tv U.S. House of Representatives Experimental Drugs Terminally Ill CSPAN March 22, 2018 4:27am-5:26am EDT
identity. we do. this is what makes us special. >> q and a sunday night on c-span. right house approved and to try bill that would allow terminally ill patients access to experiment with drugs. the measure goes to the senate where version passed last year. here's a portion of wednesday's house debate. mpore: the gentleman is recognized is recognized for as much as he wishes to use under the rule. mr. burgess: so mr. speaker, earlier this year, members of congress heard the president during his state of the union address make a specific promise to the american people that the passage of the right to try legislation would occur. this afternoon, i am proud to stand with the president and the thousands of americans with terminal illnesses and their families and their frnds in passing this important --
friends in passing this important bill in the house. since 2014, nearly three out of four states, including our home state of texas, have passed their version of right to try laws. i am pleased that the house is , in considering h.r. 5247 the trickett wendler, frank mongiello, jordan mclinn, and matthew bellina right to try , so that terminally ill patients have a chance or maybe a second chance at life. these patients are our constituents. they could be someone we know. let us take this opportunity to improve access to experimental treatments for them. over the course of the past decade, our nation has achieved an unprecedented number of innovations and scientific breakthroughs. through the contributions of researchers and academia and the private sector, americans now have more innovative treatments at their fingertips, but despite these achievements,
i still hear from patients with serious life-threatening conditions, including my own constituents in north texas, who are frustrated with what they see as regulatory barriers from trying new therapies when everything else has failed. mr. speaker, as a physician, i understand that access to investigational drugs and therapies is a deeply personal priority for those seeking treatment for their loved ones with serious life-threatening conditions. to my friends on the other side of the aisle, i have a simple question. why do you not want to allow these patients to exercise their right to fight for their future? it is worth mentioning that the bill before us today is a revised, more narrowly crafted version of the one that passed the senate last august. since that time, the energy and commerce's health subcommittee held a hearing in early october to consider the senate bill where members heard from the
commissioner of the food and drug administration,
dr. scott gottlieb, about agency concerns. we also heard tms from patients and other -- testimonies from patients and other groups, groups that supported it and groups that opposed right to try. from them to just recently, our committee engaged in multistakeholder efforts to improve the original right to try bill as passed by the senate. it entailed numerous conversations with patients, with advocates, with the administration, with the authors of the bill and stakeholders on all sides of this complex topics. the food and drug administration was never left out of the discussion. in fact, the agency provided valuable input throughout the process and up until the introduction of h.r. 5247. the aim was to open the door to innovative experimental drugs for terminally ill patients without necessarily compromising the vital work and the mission of the food and drug administration. the current compassionate use
program at the food and drug administration
does make a good-faith effort to help patients who do not qualify for clinical trials, but right to try would actually offer patients an alternative pathway to access eligible investigational drugs so long as they are certified by a physician who is in good standing and abides by the rules laid out in the bill. again, we have worked closely with the food and drug administration to ensure that this new alternative pathway does not hinder nor conflict with the critically important oversight that the agency conducts. additionally, this bill protects patients from manufacturers mislabeling or misbranding drugs. it requires sponsors and manufacturers to report adverse events to the food and drug administration and provide certain liability protections for parties participating in the new pathway. mr. speaker, this alternative pathway would also be limited
to individuals who are suffering from a disease or condition where there is a reasonable likelihood of death thin a matter of months or significant irreversible morbidity who have exhausted all f.d.a.-approved treatment options. lastly, it is essential we do not create additional hurdles in this process so that manufacturers in the drug approval process have the certainty that they need. the revised right to try bill clearly states that the secretary of the department of health and human services may not use a clinical outcome associated with the use of an eligible investigational drug to delay or adversely affect review or approval of such a drug. after months of work and thoughtful discussions, this legislation is a positive step forward and our shared goal of improving care for america's
patients. it strikes the proper balance between ensuring patient safety and granting access to new treatments. the president outlined in his state of the union address that this was an important priority for the administration. in the words of our vice president, our former colleague, mike pence, it's about restoring hope and giving patients with life-threatening diseases a fighting chance. for these reasons, i urge my colleagues in the house to vote in support of h.r. 5247, and i will reserve the balance of my time. the speaker pro tempore: the gentleman from texas reserves his time. for what purpose does the gentleman from new jersey seek recognition? mr. pallone: mr. speaker, i ise in opposition to the bill. the speaker pro tempore: the gentleman is recognized. mr. pallone: thank you. i yield myself such time as i may consume, mr. speaker. the speaker pro tempore: and you are recognized as you wish to use. mr. pallone: mr. speaker, i rise today to voice my strong opposition to h.r. 5247, or the federal right to try act of
2018. this legislation, introduced only last week, is an egregious attempt, in my opinion, by the goldwater institute to undermine the drug standard drug approval process at the food and drug administration. the supporters of this bill claim to be helping desperate patients who are looking for hope. if this is such a patient-centered bill, then why does every major patient organization overwhelmingly oppose it? more than 100 patient organizations, including the national organization for rare disorders, the friends of cancer research, the american cancer society, they've all written in opposition to this legislation. in a letter to congressional leadership, these 103 patient organizations noted, and i quote, that the alternative pathway in the latest version of this legislation is still less safe for our patients than the current expanded process under the f.d.a. and it's not only the patient organizations that are voicing concern.
