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tv   Acting FDA Commissioner Testifies on 2022 Budget  CSPAN  June 18, 2021 8:35am-9:51am EDT

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funded by these television companies and more including charter communications. >> broadband is a force for empowerment. that's why chart has invested billions building infrastructure, upgrading technology, and powering opportunity communities big and small. charter is connecting us. >> charter communications supports c-span as a public service along with these other television providers giving you a front row seat to democracy. >> dr. janet woodcock is of the acting fda commissioner p or q testified on the president 2022 budget for the fda. she appeared before a senate appropriations subcommittee to answer questions about covid-19, new drugo research, and agencies new drug approval process. this is and hour and ten minute. [inaudible conversations]
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[inaudible conversations] [inaudible conversations] >> good morning. i want to welcome everyone to our first budget hearing of the subcommittee for fiscalud year 2022. and, dr. woodcock, thank you so much for being here this morning.g. we are looking forward to your testament and having a good discussion about the needs of the fda. the responsibilities at the fda are vast and have an impact on
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every american. that's been made even more clear during our response to covid-19. we must continue to invest in safer drugs, safer medical devices and the safest food supply in the world. and for now and for the future. dr. woodcock, i'm looking forward to hearing your visions for theou fda and what this committee can do to support your vital work. that works begin now with the fiscal year 2022 budget request that is in front of us, and the request for fda includes an increase of $343 million in total budget authority. this increased touches a wide array of activities at fda including protecting public health, food, and medical product safety. as was continue to address the ongoing opioid crisis. ticularlyn learning about your proposed
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increases for fda's core safety programs in the budget request includes significant increases for food and drug safety, device shortages, as well as a focus on infant health and nutrition. these are all important investments and the subcommittee will play the role in advancing these priorities. doctor woodcock, your job is constantly changing and i know it is difficult to try to keep up with all the changes in research and technology and manufacturing that are going on in the private sector and to make sure that the vast number of products fda regulates are safe while at the same time not slowing down the important advancements that will ultimately benefit us all is quite a tightrope to walk. i think last year showed the importance of fda and relying on sound science when making decisions that impact so many of us. the work that fda did to authorize multiple covid vaccines under a short timeframe cited by science, sound data and
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transparency would truly remarkable. you should be commended for that and i look forward to seeing how the fda will continue to work to make covid vaccines more available. however, i think there is room for improvement and i would be remiss if i did not briefly mention my continued frustration with the fda slow progress on enforcing standards of identity for milk and dairy products. i recently reintroduced the dairy pride act that would require fda to issue draft guidance on enforcing these standards. i would note yesterday that the fda issued a final rule on the standards of identity for yogurt but more work needs to be done. and so, i hope as chair of the subcommittee we can continue to work together to start making meaningful progress on this issue of significance of
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significant importance to my constituency. again, i look forward to your testimony and appreciate you being here today and with that, i will turn it over to ranking member hoven for any opening remarks you may have. >> thank you, madam chair. thanks, doctor woodcock for being here today to discuss fda's funding priorities for fiscal 22. your many years of service and your commitment for health and safety and for the american people is very much appreciated and thank you. i would like to reiterate chairman baldwin's comments regarding the fda's covid response efforts in the agency has worked tirelessly to ensure that all medical products including covid-19 vaccines meet standards of quality, safety and effectiveness. your efforts are to be commended there. as we dive into this budget request i want to stress that fda has been and continue to be the gold standard for food, drug and device safety. the rest of the world looks to the fda to lead in the standard-setting and what we can always do better in supporting
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technology that the fda is the leading, is leading the way in terms of evidence-based scientific advances and revelatory actions. doctor woodcock, your agency invests the daily life of every american citizen. fda is authority of over more than 2.5 trillion worth of products used by consumers. americans expect the food that they eat and the drugs they take will be safe and effective and the fda vast reach covers more than 300,400 establishments and 185,000 domestic establishments ranging from food processing plants to facilities that manufacture life-saving medications. in addition to the facilities themselves the fda is tasked with revelatory responsibly for individual products and in delivering these regulatory responsible use your private sector partners expect transparency and certainty from the fda. in my speech to small business owners and act produces the overwhelming concerns that of
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the overwhelming burdensome stifle innovation and hinder their ability to great jobs and respond quickly to an emergency situation. while all of this or excuse me, and emergent situations. while we all support fda's mission that we must be mindful of these concerns not more so than ever. i believe the fda must avoid the trappings of a quote, one-size-fits-all approach to regulation. i urge you and your staff to take a commonsense approach that supports our nations innovators while adhering to your mission of ensuring safety and efficacy. so, with that i look forward to your testimony. >> doctor woodcock, we would like to hear from you now. >> thank you. >> can you hear me?
