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tv   FDA Commissioner Testifies on Baby Formula 2023 Budget  CSPAN  May 20, 2022 4:04am-5:53am EDT

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importing from overseas manufacturing plants. >> good morning. i want to welcome all of you to today's hearing. the hearing this morning is reviewed the food and drug administration's fiscal year 2023 budget request. our witness is the commissioner of the federal drug
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administration, dr. robert califf. before we begin with the proceedings, i would like to welcome a new member to our subcommittee. ms. julia ludlow representing the fifth district of louisiana was recently selected to join us. welcome to the wonderful world of agriculture appropriations. dr. califf, we would first like to congratulate you on your confirmation. it has been over a year since the fda had a permanent leader during a time when the agency continues to have vast and ever-growing responsibilities. our fda continues to play a vital role in ensuring the safety and efficacy of vaccines and drugs designed to address the coronavirus. there are countless ways in which your work matters to all americans and we need to make
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sure this gets the critical attention and needs. we will discuss the overall safety and effectiveness of their products under the fda's preview and progress can be made on the food and medical sides. aside from covid-19, a myriad of other issues including combating the opioid crisis, tobacco use and standards on tobacco flavors all have real-world impacts on americans and their health. at the forefront of many minds right now, is a critically low supply of infant formula affecting so many american families. the american people rely on the fda to protect infant health by ensuring they have access to safe formula. we will discuss with the fda is doing to mitigate shortages and what changes can be made to move the inspection process of
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manufacturers. this includes harmful delays and inaction on warnings at the sturgis, michigan facility. the agency received a warning as early as december 2021 but did not take action until january 2020 two, which is indeed unconscionable. i would also like to hear about the backlog of foreign inspections. over 75% of active drug ingredients are provided by foreign countries including some with very poor safety profiles. feeling concerns of drug manufacturing from foreign countries, these facilities must be held accountable and treated equitably with u.s. manufacturers. unfortunately, food related illness, outbreaks of e. coli and salmonella, of toxic metals
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and baby foods and other concerns continue to be of monumental concern. every time the fda sits down for a meal or takes a pill, they deserve an fda that is at the top of its game. we will work with you to help modernize the fda so you can carry out your mission of protecting the health and safety of all americans. i want to thank you for being with us today and i look forward to our discussion. i wish to commend the commitment and talent at the agency of certain issues. we recognize the commission -- commitment of those who work so hard at the agency to keep our food, medical devices and prescription drugs safe. in that vein, a special shout
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out to the leadership and staff at the center for biologics and center for devices for the monumental efforts to get vaccines and tests for covid-19. now let me ask our distinguished acting ranking member, dr. harris, to give any opening remarks he might have and i certainly would like to recognize him at this time for that purpose. dr. harris, you are now recognized. >> thank you, chairman bishop. i also want to welcome ms. letlow to the committee and congratulate her on being a subcommittee member. we all look forward to working with you this year. dr. taylor, -- dr. caliph, i want to welcome you to the meeting. $8.4 billion is quite steep.
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i recognize the $1.6 billion in many where -- mandatory funding is part of the preparedness plan, but setting that aside, the fda is still seeking an overall increase of $509 million, above fiscal year 2022 with 150 $3 million coming from new user fees. without a doubt, the fda does critical work that touches the lives of all the americans. however, this does not address the economic reality our nation faces. in times like these, as stewards of taxpayer dollars, we must make tough decisions in the greater interests of the american people. growing aside the government programs and federal workforce is not in the best interest of the nation's economy and future. it further i believe many problems facing your agency can be solved strong leadership rather than more money. for example, if i'm sure you are aware, last month politico ran an article titled the fda's food
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failure. there were repeated concerns like the lack of leadership, the slow decision-making processes and the lack of transparency and accountability to congress. too often, we as appropriators hear how problems will be solved if there was only more money or only more staff, but i disagree. leadership is needed to be good stewards of the resources at your disposal and to make sure the fda's fulfilling its core critical mission. nothing makes that clearer than the recall on shortage -- and shortage of infant formula that is causing an unimaginable a bul amount of stress and anxiety. 40% of formula is out of stock yet one of the largest manufacturers has had one of third -- one third of its production halted since february. we need to make sure the plant is re-safe to open but it hardly seems the fda has made a priority to get the plant clean and clear them back online. in light of this issue and many other highlights, it gives me
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great concern. i want all populations to have healthy foods and nutritional information they need to make healthy decisions, but other agencies within the department of health and human services along with the u.s. department of agriculture are already doing this type of work. rather than engage in duplicate of efforts, i urge the fda to focus on its core response abilities. it is clear upon the infant formula recall, and examples in the politico article, that they don't need to take on new initiatives, they need to focus on critical shortages first and let the other agencies pass with promoting and nutrition information do their job. dr. califf, we had the chance
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to talk and i asked about the standards, health care supply chain vulnerabilities and other topics i look forward to discussing today. specifically i would like to see the fda do more to utilize emergency authorities to mark quickly and effectively respond in times of crises. i'm sure all of us are eager to hear how you will be bringing leadership in light of the recent challenges the fda has faced. i look forward to working with you and i appreciate you being with today's hearing. thank you mr. chairman and i yield back. >> thank you, very much. at this time, i see we are fortunate to have the full committee chair with us. i would like to know yield to chair woman rosa delauro with any remarks she may have. you are now recognized. the floor is yours. >> thank you chairman and thank
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you to the acting ranking member harris for holding what is a very important hearing. i want to say thank you to you, commissioner califf, for testifying this morning. we are dealing with an infant formula emergency in this nation, a crisis of both safety and supply. i sounded the alarm on this crisis and have been working on this issue since news of the recall broken february. i'm glad you're testifying before us today because we need to get to the bottom of the disgraceful lack of oversight and terrible safety issues from an abbott nutritional manufacturing plant that led to at least two babies dying and several others being hospitalized after consuming habits info -- abbott's infant formula.