four former f.d.a. commissioners, drst hamberg and calif, who served under the obama administration, and the two under the bush administration also oppose this legislation. that's two former republican commissioners and two former democratic commissioners who are opposed to both the house bill and the senate bill on this same issue. these four commissioners explained their opposition by saying, and i quote, there is no evidence that either bill would meaningfully improve access for patients but both would remove the f.d.a. from the process and create a dangerous precedent that would erode protections for vulnerable patients. i also, and i think most importantly, mr. speaker, would stress that this legislation is simply not needed. there is already a successful program in place today at the f.d.a. in which seriously ill patients and their doctors can request access to an experimental treatment from a manufacturer. this application process, which takes as little as 45 minutes for a physician to complete, has been overwhelmingly
successful. last summer, a review by the government accountability office found that f.d.a. approves 99% of the requests submitted to the agency. in fact, of the nearly 1,700 requests f.d.a. received last year, only nine were not approved. physicians and patients also receive approval quickly. emergency requests are often granted immediately over the phone and on average receive a response within four days. now, while f.d.a. approves 99% of the treatments it reviews through this expanded access process, as it's called, it also adjusts applications for 11% of the patients to improve patient safety protections. in order to protect patients, this review, in my opinion, should continue. we must protect patients from bad actors or from dangerous treatments that might make their lives worse. just imagine the health consequences to patients if these 11% of applicants had not been adjusted? and this is the very reason f.d.a. must be involved in the
process. if you eliminate f.d.a. review, as this bill does, you are putting patients at risk. now, i want to talk a little bit about the fact that many states now have right to try statutes. i fear that some members, and i heard this last week when the bill was on the suspension list, i fear that some members might support this legislation under the false belief that the state right to try laws in their states have provided help to patients. but this could -- nothing could be further from the truth. one example supporters of this legislation likes to bring up is a doctor from texas who claims to have treated patients under the state right to try. i would like to enter into the record a letter from mr. andrew mcfadon of the isaac foundation who dispels this myth. the speaker pro tempore: without objection. mr. pallone: he claims to use right to try because f.d.a. would not allow him to do expanded access, and this was for a very good reason. f.d.a. placed a clinical hold on his study due to the fact his clinic was not reporting
seriously adverse events as required as continued to enroll patients despite the clinical hold. the work of the doctor's study was associated with 40 deaths and two hospitalizations. f.d.a.'s clinical hold on his work is a sign to me that f.d.a.'s, panded pathway was working to prevent bad actors from continuing to expose vulnerable issues -- vulnerable patients to experimental treatments. so mr. speaker, h.r. 5247 is dangerous for our patients. it's an unprecedented attempt to rollback f.d.a.'s investigational treatments. i ask my colleagues to stand with more than 100 organizationes that have come forward to oppose this misguided, and i believe, harmful legislation and i would reserve the balance of my time, mr. speaker. the speaker pro tempore: the gentleman from new jersey reserves his time. the gentleman from texas is recognized. mr. burgess: mr. speaker, at this time i'd like to yield to the gentleman from pennsylvania, one of the authors of the bill, three minutes. the speaker pro tempore: the
gentleman from pennsylvania is recognized for three minutes. >> thank you, mr. chairman. thank you, mr. speaker. i want to thank chairman walden, mr. burgess, mr. griffith, and my friends andy biggs and senator johnson for that you are unflinching agreement to see right to try passed into law. moreover, i think the overwhelming bipartisan majority of the house who just last week supported the trickett wendler, frank mongiello, jordan mclinn, and matthew bellina right to try that roved emphatically right to try is about more than politics. mr. fitzpatrick: it's about hope. each year thousands of americans received a life-altering diagnosis of a terminal illness, and even with the amazing work done in american medical research and development, for too many families, access to these potentially life-saving treatment also come too late or not at all. as representatives, we should each endeavor to support these individuals in their time of need as well as support new pathways to potentially life-saving treatment. that is what right to try is all about. for those patients caught between traditional drug approval delays, a clinical
trial process for which they do not qualify and limited time, right to try simply establishes the freedom for patients and their doctors to try therapies where the benefits far outweigh the risks. it gives them the option of trying to save their life. although the f.d.a. has a program that allows terminal patients to apply for early access to a promising treatment, right to try is needed because the f.d.a. compassionate use process doesn't help enough people. moreover, the application process is complicated, time consuming and expensive. only about 1,200 people each year can make it through the application process. in 2014, more than 12,000 people in france were using investigational treatments through that government's equivalent program. if a country with 1/5 of the population of the united states can help 900% more people, the f.d.a. program clearly is not working. . in australia doctors are able to provide investigatal treatments
to terminal patients without the government's approval. they must report to the government at some point that the patient received the drug. no permission slip is required. this bill requires robust informed consent between the patient, doctor and manufacturer, while requiring notification be given to the f.d.a. after an unapproved drug becomes available to an eligible patient. and requires doctors and manufacturers to report adverse events to the f.d.a. mr. speaker, when life hangs in the balance, the federal government should not stand in the way to access to these potential treatments. i've traveled our district in all corners and have met so many different people. mr. speaker, these people are an inspiration for this bill. they want to see this bill pass. let's get this done for. they i yield back. -- for them. i yield back. the speaker pro tempore: the gentleman from new jersey is recognized. mr. pallone: thank you, mr. speaker. i yield such time as she may consume to the gentlewoman from illinois, who is our
subcommittee rancor for the digital commerce and digital protection subcommittee. the speaker pro tempore: the gentlelady from illinois is recognize for as much time as she wishes to use. ms. schakowsky: i thank the gentleman for his generosity in time and i want to say, mr. speaker, that i rise in opposition to h.r. 4257. because it creates a dangerous back door for modern day snake aroundesmen, a back door the f.d.a. approval process. for people who may or may not be preying on desperate people and ignores that there actually is a safe pathway for terminally ill patients to get treatment. this bill failed to pass last week and it should fail again. it is a harmful policy that both republican and democratic appointed former f.d.a.