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>> try your microphone. >> yes, much better. it's turned on. >> thank you. ranking member hoven and members of the subcommittee thank you for the opportunity to appear before you today to discuss the president's fiscal year 22 budget request for fda. i would like to begin by thanking the subcommittee for your continued support in the agency over the recent years and i have gone over these budgets and it is been very helpful. in particular, in the last year and half as the agency has worked tirelessly to respond to the covid-19 public health emergency. i think the past year has reinforced the central role that the fda plays in protecting and promoting public health. i want to think the entire fda staff for their unwavering dedication, commitment and contribution to public service through what has been a very stressful time. however, despite our remarkable progress over the last year our work is far from over in our
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commitment and mission is unwavering. the pandemic presented new challenges for the agency has given us an occasion to reflect on our strength and identify areas to improve overall operations and performance should this happen again or in general. the budget i present to you today will directly support our efforts to evolve and modernize how we accomplish our mission, our workforce and operation. we are embarking on a multiyear effort to upgrade and modernize our physical and technological infrastructure, strengthen our talented workforce and improve our scientific capability and regulatory structures. the industries that we regulate are constantly innovating as the point was just made attracting skilled professionals in upgrading their technological capabilities. fda must keep pace with this. with that in mind, or budget
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request focuses on investments of three main categories to support our modern station. the first is the critical public health info structure. the agency's infrastructure is fundamental to every aspect of our work and her budget request a total of $185 million to support it. we will invest this funding in several areas, including data modernization, maintenance repairs to our facility and expanded laboratory safety efforts. i want to take a moment to discuss our data modernization requests in greater detail while some may not consider this data modernization as exciting as vaccine development or food safety science i cannot overstate how critical it is to our success as an agency. we are requesting $76 million to support much-needed data modernization efforts and as we saw firsthand during the pandemic technological advances have and will continue to revolutionize human and animal
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health. scientific breakthroughs have enabled the development of personalized therapies, advanced manufacturing and state-of-the-art solutions such as genomic information, real-time analytics. as a byproduct of these exciting advances the amount and variety of data the fda generates needs and uses is rapidly increasing but we are often hampered by antiquated methods, including large volumes of information we get on pdfs and often done by hand in order to identify critical safety signals such as human and animal drug and device safety concerns or emerging foodborne outbreaks. the investment requested would modernize our data infrastructure and allow us to more efficiently gather data and identify analyze and respond to potential problems more quickly and further improve review times
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for medical products. turning to our second budget category requesting an increase of $97 million to invest in our core food and medical product safety programs and throughout our covid-19 response, as you undoubtedly know medical products supply chain issues have been a constant challenge, especially at the height of the pandemic with critical shortages. we want to continue to play a role in fixing this issue going forward and are requesting $22 million to build a resilient supply chain and shortages program specifically for medical devices. medical devices including ppp and some other critical items such as ventilators were often in a shortage during the pandemic. another vital area for which we are requesting funding is an additional $18 million to expand the agency's capacity to review increasingly complex infant formula submissions and continue
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to reduce babies and young children's exposures to toxic elements in their food. as you all know nutrition during pregnancy and early childhood is critically important in supporting the health and well-being of mothers and their children and we think these investments cannot be emphasized enough. the importance of nutrition and food safety and childhood were equally committed to making sure that the food each of us eats everyday safe as well and foodborne illnesses remain significant public health challenge so we are still facing these illnesses. the availability of safe and nutritious foods across the population as a key element of ensuring equitable health outcomes and our budget seeks to address this challenge through requested increase of $45 million to further implement our new era of smarter food safety blueprints and finally,
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our third and last category relates to public health issues confronting the nation today. while covid pandemic has predominated these other health challenges have not vanished and we request an additional $61 million to further our effort, specifically requesting 38 billion to support the development of opioid overdose reversal treatments and better guidance for clinicians, advance the development authorization of digital health medical devices and treatments to address opioid use disorder to establish satellite laboratories at our international mail facility so we can better screen for illicit opioids through the mail and we are also committed to modernize fda inspectional activities to support this inspection work our budget requests increase of $19 million which will allow us to maintain staff that we hired with supplemental funding and increase our or an inspection
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teams. finally, i am pleased to request an increase of $4.7 million to enhance fda's ability to support and expand health equity and combat health disparity. finally, fda also protects americans from tobacco and death and disease by regulating the products. we have proposed an additional $100 million in user fees to enhance product review and all the activities to go along, including enforcement. this increased funding will strengthen our actions to combat youth use of tobacco products. i would like to close by thanking the subcommittee again for your continued support of the agency and as the gold standard for protecting public health we are trusted by americans and around the world for our work in ensuring the safety, efficacy and security of our nations medical products and our food supply. thank you for inviting me and i look forward to answering your
