FDA Commissioner Martin Makary Testifies Before The Senate Appropriations Committee

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The Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies received testimony from US Food and Drug Administration Commissioner Martin Makary.

Transcript

00:00:00We'll call this hearing to order.

00:00:01Dr. McCrary, thanks for being here.

00:00:03We appreciate it very much.

00:00:04I know that it's a busy day for you,

00:00:06and so I appreciate you being here.

00:00:08And of course, Ranking Member Shaheen, thank you.

00:00:13Look forward to working with you on this appropriate subcommittee.

00:00:17You and I worked before on an appropriate subcommittee,

00:00:19and so I'm pleased now I have that opportunity here with Ag.

00:00:24Agriculture is incredibly important.

00:00:28My state, and I know the ranking members' state,

00:00:31what our great farmers and ranchers do every single day

00:00:35affects every American every single day

00:00:38with the highest quality, lowest cost food supply in the world.

00:00:41And of all the developed countries,

00:00:44Americans spend less of their budget on food,

00:00:46and they have better choice and better quality

00:00:49than any other country in the world,

00:00:52and we can't take that for granted.

00:00:54And so you'll find that we're pretty strong advocates

00:00:59for our farmers and ranchers.

00:01:01We understand that your job at FDA is to keep people safe,

00:01:06whether it's primarily the drugs they eat,

00:01:09but many food products, obviously, as well.

00:01:13I've appreciated the conversations that we've had,

00:01:17and I must say, as I've told you in our conversations,

00:01:21I think you've got an incredible record in healthcare.

00:01:26I certainly believe that John Hopkins

00:01:28is one of the finest hospitals,

00:01:30medical centers in the country.

00:01:32I have direct personal experience,

00:01:33so I've taken family members to John Hopkins,

00:01:35and I've been impressed not only with the quality of healthcare

00:01:37but with the culture of the people there and the caring.

00:01:42And then not only your tenure there

00:01:44but all that you've accomplished is remarkable.

00:01:47And so we appreciate your willing to take

00:01:50on this public service,

00:01:51this incredibly, incredibly important job.

00:01:55In it, you're going to have to, of course,

00:01:56primarily to make sure that our food and drugs are safe,

00:02:00that the organization is working as absolutely well as it can,

00:02:04which is why I appreciate your background

00:02:06not only in medicine but in business.

00:02:09Obviously, we're all trying to find savings across government

00:02:12to address the debt and the deficit.

00:02:14I know you've been charged with that task as well.

00:02:16But paramount, your job is safety.

00:02:20I understand, of course,

00:02:21they'll be releasing the MAHA report today.

00:02:23You're looking at new ways to do things.

00:02:27That's important.

00:02:27We need to do those kind of things.

00:02:29At the same time, there are practical realities,

00:02:32which you and I have talked about,

00:02:34that our farmers and ranchers face every day,

00:02:36producing that highest-quality, lowest-cost food supply

00:02:39that I just referenced that benefits every American

00:02:41every single day.

00:02:42So whether it's the fertilizers, the pesticides, the equipment,

00:02:47all the things that go into them producing that food supply,

00:02:51they have to face the practical realities

00:02:54of operating in a market

00:02:55that every day they don't control.

00:02:57They don't control the weather.

00:02:58They don't control the prices.

00:03:00They don't control trade agreements.

00:03:02And on and on it goes.

00:03:04And when you look across our economy,

00:03:09so many industries are a few big companies,

00:03:12a few big companies that run the whole thing.

00:03:15I personally am not a fan of that.

00:03:17But when you look at agriculture,

00:03:1916 million people directly or indirectly involved

00:03:22in agriculture, small family farms

00:03:24and businesses across this country

00:03:26that have become quite sophisticated

00:03:28with precision ag and everything else,

00:03:30and we do it better than anybody in the world

00:03:32and have higher standards.

00:03:34But that is what we have.

00:03:36And I firmly believe that that's what Americans

00:03:39want to make sure we have for long into the future.

00:03:43So I spent a little time on that in this opening statement

00:03:45because we have to be aware,

00:03:47you have to be aware of how that works.

00:03:50And as we make changes, again,

00:03:53making sure we do all we can for a healthy America,

00:03:58that we understand those realities

00:04:00and the challenges that those people have

00:04:03and that we can't just take it for granted

00:04:06and that we have to understand and make sure

00:04:08that all of this works for everybody

00:04:11on both sides of the equation.

00:04:13So with that, I'll turn to our ranking member.

00:04:15And I'm gonna have to ask to excuse myself to vote.

00:04:18I may miss some of your opening statement,

00:04:19but I'll see if I can't get anything that I miss

00:04:22via the written remarks and then be back.

00:04:24Ranking member.

00:04:26Well, thanks very much, Chair Hoeven.

00:04:27And let me just welcome, as you did, Commissioner McCary.

00:04:32Very nice to have you here this morning.

00:04:34And I would echo the chair's commitment

00:04:38to agriculture and how important it is our farmers are

00:04:41to our food supply and to the economy of this country.

00:04:45It's a very different enterprise in New Hampshire

00:04:49with our farms because they are small family farms,

00:04:52but very important to the state nevertheless.

00:04:56But of course, this morning, we're here to talk about

00:04:59the role of the Food and Drug Administration.

00:05:03Federal investment and stability in biomedical innovation

00:05:07are vital not just for our competitiveness

00:05:09and national security, but also for local economies

00:05:12in New Hampshire and across the country.

00:05:15Right now, we have the earliest access

00:05:17to new cures and treatments,

00:05:18and we attract the best talent from across the globe

00:05:22because of the good-paying jobs

00:05:24that are in emerging research.

00:05:26Those jobs fuel our small towns and cities,

00:05:29including in New Hampshire,

00:05:31where we have a growing industry in biomedical companies,

00:05:37it's very exciting to see the growth

00:05:39that's occurring in our state.

00:05:41As we speak, they're developing cutting-edge

00:05:44cell and gene therapies to cure terrible diseases

00:05:46like diabetes and cancer.

00:05:48And I think when we met, we talked about

00:05:50some of the work that's being done in New Hampshire,

00:05:52particularly at ARMI,

00:05:54the Advanced Regenerative Manufacturing Institute.

00:05:59But of course, to keep pioneering breakthroughs

00:06:02in curative treatments,

00:06:03they need stability and predictability,

00:06:05something this administration, sadly,

00:06:09has failed to provide so far.

00:06:12It's more than just a lack of stability.

00:06:14I fear the very mission of the FDA is at risk

00:06:17because of the actions of this administration.

00:06:21More than 4,000 people have been pushed out of FDA

00:06:24since January, the majority of those targeted

00:06:27by probationary terminations and reductions in force

00:06:31that don't seem to have any real analysis

00:06:34of who's important to keep

00:06:35and who is not critical to the mission.

00:06:40To date, this committee has not received key information

00:06:44on where specifically these workforce cuts

00:06:47are happening across centers and offices at the FDA.

00:06:50And that's information that we need

00:06:52as we're going to write this budget.

00:06:54What I want to emphasize is that

00:06:57it didn't really have to be that way.

00:06:59I think there is bipartisan support

00:07:01to see how we make our government agencies

00:07:05and departments more effective and efficient.

00:07:08But to do that, we need to have a process

00:07:11that people understand and are engaged in.

00:07:14And I fear that the process that's been done so far

00:07:17is going to prove to be very wasteful to patients

00:07:20and families in New Hampshire and across the country.

00:07:23Scientists at the FDA have been fired,

00:07:25along with support staff who make their work possible,

00:07:29from those who assist with product reviewers

00:07:31to those who quite literally keep the lights on.

00:07:34Patients across this country are depending on the FDA,

00:07:37as you know, to review medical products

00:07:40to ensure that new and novel treatments are approved.

00:07:43And yet reports now suggest

00:07:44that medical product reviews have slowed,

00:07:47that essential meetings have been postponed or canceled,

00:07:50and that deadlines for user fee agreements have been missed.

00:07:54And as Congress has provided the FDA

00:07:56with new authorities and directives,

00:07:58from the Tobacco Control Act

00:08:00to the Food Safety Modernization Act

00:08:02to the Modernizing of Cosmetics Regulation Act,

00:08:05the FDA has hired talented people

00:08:08who have gotten the work done to keep the American people safe.

00:08:12Going backwards, I think, is unacceptable.

00:08:15I'm seriously concerned that the workforce cuts

00:08:18across the agency will harm the progress

00:08:21that this committee has supported on a bipartisan basis

00:08:25to ensure a strong FDA

00:08:27that supports innovative treatments

00:08:29and gives families peace of mind that the drugs we take,

00:08:32the food we eat, and the cosmetics we use are safe.

00:08:37Now, moving on to the fiscal year 2026 budget,

00:08:40which is the topic of this hearing,

00:08:43I wish we'd received and had a chance

00:08:45to review the full President's budget request

00:08:47prior to this hearing,

00:08:49though I would point out that that's not unique to FDA.

00:08:52We haven't gotten the details of the budget

00:08:55in any other appropriations hearings

00:08:57that I've been part of.

00:08:59The FDA was not mentioned in the preliminary budget materials

00:09:02we received three weeks ago.

00:09:05So, we're sitting here today talking about a budget

00:09:08that this committee has not received.