commissioners concluded that there is, quote, no evidence, unquote, that this bill, quote, would meaningfully approve access for patients, but would just remove the f.d.a. from the approval process and create a dangerous precedent that would erode protections for vulnerable patients, unquote. the most vulnerable patients. people who are, you know, their life is in danger. they feel that they'll try anything. and there are people out there who will prey on that. this bill denies patients what they really need, which is a safe and effective treatment. this bill strips away important safeguards in the name of helping patients. but it does not. and that is why 78 patient groups, actually, patient groups, and doctor groups, like the american cancer society, the cystic fibrosis foundation, the leukemia and lymphoma society,
oppose this bill. and in total, there are now 110 groups opposing this bill and, mr. speaker, i ask unanimous consent to put this multipage list of opponents to this bill in the congressional record. the speaker pro tempore: without objection, so ordered. ms. schakowsky: it opens the door for bad acters to take advantage of terminally ill patients. it is the f.d.a.'s job to ensure that drugs are safe and effective and we can't trust manufacturers to act as a gate keeper. there's already a safe process for terminal illinois patients to access experimental treatments. under what is called the expanded access program, 99% of applications are approved. and the expanded access program plays a vital safety role.
i am very troubled by what can happen to patients in some states that round go treatment from, quote, right to try, unquote companies. -- unquote, companies. in 19 states patients using an investigational drug could actually lose their hospice coverage and in six states they could be denied home care coverage. these are the very people who are dependent on hospice and me health care and this bill would cause them to lose that coverage. this is not a humane patient-centered bill for people who are facing death. it is just a dangerous pathway for bad actors to exploit those very people. i urge my colleagues to oppose h.r. 4257 and, again, i thank you for the opportunity to speak against this legislation.
thank you. i yield back. the speaker pro tempore: the gentlelady yields back the balance of her time. the gentleman from new jersey reserves his time. the gentleman from texas is recognized. mr. burgess: thank you, mr. speaker. at this time i'm pleased to yield to the chairman of the full committee, mr. walden of oregon, such time as he may consume. the speaker pro tempore: the gentleman from oregon is recognized for as much time as he wishes to use. general waldhauser: thank you, mr. speaker -- mr. walden: thank you, mr. speaker. i rise today on behalf of the patients. patients who have exhausted all available known treatment options. before us today we have legislation that received 260 bipartisan votes last week. that was nearly 260 votes to increase patient access to investigational drugs through a new pathway. and i want to thank dr. burgess for his incredible work on our energy and commerce committee, to do our due diligence. to take an issue that's important to our citizens and our colleagues and make sure that it has been properly vetted, reviewed and improved upon what we got from the senate. 38 states, mr. speaker, have the
right to try laws, including my own state of oregon. this is something the people want. and deserve. wisconsin will make it number 39 once the bill they've passed gets across governor scott walker's desk. while the state policies vary, they have a common goal and that is helping vulnerable patients. president trump praised the movement during the state of the union saying, people who are terminally ill should not have to go from country to country to seek a cure. i want them to have a chance here at home. i've spoken with the president directly about what we're doing here and he gave me a shoutout when he was up in new hampshire the other day about moving this bill forward. we've worked closely with the vice president and his team and with scott gottlieb, the doctor who heads the f.d.a., the food and drug administration, to get a really good thoughtful product before this house. and they support what we are doing here. president trump also highlighted
this bill when he was in new hampshire and it's important to note that this isn't the first time we've considered this bill, as you may know. last week we tried to move this on the suspension calendar. never imagining that the democrats would actually whip against giving dying patients the right to try one of these drugs. we had 32 democrats support it, this legislation, and that's why we brought it back under regular order and rule today. now today there is an existing process, and you've heard about it and we looked at this in the committee, for patients to access unapproved drugs. the f.d.a. oversees expanded access known as compassionate use. this program has been critical in helping patients access experimental drugs. it does work. commissioner gottlieb and the agency should be commended for their continued work to improve the expanded access program for patients. as you've heard from my colleagues on both sides of the aisle, the program works and works effectively. but it doesn't do it all. and that's why this legislation is before us.