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we need to get to the fda response which continued to let this be on the shelves, and now forcing parents to play a game of russian roulette that they did not know they were playing. as a thank you to chairman bishop for holding this hearing and your long-term leadership on the subcommittee. in september 2021, fda inspectors conducted a routine inspection of the abbott laboratories. from a reporter who obtained the fda report through a freedom of information act request, on october 20, 20 21, a whistleblower who worked at that facility submitted a report to the fda, unveiling a damming list of allegations of wrongdoing at the hands of abbott. but if the allegations are true, the company has lied, cut
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corners, falsified records to cover up their misgivings at the risk of infant health, and retaliated against employees who try to correct the problem they were seeing. they knowingly put a contaminated product on the market. that is plain wrong. the fda knew about what abbott was doing in october but it was not too late in december when the fda interviewed, and not until on the month after that was the plant inspected in person. abbott then issued a recall in february, some four months later. in march, i requested an hha office of the inspector general to look into the tragedy and then i got a submission of the record for the whistleblower support with awful allegations against abbott. the wrongdoings include the falsifications of records, the testing seals on empty cans, releasing untested infant formula, just to name a few.
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it all begs the question, why did the fda not spring into action? why did it take four months to pull this formula off of shelves? how many more illnesses were caused and deaths due to this response? who received the report from the fda? what did they do with the report? who in the leadership had access to the report? who didn't have access to that report and why was there no reaction? it makes me question on the side the fda is on. r8 they on the side of abbott, industry or the american consumers? in this case, babies and their moms and dads. we must get to the bottom of the food safety issue but today we are dealing with a serious infant formula shortage in the country. parents, many of them struggling, are now scrambling to find formula to feed their babies. the shortage was caught by the lack of action by the fda and by corporate greed and consolidation. in this case, abbott putting
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profits and production over people. this should not happen in the wealthiest nation in the world and there are two parts of the shortage. safety and supply. we cannot and should not have to choose between the two. i reject this dangerous and false tech caught me. president biden -- this false dichotomy. president biden plans on using federal planes to fly formula in from abroad. i have been calling for the swift importation of safe infant formula from fda approved facilities overseas. that is the direction we need to go in. that is w what hope is being planned. i applaud the first steps. this week and this past evening, we have a bill. last night we voted on a bill to provide $28 million in new funding for the fda to address
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the shortage, to prevent fraudulent products from entering the marketplace, and help acquire better data on the situation in the marketplace. to prevent shortages from happening again, we will work to strengthen the workforce, focusing on formula issues and increased fda inspections. but as the ranking member has pointed out, funding is not the only answer. this issue goes beyond funding. that has to do with a structural problem. for another time, i would like to discuss the need for a deputy commissioner for food with accountability for the commissioner and have direct line authority over the centers for food safety and applied nutrition, the center for veterinary medicine, and food related components and operation of the office of the regulatory affairs. this should happen immediately and the person who is appointed
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needs to have relevant and appropriate food credentials. someone with that background who understands this issue. i understand the fda has begun to take action to address the shortage, which is encouraging. i remain concerned about the safety of the formulas that end up on our shelves, and as i have said, we cannot be forced to make a false voice -- choice between safety and supply, and i'm disappointed that the recall did not go far enough to ensure formulas are safe for babies because the food we feed babies must be the safest product on the market, which is why i want to focus on fda approved facilities. we have a standard that may not have been applied to abbott, but we have a standard. when people grab a container of infant formula from the shelf, i want them to know that they do not have to play a guessing game. i want them to know that they can have confidence that it is
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safe. commissioner califf, i hope you have been able to reflect on what went wrong, and with that comes answers, because we are all waiting for them. we need to get to the bottom of this terrible tragedy to prevent anything like this from ever happening again. and i thank you so much chairman bishop and acting ranking member harris and i yield back. >> thank you, ms. delauro. thank you for your passion and compassion on this issue. it appears that ranking member ranger has not yet entered the meeting. so with that, dr. califf, without objection, we will recognize you for your testimony during your entire written testimony will be included but i hope you will give a somewhat abbreviated statement so we can
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proceed. i'm sure members have a number of questions and we would like to expedite as much as possible. so at this time, dr. califf, you are recognized for your opening remarks. dr. califf: thank you, mr. chairman ed i will go quickly because i certainly understand your request. chairman bishop, ranking member harris and members of the subcommittee, thank you for the opportunity to appear today. let me thank the subcommittee for your continued support of fda particularly over the last two years as the agency has worked tirelessly to respond to the covid-19 pandemic and other challenges facing the agency including the recent stress on the recent formula supply chain. before discussing the fiscal year 2022 request, i want to address the formula.
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as a parent and grandparent, i recognize many parents and greater -- caregivers have been unable to access the infant formula and critical medical foods they need, and they are understandably frustrated and anxious. my daughter spent a month in an intensive care unit as an infant, and the memories are certainly still with me. the united states was facing infant formula supply chain stress even before the abbott nutrition recall that began in february. the pandemic, the war in ukraine, and labor supply issues all had an impact and i can assure you the fda has been working tirelessly to address this issue. this week, we set up a mechanism that streamlines the ability for companies that do not normally sell infant formula in this country to do so and provides other flexibilities to domestic distributors to help increase the availability. i want to be clear. under this process, and infant formula would only be imported after the agency reviews the product and determines the
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product is safe and provides adequate nutrition. safety is paramount. in addition, a consent to create and permanent injunction was entered between the fda and abbott nutrition. under the consent degree, abbott has agreed to take action overseen by the fda and independent experts that will result in an increase of infant formula products, and ensure safe powder to formula is produced at the facility. as you also know, yesterday the president boasted the defense production act to ensure manufacturers have the best ingredients to make safe, healthy in front formula, here at home and announced operation fly formula to speed up the import to stores as soon as possible. again, we know many parents and caregivers are feeling frustrated. with these three recent actions, we anticipate additional products can quickly hit u.s. stores. we have a critical opportunity here to invest in the fda's ability to work with partners to
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ensure safe, adequate supply of infant formula and metabolic formulas for the millions of infants who rely on them for their sole source of nutrition. approximately 3.5 million infants are born annually in the u.s., yet this is funding for only 13 staff members to ensure the safety and adequate nutrition of these products. we also have no authority or dedicated resources to monitor and respond to supply chain disruptions. this crisis has shown us the impact of having a single manufacture ceased production for a brief period and unless we strike, the resilience of our supply chain, we can be one natural disaster, mishap or cyberattack from being here again. i hope i can work with this committee to ensure we have the tools and resources we need moving forward. i know parents want formula on the shelves for healthy infants and in the hands of pediatricians for infants with special metabolic problems.