00:09:10I'm disappointed to see the vast and drastic proposed cuts

00:09:14to the Department of Health and Human Services,

00:09:16and my priority is that the FDA has the resources

00:09:20that you need to carry out the core missions of the agency.

00:09:24But without a budget, it's hard for us to assume

00:09:27that the President's proposal will meet those goals.

00:09:30Now, in closing, the FDA, at its core,

00:09:32has an incredibly hopeful mission.

00:09:35The agency has the power to bring hope and comfort

00:09:37to millions of people by approving groundbreaking cures

00:09:41and treatments developed here in America

00:09:43by the best scientific minds in the world.

00:09:47So, I think we on this committee stand ready

00:09:50to be partners in this effort,

00:09:52and with that, Commissioner McCary,

00:09:55I appreciate your being here today again,

00:09:57and I look forward to hearing your statement

00:09:59and to the discussion that we will have

00:10:01with members of the committee about your budget proposals.

00:10:07Thank you, Chair Hoeven, and thank you,

00:10:09Ranking Member Shaheen and members of the subcommittee.

00:10:13Thank you for having me here to testify on the FDA budget

00:10:17for 2026.

00:10:19The Trump administration is proposing a $6.8 billion budget

00:10:23for the FDA, including $3.2 billion in budget authority

00:10:27and $3.6 billion in user fees for fiscal year 2026.

00:10:34This allows us to take the necessary steps

00:10:36to support the Make America Healthy Again agenda

00:10:40as we have already been busy implementing.

00:10:43Now, I've been at the FDA for about seven weeks,

00:10:46and I'm proud of the early progress we've made,

00:10:50working to remove all nine petroleum-based food

00:10:53diets from the U.S. food supply,

00:10:55eliminating unnecessary animal testing requirements for drugs.

00:11:01We approved a new blood test for Alzheimer's,

00:11:04which could help enable more early treatment.

00:11:07For the pharmaceutical manufacturing facilities

00:11:09overseas that the FDA inspects,

00:11:13there has been a routine of using scheduled inspections,

00:11:16which, in my opinion, are no inspections at all.

00:11:19They're a joke.

00:11:20And we are moving towards surprise inspections.

00:11:24We don't allow FDA inspectors anymore to accept limo rides

00:11:29from the pharmaceutical manufacturing companies

00:11:31that they are there to inspect.

00:11:34I'm amazed at some of the stuff that I'm learning

00:11:35when I look under the hood.

00:11:38We've begun taking action against new challenges,

00:11:41such as gas station heroin and childhood

00:11:44vaping with illegal Chinese vaping products.

00:11:48Our borders have been far too porous.

00:11:50Working with the Trump administration's

00:11:52re-energized Customs and Border Protection,

00:11:57we're not wasting any time.

00:11:58Today, we are announcing the seizure

00:12:00of nearly 2 million illegal vaping products from China.

00:12:05Last week, we announced plans to withdraw from the market

00:12:08chewable, ingestible fluoride tablets

00:12:11currently prescribed to 6-month-old babies.

00:12:15And this week, we published in the New England

00:12:17Journal of Medicine our framework

00:12:19for COVID vaccine booster regulation

00:12:22so that developers and companies can see what we're thinking

00:12:27and have predictability.

00:12:30And we are planning to bring back gold standard science

00:12:33and common sense.

00:12:35We also have to modernize.

00:12:37On day one of me being on the job,

00:12:41I actively began an effort to organize,

00:12:44to use AI for our scientific reviewers

00:12:48to make their jobs easier.

00:12:51Well, two weeks ago, we just announced

00:12:53our first AI-assisted review

00:12:55with the latest generation AI technology.

00:12:59One reviewer said that what normally took him

00:13:01two to three days, the AI did in six minutes.

00:13:05I've set an aggressive goal of June 30th

00:13:08to have AI-assisted scientific reviews

00:13:10help our reviewers agency-wide.

00:13:13And we're going to be ahead of schedule

00:13:15and under budget on meeting that aggressive goal.

00:13:18The goal is to reduce the paperwork burden of reviewers,

00:13:21which is tremendous, so that we can deliver more cures

00:13:25and meaningful treatments to the American people faster.

00:13:28That's been the first seven weeks of my job at the FDA.

00:13:33Here are other important goals I have for the FDA,

00:13:35and we're already hard at work on them.

00:13:38Healthier food for children.

00:13:39A universal flu shot.

00:13:42Meaningful treatments for ALS, Parkinson's,

00:13:46and other neurodegenerative disorders.

00:13:48Treatments for rare diseases.

00:13:50Cancer therapies that are so powerful,

00:13:53a tumor is eliminated without the need for surgery or chemo.

00:13:57That's not a theoretical.

00:13:58That's something we've already seen.

00:14:01And one of my highest priorities is to ensure

00:14:04that we are not wasting any time

00:14:06in evaluating novel treatments for PTSD.

00:14:10Many of our brave veterans served in unnecessary wars,

00:14:16and we owe it to them.

00:14:18I've not yet hit the two-month mark,

00:14:21so I'm doing a lot of listening.

00:14:23I appreciate all of your input.

00:14:25But one question we must ask is,

00:14:27why does it take over 10 years for a new drug to come to market?

00:14:32My team and I are working very actively

00:14:35to examine the approval process in all of its details

00:14:39so we can try to figure out how to deliver more cures

00:14:43and meaningful treatments and devices faster

00:14:46and in a more user-friendly way for developers

00:14:49without cutting any corners

00:14:51on the scientific review and independence.

00:14:54We're also committed to President Trump's promise

00:14:57to lower drug prices at the FDA.

00:14:59We can help by bringing more low-cost generics

00:15:02and biosimilars to market,

00:15:04among many other strategies we're exploring.

00:15:07In conclusion, the FDA is filled with an enormously talented

00:15:12and committed group of employees representing, in my opinion,

00:15:15one of the greatest brands in the world.

00:15:18It's my duty to make sure that everybody central

00:15:20to the core mission has all the resources

00:15:23they need to do their job well.

00:15:25So I look forward to answering your questions.

00:15:28Thank you very much, Dr. McCary.

00:15:30We're honored to have the chair of the Appropriations Committee,

00:15:34Senator Collins, with us.

00:15:35And Senator Collins, Senator Hoeven went to vote,

00:15:39so he turned the gavel over to me,

00:15:41so I will turn it over to you.

00:15:44Thank you very much, temporary chair.

00:15:49But it's been an honor to work with you on so many issues

00:15:54that we care about in this space,

00:15:56including type 1 diabetes in particular.

00:16:01Doctor, I appreciated hearing your comments this morning.

00:16:05Americans have relied on the FDA for more than a century

00:16:10to ensure that their medicines are both safe and effective.

00:16:15Recognizing that America biotech leads the world in innovation,

00:16:21we in Congress have taken a number of actions

00:16:26to ensure that FDA's rigorous regulatory review

00:16:30keeps pace with the speed of science

00:16:34and solves problems in the areas where we don't have cures

00:16:39or effective treatments or a means of prevention.

00:16:44Recent staffing changes at the FDA

00:16:48appear to have affected the balance between innovation

00:16:53and regulatory review from what I'm hearing.

00:16:57I'm particularly concerned about the downstream impact of delays

00:17:02on patients suffering from debilitating rare diseases

00:17:10like ataxia and Barth syndrome,

00:17:13as well as more common terrible diseases like ALS,

00:17:19which you mentioned, Alzheimer's,

00:17:21and other neurodegenerative diseases.

00:17:24As I mentioned, Senator Sheehan and I,

00:17:30I'm sorry, I'm out of it today apparently.

00:17:33We'll wait until the morning.

00:17:36We have worked together on type 1 diabetes for many years.

00:17:42We're encouraged by what's going on in stem therapy

00:17:45and immunotherapy in that area.

00:17:49And today, you yourself talked about the need

00:17:53for more efficient regulatory pathways

00:17:56and innovative treatments for rare life-threatening diseases,

00:18:01particularly when there are no major safety issues

00:18:05and existing treatments are either don't exist

00:18:08or they're limited.

00:18:10So, what I'm hearing is there's a real slowdown at FDA.

00:18:18And that's not what you were committing to today,

00:18:22but that's what I'm hearing the reality is.

00:18:26There are a number of rare disease new drug applications

00:18:31that have been pending at FDA for some time.

00:18:35What specifically is FDA doing under your leadership

00:18:40to accelerate getting new treatments for rare diseases

00:18:46to patients safely and as soon as possible,

00:18:49particularly since we have developed

00:18:52these accelerated pathways,

00:18:56particularly for those patients

00:18:59for which there are no treatment options now?

00:19:06Good to see you, Senator Collins.

00:19:07I share in your interest in this topic

00:19:10because I have cared for people with rare diseases

00:19:14and rare cancers, and it is the worst feeling in the world

00:19:17to have to break bad news.

00:19:18And when people say, is there anything out there

00:19:22to not have anything to respond with,

00:19:25is a very difficult position.

00:19:27So, we need to customize the regulatory process

00:19:31to the condition being treated.

00:19:34And so, if it is a rare condition,

00:19:37we have to drop our randomized control trial requirements

00:19:40in some instances.