to improve upon the successful program, the bill before us today provides liability protections for manufacturers, sponsors, physicians, clinical investigators, and hospitals that participate in the existing expanded access program, and the new alternative pathway that we create under this legislation. this was a very big issue for those who needed to be brought in to participation who might otherwise have sat on the sidelines and never made these drugs available. this provision removes one of the biggest hurdles that patients face and that was identified by the government accountability office, the biggest hurdle they face in gaining access to experiment altherrpies. manufacturer hesitancy to participate. that's the hurdle we're trying to overcome today in a safe way. the bill also creates a new alternative pathway for patients who do not qualify for a clinical trial. this legislation strengthens patient protections with clearer informed consent and adverse
reporting events -- event reporting. the bill also ensures the f.d.a. is notified when a patient receives an unapproved drug through the new alternative pathway to ensure proper oversight. i want to thank my colleagues in the house and especially dr. burgess on the health care subcommittee, but including representatives brian fitzpatrick, andy biggs, who is behind me, and morning griffith, and our vice president, mike pence. i'm grateful for their work and for their understanding that our job here in the house is to do our work. to hear from people who are affected or might be affected, to improve upon products, to go through regular order and bring this bill to you today. i urge all of my colleagues in the house to support this legislation. and i yield back. the speaker pro tempore: the gentleman yields back the balance of his time. the gentleman from texas reserves his time. the gentleman from new jersey is recognized. mr. pallone: thank you, mr. speaker. i yield to the gentlewoman from california, ms. mat suey, such time as she may consume -- ms. matsui, such time as she may consume.
the speaker pro tempore: the gentlelady is recognized. ms. matsui: thank you, mr. speaker. and i thank the gentleman for yielding to me. mr. speaker, i rise in opposition to h.r. 5257. the so-called right to try legislation -- 5247. the so-called right to try legislation. this bill gives patients the right to request. which fails to address real barriers to accessing experimental drugs such as drug costs or company restrictions. i will reiterate that patients already have the right to try through an expedited process that approves 99% of requests it receives. this legislation, however, fails to recognize that if a patient is denied access, it is usually because a drug manufacturer says no due to manufacturer concerns about safety or side effects. not because the f.d.a. denied the request. i know, like everyone else, i have heard from many constituents suffering from
terminal illnesses. such as a.l.s., who are desperate for years -- cures. and i believe every single one of us in this chamber has confronted in some way a family member, mother, father, spouse, who had an illness that had no cure. and we have gone through the process many times. and i think we all have felt desperate from time to time. however, having said that, just because a person is at the end and has no hope, to try something that might make things worse, you cannot go on to a more peaceful resolution, would be hurtful not only to the patient, but to the family. opening up unregulated pathways to drugs after only a phase one clinical trial may expose patients to severe and
unpredictable side effects. this bill would prevent f.d.a. from documenting these side effects and, worse, would prevent f.d.a. from protecting other patients from a similar fate. when a loved one is in pain, the last thing a family wants is to cause further suffering. we need clinical trials to ensure drugs are safe and effective, to find real cures and treatments for patients. and we need the f.d.a. to be a part of the process as a matter of patient protection for all. rescinding any f.d.a. oversight on unproven therapies that have not undergone multiple clinical trials is a slippery slope. the expedited process we have now is working and i cannot support a bill that offers a right to ask alongside proposals that could be dangerous for all. i urge my colleagues to oppose this bill. thank you and i yield back.
the speaker pro tempore: the gentlelady from california yields back her time. the gentleman from new jersey reserves his time. and the chair recognizes the gentleman from texas. mr. burgess: thank you, mr. speaker. at this time i am pleased to yield three minutes to a valuable member of our committee on energy and commerce, the vice chairman of the subcommittee on oversight and investigations, mr. griffith of virginia, three minutes. the speaker pro tempore: the gentleman from virginia is recognized for three minutes. mr. griffith: thank you very much, mr. speaker. i appreciate it. i have heard people say that they don't want to support a bill that makes things worse. we have people who are terminal, whose life expectancy is measured in months, not in decades. and how do you make things worse? i said last week and i repeat it today, that if i, if, and i'm not, thank god, but if i were faced with one of these heart-rendering situations, i would take any risk, including injecting monkey urine, if that meant i could spend a few more days, months or years with my
children. i think many people are in that same boat and the american people deserve a right to try. when we were doing our hearings on this, we had an energy and commerce subcommittee on health hearing where matthew bellina, who graduated from virginia tech in my district, and served in the united states navy, testified before us and he said in the conclusion of his comments, i know that it is probably too late for me, i have made my peace with that. i need to know before i die that if my children find themselves in this unenviable position, that this nation that i proudly served will respect their liberties and their right to make their own decisions about their medical treatments. . he suffered from a.l.s. i have three friends that died. ray, my predecessor in the virginia house of delegates. julie mullins, whose family i've known for decades.