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the american public is our customer, hi erdogan considering the budget to give our public funding for technology and experts at least as good as businesses we regulate. no modern company or health system would make such major decisions without a robust and good analytical system. our budget requests will help build a foundation for fda to ultimately enable the agency to meet the growing needs and mandates upon which the public depends. while there are many critical priorities in the budget proposal, i would like to mention three specific needs that do not get enough public attention public attention. the technology and data systems we have are not of the quality we need for us to fully facilitate innovation in a rapidly moving industry, in order to protect the public from well-meaning or intentionally harmful products.
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final thought here. when we review the infant formula situation, we will certainly find specific issues where we could have done better, and we will of course take accountability for any shortcomings, but unless we make the wrong investments in our infrastructure, including technology data people and a modernized supply chain system, we will continue to seek shortages and problems across the industries we regulate. thank you for inviting me and i look forward to answering your questions. >> thank you very much, commissioner. at this time, we will begin our questions and i will begin. commissioner, there will be a lot of questions about the infant formula crisis, but i want to lead with the most basic question, and the subcommittee wants a real answer. it is unconscionable that it
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took four months from the time the first report at the plant. why was that? anyone goes through how you get the abbott plant back on land? the president has invoked the defense production act for the shortage, and we will get formula from other countries flown to our shelves. but this is a temporary action. what is the fda going to do to assure that this product is safe? as the chair lady has pointed out, not only do we need supply, but we need safety. would you address that? dr. califf: first of all, the question of what happened. i think the chairman delauro correctly stated the time frames. the dates are well known.
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the information is in the public. we have an ongoing investigation about the details of exactly what happened from point a to point b along the way. since it is ongoing, i can't give extensively more details on that part of it. i will comment directly on the issue of bringing the sturgis plant backup. i think the issues you had raised in your opening comments are really exemplifying the problem we faced when we have a concentrated industry, where taking down one plant has such an enormous impact. this creates a situation where we have a delicate balance. if conditions are unsafe, how do we get the plant backup and now operating without interrupting supply chain? this plant not only makes infant formula, what is the largest supplier of a special metabolic formula for 3000 infants in the country that are totally defended -- dependent on this
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special formula no one else makes. we had to really wrestle this to the ground with abbott and have a consent degree with the justice department to make sure as we bring the plant up, both the fda and external experts are watching every step of the way. i am pleased to say today we already made significant progress and i think we are on track to get open within the next week to two weeks, most likely at the outer bound, two weeks. >> thank you, commissioner. i hate to interrupt do, but i wanted to go to another question, quickly as my time is going to be expired. you heard references to the politico story indicating a quote that current and former officials using the terms ridiculous, impossible, byzantine and a joke to describe regulations at the fda and there are questions about the leadership. what can we expect?
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you announced last night you plan to leverage the principal deputy commissioner expertise to print -- to provide accountability including the center for food safety in the office of ray literary affairs. what can we expect from this to improve the situation? what is your option for restructuring the center? dr. califf: thank you for raising those questions. i learned in 2016 that the food side of the fda was under resourced consistently, very much so compared to the medical products side. we will make sure you are supplied with a comparative information it. is very important we have the proper hiring authority and are able to pay the salaries of scientists, but you are also raising the question of leadership. i will mention many of the most critical people were in positions of leadership in the past. they are certainly in a place to
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know this is not a surprise. as i was considering coming back to the fda, many of them called me. i was very well aware coming and that we need to do major improvements on the food side of the fda, not because people are bad, but there is a need for consistent leadership and the right resources for people to get their work done. >> mr.
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under that guidance, could we be importing formula from china? >> it is not our primary intent to be bringing an formula from china. it is not our first call. that is not excluded under the guidance but we know a number of the facilities around the world where we have experience already as the chairman already pointed out. >> thank you. my concern is that during covid, we have not done as many inspections overseas and now we are going to be bringing in things from overseas where perhaps the inspections over the past few years have not been as rigorous. a lot has been said. that it came from the abbott
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plan. in my right is saying there was no link based on the genetic analysis? >> this is very complicated so we will have to get back to you on the details but we cannot connect the cases directly to the abbott plant. but the investigation is not over because corona factor is a very difficult organism to culture. we have five different ones that don't match up. saying that the cases came directly from that plant is not something we can say until the investigation is entirely completed. >> thank you. i think that ms. psaki of the
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white house said it came from that plant but to correct the science, that link has not been definitively made. it may well happen but it is not proven. the administration said we could have 100 million cases of covid this fall. it could be a new variant. i am still concerned there is no end-stage treatment. those are for individuals who have gone to the icu and put on a ventilator, had pneumonia. we know there is not a good treatment for that under emergency use authorization. i would just urge and ask if this is of concern to the fda. i know -- we have talked about this. the regulation is pretty clear and the statute is clear. it may be effective. it should be the guideline for
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when it may be issued. as you know, there are studies being done. phase three trials on that stage therapies. they may be effective there in stage three. there is no other treatment. could you address what the fda is doing this fall? we actually have this emergency use. >> we do have treatments that are effective. they are not curative but they have a benefit. we are always looking for this. this happened very quickly.
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>> thank you very much mr. chair, i yield back. >> at this time, i am delighted to yield to the gentlelady from connecticut who has been so vigilant -- diligent in monitoring this issue and bring it to public attention. i will yield for questions. >> thank you very much. a couple of very quick facts. food safety is not a priority. there needs to be a restructuring on people who know about food safety. it mutates overtime.
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my question is if you have read the report. >> i have looked at it, yes. >> what was the allegation that concerns you the most? >> i have recently been in the position of being the person in charge. the most concerning charge is the integrity of the organization was compromised. once that integrity was compromised, the question is how can you trust any of the systems in place? >> and yet, whoever looked at that report felt there was no need to respond at all from october to february.
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it appears that person is going to oversee this effort. that is the fox in the hen house. let me ask you about this issue. for the guidance you put forward, you said it is recommended but not required information for the manufacturers and the manufacturers are most likely not fda approved. you have seven fda approved facilities you could go to a medially but what you're talking about in the guidance are recommendations that are not required to be followed.