00:19:42I will say, however,

00:19:44that the trains are running on time at the FDA.

00:19:46There have been no staffing changes

00:19:48that have changed any approval schedules.

00:19:51We are on track to meet all of our PDUFA targets.

00:19:54There are, on occasion, essentially every year,

00:19:58a couple drugs that are very complex

00:20:01where the career scientists ask for more time,

00:20:04either to convene an advisory committee to weigh in

00:20:08or to design a very unique, specific randomized trial.

00:20:12So, in reference to one of the products

00:20:16that you had mentioned, I had gotten briefed

00:20:20and was assured that there was no delays

00:20:24related to staffing.

00:20:25These were additional time

00:20:28because of the complexity of the early data.

00:20:31And the staff truly, the career scientists,

00:20:33truly believed they needed a few more weeks.

00:20:36And I thought, we're on track to meet our PDUFA targets.

00:20:39They believe we're completely on track

00:20:41to meet our PDUFA targets if they took a few more weeks.

00:20:44And I thought that was reasonable.

00:20:46The trains are running on time.

00:20:48The food inspectors are doing their job.

00:20:51We have 12 food labs.

00:20:53There's no backlog at the food labs.

00:20:56The cuts that you referenced

00:21:00and Senator Shaheen referenced were to things like this.

00:21:062,600, this is at the FDA,

00:21:102,600 HR staff, contract staff, and budget staff.

00:21:16Now, I think that's too much.

00:21:19They were part of the reduction in force.

00:21:21In total, about 1,800, almost 1,900 people

00:21:26were involved in the reduction in force.

00:21:28And I think a lot of that is consolidation.

00:21:30Just to be clear, there were no reductions

00:21:33in scientific reviewers

00:21:36as a part of the reduction in force.

00:21:37And we're actually hiring scientists

00:21:40because there's normally turnover with our scientific staff.

00:21:43And I hope the AI and the other tools

00:21:46will help make their jobs more efficient.

00:21:49Well, I am hearing something entirely different.

00:21:54So I will convey directly to you

00:21:58the concerns that I'm hearing

00:22:01since Dr. Peter Marks was removed from his position.

00:22:06And it is disheartening

00:22:11for patients with serious diseases,

00:22:14as you know very, very well from your clinical practice

00:22:19for which I know you are a dedicated physician.

00:22:23But it is disheartening

00:22:27when it appears that a new treatment or drug

00:22:32is on the horizon.

00:22:35And then FDA says, no, we need three more months.

00:22:39We need three more months.

00:22:40We need three more months over and over again.

00:22:43Despite the years that have gone into developing

00:22:48a particular treatment for an illness

00:22:53that has no treatment.

00:22:55And again, that's why we work so hard

00:23:00to establish these accelerated pathways.

00:23:04So I'll be in further touch with you.

00:23:07I don't disagree with the need to look

00:23:12at the staffing of FDA

00:23:16and to make sure that as much of it as possible

00:23:19is going into the process

00:23:23that speeds food inspection,

00:23:28new drugs to the American people,

00:23:30sensible regulation and guidance on diet,

00:23:35lifestyle factors, all of that is extremely important.

00:23:40So it's not that I object to looking at that,

00:23:43but I don't want it to come at the expense

00:23:47of drugs that are desperately needed.

00:23:52Thank you, Senator.

00:23:53I will just say that the person,

00:23:55the scientist replacing Peter Marks is outstanding.

00:23:59And I would say, take a close look at his credentials.

00:24:01He has published over 540 peer reviewed scientific articles.

00:24:06He's a professor from UCSF

00:24:08trained at the National Cancer Institute.

00:24:11He's a scientific genius.

00:24:13So I've rejected the idea

00:24:15that there's only one scientist in the world

00:24:17that can run CBER well.

00:24:18And I think we need fresh new ideas.

00:24:21The new scientist replacing Peter Marks is 42 year olds.

00:24:24He brings a fresh new perspective

00:24:26and it will not change our approach to rare diseases

00:24:29or the predictability that people need in the market

00:24:32and development investment space

00:24:34to know that they need to continue

00:24:36to invest in those technologies.

00:24:38I look forward to meeting him.

00:24:44Thank you, Madam Chair.

00:24:45Appreciate you being here.

00:24:48Doctor, you came into roughly a 19,000 person agency.

00:24:53Your budget top lines about 3% less,

00:24:58but there's been estimates as high as potentially

00:25:034,000 reduction force voluntary or actual RIFs.

00:25:07Where are you on that and how's it going?

00:25:09You and I again talked about this before I was,

00:25:14and at that time, we talked about how once you got in there

00:25:17and had more time, you were gonna obviously

00:25:20have a better analysis of what your needs are

00:25:22and where you're at with the personnel situation.

00:25:24So go through that for us, will you?

00:25:26Sure, so there have been about nearly 1,900 people involved

00:25:31in the reduction in force.

00:25:33Roughly another 1,200 plus involved

00:25:39in the early retirement package.

00:25:41We are hiring scientists to replace scientists

00:25:44that may have left for an early retirement,

00:25:47but no scientific reviewer or inspector was cut

00:25:52as a part of the reduction in force.

00:25:54Now, any discussion of the reduction in force,

00:25:57I believe, deserves one important fact of context,

00:26:01which is always omitted in the media coverage,

00:26:04and that is in 2007, the FDA had a little over 9,000

00:26:10employees, and a few months ago, it was 19,000.

00:26:13So there was a 100% increase in the number of employees

00:26:16at the FDA over the last 15, 16 years,

00:26:21and that is how we get 2,600 HR people coming in

00:26:27and contracts and budget people at the agency.

00:26:30380 communications positions.

00:26:33We're now down to about 160.

00:26:35They're doing a good job, 160 people.

00:26:38That covers a lot of the communication work.

00:26:41Did we need 125 travel coordinators

00:26:44and travel offices in each center,

00:26:47or 13 strategy offices at the FDA?

00:26:50A lot of this reorganization is smart,

00:26:53and it's being smart with taxpayer dollars,

00:26:55because I personally believe when this institution here,

00:27:00U.S. Congress, is spending $2 trillion more

00:27:02than we have as a country, it is driving inflation,

00:27:05which is a backhanded tax on the poor,

00:27:07and that is the harsh reality.

00:27:09It doesn't affect people of wealth like myself.

00:27:11It affects the 50% of Americans that have less than $500

00:27:15of cash on hand, and they are forgotten

00:27:17when we spend too much money and we drive inflation,

00:27:21and that's why I support many of these reductions

00:27:25in force where it makes sense.

00:27:30But you also get fee agreements from drug companies

00:27:35that want to get new drugs to the market,

00:27:38and so you have to be able to staff for that

00:27:39so that you bring in that fee revenue,

00:27:41which of course is not a cost to the taxpayer.

00:27:44So I agree with you.

00:27:45We need to find better ways to do things.

00:27:47We need to find savings, and that's good,

00:27:50but talk to us how you're making sure

00:27:52that you manage things.

00:27:53Again, Paramount, your mission of safety

00:27:54as we talked about in the front end,

00:27:55I know you understand that.

00:27:57You're a doctor, took the Hippocratic oath.

00:28:01But those fee agreements make it more complicated,

00:28:03but they bring in revenue.

00:28:04Talk about that, as well as making sure

00:28:07we get these new drugs to the market

00:28:08as safely and efficiently as possible

00:28:11because that ultimately saves lives.

00:28:13Yes, Senator, so thank you for that question,

00:28:16and again, I want to reassure the public

00:28:18to see through the headlines and to know

00:28:22that the trains are running on time at the FDA,

00:28:24and we're on track to meet all of our user-free fee targets

00:28:28as an agency, and we need the staff to help

00:28:31with the user-fee management,

00:28:33and that's why I've made sure

00:28:35that we have the appropriate staff

00:28:37to make sure that we can report on our user fees

00:28:40and sort of service conductors

00:28:43in managing the user-free fee targets.

00:28:46Now, look, I'm a surgeon,

00:28:48and so the reductions in force are never perfect,

00:28:52so I've done everything humanly possible

00:28:54since I've gotten there to try to make sure

00:28:57we heal and reorganize appropriately.

00:29:00We have brought back some people,

00:29:02and my job is to make sure that the scientists

00:29:05and inspectors, that the law enforcement officials at FDA

00:29:08have all the resources they need to do their job well.

00:29:11Okay, I think I'm gonna give you a short question,

00:29:16well, no, I'm gonna go with a longer one.

00:29:19I'm gonna probably run over my time a little bit,

00:29:21ranking members, so I'll beg your indulgence

00:29:24and certainly return the favor.

00:29:27The Maha Commission's coming out with their report,

00:29:30I think, pretty much right after this hearing.

00:29:33Yeah, noon.

00:29:34Yeah, so if you want to kind of give us

00:29:35all the details right now, that's great,

00:29:37and just get a jump on things,

00:29:39but guessing that you might not,

00:29:41you do need to talk to us about it in that,

00:29:44as I laid out in my opening statement,

00:29:46this committee has jurisdiction,

00:29:48both in regard to all of your funding at FDA,

00:29:52but also USDA for our farmers and ranchers,

00:29:57and we have to address both.