and mike who was connected with the united states senate through his sister. all of these folks were people who lived in salem or roanoke county and they all died from a.l.s., they were all very brave people. they should have had a right to try. but even more poignant is my family friends who lost both a randparent and their mother to a disease. i was their family lawyer. i did their will. i would like to believe and i know they would have liked the option that their mother would have chosen the right to try knowing that even if it failed it might help another generation because, as you know, huntingston corea is a transmitted disease. so, ladies and gentlemen, i don't understand why people are afraid of letting people try who have no other hope, whose
life is going to be cut short without taking that hail mary pass, and so i hope that everyone will support this reasonable, measured effort to let people have a choice and a right to try and i yield back. the speaker pro tempore: the gentleman from virginia yields back. the gentleman from texas reserves his time. the chair recognizes the gentleman from new jersey. mr. pallone: thank you, mr. speaker. i yield myself such time as i may consume. the speaker pro tempore: the gentleman is recognized. mr. pallone: thank you. i want to explain some other reasons why i am very opposed to this bill. i am concerned that h.r. 5247 essentially does nothing to address what may be the true barrier to expanded access and that is the determination by the manufacturer as to whether or not they will provide access to their product that is under development. and i want to stress this, nothing in this legislation before us today that would compel a manufacturer to grant access upon request. further, i believe that trusted
manufacturers, like johnson & johnson, which is headquartered in my district, who said any compassionate use request must be subject to f.d.a. review. now, i heard my colleagues say -- refer to this as a hail mary pass for the terminally ill, but i think in reality it's offering false hope of a cure to patients and their families when there's no guarantee that any patient will receive access to treatment from a manufacturer. in fact, h.r. 5247 sets an extremely low threshold for the types of experimental treatments that may be available through this alternative pathway. by allowing patients access to investigational treatments that have only completed a phase 1 clinical trial, patients will be exposed to treatments with low no or little data. these extremely small trials only examine the safety and toxicity of a drug and do not determine the effectiveness or potential side effects.
access at this phase 1 stage in the development could expose patients to untested products and further harm and result in delaying access to a treatment that may be more appropriate and more beneficial for their underlying disease or condition. only one in 10 products move on from pays 1 clinical trials to f.d.a. approval. mr. speaker, the bill does not make any adverse event reporting to the f.d.a. immediate. it also limits f.d.a.'s ability to use clinical outcomes associated with the use of an investigational product when reviewing a product for approval if it could adversely impact its review. and it also prevents any entity from being held liable for use of a treatment. so, again, these are some of the many reasons that more than a hundred organizations oppose this dangerous bill, and i would reserve the balance of my time, mr. speaker. the speaker pro tempore: the gentleman from new jersey reserves his time. the gentleman from texas is recognized. mr. burgess: mr. speaker, at this time i'm pleased to yield four minutes to another member, valuable member of the
committee on energy and commerce on the health subcommittee, mrs. brooks from indiana, four minutes. the speaker pro tempore: the gentlelady from indiana is recognized for four minutes. mrs. brooks: thank you, mr. chairman. i thank the gentleman for yielding. mr. speaker, the right to try legislation will be considered on the house floor today. this is about giving people hope to try. it is about hope to try investigational drugs which have passed the first of three phases of the f.d.a. clinical trial process, the safety testing phase. and these investigational drugs could possibly prolong or save the lives of terminally ill patients. i'd like to remind my colleagues that a little boy was in washington, d.c., on the house floor just last week when we first voted on this legislation. prior to that vote, i had met jordan during an energy and commerce hearing focusing on the implementation of 21st century cures act. jordan mclinn is a second grader from indianapolis who may look like any other healthy
child, but he has duchenne muscular dystrophy, a fatal disease that causes muscle weakness. it's caused by an absent of a protein that keeps muscle cells intact. oftentimes, kids are wheelchaired bound by age 12 and have a life expectancy of just 25 years old. d.m.d. is typically passed onto boys through the mother's x chromosomes. sometimes there is no history of a disease but a child is born with the disease anyway. this is what happened to jordan mclinn. his mother, laura, is not a carrier. this disease does not run in their family. jordan was born with d.m.d. but was not diagnosed until he was 4 years old. so can you imagine what this family has been through? after jordan was diagnosed, his family hit the ground running, trying to find the best
possible treatment options and therapies for people with d.m.d. his mother, laura, was quoted in "the indianapolis star" today in an article focused on the right to try bill saying, and i quote, the reason we remained on this journey and fighting so hard for it is not necessarily for jordan immediately. it's for all patients we've met along the way. jordan and his family have been on this journey advocating this fair and compassionate bill in indiana and beyond for jordan but also for so many others. in 2015, then governor mike pence signed indiana's right to try law with jordan mclinn by his side. now a total of 38 states have already passed laws that take a variety of approaches to helping vulnerable patients. by passing this legislation in the house today, we will increase access nationwide to unapproved investigational drugs for patients with a terminal illness. in that same "indy star" article i shared earlier, laura
shared that jordan always want to be a firefighter. but now coming to the nation's capitol many times he has aspirations to be something else. he now wants to be president of the united states. this bill allows jordan to have those bill dreams and it will be providing patients across this country with hope. yes, it is hope, hope for patients that they may find a cure someday that they have been searching and fighting for. hope for patients and their families that there will be more time to make more memories that can last a lifetime. in closing, i'd just like to emphasize how critically important it is that congress join together to support the bill for the millions of americans who fight for their lives because of a terminal illness. i urge my colleagues to support this bill, and i yield back the balance of my time. the speaker pro tempore: the gentlelady from indiana yields back her time. mr. burgess: reserve. the speaker pro tempore: the gentleman from texas reserves his time. the gentleman from new jersey is recognized. mr. pallone: mr. speaker, can i inquire how much time remains on each side? the speaker pro tempore: the gentleman from new jersey has
15 1/2 minutes remaining. mr. pallone: i'd like to yield now such time as he may consume to the gentleman from texas, mr. green, who is the ranking member of the health subcommittee. the speaker pro tempore: the gentleman from texas, mr. gene green, is recognized. mr. green: thank you, mr. speaker, and thank my -- our ranking member for yielding to me. i rise in opposition to the right to try legislation that would bypass the food and drug administration's long standing review of oversight of drug treatments and endangering patients with life-threatening diseases. many states have passed this right to try piece of legislation, including my home state of texas, but the states don't have the f.d.a. the federal government has the right to be able to make sure we can protect both constituents and consumers. my heart goes out to the loved ones who are terminally ill and desperate for the breakthrough treatment. i can't support legislation that offers false hope to the
terminally ill and their families. the f.d.a. has a pathway whereby those in need of investigational medications may seek to obtain them. this program's known as the expanded access pathway or compassionate use which have been in the law since 1987. over the last decade, the f.d.a. has a clinical hold on only two commercial drug development programs due to adverse events associated with compassionate use. there are many patient advocacy groups that are opposing this legislation. groups such as the alliance for aging research, the american cancer society, cancer action network, the american lung association, the american society of clinical oncology, the cysticify broy cis foundation, the disability rights legal center. dozens more that are committed to seeking effective treatment, cures to many diseases which are terminal are against this bill.