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questions. >> thank you, doctor woodcock. i have a number of questions that dive deeper into some of the things that you have already described in your testimony. broad ranging issues in the food and drug administration, i will start with the issue of strengthening the mystic supply chain for some of the things that we need in needed in this pandemic but also could need in the future. i was very concerned last year about and i have been for a long time about our overreliance on foreign manufacturers for critical medical supplies and pharmaceuticals. it is vital that we work to make these supplies in america and to do that we need to make sure
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that there are policies in place at the fda to make it more attractive for companies to make their products here in the united states. in setting up a new pharmaceutical manufacturing facility 36 months may have lapsed between the start of construction and the first product being released to the market. ten months which may be spent awaiting regulatory review. what does the fda need from congress in order to streamline and prioritize inspections and approvals for new domestic facilities? >> fda has been working for some time on improving manufacturing and getting to advanced manufacturing which we think for pharmaceuticals is the way we will be able to bring manufacturing back into this country. advanced manufacturing doesn't use the methods that have been used for hundreds years but used
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advanced continuous methods, both for compounds and making the final dosage form. ... >> for the testing and so forth, their much smaller and better environmental footprint and so many of those obstacles as regulatory obstacles are diminished however, we must quie fda must make new regulatory framework for this type of advanced manufacturing. we are working on that, we are working on creating drugs and biologic a centers a new center of excellence that will help
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bring these facilities along. in addition, the administration has announced investments as part of their efforts to both boost the u.s. jobs in manufacturing and to deal with the critical supply chain issues and pharmaceutical is one of those. so they plan to invest in manufacturing science in the united states so that they can get to this advanced stage of manufacturing. fda's roll will be to have new regulatory standards that apply to these advanced methods. we've actually asked for and you all have provided some money for field organizations for example to get training on these new methods so the entire fda is ready for these methods and is encouraging them. >> thank you as a follow-up, for many years the fda has been working to develop a framework for conducting quality
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management assessment. other manufacturers and avoid the system to incentivize industry investments. what is he is the overlap between a quality rating system for manufacturers in this larger effort that we are talking about to bring manufacturing back to the u.s. trade. janet: i believe that the manufacturing method is will and this is a technical opinion of mine, boosted by any other people who are very good in this area that they will eventually have a better quality maturity because the computer-controlled process that is very small tolerances will achieve tighter quality. the quality maturity measures will be somewhat of a little bit of a stick i think in the ability to advance manufacturing is sort of a carrot in the
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united states. i think these two methods will be synergistic. >> senator . >> thank you chairman. dr. janet woodcock thank you for your presence here and i want to ask three questions and give you a compliment. as we devolves and determined mentioned this in her opening salmon, fda standards of identity needed to keep pace to avoid research and development to make sure that we get the most nutritious now the feds and that the consumers are knowledgeable about what they are buying. that's really important for the fda process, this bureaucracy in my view updating standards of identity as well and perhaps a bit of a limited to the fda and its announcement yesterday regarding identity of yogurt. what i understand is the dns 31st petition for an update in the yogurt standards in 2000.
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fda issued a proposed rulemaking in 2009 and help i finalize the new identity history updating a single standard of identity for a popular food item should not take 21 years. the company and my state of kansas, recently petitioned the fda to update the standard identity or margin. as a critical for the agency not to take years to modernize the standard of identity for margarine as was unfortunately the case and yogurt. in the past that we have heard these due to lack of resources as a real thing congress this committee and some committee has provided increase in office nutrition and in food labeling. for the past three cycles and i've been involved in the process doctor woodcock, just reassure me that the steps are being taken to improve the process and modernizing identity standards. janet: yes they are and, yes, i
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agree there's too long for modernization however i will tell you that more technical assessment is that certainly the food science and nutrition it did not have enough staff on this to get the job done previously. concurrently, we still do not have enough staff to get because there are 280 standards. these monies to be done by rulemaking. it does not solve it. and i think that many were data efforts and so forth will help. there also exploring more innovative methods which they call horizontal standards which is crosscutting for example, ultrafiltered milk to put into standardized jesus would go across a number of pieces standards and so you could put that in modernize all of those at once without having to go
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through rulemaking for each of the standard. so they are exploring additional methods that would get this process moving quickly. moran: instruction is hard to modernize something the answer on how to modernize good takes on what time the answer is given, is no longer modern. dr. janet woodcock it currently takes three - five years took fork feed ingredients to be approved. this is your 2020 ever to increase funding to hire additional personnel to feed agreement approvals i've offered to continue to work with you to pursue that decrease the amount of time to bring in new ingredients market. as one of flag policy concern for the approval rss for the industry is looking to offer solutions meeting the challenges related to climate. however, the current fda halsey regulate certain feed ingredients which could reduce greenhouse emissions and benefit
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the environment as animal drugs instead of feed ingredients. by understanding the fda center for policy manual dictates these decisions and it has not been updated since 1998. i just asked for your commitment again to address this issue in a way that is timely and beneficial. speech of thank you and i certainly go with that commitment of we've approved one product for increasing admissions from animals or their waste and were working very diligently and closely with manufacturers who are working in the space. i certainly will be glad to look into this more. moran: thank you and let me also suggest a >> i'm sorry, 30 -- i had four minutes and 30 seconds to issue my concerns and 30 seconds to give the fda a compliment. i paid a lot of attention to research in regards to alzheimer's and i want to express my gratitude for the decisions that the fda made just in recent days. and i think again, it's talking