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in the application for certification and for review. will you commit to not exercising enforcement discretion with respect to critical statutory and regulatory safety requirements? >> yes with an emphasis on those critical requirements. we will not let formula enter the u.s.. >> these people do not have to abide by your recommendation. it is a guidance. nothing is required. >> with due respect, madame chairwoman, you are correct. we have control over whether we can let the product in or not. >> if you have someone who is certified and you are also talking about this, people can
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have a third party certified so that you in fact do not have the tangible evidence from the facility that it is safe to be imported, that baby formula is safe. i just want you to commit to the safety portion of this effort and you don't have in place a mechanism that would guarantee the safety right now. you just don't. that guidance does not allow you to determine and to define the safety of the products that may be coming from facilities that are not fda approved. why aren't we going to facilities that are fda approved and not allowing all of these other potential manufacturers to enter into our system with the
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potential of creating another crisis. guidance does not does not standardize across applications. you pick and you choose. if you don't have standards going across the board, you don't have a standard application. i apologize to you mr. chairman for going there. >> thank you. hopefully we will be able to come back. i would like to recognize the gentleman from california. >> thank you, mr. chairman. mr. taylor, thank you for coming to testify. this hearing is very timely as the shortage is an emergency.
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we are all hearing from our constituents about the dire situation. between the formula recall and plant shutdown and ongoing supply chain disruption, they will not be able to see the babies. this has become a dangerous situation. many in my district are suffering from the consequences of the recall that started three months ago. these families have been suffering through the covid-19 pandemic, ongoing supply chain issues and inflation and more and they need a break. it has taken too long to get to this point. we must ensure the shortage immediately. because in our countries are not a new thing. it seems the fbi did not take this seriously. this is not about purchasing a popular and trendy kind of
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formula. this is about a specific formula that parents need for their babies. i had to drive all over town to chase specific formulas. i can only imagine what these parents are experiencing. did the fda to treat this like any other recall they have had to deal with or did they understand the graduate -- understand the gravity of the situation? do they grasp how devastating this entire situation has been and continues to be? >> i think you for raising specific issues of concern. from day one, when we saw the problems, we knew this was a critical plan for the supply chain and the team was meeting
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on a regularly -- very regular basis trying to figure out how to manage the situation, hoping to keep the plant open with better quality measures. that became clear that was not going to work. we had to reach a consent decree which brought forth a legal proceeding. many of us are grandparents or parents. many of us have relatives in the same situation. we are hearing from everyone so we are very focused. >> we appreciate that. we hope you understand that this is something that has had immediate -- had an immediate effect. i know that chairwoman had mentioned that -- i would like to know what the fbi is doing on the ground and what the plan is to help the situation as much as they can. are they working with them? are people on the ground making
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sure we can get the facility up and running? >> we are working with them every day and i am getting a report twice a day about the progress being made. we recognize we are just on day three now but it looks like it is going well. it looks that abbott has remediated a lot of the issues. >> i think you mentioned dr. woodcock will have a greater role in the strategic counsel. i know she has tremendous expertise on the drug side. i am hearing about whether this decision will lead the food side. will you help me understand the rationale of that decision? >> sure. i would say this is just a start of the change. we are going to do to make major
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changes. dr. woodcock knows every nook and cranny of the fda. she knows how the operations work. she already has information technology redesign underway which is critically needed. to think about our inspectors out there comparing the technology they have. it is night and day and we had to fix that. that way they can be efficient. that is just the start of a change. she is not going to be permanently in the job. she still reports to me and we will make further changes that you will hear about. >> thank you. i am delighted to recognize the gentlelady from maine. you are now recognized for your questions. >> thank you so much, mr. chair. thank you for having this critical hearing at this moment in time. thank you for being with us
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today and answering our questions. i just want to associate myself with the questions that have already been asked by chair bishop, mr. val dale on both sides of the aisle. obviously this is a very troubling situation and i will not repeat all of the same questions, i just want to say i am concerned that you are not providing us with more detailed information. i think we have to dig deeper into this troubling pattern of leadership challenges and structural issues. food safety at the fda, this is new and we have to work on this and this is a huge crisis for america and i am very concerned about where we are. i will just pivot because like i said i feel very grateful that my colleagues have been asking the questions and i know others will be asking more as well. i want to talk more about vaccine access for children. i really appreciate that the fda has done some challenging
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essential work over the last two years on covid. particularly in the vaccine space. one key group with no authorized vaccines are children five and under. i appreciate how important it is to evaluate safety and efficacy. that is a huge concern in america. i am hearing all the time from parents and caregivers in maine that are really frustrated and feeling behind. any further delays, these children will go through another school year unvaccinated. can you commit to us that reviewing any potential authorization for vaccine covering children under five will happen as quickly as possible and what time length can we reasonably expect and tell people you will follow once an application is received? >> i have been involved in children's therapeutics my whole career and one of the major lessons is children are not just
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small adults so you have to do specific studies for the size and mechanics of our children. having said that, we now have the moderna application in hand. as soon as we are ready, we have a number of days reserved for the advisory committee meetings. as soon as we are ready, we will have that meeting and have the advisory committee weigh in on whether the safety and efficacy are adequate. the pfizer application should be coming sometime soon also. i have two grand children age five. i am very much in the same boat being described. >> there was some talk for a while that the fda would wait until the pfizer application was in which seems really unthinkable not to move forward as quickly as possible but for
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some level of efficiency, i don't know what the rationale was. >> there is no delay in the modern application because of another application. i don't need to tell you that sometimes discussions that are held as you are developing a strategy gets touted as if that is a decision that has actually been made. that was never the case. i want to refute that from the beginning. >> thank you for setting that straight and for moving with all appropriate speed. that is a critical age group. they have different bodies and needs. i do want to be as safe as possible. congratulations to you on having these two grandchildren under five. we hear this from other caregivers all the time. thank you for the work you have been doing. please continue this.
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>> i know recognize mr. mona of michigan. he is on mute. technology gets you, we will come back to you.