00:29:58So I know you're coming out, HHS writ large

00:30:02is coming out with this Maha study plan today,

00:30:09but as I said in my opening, we're very concerned,

00:30:11not only how that's gonna affect the American consumers,

00:30:16but also how that's gonna affect agriculture.

00:30:18And as you know, agriculture goes,

00:30:20I mean, they're regulated like everybody else.

00:30:22In fact, in my opinion,

00:30:23they're over-regulated like everybody else.

00:30:27And so, with this report coming out,

00:30:31yeah, I get y'all are gonna be working very hard

00:30:33to make sure it's scientifically based and all that,

00:30:35but a lot of what our farmers and ranchers

00:30:38in producing that food supply have had to do,

00:30:39that's all scientifically based too,

00:30:42heavily regulated,

00:30:43and there's been years and years and years

00:30:44of that analysis and regulation done,

00:30:46and a heck of a lot of expertise.

00:30:48So how do you approach that in this plan of action

00:30:55and the analysis that you're doing and so forth,

00:30:57and the studies you're doing,

00:30:58to make sure that that's adequately included

00:31:02in terms of your evaluation and the results

00:31:04and the recommendations that you make?

00:31:07Well, Senator, you shouldn't be concerned

00:31:09about the Maha report.

00:31:11It is simply information,

00:31:12and it's important information about health,

00:31:15written by people who have excellent citations

00:31:19and are representing the many scientists

00:31:21that have been waving a flag in the air for many years,

00:31:24saying, hey, look at root causes.

00:31:25We have the sickest, most disabled, most medicated,

00:31:29most obese population in the history of the world.

00:31:33Half our nation's kids are sick, and why are they sick?

00:31:36Because when the immune system

00:31:38or some inflammatory response is reacting

00:31:41to the many different chemicals that go down their GI tract,

00:31:47they feel blah, they don't feel well,

00:31:49and so we have got to look at root causes.

00:31:52Now, there's no single chemical in the food supply

00:31:56that is accounting for a root cause

00:31:57for driving our chronic disease epidemic,

00:32:01but I think everything has to be on the table.

00:32:05We, for example, at the FDA,

00:32:07just convened two days ago a roundtable on talc.

00:32:10Now, talc has been identified as a cancer-causing agent.

00:32:14It's been removed from baby powder.

00:32:16There have been 30 studies saying

00:32:18that talc may cause ovarian cancer in women

00:32:20with a high odds ratio and statistical significance.

00:32:24International cancer bodies have warned

00:32:27about the cancer-causing effect and the mechanism of talc,

00:32:31and so it's been removed from baby powder.

00:32:33Do you know kids are eating talc every day?

00:32:36It's in candy.

00:32:37You take chewing gum, and the white powder on there,

00:32:39people think it's sugar.

00:32:40Sometimes it's talc.

00:32:41Talc is in our food supply.

00:32:43Kids are eating talc, and it's not just in food.

00:32:47It's in medicines.

00:32:48The number one, three, nine, and 10

00:32:50most common medications in the United States

00:32:52have talc on it.

00:32:53Why?

00:32:54Because it's a lubricant.

00:32:55It's just the way we've been doing business.

00:32:57It's a lubricant in the machines when it's mass-produced.

00:33:00Well, there's a low-cost alternative

00:33:03that is generally considered to be safe.

00:33:06We're not fighting anybody here.

00:33:08We're trying to bring the latest scientific information

00:33:12to inform good decisions.

00:33:13And I think you're gonna be pleased

00:33:15with the Maha Commission Report.

00:33:16It puts at the forefront of our discussions of health

00:33:20many issues that scientists have been talking about for years.

00:33:23Never in my oncology meetings

00:33:25do we talk about the root causes of cancer.

00:33:29Cancer's going up in kids.

00:33:30Young people under age 50,

00:33:32it's everyone scratching their heads.

00:33:34You get a diagnosis.

00:33:36They come to Johns Hopkins.

00:33:37We would look at them and parents would say,

00:33:39what could possibly cause this?

00:33:42Well, guess what?

00:33:42We don't talk about any of this in our national conferences.

00:33:46That is what the Maha Commission Report's gonna talk about.

00:33:49What have we been talking about?

00:33:50Insulin, chemotherapy, CAR-T therapy,

00:33:53radiation, sophisticated operations.

00:33:56We've gotta talk about food and chemicals,

00:33:58not just chemo and insulin.

00:34:00And so this Maha Commission is gonna put front and center

00:34:03as they're setting our research priorities,

00:34:06setting a national conversation,

00:34:07setting our own internal goals

00:34:09so that we're gonna deliver in another 100 days from today

00:34:12some of what we're gonna do.

00:34:14The Maha Commission Report is a diagnosis.

00:34:17And I think we have to do something differently.

00:34:21We have a healthcare system that's breaking the budget,

00:34:24that's resulting in inflation, that's burdening businesses,

00:34:28that's the number one cause of household bankruptcy

00:34:30in the United States is medical bills,

00:34:32and no one is talking about the root cause,

00:34:34and that is the health of the population

00:34:36that is actively deteriorating right in front of our eyes.

00:34:40And so we've gotta move from a reactionary healthcare system

00:34:43where we're playing whack-a-mole with all these treatments

00:34:45in the hospital in late stages and be proactive

00:34:50and actually talk about the root causes

00:34:52and why we don't see some of these problems

00:34:54in other countries.

00:34:56I think this report is going to be the cornerstone

00:34:59of a broader discussion.

00:35:01And there's no one single ingredient

00:35:03that's gonna be vilified.

00:35:05So after the report comes out,

00:35:08after we do some work on your budget,

00:35:10we're gonna want you to come back and talk to us.

00:35:12Are you gonna be willing to do that?

00:35:14Of course, I love to talk.

00:35:15Good.

00:35:16Thank you very much.

00:35:17Ranking Member Sheen.

00:35:20Well, thank you, Chair Hoeven.

00:35:22And I certainly agree with you

00:35:25that we gotta focus on the root causes

00:35:26of what's causing diseases.

00:35:30And I've been trying for years

00:35:32to change the sugar subsidy system that we have

00:35:37that encourages sugar to be added to our food supply

00:35:41in so many ways.

00:35:43But so far, there hasn't been the political will to do that.

00:35:46So one of the things that I would urge you to do,

00:35:48Senator Chair Hoeven suggested that we would like

00:35:51to have you come back and talk about this.

00:35:53I hope that there will be more of an effort

00:35:56to engage Congress in the changes

00:36:00that you're talking about making

00:36:03than there was in the cuts that were made.

00:36:05Because again, I think there's a lot of appetite

00:36:10to try and look at how we do things better.

00:36:13But boy, there's not an appetite to have one person

00:36:17and a DOJ commission go around

00:36:19and make all these decisions without engaging Congress.

00:36:22Because so much of that has not only been not well received,

00:36:26it's been outright illegal.

00:36:28That's not your problem.

00:36:29But I hope as you think about looking at the changes

00:36:33that we need to make to get at root causes,

00:36:36that you will come back and engage with us

00:36:38on what you're proposing.

00:36:39Because there's a lot of expertise on this committee.

00:36:43And I'm sure a lot of ideas

00:36:45for what we ought to do better, too.

00:36:48But I want to go back to diabetes,

00:36:50one of the most expensive chronic illnesses we have.

00:36:53It's one that you and I talked about.

00:36:56Senator Collins and I have done a lot of work

00:36:58as co-chairs of the Diabetes Caucus on this.

00:37:01As I explained to you, for me, it's not just a policy issue.

00:37:05It's a personal issue.

00:37:05I have a granddaughter with type 1.

00:37:07So I know the struggles that the community has had.

00:37:10And many of those with the FDA, before you got here,

00:37:14but they have been real.

00:37:16And one of the issues right now

00:37:21that I'm hearing from the diabetes community

00:37:25is about C-peptide,

00:37:28which is a marker of the body's own insulin production.

00:37:31It's emerging as a potentially more accurate tool

00:37:34for measuring how well a person's cells are functioning.

00:37:38However, the FDA does not currently recognize C-peptide

00:37:42as a validated surrogate endpoint,

00:37:46meaning that the community has to use other endpoints

00:37:50that are less, many people believe, less accurate.

00:37:55So will you commit to reviewing C-peptide

00:37:58as a validated surrogate endpoint?

00:38:00I'm happy to, Senator.

00:38:01I love C-peptide.

00:38:03I'm a pancreatic specialist.

00:38:04And so I don't understand why it would not be recognized.

00:38:07It is a naturally occurring hormone

00:38:09that is an indicator of the physiologic health

00:38:11of the pancreas.

00:38:12So I'll take a look at that for you.

00:38:13Happy to.

00:38:14Good, thank you.

00:38:15I hope we can stay in touch on that.

00:38:19In the last couple of days,

00:38:20there have been a lot of news reports about the COVID-19.

00:38:23So I was surprised to hear about the FDA's announcement

00:38:42earlier this week that would limit access

00:38:44to COVID-19 boosters.

00:38:46And it seems like the announcement

00:38:51would take away people's ability to make that choice

00:38:54on their own by limiting it to only people 65

00:38:58or at high risk.

00:38:59So can you help us understand why that decision was made

00:39:03and why people who may think that that booster

00:39:08would be helpful to them will no longer be available?