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about the timeliness and certainly the process matters, but i'm convinced that with more timely approvals that there will be more private investment in research to find these life saving and life-improving drugs. the fda has a role while we've been generous as an appropriation committee in congress supporting research at nih and a lot goes on elsewhere and the reward for the research comes in a drug approved for the market and so sending a message to the market, that they're in the process, a reward, a return on investment is valuable. i suppose you could say to the company and much more important is those who suffer from alzheimer's and their families. >> thank you. >> senator hyde-smith and i would just announce there will be additional rounds of questions as senators would
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like. >> thank you, chairwoman baldwin and thank you, dr. woodcock for being here today. my first question, the fda frequently touts expanded generic drug approvals as an accomplishment, but i'm concerned that the fda is lagging for complex generic drugs, one is restasis that costs the health care system more than $2 billion annually and i can tell you that this costs medicare beneficiaries a pretty penny. i'm very familiar with many people that have the tiny tubes that cost a lot of money. but more than seven years after companies filed applications to develop a lower cost generic of this drug, the fda has still not approved a single application. as a result, the patients are still paying the increasingly
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high brand name drug price. will you commit to prioritizing the review of complex generic drug applications and ensuring that patients receive timely access to more affordable medications? >> absolutely. the -- that is one of our high priorities within the drug center as well as getting similar applications out there to lower costs for biological products when they're legally available and they are spending a lot of work on research for complex generics and for biological products so we can actually get more affordable versions out on the market. >> because it is really burdensome for so many people there. and i led a bicameral letter to you in april concerns with the
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decision not to reinforce the evaluation and mitigation strategy for-- mis-- the chemical abortion drug for the remainder of the public health emergency and the fda decision is alarming because this drug is dangerous. the limited data we do have shows unacceptable rates of complications for women and girls, specifically more than 20% of reported complications were life threatening or resulted in death and over 70% of reported complications required follow-up surgeries, including total hysterectomies. i'm particularly struck by the inconsistency of the fda's actions. for instance, the fda and c.d.c. imposed a pause on the johnson & johnson covid vaccine after reports of blood clots in some women. at the same time fda is
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expanding approval for chemical abortion pills that have much, much higher risk of blood clots than the j&j vaccine. your response to my letter which i received just this morning, a few hours ago, states that fda will be undertaking an overview of the issue. in my letter to you, i encouraged you to mandate the collection of complete and accurate information on all adverse events related to this drug and will you commit to requiring this data be collected so that fda has complete data for its review for this abortion pill? >> well, i can certainly-- i will have to look at the conditions as far as which serious events need to be reported to the fda. so, let me look into that, but it may well be that if a person has a headache after, you know,
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using this drug that that may not have to be reported because serious self-limited event. >> 20% though, you know, that's pretty serious for the life threatening resulted in death. i'm going to follow up with you to provide some studies on the adverse events that i would like to ensure that the fda reviews. chair baldwin i'd like to ask consent to include the studies in the records for this hearing. thank you. >> senator. >> thank you, madam chairman. chair baldwin and i, along with chair and ranking member on the house side wrote to you recently regarding fda's drug inspection program backlog and the importance of resuming domestic and foreign inspections and we did provide additional resources to part of that covid pandemic
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legislation. including the facilitation and conduct of inspections related to the manufacturing of vaccines and therapeutics and devices, delayed or canceled for reasons related to covid. how does fda plan to deploy those resources to ensure applications are not further delayed? >> first of all, fda was able to act upon over 90% of all applications, premarket applications that came in during this period so far. so with combination of our usual processes and inspections for mission critical products, we were able to get a lot of products out. we only had 68 products, applications that are waiting. waiting for an inspection because we can't do an inspection. for example, right now, we cannot do an inspection in india. and if we determined we had to do a physical inspection to
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approve the product, whatever it might be, then we must do a physical inspection. on the other hand, we're not turning those applications down. we're simply waiting until a time would come that we could actually go into that country and actually accomplish an inspection. >> as far as most of the inspections you're referring to, the backlog, most of them are what we call surveillance inspections, they're a plant's food processing facilities, other areas that are currently operating and we inspect them on a schedule every so often, on a risk-based or a statutory based and what happened we couldn't get into a lot of the plants because we couldn't travel. if you think about a rubber band with marks on it and this is how often we'd like to inspect that plant. what's happened, we've stretched that rubber band and for every plant there's going
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to be more time between inspections than there ordinarily is. so that's one part of the answer, if that makes sense to you. okay, the second part of the answer is, along the money we're asking for here, we really need an overhaul of how we operate our inspectional program. our i.t. systems are completely antiquated. many of them are at the end of service or end of life. they don't talk to each other. we can't get them on the cloud because they're too antiquated and so much of the technology and data ask that we have here is going to, number one, be working on things like the food establishment inventory to get that correct and digitized and quality controlled to upgrade the field systems so that they all talk to each other or are integrated with the commodity areas so we have all the information at our fingertips.
