank you. >> time has expired. the chair is more than pleased to yield to the gentlewoman from illinois, ms. kelly, for your five minutes. >> thank you, madam chair and ranking member guthrie, for
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holding this important hearing to curb the opioid crisis in this country. unfortunately, overdose deaths are beginning to rise even before the pandemic. i know we have talked a lot about that. and black and brown communities are experiencing the fastest increase rates of overdose deaths involving synthetic opioids. i continue to be concerned about using the criminal justice system to address a public health issue. i worry about the impact this will have on the very communities that are suffering in silence without the sympathy of the media and of society at large. we need to make sure that we are taking a deep look at how this proposal to move fentanyl related substances to schedule i may perpetuate existing racial disparities in our criminal justice system. mr. chester, what is the evidence that increasing criminal penalties of fentanyl related substances will actually reduce drug related mortality and morbidity, particularly
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among black and brown communities? >> thank you, ma'am. i would offer you this, that what we are not doing is increasing criminal penalties but rather gathering up a class of substances and placing them in schedule i. i think it's an important distinction. i appreciate your question, but we're not increasing penalties. we're taking substances that are dangerous substances as part of a class of dangerous substances and placing them in schedule i, not increasing penalties. >> okay. as fentanyl related substances are increasingly criminalized, this may increase the development of new synthetic opioids. how does ondcp plan to address this to avoid a whack-a-mole approach to regulating harmful synthetic opioids? >> thank you, congresswoman. you used the exact right word. you characterized it perfectly, whack-a-mole. we have to insure that that's not what we're doing. i think we need to understand a
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few things. the first one is, it is clear that when we take an action, drug traffickers change their behavior. it's almost impossible to get ahead of that, but at least we can close the gap. this particular action, class scheduling, was done for the exact reason that you just mentioned. so we were in a situation in the past, and by the way, we asked the chinese government to do this as well, and they did. we were in a situation in the past where we would detect a fentanyl analog in the united states. we knew it came from china. we would go to the chinese and say please hold someone accountable. they say it's not illegal in our country but we'll do that. and by the time it was made illegal in china, the traffickers had already moved to another substance. that necessitates class scheduling. in my oral statement when i said they're creating these substances faster than we can schedule them exactly the situation you're talking about. >> thanks. i want to make sure congress is
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taking a holistic approach to tackling this epidemic, which includes investing significantly in prevention, treatment, and recovery also. this committee has heard from the research community that current research requirements on the controlled substance act take significant time and effort to obtain. one of the criticisms of placing substances in schedule i is the chilling effect that may have on research of those substances. dr. volkow, the administration's fentanyl related substances proposal seeks to establish a simplified process that would align research, registration for all schedule i substances more closely with the research registration process for schedule ii substances. can you explain the difference between the two processes? >> yeah, on this we'll make it basically the proposal to do research on schedule i equivalent to doing research on schedule ii. and it eliminates the need of an
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extra review of the proposal of the researcher, which is not necessary for schedule ii but schedule i. and that takes time and is much more lengthy, so it will facilitate that, in addition to other provisions that will make it easier for researchers to actually perform their work. so it is an advance, and we're excited and supportive of this proposal. >> thank you so much. research is essential for understanding the opioid epidemic, identifying effective solutions, and informing our policy making, and it is critical that we insure that no barriers to this type of research exists. so thank you so much, and thank you to all of the witnesses. i yield back. >> i'm going to recognize the gentlewoman from california, ms. bear agone, but i also want to say before she begins her
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questioning that we have votes on the floor. we still have several members that are in the queue to ask their question of the witnesses. so i think the good news for the witnesses is you're going to get a break for at least 45 minutes. and the downside is that we're going to be back after that 45 minutes to finish out our hearing by allowing all members who wish to question the time to do so. so with that, i recognize the gentlewoman from california for your five minutes of questions and then we'll recess after her questions for 45 minutes. >> thank you, madam chair. i'm glad that we're here today to discuss legislation that will hopefully allow us to stem the overdose epidemic that has taken far too many lives too soon. i want thank all of our