00:39:13Happy to.

00:39:14It's been four to five years

00:39:15since we've had a randomized control trial.

00:39:17And so we don't know the right number of boosters

00:39:20that a healthy American should take.

00:39:23What is that number?

00:39:24Is it two like the MMR vaccine?

00:39:27Is it two or three like HPV or hepatitis B?

00:39:31Or is it 80?

00:39:32Do we believe in giving 80 mRNA shots to a healthy girl

00:39:36born today in her average lifespan of 80 years?

00:39:38Is that the right answer?

00:39:39That has been a theory that the repeat booster strategy

00:39:43in healthy individuals

00:39:46is the correct evidence-based strategy,

00:39:48but there's been no data to support it.

00:39:50So we are doing our job to say that

00:39:53if we're going to approve a COVID vaccine

00:39:57for younger, healthy Americans,

00:40:00we'd like to see some clinical trial data,

00:40:03given that it's a much different population

00:40:06from five years ago.

00:40:08There's broad, ubiquitous population-based immunity.

00:40:13There's also a different virus circulating,

00:40:16and this is a new vaccine formulation

00:40:18that creates a new protein in the body.

00:40:21Should we blindly rubber stamp a vaccine

00:40:24that creates a new protein in the body

00:40:26every year for the rest of our lives

00:40:28for the next hundred years?

00:40:29I don't think so.

00:40:30And so that's why we published

00:40:32in the New England Journal of Medicine this week

00:40:35a framework for sensible COVID vaccine booster regulation

00:40:40in the United States that uses an age-stratified approach.

00:40:44And really, honestly,

00:40:46we are catching up with the rest of the world.

00:40:48Some of the rest of the world has been laughing at us

00:40:50using this blind strategy.

00:40:52We're now switching to a scientific strategy.

00:40:55The UK only recommends COVID boosters

00:40:58in people 75 years of age and high-risk.

00:41:03France, 80 years of age and high-risk.

00:41:06I don't think we should be pushing this

00:41:07on healthy 6-year-old girls

00:41:10without any evidence every year for the rest of their lives.

00:41:13And so that's why we've outlined this framework.

00:41:15And by the way, the vaccine manufacturers

00:41:17put out positive statements about the framework

00:41:20because I believe they like predictability.

00:41:23Well, so I understand that rationale.

00:41:25Do you have a timetable for when you expect

00:41:27to have the trials done and a decision made about the future?

00:41:32When the companies present trials to us,

00:41:35and in the case of high-risk,

00:41:36our New England Journal paper outlines

00:41:38how they can seek clinical trial data

00:41:41after approval in high-risk populations.

00:41:45But it's up to the companies to present data to us.

00:41:47It's always been that way, where the FDA reviews

00:41:50clinical trial data that companies present,

00:41:53and we make a decision about safe and effective.

00:41:55We have been suspending that role

00:41:58for the last four years with COVID boosters.

00:42:00And so we're saying this is a reasonable time to check in

00:42:03and look at clinical trial data,

00:42:05given how different it is.

00:42:06By the way, America doesn't want COVID boosters.

00:42:09I'm sorry to interrupt, but I'm out of time, actually.

00:42:13I assume that you're talking to some of those companies,

00:42:16so you have some idea of their level of interest

00:42:20in coming back to do those clinical trials

00:42:22and what they may be thinking about in terms of a timeframe.

00:42:25Look, some of these companies made $100 billion

00:42:28in the COVID booster.

00:42:29They can afford to run a clinical trial,

00:42:31and they have time to run a clinical trial.

00:42:33The VRBPAC meeting meets later today to pick a strain.

00:42:37So there's time and there's money.

00:42:39We're setting a common-sense framework.

00:42:42Yeah, but I get that.

00:42:4385% of healthcare workers.

00:42:45Are we talking about six months, a year, five years, 10 years?

00:42:51I'm just trying to get some ideas

00:42:52so that when people call our office and ask,

00:42:55when I run into people and say,

00:42:56well, how come I can't get the COVID booster,

00:43:00that we can give them some kind of an answer

00:43:02for what they can expect?

00:43:0485% of healthcare workers said no to the last COVID boosters.

00:43:07You're not suggesting that we blindly approve

00:43:10COVID boosters each year without clinical trial data.

00:43:11You're not listening to me, Dr. Makary.

00:43:14I'm not asking for a blind approval.

00:43:16I'm saying that I understand the argument you're making.

00:43:19What I'm asking you is, do you have any timeframe

00:43:21for when you think this might happen?

00:43:22And I'm sure you're talking to pharmaceutical companies

00:43:25so that they might have some idea

00:43:28so that we can just answer questions from the public.

00:43:31Part of what I'm objecting to here

00:43:34is that all of these decisions are being made

00:43:36without engaging the public, and I think that's a problem.

00:43:40Public has said no to COVID boosters.

00:43:4270% of the public has not gotten a COVID booster,

00:43:45and they don't trust us because there's no...

00:43:47You're still not answering my question, though.

00:43:49So, the timeframe...

00:43:50Do you not have any idea?

00:43:51The timeframe is reasonable,

00:43:53and it is amicable to what the industry thinks they can do,

00:43:58and so we've had these conversations,

00:44:00and we do with the industry.

00:44:01I can't share individual product conversations

00:44:04with the manufacturers, but they think that the timeframes

00:44:06that we've outlined are reasonable,

00:44:08and we think they're reasonable.

00:44:10But you still haven't said what they might be.

00:44:12There's plenty of time between now and the fall,

00:44:15and so there's plenty...

00:44:16So, you think it's going to be more of a short-term timeline?

00:44:20So, we in the high-risk group...

00:44:21This is not a trick question.

00:44:22I'm not trying to trick you here.

00:44:23I'm just trying to get some answers.

00:44:25And I'm not trying to not answer your question.

00:44:28It's just different for each age group.

00:44:30For young, healthy individuals,

00:44:32we have a different timeframe from the high-risk community,

00:44:35where we are approving the COVID...

00:44:38Well, I shouldn't say we are,

00:44:40because we haven't reviewed all the data

00:44:41and all the applications are not in.

00:44:42But for high-risk individuals, we do have a framework now

00:44:46by which they can run the trials

00:44:48after the approval in high-risk individuals

00:44:51throughout the COVID season,

00:44:52and then Americans will know it either works or doesn't work.

00:44:56So, it's roughly a year.

00:44:58It's roughly a year.

00:44:59In Operation Warp Speed,

00:45:01they ran that phase three clinical trial over the summer,

00:45:04and if they want to do the same thing,

00:45:06there's plenty of time, in my opinion.

00:45:08Thank you. Thanks.

00:45:09Senator Hyde-Smith.

00:45:11Thank you very much, and thank you, Dr. Macri,

00:45:15for being here and joining us on the Hill today.

00:45:17We've discussed the issue of chemical abortion before.

00:45:20However, I'd like to revisit the topic

00:45:23in light of new data published last month

00:45:25by the Ethics and Public Policy Center.

00:45:28This data reveals a much higher risk

00:45:31from the abortion drug mefapristone

00:45:34than previously acknowledged,

00:45:37and this raises the questions

00:45:38whether it's time to reconsider

00:45:39the broadly unrestricted access to the drug.

00:45:43It makes me question if the FDA

00:45:45should reinstate the original safeguards

00:45:48in order to protect vulnerable women and minors

00:45:51from experiencing the horrible, adverse,

00:45:53and life-threatening complications

00:45:56that could follow the chemical abortion regimen.

00:46:00First, let me summarize the new data.

00:46:02In April 2025, researchers from Ethics

00:46:05and Public Policy Center

00:46:06and the Foundation of the Restoration of America

00:46:09reviewed the outcomes of 865,000-plus

00:46:15drug-induced abortions from 2017 to 2023.

00:46:19These abortions occurred after the FDA, in 2016,

00:46:23removed the requirement for doctors

00:46:25to report non-fatal but adverse complications.

00:46:30The data shows that 94,605 serious adverse events

00:46:38proving conclusively that more than one out of 10 women

00:46:43are put at risk by the mefapristone.

00:46:46This real-world rate is 20 times greater

00:46:50than the rate the FDA used

00:46:52when it originally approved the drug.

00:46:55Specifically, this data shows that, quote,

00:46:59their words, 10.93% of women experience sepsis,

00:47:03infection, hemorrhaging, or other serious adverse events

00:47:07within 45 days following the chemical abortion.

00:47:12If serious complications have increased

00:47:15as safety rules have been loosened over the last 25 years,

00:47:18then logically it makes sense

00:47:20to bring those safety protections back.

00:47:23At the very least, the FDA should restore

00:47:25the original safety requirements from 2000

00:47:29under its risk evaluation and mitigation strategies.

00:47:33How do you view this new data,

00:47:35and will the FDA be taking this new data into consideration

00:47:40and commit to restoring common-sense protections

00:47:43like requiring an in-person doctor visit

00:47:46before women can actually access mefapristone?

00:47:51Thank you, Senator Hyde-Smith, and good to see you again.

00:47:54I think a lot of people are asking those questions,

00:47:56and so I did see those top-line results

00:48:00that you referenced,

00:48:01and we are gonna take a look at those data

00:48:05as they become available.