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so we will, at the same time, we're recovering, we're going to upgrade in everything we do. we're going to work on these remote assessments where people wear cameras and so forth and go around the plants. they wouldn't substitute for in-person inspection, but they will augment the information that we get. so we are committed to getting our inspectional program up back and running fully by the summer to the extent that we can domestically. we probably can. it's going to depend on the state of the country and whether we can actually get into the country. so i can't commit to having a full, you know, inspection program fully operating boo i fall because we may have parts of the world where the pandemic is still raging. but we have a plan, we published our resiliency
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report, which i hope you have a copy of and we can provide a copy of, which goes over how we plan to recover from this time when we were not able to do so many inspections. >> yeah, and so that, to me, leads to -- and i'll start the question and then i'll have to ask you in the next round, but the lessons learned. not just how you modify how you operate based on what you learn in covid, but how we prepare so that, a, we don't have another situation like we've had with covid. not only trying to prevent it, but if we do face another virus or variants, how we make sure we deal with it without the incredible challenges, disruptions and problems we had this time. not just your agency. this is something we all have to look at. i'll pick up on that in the next round. >> absolutely. some of the ask here is for supply chain monitoring so that we have a better handle where
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the products are actually coming from. as chair baldwin pointed out, many of them are coming from overseas, especially for devices. we don't have really authorities and we don't have a system to monitor those supply chains. >> thank you. >> all right. i was pleased to hear bipartisan concern about the issues of standards of identity. i wanted to dig a little deeper because as i mentioned in my opening statement, i recently introduced the dairy pride act. that legislation would require fda to issue guidance for nation-wide enforcement of mislabeled immigration dairy products within 90 days, this is an issue that i've been working on for many years now and it's important to dairy farmers and the entire wisconsin dairy industry.
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i'm often dismayed that i have to offer a measure like this. fda does not enforce the regulations it has on the books, so dairy farmers follow these rules day in and day out in order to be able to honestly label their product as milk or cheese or yogurt, yet, a range of imitation dairy products have got ten away with using these dairy terms even though they don't follow the agency's rules. i really think it's high time that the fda address this violation of its own labeling requirements. so please update me on what fda is currently doing to ensure consumers are not misled by the use of dairy terms on non-dairy products. >> we are working on updated guidance that would make sh your consumers understood. we're particularly concerned about nutritional values,
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calcium, vitamin d, protein. some of these other products are not comparable say if they were fed to a young child or an infant, they wouldn't be getting what the consumer, the mother or parent thought the child was getting. so we really need clear labeling in those instances to make sure that it's not misleading. and we will try to get that out as soon as possible. >> okay. i certainly appreciate your assurance that you'll continue to work on this and with this committee to make standards of identity a priority in the agency. next, i wanted to just add my words to another inquiry that senator moran made about feed additives and live stock emissions. the administration has set
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ambitious goals with regard to climate change and reducing emissions and the agriculture sector really can play a key role here. feed additives have been shown to dramatically reduce methane emissions from live stock, however, the fda's existing approach to these additives have prevented their widespread adoption. the central issue is that fda limits the definition of feed additives to products that affect the nutrition of the animal. environmental benefits such as reducing methane emissions, are really not considered. europe has adopted a registry framework that considers any environmental benefits as feed additives and new zealand is poised to do the same thing. that means that others will be using this reduction technology four or five years earlier than we will be able to in the
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united states. materially disadvantages u.s. farmers and ranchers in terms of export markets for beef and dairy products. so, will you take a look at this issue and identify a solution that allows these critical products to be available for use in the u.s. agricultural sector and can fda issue guidance allowing the approval of safe feed additives that strictly provide environmental benefits or does this change need to happen legislatively? >> i'll certainly be glad to look at this and get back to you on this issue, i'm very well aware of the issue, but not further solutions. >> okay. senator braun. >> thank you, madam chair. >> enjoyed the conversation just yesterday and of course,
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i'm real interested in general to try to get the fda to maintain all of its integrity and standards, but pick up the pace a bit. co-founded the alf caucus in the senate. know that we've recently got an alzheimer's drug out there approved. i fill sense-- i still essential extreme frustration, and they see good results and especially willing to take the risk with an als patient, three to fewer years from day of diagnosis to when your life ends and if you're in one of those trials and it at least seems to be working, how do we get more agility, maybe
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entrepreneurialism, look what we did recently with the vaccine, without sacrifices the process and the safety features. generally in life, you can't take forever to get things done and avoid all risk. things pass you by in the interim. so, love to hear your thoughts on that. >> well, i think there are some misperceptions about where the barriers are and the blockages, right? fda does review drugs very rapidly due to the user fee programs. we're probably the fastest agency in the world in a developed country to get things reviewed and if approvable, on the market. but for the neural degenerative diseases that als and alzheimer's are a part of. the science was slow to develop. when we had a war on cancer