these patients' rights groups seek to ensure the medication that's offered to individuals is safe and have been tested and has gone through proper approval process before it's given to a patient. the most vulnerable and terminally ill individuals deserve to have access to safe therapies that are -- have undergone the necessary approval process before it can be given to those that can -- may not -- may do them more harm than good. in addition to the physical harm, which unproven treatments may cause, there's also the risk of financial exploitation of terminally ill patients given that such treatments are not covered by insurance. manufacturers are not required to cover the cost of investigational treatment. the majority's decision to go around our committee's consideration and effort to pass a bill on suspension last week exemplifies what this legislation is trying to do, circumvent existing rules and processes that have been created to protect americans
from hasty decisions. i ask my colleagues on both sides of the aisle to oppose this unnecessary and potentially dangerous legislation and i yield back the balance of my time. the speaker pro tempore: the gentleman yields back the balance of his time. the gentleman from new jersey reserves his time. the gentleman from texas is recognized. mr. burgess: mr. speaker, at this time i'm pleased to recognize and yield three minutes to the gentleman from arizona, mr. biggs, one of the primary drivers on this legislation. three minutes. the speaker pro tempore: the gentleman from arizona is recognized for three minutes. mr. biggs: thank you, mr. speaker. i thank the gentleman from texas for yielding to me. i also pay my respects and give honor to ron johnson, the senator from wisconsin, who championed the bill in the senate, gave us a superb bill, and also to chairman walden and his committee that worked hard to give us this bill today. and also my original co-sponsor on the bill i introduced, mr. fitzpatrick from pennsylvania. now, i want to address a couple of things that i think are
really intreeings to me because it -- intrigues to me because it sounds condescending to me saying, i won't support this because it gives false hope that people might be taken advantage of by bad actors. they cannot identify the bad actors but they might be taken advantage of them. that's a fallacious and specious argument to make when you're denying people who have a terminal illness, who have been diagnosed with a terminal illness who have gone through all the already-approved f.d.a. processes in order to get and petition a pharmaceutical company for a drug that might prolong their life and might heal them. false hope, that argument is the argument that i'm hearing, but the reality is, these people are individuals. they have a higher sense of
reality than virtually anybody else i know because their mortality is there. they want the opportunity. it's not false hope. it is hope. support of this bill is compassionate. support of this bill is fair. i've also heard there may be some liability issues on the part of pharmaceutical companies which might impede them from providing drugs. yet, in order to satisfy them, the bill itself says that they are excould he pated unless their conduct -- excopated unless their conduct is willful. that means they have protection. what i'm asking here today and what everyone that i met with over the years who want a right to try is simply a chance to have some determination and control over their own life. one of the intriguing arguments i hear today, and i heard last
week, is, well, you know what, the pharmaceutical companies aren't compelled to provide these drugs. so my immediate question is -- so you would be more comfortable, then, if we would in ude a compulsory means the bill? do you want them to be compelled to provide these? and the answer is no. and it's simply they don't like this bill. they don't want the bill. and when you have 38 -- soon to be 39 states that want to give their citizens, americans all, the right to try to preserve their lives and to be healed and have a chance, they need to get that. they need that opportunity. we need to give it to them today. thank you, mr. chairman. i yield back. . the speaker pro tempore: the gentleman reserves the balance of his time. the gentleman from new jersey is recognized. mr. pallone: thank you, mr. speaker. i combliled self sufficient time as i may -- i yield myself sufficient time of as i may consume. the speaker pro tempore: the
gentleman is recognized. mr. pallone: there's been a lot of misinformation spread by supporters of this legislation that f.d.a. is a barrier to patients receiving access for these investigational treatments and i want to be very clear that that is simply not the case. f.d.a.'s expanded access program approves nearly all requests for investigational drugs or bi-- drugs it receives. for the past five years, f.d.a.'s approval rate for expanded access request has been over 99%. nine cal year 2017 only individual requests were denied. f.d.a. also conducts its reviews quickly. f.d.a. physicians are available 24 hours a day to approve any emergency expanded access requests the agency receives, typically grants emergency requests immediately over the phone and nonemergency requests in a median time of four days and generally no longer than 30 days. f.d.a. has also taken actions to stream line the expanded access request process for physicians to make it less burdensome. i think that was mentioned by mr. walden, the chairman.