00:48:06There is no peer-reviewed publication,

00:48:08and the underlying data set is not available,

00:48:10but when it does become available,

00:48:12we're gonna take a hard look at it.

00:48:14Thank you, I would appreciate that very, very much.

00:48:19Senator Assa.

00:48:22Thank you, Mr. Chairman, and Dr. Macari, good to see you.

00:48:25Good to see you.

00:48:26Thank you for joining us.

00:48:27I was pleased to see that the secretary

00:48:30has made the safety of infant formula

00:48:34a priority for the department, is that correct?

00:48:36That's right, and the FDA will be convening

00:48:38the world experts on infant formula June 4th,

00:48:43and we're going to be having a robust discussion

00:48:45because parents want infant formula options

00:48:48with a better supply chain

00:48:50and without added sugar and seed oils.

00:48:52Did you see a recent Consumer Reports study

00:48:55which found that of 41 tested infant formulas,

00:49:00more than 30 were found to have

00:49:01potentially dangerous levels of lead?

00:49:04Yeah, heavy metals in infant formula

00:49:06is something that's getting a lot of attention,

00:49:08as it should,

00:49:09and so that is part of Operation Stork Speed

00:49:12to take a hard look at that,

00:49:13and it is one of the priorities

00:49:15of our infant formula roundtable at the FDA on June 4th.

00:49:18And it's the human foods division of your agency

00:49:23responsible for infant formula safety,

00:49:25at least in large part, yes?

00:49:27Yes.

00:49:30Trying to make sure I understand

00:49:31some of the relevant personnel decisions,

00:49:33given the concern that families in Georgia

00:49:36have about the safety of infant formula,

00:49:39the safety of the food supply,

00:49:42James Jones, the deputy commissioner for human foods,

00:49:45submitted a resignation letter February 17th,

00:49:50included the quotes,

00:49:51quote, the indiscriminate firing of 89 staff

00:49:53in the human foods program is beyond short-sighted.

00:49:57The foods program staff at FDA is the envy of the world

00:50:00and its technical, professional, and ethical standards.

00:50:02It goes on, the employees fired this past weekend

00:50:04are the most recent hires

00:50:06and generally come to federal service

00:50:08with the most recent education

00:50:09and represent the future of the agency.

00:50:10They included staff with highly technical expertise

00:50:13in nutrition, infant formula, food safety response,

00:50:16and even 10 chemical safety staff

00:50:18hired to review potentially unsafe ingredients

00:50:21in our food supply.

00:50:22That was February 17th.

00:50:25You were asked on April 17th

00:50:30whether any of the personnel reductions

00:50:31had included personnel responsible for food safety

00:50:34or infant formula safety.

00:50:36You said, quote, there were no cuts to scientists

00:50:39or reviewers or inspectors, absolutely none.

00:50:42You were asked on April 23rd on CNN and said, quote,

00:50:46again, there were no cuts to scientists or inspectors.

00:50:52But then just two days later,

00:50:54an HHS spokesperson confirmed that, in fact,

00:50:59scientists had been fired

00:51:01and that you were scrambling to rehire them.

00:51:04Is that, did you, in fact, say on April 23rd

00:51:09there were no cuts to scientists or inspectors?

00:51:11Just before we get into the details,

00:51:12is that an accurate quote?

00:51:13No scientific reviewer was cut

00:51:15as part of the reduction in force.

00:51:17But you said there were no cuts

00:51:18to scientists or inspectors.

00:51:19Didn't you say that?

00:51:21My understanding was that there were no cuts

00:51:23to the scientific staff,

00:51:25but specifically the scientific reviewers

00:51:27is what I was referring to.

00:51:28But you said there were,

00:51:29I mean, I've just, it's a very straightforward question.

00:51:31You said there were no cuts

00:51:32to scientists or inspectors, correct?

00:51:34Scientific reviewers is what I was referring to.

00:51:37That's the vast majority of scientists there.

00:51:39Jim Jones is an economist.

00:51:40Five days before you had said

00:51:41there were no cuts to scientists.

00:51:44You said that, right?

00:51:45I was referring to scientific reviewers.

00:51:46There are a couple of researchers.

00:51:47But scientists had been fired, correct?

00:51:49There have been a couple,

00:51:50there have been research scientists in some labs

00:51:53that have been doing some research.

00:51:55Some of that research is good.

00:51:56Some of it is not good.

00:51:58And so there have been no cuts to scientific reviewers.

00:52:01In fact, scientists who study the safety

00:52:03of infant formula had been fired, correct?

00:52:07I'm not aware of any scientists

00:52:09who studies infant formula.

00:52:11Well, here's the reporting in the New York Times.

00:52:15It says the HHS spokesman said

00:52:17those employees called back had been inadvertently fired.

00:52:21And the decision to rehire specialists

00:52:23on outbreaks of food-related illnesses

00:52:26and those who study the safety

00:52:27of products like infant formula.

00:52:30Is this reporting accurate?

00:52:32Had, in fact, scientists who study outbreaks

00:52:35of food-related illnesses

00:52:37and the safety of infant formula been fired?

00:52:39The reason it's not accurate, Senator,

00:52:41is that people were not fired.

00:52:43They were scheduled for the reduction in force.

00:52:45And that was before I got there.

00:52:47When I got there, we did an assessment.

00:52:48And so some of those individuals

00:52:51out of the 19,000 were restored.

00:52:54Jim Jones was an economist

00:52:56and he was upset about the doge cuts.

00:52:58So he self-doged.

00:53:00He was not fired.

00:53:01I wish he would have stayed, but he chose to leave.

00:53:03Have all scientists responsible for food safety

00:53:07and infant formula safety been rehired or reinstated?

00:53:11Look, we have not reduced in force

00:53:16the scientific review staff.

00:53:17I know where you're going with this.

00:53:19We're not allowed to let go of a single person.

00:53:20I'm trying to get clarity on your statement.

00:53:22You said there were no cuts to scientists.

00:53:25And then the HHS spokesperson said,

00:53:27actually, there were cuts to scientists

00:53:30and now we're trying to rehire them.

00:53:30I mean, so it gives the impression

00:53:32you're not sure about the personnel actions

00:53:34ongoing in your own agency.

00:53:35And that's the indication from your testimony today.

00:53:39No one was cut in the reduction of force.

00:53:41They were scheduled for the reduction in the future.

00:53:44And down the road, it has not happened yet.

00:53:47So the people scheduled to be cut,

00:53:50we did a review and found some research scientists.

00:53:53When I made those statements, it was very specific.

00:53:55I was very clear.

00:53:56We're talking about scientific reviewers

00:53:58because the trains have to run on time.

00:54:00And if you're concerned about-

00:54:01My time is up, my time is up, but you were very specific.

00:54:04You said there were no cuts to scientists.

00:54:06And then five days later, there were no cuts to scientists.

00:54:10Those are your direct quotes.

00:54:12There were no cuts to scientists,

00:54:14but there were cuts to scientists.

00:54:15No, there were no cuts to scientists

00:54:17because people were scheduled

00:54:19for the reduction of force in the future.

00:54:22And the people scheduled were reevaluated

00:54:25and we restored a couple research scientists.

00:54:28And I was referring not only to them,

00:54:29but to the scientific reviewers.

00:54:33How many scientists responsible

00:54:35for preventing outbreaks of food-related illnesses

00:54:40and the safety of infant formula

00:54:41have been restored or reinstated?

00:54:44There were no scientists that were in charge

00:54:46of preventing outbreaks that were part of the reduction.

00:54:48I didn't say in charge.

00:54:49But I mean, this is the problem in government.

00:54:51Somebody has a fancy sounding name

00:54:53like infant formula safety and no one can ever touch them,

00:54:56even if they're not doing their job.

00:54:58Okay, I'll tell you what, how about this?

00:54:59I'll send you, so that you can get accurate information

00:55:03to the committee, I'll send you

00:55:05some very detailed questions about this

00:55:07and you'll respond in full, yes?

00:55:10Yes, just keep in mind the agency was half its size in 2007.

00:55:14We didn't have outbreaks and rampages and food outbreaks.

00:55:17But we had a huge infant formula safety crisis

00:55:19in this country just a few years ago.

00:55:21Do you recall that?

00:55:21That was because of several problems, including-

00:55:24Yeah, but so you will respond in full

00:55:26to the questions that I send you.

00:55:27I'm always happy to respond in full.

00:55:28Thank you so much, Dr. McCarthy, thank you.

00:55:31Doctor, I know that you're working on Operation Stork Speed,

00:55:36speaking of baby formula, that Secretary Kennedy

00:55:40has already talked about Operation Stork Speed,

00:55:43which goes right to this issue.

00:55:44You're already working on it, made it a priority.

00:55:47Would you like to address that?

00:55:48We're working hard on it and that's why

00:55:50we're convening the world's experts.

00:55:51And the part of the problem with infant formula

00:55:55that the Senator is alluding to, which is a real problem,

00:55:59is that the FDA has been so rigid

00:56:02in the way it evaluates infant formula.

00:56:04Basically, we have for decades said,

00:56:07you have to follow this recipe because we,

00:56:10as the government, know exactly what infants need

00:56:12and you can't deviate from this recipe.

00:56:14And guess what?