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started in the '70s, now in the last 10 years we're seeing the fruits of that, new cancer drugs that are unprecedented that really make a difference and are not so toxic, that aren't just-- and the reason is that we understand cancer. we understand the molecular changes that lead to somebody getting a cancer and what's happening is, we're getting drugs that target the specific mutations that are driving that cancer and can block it. and we're -- or that stimulate the immune system. and neural degeneration, we're still in a more primitive area of science. we don't really understand why these things are happening to people. for example, with als. and so then it's very hard, the problem is more in the development area. we are still in empirical development in some sense, just try it and see if it works rather than we're trying to interrupt very specific pathway
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and we understand its role in bringing on the disease. so i believe fda has worked very closely. i personally have corresponded recently with manile individuals and families of people with als. i totally understand the devastating tragedies that are occurring every day to families and to people because of this illness. and we will do everything we can to move these therapies along and be very flexible. however, we need good science because we need treatments that are going to work to advance the treatment of this disease. >> so he think then, it begs the question of the main stakeholder in all of this to me is the patient. and to me it looks like the patient often times is not the driver behind whoo what might
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be out there to help them. so is the patient driving the process at least in terms of that trade-off between the risk of having something that's not ready, but the willingness to take it on? so comment a little bit about to me, it shouldn't be the agency, it shouldn't be the drug company. maybe it ought to be the patient that has had a little bit more say-so in the speed at which that only remedy that may be out there is going to be available to them. >> well, we certainly, we have something called patient focused drug development we've been doing for some time and we really hear the voice of the patient. we feel the voice of the patient should be central. a long time ago we heard the same reasoning with people with hiv when aids was common and people were dying and they said
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we'll try anything, we don't care, just get to us. as soon as we got semi effective drugs people wanted drugs that were more effective, let us live longer and best drug for me, to keep me -- have fewer side effects and keep me going. now because of the flexibility and effort that we put in living with hiv is a chronic disease, and that's where we'd like to as step one to get some of these neurodegenerative diseases. we do listen to patients, however, get effective remedies out there would not be in conformance with the law because if we have those advocating from ineffective therapies. we don't know if they work and that's not how medical science gets to people, like with hiv,
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and improving survival rates with cancer. we have to keep a balance between understand and we have, you know, congress passed, for example, right to try. so people can access investigational therapies if companies are willing, right? and we have expanded access programs, so if the compounds are being studied, then people can get them for treatment during, if they're not able to get into the studies. so we have those mechanisms because we understand we have a problem right now. people are dying. we have another problem we have to build the medical science so we can treat this disease and turn it into a chronic disease that people can live with. >> thank you. >> senator hyde-smith. >> thank you, madam chairman. one last issue i'd like to raise with you relates to the novel medical devices, specifically for end stage
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renal disease, population, 400,000 medicare beneficiaries are on dialysis and those patients have not benefitted from any meaningful distances and innovations in a long time. to address this i've worked for several years with a bipartisan group of my colleagues to encourage adoption of a new policy to spur innovation and medical technology for medicare patients under the esrd bundled payment system. while we have made some progress, there still seems to be a misalignment between how fda evaluates novel devices for safety and how they have reimbursement decisions. that creates where a new novel device can gain fda clearance, but got net to the hands of the
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patients with different interpretations of the same data. how can fda and cns work together on coordination how clinical data is interpreted for novel, new technologies? >> i'll be happy to take that back and work on it. i recognize the plight of people with esrd and a lack of new therapies and a lack of convenient and a really truly portable dialysis and the burden that puts on folks. so i'm very happy to work on this. i can't speak to cms policies because i don't know very much about that, but i will definitely commit to you, to look into this. >> i sure appreciate it, thank you. >> senator hoeven. >> madam chair, i guess it would be your turn again if you wanted to go under alternating so i don't want to-- >> i'm looking just at human beings in the room. >> all right. >> then we'll go to--
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ments. >> i wanted to-- >> and then senator moran. >> you can arm wrestle it out. >> thanks, madam chair. so the question i have would be in regard with the nonprescription safe use of regulatory expansion final rule. when do you expect that to be released? >> i never try to commit to because there were layers-- >> you good in the last round, by fall catch up to it, and you're on a great trend line. >> i will tell you, i was one of the instigators of that program when i was head of the center for drugs, i'm extremely interested in it. i think that it will be tremendous for consumers to have more choices in self-care because it's getting harder and harder to get to the doctor's
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office and all of these types of things, i believe that we can use technology to enable people, say they have chronic diseases, to continue to get some of their medications as appropriate at the drug store, using technological solutions, so i'm very interested in moving this along and getting this out. >> any guesstimates. >> i would hate to do that. but you're saying you're an advocate and-- >> absolutely. >> there's more plant-based proteins on the marketplace and a challenge how they get labeled and does it-- is it confusing, you know, if there's animal terminology or imagery used and of course, on the animal side we want usda doing driving the labeling and you know, we understand you have it on the food and drug
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side or on the plant on drug side. how do you prevent misleading labeling for these products? >> well, i think we have to do -- we have an establish clear standards and we work very closely with usda on these issues to make sure they have labeling principles and so forth to make sure they're out there and people understand them. some is in education and some he enforcement to make sure if things are mislabeled that we provide feedback to companies. >> well, senator moran gets very, very concerned if a beef product, you know, there's substitute plant product for that beef product and consumer become confused about that and as do i, and so, you know, we want to really emphasize that that's important, that clarity. not only for the consumer, but, you know, for our live stock producers so they feel there's