pharmaceutical companies can choose to deny a patient access to an experimental treatment because, for example, there's not enough of the drug available or the concern -- or they're concerned about dangerous side effects. the fact is when a patient is denied access to an experimental treatment, it's because the company has said no. not the f.d.a. so let's be clear as to what this legislation is. it's an attempt to undermine the authority of the expert public health agencies charged with reviewing drugs to ensure their safety and efficacy. i would urge my colleagues to oppose this grab at f.d.a.'s authority. that's really what this legislation is all about. i reserve the balance of my time. the speaker pro tempore: the gentleman from new jersey reserves his time. the gentleman from texas is recognized. mr. burgess: mr. speaker, at this time i'm pleased to yield three minutes to the gentleman from georgia. the speaker pro tempore: the gentleman from georgia is recognized for three minutes. >> i rise today to encourage my colleagues to join me in supporting h.r. 5247, the right
to try act, and i think -- i thank dr. burgess and the energy and commerce committee for bringing this important legislation to the floor of this house. in certain states across our nation, patients who are diagnosed as terminally ill are being told by doctors that all of the treatment options have been exhausted because they do not have access to experimental drugs. mr. allen: this type of overregulation by the federal government is creating hopeless situations for thousands of americans that we hold dearest to our hearts. this right to try legislation allows terminal patients to have a choice on whether or not an experimental approach is the path for them. and sometimes and many times this is their only option. should this bill become federal law, our terminally ill patients will have increased access nationwide to unapproved drugs, leading to more scientific
breakthroughs that will benefit l americans and in lots of cases will save a life. now is the time for congress to take action and give terminally ill patients a fighting chance for their god-given right to life. how in god's name can this congress deny an american the right to life? i urge all of my colleagues to join me today in supporting this bill on this floor and with that , i yield back. the speaker pro tempore: the gentleman from georgia yields back. gentleman -- back. the gentleman from texas reserves his time. the gentleman from new jersey is recognized. mr. pallone: mr. speaker, i yield myself such time as i may consume. the speaker pro tempore: the gentleman is recognized. mr. pallone: mr. speaker, i said before that i found that some members were looking to vote for this bill because they said, well, we have right to try in our state by state statute, so what's the difference if we do it on the federal level? and i just want to stress again
that the state right to try laws do not give patients a right to try effectively and have done little to expand access to investigational treatments. there are 37 states and the district of columbia that have enacted right to try laws. and there's no evidence that anyone has obtained an investigational treatment via these laws that couldn't have been obtained through f.d.a.'s expanded access program. right to try laws do not compel companies to provide patient access to investigational treatments, therefore under these state laws, patients still do not have a right to try, only the right to request the treatment from the company. and state right to try laws do not address the fundamental barriers of cost and company restrictions. neither the f.d.a. nor states require insurers or farm suit cap companies -- pharmaceutical companies to cover the costs of these treatments. instead these laws put patients at higher risk by weakening f.d.a.'s oversight of investigational treatments. and i would reserve the balance of my time. the speaker pro tempore: the
gentleman reserves the balance of his time. the gentleman from texas has 5 1/2 minutes remaining and is recognized. mr. burgess: thank you, mr. speaker. at this time i'm pleased to recognize the chairman of the veterans' committee for three minutes. the speaker pro tempore: the gentleman from tennessee is recognized for three minutes. mr. roe: thank you, mr. speaker. i rise today in strong support f h.r. 5247, the right to try. i'm a physician and scientist with over 40 years of experience traiting patients, some of whom had the dreaded diagnose siffs cancer -- of cancer. six months ago i was -- diagnosis of cancer. six months ago i was diagnosed with cancer and i am a cancer survivor. if needed i would like to have the right to try. a little over three years ago my beloved wife, pam, a nurse, and friend died of stage four colon cancer. she would have liked to have had the right to try.
less than two month after that, one of the best friends i will have in my life, filip street, a vietnam veteran, air force veteran, died of a cancer related to agent orange. he would have had liked to have the right to try. my senior partner in medical practice a year later, good friend, was diagnosed with brain cancer. he would have liked the right to try. shortly after that, linda baines, a scrub nurse that i operated with hundreds of times in my medical practice, was diagnosed with cancer. linda would have liked the right to try. i have two dear friends at this moment who are both being treated for stage four cancer. if those treatments don't work, and i've had to look patients in the eye and say, mr. speaker,
your life is not in my hands anymore, it's in god's hands. they would like to have the right to try. i ask you this, that all these patients want and deserve is a right to try. please, i'm asking you to support this legislation. mr. speaker, with that i yield back the balance of my time. the speaker pro tempore: the gentleman from tennessee yields back his time. the gentleman from texas reserves. and the gentleman from new ersey is recognized. mr. pallone: i was going to ask how much time remains. do you have any additional speakers? on your side? mr. burgess: i'll be closing. the speaker pro tempore: the gentleman from new jersey has nine minutes remaining. the gentleman from texas has two minutes remaining. 3 1/2 minutes remaining. mr. pallone: i'm prepared to close. the speaker pro tempore: the gentleman from new jersey is recognized. mr. pallone: i yield myself such time as i may consume. the speaker pro tempore: the gentleman is recognized for the remainder of his time. mr. pallone: thank you, mr.