00:56:15They got added sugar on there and seed oils

00:56:17and there's been no innovation in infant formula

00:56:20practically since 1998 when we saw the last change

00:56:24in infant formula on the Monograph recipe

00:56:27with the exception of selenium that was added.

00:56:29Basically, no innovation in infant formula since 1998.

00:56:33And so that's what we're working to fix.

00:56:35That is one of the underlying problems.

00:56:37The more innovation, the more competitors

00:56:40that can come to market, the more predictability

00:56:42with the regulatory process,

00:56:44the better products we're gonna see,

00:56:46more options for moms that want infant formula,

00:56:49that's safe, low in heavy metals,

00:56:51without seed oil, without added sugar.

00:56:53And that is, I think, gonna help also lower prices

00:56:56and increase the supply chain.

00:56:58And of course, moms know, but there needs to be a choice

00:57:03in that baby formula so that you've got the product

00:57:05you need for your child.

00:57:07Absolutely, we're all about choice.

00:57:09And so there's a lot to it.

00:57:11And again, I commend you and the Secretary

00:57:16for making that a priority.

00:57:18And I do like the name Operation Stork Speed.

00:57:22That's a great name.

00:57:23I don't know if you came up with it or the Secretary,

00:57:25but it's a good one.

00:57:26I did not, but I'll pass along to the person that you like.

00:57:29And the other thing is, this seems like a timely thing

00:57:32to say because the senior senator

00:57:36from the state of Michigan just showed up.

00:57:40And he and I actually have legislation on baby formula,

00:57:44bipartisan legislation.

00:57:45I don't know if you had a chance to look at it yet,

00:57:48but I would ask that you work with us on it

00:57:49because it goes to some of these very same things.

00:57:51And I think we work very hard to make it very practical,

00:57:53actually reflecting some of the things

00:57:54you just talked about.

00:57:56How do we make sure safe, but we innovate and have choice?

00:58:00It's great legislation, Senator.

00:58:01Thank you for working on it.

00:58:02Well, that was the right answer.

00:58:05And I've got another question,

00:58:07but I'm gonna turn to Senator Murray

00:58:10before I ask my final question.

00:58:12And then of course, Senator Peters.

00:58:14Senator Murray.

00:58:15Thank you very much, Chair Hoeven.

00:58:17Look forward to working with you

00:58:18on this really important committee.

00:58:21Commissioner McCarty,

00:58:22the FDA has a really important job to do.

00:58:25Lives literally are at stake.

00:58:28And that work requires the utmost diligence

00:58:32and care and commitment to following the science

00:58:35and uploading FDA's gold standard.

00:58:37We all expect to walk into the drug store

00:58:39and know that what we are buying

00:58:41has passed a safety and efficacy standard.

00:58:44And we have to be assured of that.

00:58:46And we have to be assured that the work's been done,

00:58:48that we don't have to question that.

00:58:51So I don't think it's careful leadership

00:58:53when you do mass fire one in five people across FDA,

00:58:57only to frantically then bring some back

00:58:59because you didn't stop and think two seconds

00:59:01about whether those jobs were actually important.

00:59:04We really, Mr. Chairman, cannot cheap out on the FDA

00:59:08and expect to maintain that gold standard

00:59:11that means that people know that drugs are safe.

00:59:14We can't just cut and cut and hope nobody gets sick.

00:59:17When you're slow to issue a recall,

00:59:19or hope no one needs that medicine

00:59:21that had its approval delayed,

00:59:24or hope there isn't another infant formula issue

00:59:26while your staff are getting fired

00:59:28or getting rehired or wherever they are.

00:59:31This work really takes investments.

00:59:33This committee knows that.

00:59:34And it expects expert staff,

00:59:37like the people that have been shoved out the door.

00:59:40Drug approvals are already getting delayed.

00:59:43Food and drug safety inspections are lagging behind.

00:59:48We are going in the wrong direction fast.

00:59:50We still have yet to see from you a full budget request.

00:59:54That is unacceptable.

00:59:57You are now testifying that the budget proposes

01:00:01to slash FDA by more than 11%.

01:00:04That's actually news to all of us.

01:00:05And I'll tell you right now, it is not gonna fly.

01:00:08It's reckless and it's not gonna happen

01:00:11as long as I have anything to say about it.

01:00:13Now, Commissioner McCary,

01:00:14when it comes to your mass firing of FDA employees,

01:00:18in April, you said, quote,

01:00:19I can tell you there were no cuts

01:00:21to scientists or inspectors.

01:00:23Well, that is not true.

01:00:24I think Senator Ossoff covered that.

01:00:27And I think the point here

01:00:28is that all of this firing and rehiring,

01:00:31I don't see how that's efficient.

01:00:33Frankly, it kind of shows

01:00:34that you don't know what you're doing

01:00:36and you're breaking things in the process here.

01:00:39So let me ask you a question

01:00:41and hopefully it is an easy one for you.

01:00:44Does it save taxpayer dollars

01:00:47to fire staff who work in centers

01:00:49that are fully funded by user fees,

01:00:52not taxpayer dollars?

01:00:53Yes or no?

01:00:56Nice to see you again, Senator Murray.

01:00:58You asked me to do an assessment of the staff

01:01:01when I came here for my confirmation hearing.

01:01:04And I hear that you're criticizing me

01:01:06for bringing back some individuals

01:01:08after the cuts that I was not a part of.

01:01:10No, I am saying that's good.

01:01:11I'm just saying in the long run,

01:01:12this has been very inefficient.

01:01:14But my question to you is not about that.

01:01:17And I know you've covered it with several other members.

01:01:19So does it save taxpayer dollars

01:01:22to fire staff who work in centers

01:01:24that are fully funded by user fees,

01:01:27not taxpayer dollars?

01:01:29Is that efficient?

01:01:32Does it save money?

01:01:33The cuts were to HR, IT, communications.

01:01:37There were 2,600 HR staff.

01:01:38But they're funded by user fees.

01:01:40They're funded by user fees.

01:01:42In part.

01:01:42It is not saving any money.

01:01:43Well, many of the staff you fired

01:01:47were in centers that are actually

01:01:49fully funded by user fees.

01:01:50You know that, correct?

01:01:51So if we have 2,600 HR people,

01:01:53do you want me to not make any cuts?

01:01:55No, I'm asking you a specific question

01:01:57about the centers that are fully funded by user fees.

01:02:02That's one center.

01:02:04It's the tobacco center.

01:02:05Well.

01:02:09Okay, well let me just say.

01:02:09You said we can't just keep cutting and cutting.

01:02:11We can't keep hiring and hiring.

01:02:12The agency doubled since 2007.

01:02:14So let me ask you,

01:02:15what is the right number of employees?

01:02:16You're here to answer my question, sir.

01:02:18And I'm gonna ask some more.

01:02:19Without critical support staff you fired,

01:02:21inspectors cannot plan their trips.

01:02:24They cannot do their jobs.

01:02:25I want to ask you,

01:02:26what percent of planned inspections

01:02:29has FDA missed since those April 1st firings?

01:02:34In the 12 labs that we have

01:02:36that evaluate food products in the food inspection realm,

01:02:40there are no, as of last week,

01:02:43there are no backlogs.

01:02:45They are running at 100% efficiency.

01:02:47There are no drug approval delays

01:02:49despite what people want to attribute.

01:02:52That is not what I have been told.

01:02:54I have been told,

01:02:54and I would like you to go back and check

01:02:57and report back to us

01:02:58because we know that some of the planned inspections

01:03:01at these that were supposed to take place have been missed.

01:03:06And to me, why that's so important,

01:03:08if there is not inspections,

01:03:11the public doesn't have the information that they need.

01:03:14I am gonna run out of time,

01:03:16so I want to move on.

01:03:17There were no cuts to inspectors.

01:03:19Will you go back and check for me, please?

01:03:21Absolutely.

01:03:22I understand, and by the way,

01:03:24inspectors, one thing,

01:03:25but if you don't have the support staff

01:03:27to make sure that they know where they're going.

01:03:27You have a 2,600 HR staff and procurement staff?

01:03:31I understand that the FOIA staff

01:03:33producing documents related to ongoing litigation

01:03:36by the Children's Health Defense,

01:03:39Senator Kennedy's organization,

01:03:41were shielded from the RIF,

01:03:43while other FOIA staff are responsible for FOIA responses

01:03:46at other FDA centers were targeted for termination.

01:03:50Is that true?

01:03:51That's not true, Senator.

01:03:52We have our FOIA staff.

01:03:57They continue to work at the FDA.

01:03:59I've made sure that all the FOIA staff at the FDA

01:04:01are doing their job.

01:04:02We are also using AI to reduce the burden on that staff.

01:04:05Well, for the record,

01:04:06my understanding is that

01:04:07the Children's Health Defense FOIA staff were not fired

01:04:11when other ones were.

01:04:12All the FOIA staff were there.

01:04:12And that seems like a real conflict of interest to me,

01:04:15considering that the Secretary's extensive history

01:04:18with that organization, Children's Health Defense,

01:04:20and his goal to remove authorizations for vaccines.

01:04:24So I just want that on the record.

01:04:25It's not true.

01:04:26Well-

01:04:27All FOIA staff are in place.