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fair treatment out there. >> absolutely. on the plant side we want to make sure they know they're eating a plant product. it's labeled clearly which one they are, so that people are not misled. >> packaging so there's an increased desire among, i guess, the manufacturers, retail industry, state lawmakers to advance minimum recycled content requirements and of course, that's an area where there's food contact, you regulate. so, where are you on that issue? >> that is-- i understand that they're working on that. we have many different food contact issues that we have to deal with. there are, of course, many chemicals that people are more concerned about now days such as pfas and other types of chemicals that we have to make sure that food contact is safe
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and that nothing leaches into those, but we also can't establish a program that is so burdensome that it doesn't able recycled products to be used. >> it's clearly an area where there's more recycled materials which is a good thing. >> i agree. >> we need to have a good program. with that, madam chair, i yield back. >> senator moran. >> thank you again. vaccines clearly are the factor getting the country back to normal, but covid-19 testing will continue to have an essential role. direct to consumer covid-19 testing expedites the process in getting test kits to americans. the fda appears to know the importance for kit testing since it was authorized in 2020. and several others approved since the beginning of the year. if the goal is getting as many
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dct covid tests on the market as possible, is the fda considering fair consideration between navel, swab, tests assuming all requirements are met? >> i would have to get back to you. we've allowed different tests of different kinds. most require you to send in the sample, but if you were strictly at home for molecular tests and we've done six antigen tests that are at home tests, let saliva versus nasal swab, that's a bridge too far. >> that's my questions, is there a bias or a prejudice one way or another between the two tests? >> i would doubt, as long as the performance characteristics are comparable, well then, we have a bias, there may be difference in performance characteristics and i do not know and we have to get back to you. >> i welcome that, thank you,
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doctor. >> thank you, chairman. >> thank you. in 2019 children's hospital of wisconsin first connected a mystery illness to vaping. fda took way too long, in my opinion, to crack down on companies that were clearly marketing to young people, but i'm pleased now that e-cigarettes and other tobacco products are now finally required to submit premarket review applications. so, i have a number of questions related to that. i'm hoping you can provide the committee with an update on fda's review of these applications and how you're working to prioritize public health in this process of review. i'm helping you can describe how the fda's request for an additional 1100 million dollars in user fees would support this work in reviewing product
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applications and prioritizing public health. and additionally, how the fda intends to remove new tobacco products from the market that do not meet the september 9th application deadline. >> well, to sort of go backwards, we have sent out many, many, many warning letters, 120 letters to companies that failed to submit applications. we-- there were 6.1 products that we listed that we received in applications that need to be reviewed. we have a deadline, i think, in mid september to complete, to try to get through these products. could you repeat some of your other questions? >> yeah, just basically how are you going about review of the
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applications and prioritizing public health in this process, but, also, how would you put to work an additional 100 million dollars in user fees that you described in your testimony to support the work reviewing these products? >> okay. as far as prioritizing public health, the statute that we're reviewing the products against is very clear and we have to find a net benefit to public health for these of these products and for them to go onto the market. and what it says, basically, you have to have enough benefit in helping people to stop smoking combustible cigarettes that outweighs the harm to youth and so forth and people who may start becoming nicotine dependent to the products, and that's the bar that we're using. as far as the 100 million user fees, they do not have to pay
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user fees and we've had to do a massive diversion of staff toward this review process for these 6.1 million products, and that is cutting into things like enforcement of use. we had-- i was really appalled when i read the numbers and the number, thousands and thousands of establishments that had sold end products to underage youths. and they were given warnings and enforcement, money penalties against them. that might have to be cut back. additional research into tobacco might have to be cut back and so forth. so the program as it is it was not constituted to redo this math so regulatory program over the ends product because that was a more recent development with the deeming rule. so, that's why we're asking for
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additional funds because we need to keep up this enforcement. if we can't, the good news is that use in the last survey, use of tobacco products had decreased and that is really good news because they had been markedly increasing, however, we need to keep the pressure on and we can't have people selling tobacco products to underage individuals or else we may see this happen again. so -- and we still have four plus million underage people who are using tobacco products right now. so, we really need to keep the pressure on and that's why we're asking for an additional user fee. >> thank you. one more question on this topic, i was, like you, quite horrified to hear about the scale of underage use of these
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products. one of the challenges is that there is no approved method of treating nicotine addiction in children, approved by the fda, that is. so how will you tackle this challenge and work with states to ensure that kids who are caught up or caught using vaping products underage, are presented with the best options to combat their addictions? >> yes, so we've had a number of scientific work shops on this issue to work with individuals in the nicotine research society, american academy of pediatrics and so forth, it does appear that conventional smoking cessation aids that we have approved for adults don't work that well for children for some unknown reason, right? and so that those aren't,