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witnesses today for your testimony. in los angeles county and across the country, we are seeing an unprecedented humanitarian crisis of people experiencing homelessness that requires a compassionate, thoughtful public health response. according to the los angeles county department of public health, between 2017 and 2019, people experiencing homelessness in l.a. county were more than 36 times more likely to die of a drug overdose compared to the general l.a. county population. drug overdose deaths involving fentanyl tripled between 2018 and 2020. and drug overdose remains the primary cause of death for people experiencing homelessness in l.a. county. comprehensive drug policy aimed at reducing harm caused by fentanyl related substances must include an integrated public health approach and investments in infrastructure that addresses upstream social determinants of health. this question is for
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mr. chester. can you discuss strategies the office of national drug control policy are working on to tackle social factors like homelessness that exacerbate illicit fentanyl related substance overdoses among more than 500,000 people experiencing homelessness in our country? >> yes, thank you, congresswoman, for that question. i think you have brought up a very important point. the first thing i would like to say is that evidence based prevention and prevention strategies are a key part of the first year priorities that the office has laid out for the biden/harris administration when it comes to drug policy. the second thing i'll tell you is that the social determine of drug use are part of our academic understanding of what it is that leads to the nishation of drug use in the first place. that is one of the key areas
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that the office will be working on in the coming year in order to reduce overall drug use around the country. and as we say, and we have talked about it several times today, there is absolutely a direct linkage among the fentanyl related substances that are available in our communities, their trafficking, and their use in our communities and therefore overdose deaths. you can't pull one of those strands apart. you need to be able to deal with it in a comprehensive and holistic fashion, and that's the approach that we have taken. >> thank you. dr. volkow, in los angeles county, there was a 52% increase in accidental drug overdose deaths, and a 136.4% increase in the number of fentanyl related death rates during the first ten months of the pandemic compared to the same period in 2019. this alarming uptick of deaths is disproportionately affecting people of color. how can improving research with
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fentanyl related substances help us address the opioid overdose crisis and combat drug overdose deaths within highly populated urban areas, particularly among people of color? >> first of all, i think that we resonate completely with you about the social determinance of health, because they pertain very much about why you're seeing such a dramatic increase in overdose mortality in the covid pandemic and why it's affecting some populations more than others. understanding the processes and the challenges that people that are homeless, for example, is crucial for providing solutions. without it, people that don't have a place to sleep cannot sustain treatment, nor can they actually when they go to shelters, get exposed to others taking drugs. so understanding the social and cultural factors that have been exacerbated during the pandemic including the uncertainties and the social isolation is crucial for containing the epidemic that
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we are seeing. in terms of how the fentanyl research can help us basically be better able to do treatment and prevention is first of all, we need to understand what are the characteristics of the use of the substances, who is using them, how they are combining them. we need to also understand actually how to optimize them before reverse them, and third, how do we not just initiate people on treatment, but retain them on treatment so they can recover and we can prevent an overdose. that requires that we work with -- that researches get their hands on working with fentanyl. so that they can develop models and they can actually develop new products, new ways of testing it, new ways of being able to document where people are dying from what so you can test rapidly right away as opposed to waiting months. these are just some of the
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examples. >> thank you so much, doctor. i'm out of time. with that i yield back. >> gentlewoman yields back. we'll now recess for 45 minutes. why don't we say 50 minutes? the ranking member and myself will race back after the third -- after we cast our third vote, and the witnesses take a break. i think that there you'll find the cafeteria and whatever downstairs here in the raburn building. thank you. i'm sorry we couldn't conclude before votes, but we have -- you are an all-star cast, with just one department missing. but you can see that there is very deep, broad interest in this issue. and you're the experts. and we want to make sure that everyone is able to question. so we'll be back at 2:15.

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