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>> thank you for being here with us. i won't repeat what others have said. i would like to ask you about the money that was just appropriated. i would like to know how an additional $28 million assures parents that imported formula will be safe for the children, how it will help replenish the inventory and grocery stores in a timely manner. did you request this additional funding? especially in light of the fact that we increase to the fda
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budget by over $100 million. could you shed some light on some of the money for us? >> safety has to be paramount. the book of that money would go for inspectors to make sure material is not being put on the shelves which is unsafe. we also need the in-house expertise. this takes a whole number of people to make sure that every single aspect --
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health care systems were not depend on this. we need to do something about it in my opinion. this takes a high quality scientists to do the analyses to figure out how quickly we can bring these closer to zero. these things are all critical to our most vulnerable people, our children. >> did you request the additional funding? >> yes. >> we will have a lot here.
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there is some action to be taken -- there is no direction. can you tell us about what was discussed in july of 2020? a report on mislabeling this specifically? >> the amazing plethora of derivatives of the cannabis
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plant is really quick profound. most of this has been spent on research to figure out what the risks are of this material and its different forms. we are committed. i just want to tell you, 2016, it looks pretty much the same in terms of where we are. i am very committed to take a bath on this and to put a marker down. this is what we have -- this is what we need. we would have to be very committed to do that.
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>> thank you. i really appreciated the previous conversations we had. i can't talk about it. you can talk about it. honestly, you should talk about it. you guys are not good at communicating and this is something the parents asked about. you guys have to get that down to make sure that real people understand. that is not acceptable to understand. we just want to put that out there. the public wants to know more. i also shared on all the questions people asked in this area.
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when is that going to be available? let me go to a couple of different subjects. cbd. technically, cbd sales in the eyes of the fda is legal. >> we will need a different pathway than just the standard food pathway. i told you and i really mean it, i am committed to do something about this. i hope you will work with me on that. it will take some creativity. when you come back six years later and nothing has really changed, that does not mean you can keep doing the same thing over and over.
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>> this is the frustration. also, that conversation, i sent a letter to secretary becerra. a bipartisan letter. there is an emerging science -- you recently put more import others on companies that are doing a legal and proper way of doing this. the real question is if there is a way to try to live that import restriction on the companies that followed all the rules. right now, it is kinda getting everyone with one fda order. i think it is extremely antiquated position.
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>> i do look forward to coming back to you. hopefully in a couple of months with very specific suggestions on what to do. we do have real negative things that have happened to people. it does import -- interact with multiple neurotransmitters. we will go where the science tells us to go. like i said with regard to cannabis products, we need something different for these kinds of products that are not traditional foods or traditional drugs. >> you also recently updated the backseat with only minor modifications and honestly there is not only arguable conclusions but you are linking to covertly inaccurate information again in
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this letter. secretary becerra seems to have a different position. if you could just look at that, that update is not much of an update and i think that is being very unfair to the consumers. i will yield back. >> i will look at it. thank you. >> thank you. >> you are now recognized. >> we will try to come back to
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you. misled the -- ms. ledlow, you are now recognized. >> thank you. i am honored to join this distinguished community and have the opportunity to represent the priorities and the communities throughout the delta region. as the newest member of the subcommittee, i am eager to work with my colleagues and advocating on behalf of our farmers, ranchers and forest plans. agriculture is the backbone of my district. as a mother of the four-year-old and a two-year-old, it was not long ago that i was completely defend -- completely dependent on infant formula. i can only imagine wearing the parents across this country are feeling as they desperately search for formula to keep their children alive quit literally.
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but some parents forced to admit their children to the hospital when no formula can be found. this shortage impacts parents and health care providers nationwide. it is at the forefront of everyone's mind today. for my district, it is incredibly important that we work in an expeditious fashion to increase access to say formula options because i represent i have really -- a heavily rural district. it covers the largest geographic area with a diverse economic space. i say all of this to paint a picture of what family space and urban areas has lately exasperated in rural america. we are in proximately -- we are in proximity to retailers to be a 30 minute drive to the nearest retailer. >> as i am sure you are aware there are specialty formulas but there are necessary formulas for many families. with the foreclosure of the
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abbott facility, the fbi can consider there is no one else who can step in to provide this specially formula. this is all following the closure of this plan. >> for everyone concerned, i think it is useful to divide the formula as you have astutely done in your questions. especially metabolic formula that deals with a much smaller but really credible group of infants who are totally dependent not just on formula but the very exact makeup of the formula. from the first day, we had a team of people that we were in connection with the american academy of pediatrics to try to do everything we could to keep the formula coming from that abbott plant, from their stores and releasing on a lot by lot basis as needed. carefully weighing the safety and the critical means.
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this system is not perfect but the network of communications is still very much in play with the pediatric community, hospital community and our team at the fda working together. it won't get better until we can wrap up the plan again and then diversify. you can't just start up a plan and do it. we have to work with abbott to make this work while we are also diversifying supply. >> thank you. i want to get one more question and. based on the recent announcement , how much formula do you expect will be imported and what is the real timeline of seeing those products on our store shelves? >> the way we -- the way we are thinking about it is we are pulling a bunch of this.
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i think a combination of all three should help us see improvement within days. i want to point out that we have more infant formula bonds. >> within a matter of days, they will be able to put formula on the shelf? >> it will gradually get better. the big problem we have right now is distribution. i think we have very important attention on the rural areas because they are not the major areas that are purchasing this. within days, it will get better.
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it will be a few weeks before we are back to normal. kueng thank you, mr. chairman. the fda has recently announced that they will get formula on the shelves. they were over these products from the sturgis facility. people needing urgent supplies on a case-by-case basis. can you describe how your agency is communicating with health care professionals and with families about the risks and benefits of using metabolic formula products so that parents can make informed decisions about safely accessing the products that they need? >> i know you have a nursing background so you have a very special feel for what is at stake.
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the general formula is hard enough. we have a history in this country of disaster and things occurring. this was featured in the new york times yesterday. he is a chair of the committee. if families are having problems, we need to hear from them. twice we need to address the formula shortages so that this never happens again. there were numerous disturbing allegations and it was
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especially troubling to learn the report was submitted to the fda on october 20 of 2021 but they did not do this for more than three months. in this timeframe, on december 29, 2021, the fda temporarily postponed this due to the surge but continued to do mission-critical work. there are four factors for determining if a product meets the threshold. if it is used to treat a serious medical condition, if it is related to the covid-19 response or if there is evidence of at risk advents -- events.