speaker. i just wanted to stress that, as -- the efore, we have four previous f.d.a. commissioners, two democrats and two republicans appointed by president bush, that have raised serious concerns about this legislation. because it excludes f.d.a. review. and they think could pose serious risk to vulnerable patients. and i just wanted to read once again a statement that they made jointly to "the washington post" where they said, there is no, and i quote, there is no evidence that this bill or the senate bill, for that matter, would meaningfully improve access for patients. both would remove the f.d.a. from the process and create a dangerous precedent that would erode protections for vulnerable patients. mr. speaker, i just want to stress to my colleagues on both sides of the aisle that my concern is that no one is actually going to be able to get
an experimental drug by this bill. in other words, if you're a manufacturer that actually has done something and come up with an experimental drug that you believe will make a difference to someone who is terminalliel, you're likely going -- terminally ill, you're likely going to want to go through the f.d.a. expanded process because there's a seal of approval that the f.d.a. has looked at this and said that it's relatively safe to use. and so my real fear is that the only thing this is going to do is open up to the possibility of some, you know, fly-by night snake oil drug company or manufacturer who is going to make all kinds of claims that have not been reviewed by the f.d.a. for any kind of safety, and that then people may say, ok, well, i'll take that because i'm terminally ill and i might as well try something. but that isn't really what we should be doing here. we should be providing a process, as the f.d.a. does right now, where someone is
terminally ill and they want to try something that they at least have some -- something, that they at least have some certification or approval by the f.d.a. that this is something that may help you, that may make a difference, and that, you know, in the case of that 11 -- about 11% of the cases where applications are made to the f.d.a., some changes are made to make sure that even though there's a certain level of risk, that that level of risk is reduced by the f.d.a. putting on additional safety precautions. and so my real concern here is i don't want people to vote for this legislation thinking that somehow it's going to make a difference. i really don't believe that's true. otherwise i wouldn't urge the opposition that i am. but for all these reasons, i do urge strong opposition to this bill and i ask that my colleagues vote no. i yield back. the speaker pro tempore: the gentleman yields back the balance of his time. the gentleman from texas is recognized. mr. burgess: thank you, mr. speaker.
i yield myself the balance of our time. paula: the gentleman is recognized for the balance -- the speaker pro tempore: the gentleman is recognized for the balance of his time. mr. burgess: thank you, mr. speaker. yesterday on the rule debate for this bill i outlined a case where former speaker, previous speaker, nancy pelosi, provided the right to try for a patient, a democratic donor, back in my home state of texas. so really all we're asking today is that we give regular americans, forgotten men and women of this country, give them the same rights that the speaker of the house provided to a democratic donor back in october of 2008. yesterday i quoted from an article from the dallas morning news. i have a different but similar article today. talking about the same case. talking about the individual who had a diagnosis of multiple my loama -- myloma. there was a drug that perhapses would provide some hope. the individual was clearly
terminal. this ant body that was primarily used to -- antibody that was primarily used for something else might help this parent. the drug had been through phase one clinical trials. the patient zrnt time to go -- for the dug to go through phase two and phase three clinical trials. the article says, enter nancy pelosi, through means which we've never been privy, ms. pelosi got the f.d.a. to give the manufacturer the all-clear to give the drug to the patient. the patient got the drug, the patient took the drug, but unfortunately the patient died anyway. but his family remains grateful to the speaker for interseeding on his behalf. and i don't doubt that they are. yesterday i quoted the "dallas morning news" article where the patient's spouse said somehow nancy pelosi got it done. you know what, mr. speaker, you shouldn't have to depend on the speaker of the house to
interseed on your behalf, to get the f.d.a. to get the manufacturer to make a drug available. if you're really up against a bad situation, wouldn't it be better if we provided everyone that same pathway? that's what this bill does today. that's why the right to try legislation was advocated by the president of the united states. in fact, i think it was the only legislative priority that the president laid out during his state of the union address, are we wanted to see congress act. -- where he wanted to see congress act. so today we are going to do that. today we are going to act. it's an important bill. i encourage my colleagues to vote in favor of it. and i will yield back the balance of my time. the speaker pro tempore: the
-- here's a look on look at all of our programming. the houses in it 9:00 a.m.. he is also expected to give an for policy for the trump administration and a finance meeting that starts at noon. ♪ washington journal live every day with news and policy issues. coming up today, texas republican on the finance republican funding bill line. and jamie raskin talks about legislative efforts to reduce gun violence efforts. be sure to watch washington journal live at 7:00 a.m. eastern this morning. join the discussion. a former u.s. ambassador to the ukraine moderated a