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according to my folks i've talked to, they don't-- children don't have the same cues for smoking and so forth. so we need to pursue more research on this and figure out the best ways to enable because we have a lot of children who will be becoming adults who are now addicted to nicotine and we need to figure out a way to stop that as soon as possible. we do know, and we need to remember this, that, you know, most committed smokers start smoking in, you know, when they're underage. >> senator hoeven, do you have any more questions? >> i have just a couple more. i guess it's our third round if i'm doing that, so -- the opioid crisis continues to evolve and it ravages communities across the country. early reports show a recent
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spike in reported overdoses and deaths as the pandemic has increased things like socialized isolation and stress and reduced access to treatment and harm reduction services. this committee provided fda with important resources to address the opec opioid crisis and i'm encouraged it includes additional 38 million dollars which you outlined. can you describe how that additional funding would be utilized to aid in new treatments for opioid use disorder and how are you working to appropriately weigh the need for better access to treatment with harm reduction and protecting patients? >> yes, we will use the 38 million in a number of ways. number one, we're going to continue our efforts, step up our efforts on interdiction at the mail facilities. a lot of these fatalities are
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sentinel and so forth and different substances come through the mail so we're going to step up our efforts there, have some satellite labs. we need to develop better pain medication and better treatment for opioid use disorder, treatments that are convenient, treatments that don't require lots of doctor's offices and highly effective and so forth. but we are, of course, working on that with the national institute for drug abuse and some of these dollars will go to increase our staff, okay, that can work on these issues. it's been very, very difficult to get new pain meds and every single pain med we have right now can have significant liabilities, for example, gi bleeding, right, for the nonsteroidal anti-inflammatory agents and of course, they have the liability problem.
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so we're trying to get better pain meds and at the same time encourage development for opioid use disorder that people can have access to. because the current ones have a lot of cautions around them and there's a lot of stigma associated with this and this really decreases -- there are not enough people in treatment compared to the people who suffer from this disorder. >> that's right, that's right. a couple more questions, on pharmacy compounding, in april, the national association of boards of pharmacy abp wrote to the fda requesting a delay in enforcement of section 503-a of the food and drug and cosmetics act. they noted in their letter that many state boards of pharmacy have yet to sign a memorandum of understanding under section
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503-a and have expressed conscious with the timeline, including obstacles due to the covid-19 pandemic. i'm hopeful that all states are able, ultimately to sign the memorandum of understanding put forth by the fda, however, the october, 2021 deadline is approaching quite quickly. how is fda working with the national association of boards of pharmacies to assure that allstate boards of pharmacy are able to sign this mlu and is the agency considering an extension of this deadline? >> we're evaluating whether the deadline should be extended. we've been working with the national boards of pharmacy, in fact, they hold some of the data bases that would make this whole thing work. they're a key stakeholder in this whole thing and we hope
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that the provisions to function properly, we need all the states to sign onto the mmu. as you probably know, we've revised that and we've gone through many different repetitions of this and delays of implementation to try and get it right and make sure all the stakeholders can agree on a path forward. >> thank you. i would like -- i want to just underscore the importance that diversity plays in clinical trials. health equity is something that you mentioned in your testimony among underserved and minority populations as an ongoing challenge and i'm pleased that your budget asks for an increase in 4.7 million dollars to address this issue. can you talk a little about the work of the office of minority health and health equity, what they do at the fda, and how
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will fda prioritize this additional funding? >> certainly, well, first, let me say that this is a huge priority for me personally and i believe that we really need to get the clinical trial infrastructure out into communities so that wherever a person is located, they have the chance to be in cancer trial if they have cancer. if they have als, a chance for als trial and so forth. as far as what we've done, you know, as you recall a decade ago, it was women in clinical trials and people were very concerned. we've been publishing the snapshots program and currently, say for the past five years, women have majority participants in clinical trials and that's probably how it should be, because women seek health care more and have various conditions. as far as minority populations though, we're not doing very well.
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and much more needs to be done. the office of minority health and health equities focused on this issue of getting more diverse enrollment and clinical trials and i have been working with the director because it also is really an issue that is very important to me and so, they will be reaching out to various health care institutions and providing grants. they'll be providing fellowships because we need a generation of people to be trained, right, so they can go out in the community and serve those communities. we need to shift our mindset in my mind, from thinking, well, we just need to encourage these folks to enroll. no, we need to go to where they are, okay, and offer them enrollment through the people who care for them usually and in the places where they usually get their health care and i think that this will be a transformation that will enable
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our clinical trial populations to reflect the people of this country. thank you. >> i would like to thank you, dr. woodcock for being here today. i think we had a good discussion and i look forward to working with members. committee as we start the appropriations process for fiscal year 2022. questions for the record are going to be due next thursday, june 17th, and with that, this hearing is adjourned. >> thank you. [inaudible conversations] [inaudible conversations]
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[inaudible conversations] [inaudible conversations]
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