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>> we will find specific issues where we could have done better. i cannot disagree with your statement. >> it is not optional. what steps will the fda take to ensure infant formula manufacturing facilities continue to be carried out during public health emergencies or any other time where the inspections are postponed? >> i have already assured you all that no matter what, we will be on top of this issue until we are back to normal. working around the clock day and night. it would sure help if we had a larger number of people because as we diversify the facilities and we bring in new sources as the chairwoman has already made the point of essentially, we are going to need people who can
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actually evaluate whether or not it is effective, especially in these metabolic formulas. there are only a handful of people that understand the illnesses these children have. >> thank you, i yield back. >> you are now recognized and hopefully we have the technical -- technical difficulties resolved. you are now recognized. >> thank you for continuing to call on me. i hope i am coming through. thank you for your testimony today. i know you have been getting a lot of questions done on formula shortage. i just want to share with you. i have been hearing from hundreds of michigan families about how this formula shortage is affecting them or someone they know. i wanted to share a couple of stories with you and ask how you as an agency can respond to them.
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a father wrote my child has an allergy to milk so she has to have a very specific formula. now that the formula is short, other babies that don't need to type a formula that is necessary for my daughter are purchasing it through this program, making her formula even more scarce. i have had to resort to getting formula from out-of-state and canada at times. the shipping costs are a huge burden on my family. i have had issues finding my sense formula since october of 2021. i bought in bulk. everything i had on hand was a recall. i could get it at target for a few weeks. even amazon stopped getting it. i had to switch to a different kind of formula. i am fortunate enough to be able to afford and by multiple cans at a time so when i found it at
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cosco, we but what i needed to get through six weeks. now the kind that my son is on is not even in stock at cosco. i pray i have enough to get him to his first birthday. another ends up changing the formula each time she runs out because it is all she can find. we just can't breast-feed our babies and it is scary to be a mother right now. a local grocery store owner also wrote me saying it is heart-wrenching to have to tell our customers we have no baby formula to offer them. we are concerned our local babies are not getting the nutrition they need. nutrition in general is a very challenging problem in our rural area. what would you like to tell these parents that are concerned about finding food for their babies? >> i will tell them we are very
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concerned and we feel badly they are going through this and we are doing everything we can to fix it and if i could make a couple of quick points about the things you brought up, the sales are actually higher than they were. people are buying more formula now than before the recall. the fda has no access right now under the supply chain data from the companies that manufacture and sell the formula. a bit of my week is getting on the phone with ceos and using an old-fashioned telephone to get the right product in the right place in an organized way. we are requesting that we have more authority to look at the supply chain's, much like the banks did years ago so we can preempt these kinds of problems rather than having to react to them.
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course the lack of enforcement is something i has -- i have raised with you and several of your predecessors. i hope the forthcoming guidance will move beyond that enforcement and require everyone to simply follow along. a related issue i want to raise with you is the standard of identity for yogurt. it is my understanding that the fda recently updated this in june of 2021 but the industry does not support that. >> i am so sorry but your time has expired and i want to get to wasserman schultz from florida. i will repair the subcommittee and recess subject to the call of the chair follow the votes needed.
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you are now recognized for your questions. >> thank you, mr. chairman. i appreciate your indulgence. i really want to say that everyone knows the world's best oranges are known in the great state of florida. my friends from california might disagree but florida's climate has a distinct impact on how oranges are grown. unfortunately, the more violent hurricanes are having a devastating impact. each circumstance as a result of the decline for florida's mature oranges. florida oranges did not meet the federal minimum standard of 10.5°. this was at a time when our understanding of climate change was minimal. despite these natural changes, there are no known adverse
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consequences. we need the fda to work directly to find a solution. this will modernize requirements to account for the variation. failure to do so will result in the industry losing out. what is the current engagement on this issue? are you committed to finding a solution to this problem in the immediate future? >> i am committed to finding a solution. this is something we have been talking about. changes in the climate and human health, this is high science. we need the people who can do the work to make the best judgments based on the data. it is not something that you just make hop. we appreciate that you are interested in us. >> the other thing i wanted to focus on, something i know that
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you and i talked about in florida, more than 20% of high school students use e-cigarettes. this cost florida about a point -- endpoints explore -- 8.64. these are not just numbers, these are our friends and family and our children. i lost my own mother to lung cancer. the fda has the authority to address this public health problem. i am through that the fda initiated this process. can you provide the committee with an update on the impact this would have on preventing children from falling for vape tobacco? >> i have spent time caring for
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people who were critically ill, many of them in the state of north carolina due to tobacco-related illness. i am very sensitive to the topic. these standards are now for public comment and we will have several public meetings. we will answer the comments and there may be modifications. as the standards come into play, what do we do about local enforcement if there is -- very sensitive to that issue. the fda is not involved in local enforcement. we want to make sure that people understand we are going after the people manufacturing these products. not all of the local citizens. but we want to make sure that
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local law enforcement and communities understand that. >> thank you so much. i only have a little bit of time left. i appreciate your indulgence, mr. chairman and i guild back -- yield back. >> the committee will stand in recess following the votes. we will reconvene. we will resume when we go into recess. i was about to recognize the gentlelady from new york. at this time, i am delighted to recognize miss ming. you have the floor. >> thank you, mr. chairman. thank you ranking member harris. thank you for this opportunity.
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as you know, there are concerning reports about hazardous chemicals that are known by the epa to be likely cancer-causing substances as well as undisclosed fragrant chemicals that contain some allergens in menstrual products. given that these products are frequently used and highly absorbed in parts of the body, just because an ingredient is not on the list of fragrant allergens, it does not mean it will not have an impact on a woman's health. i wanted ask about these ingredients as an allergen. are there additional resources necessary for your scientists to continue advancing this research? >> thank you for your interest in this topic which is complex.
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i was a the first principle is whenever something is told to the public, it should be listed. this has been a big challenge to get the authorities required. beyond that, in order to deal with this scientifically, we need to do an evaluation of the level of the constituent, what the effects are on the health of individuals and those who may come in contact with it. they are supportive of working toward having the correct labeling and understanding the risks and other factors involved. i think we heard quiet a bit this morning about the resource issues we have on this side of the fda. i just want to emphasize that
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this is not a simple matter. someone guessing about what the levels are and what the risks are. this is a huge scientific issue requiring big data and computational skills to get the federal agencies working together. we appreciate your interest. we look forward to working with you on it. >> thank you, definitely. i know that the fda missed its first deadline. it was not until mid april that the fda submitted its proposal for review. we wanted to ask a baby yet about the revised schedule and what the plans are for coordination with lmb. >> yes. first, let's acknowledge this.
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for the kids that drink a lot of apple juice, there would be a 3% reaction and exposure for these kids. we did have several others last week. we are going to stay in touch. we need to get that resolved.
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>> i had one of these only produce this. we ask that you please communicate with us and our families across america so we can be responsive with our effort. twice this is our main focus right now. i hope that -- i think we will be moving very quickly on that. it is the number one priority because it is essential. it is the largest population of this essential formula. >> thank you mr. commissioner.
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we have completed our first round of questions and we will now begin the second round. i continue to be disturbed by the length of time it took for the fda to really start to address this problem and secondly of the vague way about the implementation of the plan to solve it. whether it is a supply chain or the inspections, that is the real concern. i hope that before we close we would be a little bit more specific in terms of how that will happen. let me go to the foreign drug inspections. we want to ensure that safety of the drug supplier.
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and the fda practice of announcing foreign inspections weeks in advance, it brings up the issue of how we treat our domestic manufacturers and what kind of issues should be covered up. the 2021 funding was to set up a test of announced versus unannounced inspections. you know where all the perils of drug manufacturing in certain countries are. all of this as directed by congress. >> yes. let me assure you that i have been the subject of inspection and universities that i work for. also, technology development. we appreciate the money that was
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allocated. today i can say that we start of the program in india. china will fall behind but because of the covid outbreak, it is difficult to get started in china. the plan is to have hundreds of unannounced or short notice inspections that we will be able to report back to you about. >> we will focus the attention on the fact that the office only has a staff of nine people. that funding in fy 22 will ring people to the office. i worry about how the understaffed -- how many understaffed officers there are that we don't know about. it seems we only learn about those staffing shortages when there is a crisis. this has been a concern for many years and a number of administrations. we want to help ensure that all
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of the operational units are properly staffed. what are the understaffed parts that we should be concerned about? >> i would just say the entire food side of the fda is understaffed and every category. that is why on the budget, we have asked to step up and improve the authority for hiring and salaries just like we have on the product side. this is absolutely essential. i certainly want to notice that i don't disagree with your statement that money alone won't fix it. basically, there are nine people for something this important, it is not enough. in the current federal hiring authority, it takes months to bring someone on board. we don't see that with the
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authority we have. i want to employ you to help us get staffed up. i take seriously the other part of it. we also have to have leadership. >> my time has expired. hopefully this will pass quickly. let me yield to dr. harris for a second round of questions. >> thank you very much, mr. chairman. i understand that for some people, sodium is not a good thing. a lot of this is probably warranted. for others, it will not make a difference. i worry about the
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one-size-fits-all plan. will the fda conduct a study on the impact of the short-term targets to understand consumer except ability and what impact those reductions might have on public health. >> i know you are an anesthesiologist and you're talking about the topic of auto regulation. for sure, one-size-fits-all is not the solution to the problem but i know you are aware i think the data is very clear that super high levels are not good for anyone unless you have one of the strange diseases by the way post-covid is part of it. this where you don't have your blood vessels reduced.
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i'm very excited you know, focus of the administration across n.i.h. and f.d.a. and the department of agriculture. it's going to be diet, what we eat. i think covid has made us aware that we don't have enough domestic manufacturing of pharmaceutical and active ingredients. how is this budget request supporting more domestic manufacturing of pharmaceuticals and medical products so that we don't have this issue of do we
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have to depend upon foreign nations sometimes unfriendly? >> i would like to spend an hour talking to you about this. but in brief, because this is a big focus of ours. you're going to see more about it. the two cases we have in front of us now are examples of why the two extremes are wrong. we've had prominent politicians have strokes recently. one of the major suppliers of contract media have contrast media and when that shut down because of covid, now, when they roll on this stroke or heart attack, they may not get an an angiogram. what we need is a versatile supply chain built on a digital background so we can keep track of where the products are and the stress test.
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now, in the budget are manufacturing in place which i think is the most exciting part of it. and also platform manufactures. it's in the budget. i know we have plenty of time. but i could talk a long time about this as you can tell. we have to do something about this. the answer is just not ownshoring. the answer is having a diversified system so that we can prevent it preemptively instead of waiting for them to hawaii
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43% of it so when they go out of sync. so under di look leaving all of this and not for today's conversation because it's a lengthy one. we have to get out of the contracting business. not only here but in the meat-packing industry as well. it has been said by chairman bishop and i society myself with his excellents and with the ranking members comments. i understand you need resources. and i've worked to increase resources to the f.d.a. but your problems are structural. you have serious structural leadership issues. someone in this agency needs to have serious, relevant and full credentials who understand it.
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because otherwise food safety will be a second class citizen, continue to be a second class citizen at that time f.d.a. i want to just mention to you -- comment earlier on, you can't hide behind an investigation. we need answer. we need them now. who will sew this report? what did they do with i? who was heading the f.d.a. at that time. who was handling and investigating all of this? >> well, as i've said, you've got to time line down and the key issues. i know we have an oversight meeting next week and we'll be
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prepared to go into much more detail at that point. and you know, as i've said, we could do better than we did. >> you have an oversight committee next week. you're before the committee that funds what you do. so this information is relevant to this subcommittee of appropriation. >> well, i appreciate what you're saying, but the investigation is not completed yet. so i'm not in a position to answer specifics like that. so you have no idea who received the documents -- documents. who read it? what was the chain of command? you apparently don't have any answers to that question. that is indicative of again not
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responding to the seriousness of this herb shoe that says it all, dr. taylor. that says it all. one last point i want to make. i only learned this in the last 48 hours. 2014, abbott deliberately and successfully tried to weak bacteria testing safety standards. ly credit f.d.a. here. f.d.a. issue add propose proposed rule that would have increased regular safety instructions of infant formula manufacturing facilities. and in the effort to prevent the contamination of infant formula, i believe it was gerber and
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others, they led the charge to weaken the instruction regime. now, this is a company and manufactureing entity that has a sole source contact. and that is -- my question to you -- i want you to address that do you have a plan to increase testing at the facility and what is that plan? >> >> first of all, thank you again for the additional funding but is plan is tony: crease inspections in the sturgess facility. it's like a daily belongs to they're with the avid people to know what they're doing. and as for a other u.s.
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facilities we'll have to get back to you on the specific number of times we'll inspect. but we will have a very orderly specific inspection system. i would like to add, the supply chain issue that is we've all been talking about, we need to have access to the sup ploy chain data -- supply chain data, which we don't have each company has a supply chain. they handling it very carefully for their own needs. but if you answer the question, how do we fit that together? they can give it to us if they want. but we need to have the authority to get that. i am committed to get back to you and specifics about what happened. i'm just not prepared today to do it. i apologize for that. >> well, we have to change underlying -- because my colleagues have been indulgent
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with me here this morning the fact that request you are the regulatory agency and you do not have mandatory recall. and you do not have access to data. well, you ought to be up here demanding that we provide you with that kind of a source to get the information that you need in order to be able to do your job as a regulatory agency. thank you, mr. chairman, thank you to the ranking member and my colleagues. >> thank you, ms. de lauro. i would like to recognize mr. deo for a second round. >> thank you i would like to the feed additives that reduce methane emissions by as much as 30% but f.d.a.'s current approval
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process treats them as drugs even though they move entirely through the animal's digestic track. they direct f.d.a. to review ingredient claims on environmental and other issues as they provided $1 million in new funding for approval in the final bill. will you provide us with an update your agency is doing on this? >> yes, we're moving along well with that and i'm fully aware. but this is a big issue for the farming community both on the animal side and also on the agriculture side. we want to come to a resolution. we are getting a good bit of research done about the safety and benefits edition to food. and -- in a -- not too long a period of time, we'll get back to you with specifics about that. it is something that we're working on. >> it's something that obviously
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is important to a lot of folks. it's come up quite a bit especially in my district. i've got one of the largest dairy districtses in the -- districts in the country. look forward to talking to you about this. i've asked all the questions. i'll submit them for the record on this site. thank you very much. >> thank you, mr. va aladeo. >> as a registered nurse another priority is protecting our young people from the health risk of e-cigarette products. according to a 2021 survey data more than 1-10 middle school students reported they had used tobacco products and e-cigarettes were the most commonly used products.
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they have the availability of flavors and access to tobacco products remain prevalent in 2021. let's be clear, the reason why flavored e-cigarettes have been and continue to be so accessible for young people is because of the f.d.a.'s unacceptable review of premarket tobacco application and the failure by your predecessor to meet the court-ordered review deadline of 2021. while i'm pleased to see the denial order that is you've announced as being confirmed, some of the most popular products remain on the market. just last week, the f.d.a. filed a status report for the district of maryland in which the agency provided that applications reviews will not be completed until june 30th, 2023. with more kids getting addict today nicotine every day can you
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provide an explanation why the f.d.a. is projecting that reviews won't be completed until next year nearly two years after the court-ordered review deadline? >> thanks for bringing attention to this issue. and you know, as a cardiologist and someone very involved in medicine, the addiction to nicotine is a very difficult problem. and there is no question that it's an entry that develops specifically to get teenagers addicted to nicotine in which case the old state. -- statement is stopping customers for life. stopping vanz:ing is extremely difficult to. do there's nothing i would like to to do than to move this more quickly. but what we gave the court is an honest assessment and the legal requirements that we have to consider these applications and
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i want to emphasize this they have amazing cables on the legal front if we make one singleer >> in process we could be set back for years these applications. >> yes, sir. dr. califf: and for the last i don't know how many years used for user fees from the vaping industry. all of this work is entirely unfunded. we've doing it borrowing people from other parts. for such a prosperous industry we have a very reasonable user fee arrangement and i hope congress will act on this. >> thank you. they must have a marketing order before coming to market mean meaning each e-cigarette product is currently on the market illegally. and the f.d.a. has the authority to remove these products from the market. will you know using this authority while f.d.a. completes
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its review of the remaining premarket tobacco product application? dr. cc -- califf: if we take action like that, we will end up with a lot of our legal force tied up up in court. and so we're going to have to be very judiciously the way we use that authority because we want to reserve our -- our ability on the legal front to take care of the problem that is we know will be -- problems that we know will be lasting. i want to come back and discuss that specifically to make sure that we that's have an an understanding of what our capables are in that regard. >> to say that we're going to wait another several months over a year to be able to taken force able action given what we have in the community.
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thank you very much. >> thank you very much, ms. underwood. thank you, commission n. i believe that we have exhausted the questions from the members and i appreciate very much your availability, commissioner caleb. we all understand how incredibly busy you are these days and we appreciate your time. these issues are very, very important though. the f.d.a.'s work is vitally important for every american in order to keep them safe and healthy. and the challenge that is we discuss today showed just how crucial it is for the agencies to be at peak performance with all hands on deck, every single day. we want to help you in anyway that we can with these challenges and with respect with the infant formula issue that we've been dealing with today, i want to make sure that people know that we are not finished
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with this. we're going to dig down deep on may 25th, next week, we're going to be dealing with the infact formula stakeholders that we'll hear from to get their perspective on what this crisis means and how we need to deal with it. but a long with all that we've discussed, we will also forward additional questions to you for the record. and we look forward to your diligent and timely responses. dr. harris, do you have any closing remarks? if so, i will yield to you for that purpose. dr. harris: thanks for coming to the subcommittee. when we first met, you've got a tough job the f.d.a. is an agency with very broad regulatory authority in area that is are -- areas that are because of covid and because of tin fant formula are quite controversial. good luck in doing it.
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let us know in anyway that we can help. i want to thank you for -- for being willing to step up and head the agency and good luck in the future. i yield back, mr. chairman. chairman: thank you to the members of the subcommittee and thank you to our staff who put this hearing together. with that this subcommittee hearing
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