01:04:29Okay, so if a study came out saying that

01:04:32people who took a certain medication

01:04:35experienced a certain rate of, quote,

01:04:37serious adverse offense,

01:04:39but the study's authors refused to say

01:04:42what they were counting as an adverse event,

01:04:45would that raise serious questions for you

01:04:46about the study's validity?

01:04:49Yes, Senator.

01:04:50So I have the natural inquisition of a scientist

01:04:53that's done a lot of research,

01:04:54so I would want to see the underlying data, yes.

01:04:57Okay, well, I am, of course,

01:04:59talking about the SHAM study

01:05:00from the Ethics and Public Policy Center.

01:05:03It's an anti-abortion group.

01:05:04It's bankrolled by extremists.

01:05:06They fought to overturn Roe v. Wade.

01:05:08And this study, if you can call it that,

01:05:10is unsound and has been widely panned by medical experts.

01:05:15But days after its release,

01:05:16you and Secretary Kennedy are now suggesting

01:05:19that we need a, quote,

01:05:20complete review on the safety of mifepristone.

01:05:23Now, to be clear,

01:05:25mifepristone has been proven safe and effective

01:05:28in more than 100 studies over three decades.

01:05:31And the people that are now pushing that bogus study

01:05:34and saying that mifepristone is dangerous for women

01:05:37are the exact same people

01:05:39who think that abortion is never necessary

01:05:41to save a woman's life

01:05:42and that 10-year-olds should somehow

01:05:44be forced into childbirth.

01:05:45I believe that this administration is laying the groundwork

01:05:49to rip away access to medication abortion across the country.

01:05:53This has not gotten enough attention.

01:05:56And I know you'd prefer to keep it that way,

01:05:58but I want you to know I'm not gonna let that happen.

01:06:01I have not seen that study, Senator,

01:06:03and you have not seen that study.

01:06:04So how can you call it a sham, bogus study?

01:06:07Neither of us have seen the study,

01:06:08the underlying data, or the methodology.

01:06:11Actually, that's not true.

01:06:12But I will say this.

01:06:13Mr. Chairman, we have a lot of differences here.

01:06:16I know you came before this committee

01:06:19to present your side of the story,

01:06:20but I am very clear that laying off people,

01:06:23cutting budgets, is not gonna improve

01:06:26the safety and efficacy that we count on

01:06:28when we go to the drugstore to get our drugs.

01:06:31And I know that sham studies

01:06:34that try to prove a point that came from a political group

01:06:38is not gonna tell the public

01:06:40that they can count on the medications they count on.

01:06:43Thank you, Mr. Chairman.

01:06:44I yield back.

01:06:45Senator Peters.

01:06:47Thank you, Chairman Hoeven,

01:06:49and thank you for talking about infant formula

01:06:51and talking about our bill specifically.

01:06:53And thank you for eliciting a response from our witness

01:06:56that we both really appreciate.

01:06:57So thank you for doing that.

01:07:00Dr. McCary,

01:07:03as when I was chair of Homeland Security Government Affairs,

01:07:05we did a study looking at persistent drug shortages

01:07:09throughout the country,

01:07:11and found that a lot of us,

01:07:13because we're over-reliant on foreign sources

01:07:16for those supplies,

01:07:17and many of the precursors, as you know, are all overseas.

01:07:21And in fact, in that study, when I put it out,

01:07:23I said it's pretty clear based on these challenges

01:07:27with the supply chain

01:07:28that when there is a pandemic,

01:07:29we're gonna find ourselves in a very difficult position.

01:07:32Six months later, that academic study became reality

01:07:35as we dealt with the pandemic,

01:07:37and certainly saw that we had highly efficient supply chains,

01:07:40but they were not resilient.

01:07:43And I remain concerned that the FDA

01:07:45does not have the visibility it needs

01:07:48into essential medicine supply chains,

01:07:50from the key ingredients needed for manufacturing

01:07:53our drug products, to the distribution,

01:07:55to the patients in hospitals and pharmacies.

01:07:58And these blind spots clearly limit our ability

01:08:01to accurately assess national security risk,

01:08:05including our over-dependence on China in particular,

01:08:10for many critical inputs.

01:08:12So last week, I reintroduced the MAPS Act

01:08:15with several of my bipartisan colleagues,

01:08:19which would address this critical gap

01:08:20by requiring HHS through public-private partnerships

01:08:23to essentially map out the medical supply chains

01:08:27using data analysis

01:08:29and to assess all the threats and vulnerabilities.

01:08:32So my question for you is,

01:08:34do you agree that this is a significant concern?

01:08:37And if so, will you commit to work

01:08:39when we pass this legislation to make this a reality?

01:08:44Senator Peters, I love this topic.

01:08:47It's so important.

01:08:48I'm glad you're raising it.

01:08:49I've written about it in a book in 2019.

01:08:52I've written about it in the Journal

01:08:53of the American Medical Association.

01:08:55I felt like no one has been paying attention.

01:08:58I warned about exactly what happened

01:09:00at the beginning of COVID, and it happened.

01:09:02So I am totally aligned with you

01:09:03that this is an important issue.

01:09:06I think there are root causes

01:09:07that we've not been talking about

01:09:09that we need to talk about.

01:09:10I mean, we can get out a ruler and map out,

01:09:13you know, the supply chains,

01:09:15and I'm not opposed to that exercise.

01:09:17But the underlying problem

01:09:20is that manufacturing has moved overseas.

01:09:22And it's not just one or two things.

01:09:24It is most of what we use in anesthesia to perform surgery.

01:09:27It is most antibiotics.

01:09:29It is most of these cutting-edge therapies.

01:09:31It is the vast majority of generic drugs.

01:09:34And so I totally am in support of President Trump's agenda

01:09:38here to bring manufacturing back to the United States.

01:09:40And we've already had a tremendous amount of success.

01:09:44There are companies announcing moving manufacturing

01:09:46to the United States. We're creating incentives.

01:09:48We're removing regulation.

01:09:50And this is a national security issue.

01:09:52So I am 100% with you on this.

01:09:54Very good.

01:09:56In April, FDA reported suspending programs

01:09:59to improve testing for a potential bird flu virus

01:10:02contamination of milk, cheese, and pet food

01:10:04because of the mass layoffs that occurred.

01:10:09We know that the bird flu virus can kill pets

01:10:12who eat contaminated raw pet food,

01:10:14and it can pose a real danger to humans

01:10:16who also consume unpasteurized dairy products.

01:10:20As you know, the more people and animals

01:10:23who get infected with bird flu,

01:10:25the more opportunities there are for the virus to mutate.

01:10:29And I'm really worried that we only may be a couple,

01:10:33and it's not just me.

01:10:33Others are worried that there may be a couple of mutations

01:10:36away from having another potentially pandemic.

01:10:40So my question for you, sir,

01:10:42is with the continued spread of bird flu in the country

01:10:45and the significant personnel disruptions

01:10:48at FDA food safety programs,

01:10:50could you tell me on the committee

01:10:52specifically what the FDA is currently doing

01:10:54to ensure our food is free from bird flu contamination?

01:10:58Well, first of all, that story was debunked

01:11:00by the Washington Post.

01:11:02It was the normal procurement pause

01:11:04to recalibrate the equipment.

01:11:07And so when that happened, people who were trying

01:11:11to make us look bad, sometimes internally,

01:11:14sometimes externally, said,

01:11:15aha, there were layoffs and there's a pause

01:11:19in some of the milk inspection,

01:11:21and therefore the cuts may have been related to this

01:11:24or were related to this,

01:11:26and that's gonna affect food safety.

01:11:27No, it was a normally scheduled pause

01:11:30to recalibrate equipment.

01:11:32It went through its normal schedule

01:11:34and it is back up and running,

01:11:36and it's normally done to recalibrate the equipment.

01:11:39The cuts were to 380 communications people.

01:11:43What's the right number of communications people

01:11:45for the FDA?

01:11:46Not 380.

01:11:48125 travel coordinators, 13 strategy offices,

01:11:532,600 HR people and budget and procurement people.

01:11:58So I mean, are we not supposed to address

01:12:02some of this redundancy?

01:12:04My question is what exactly are you doing

01:12:06to safeguard our food supply

01:12:08and to safeguard the people from bird flu?

01:12:10So that was the question.

01:12:12I think you're prepared for a different question

01:12:14and you gave the answer to the different question,

01:12:16but the question is specifically what you're doing.

01:12:18You suggested the cuts increased our risk of bird flu,

01:12:21and I firmly reject that.

01:12:23That's not true.

01:12:24And the inspection trains are running on time.

01:12:26I think I said personnel disruptions.

01:12:29There's no personnel disruptions involved.

01:12:31There are no personnel disruptions.

01:12:32There's no calibration facility that was written about.

01:12:35So there are no personnel disruptions

01:12:36related to your work on bird flu?

01:12:38Is that what you're telling this committee?

01:12:41What I'm saying is the story that you referenced

01:12:44was saying that our milk calibration facility

01:12:49paused because of personnel disruptions.

01:12:51I don't think I cited a particular article.

01:12:54I don't know where you...

01:12:55Obviously, you're prepared for a question

01:12:57that I didn't ask.

01:12:58That's fine.

01:12:59You probably gave a good answer to a question

01:13:01that I didn't ask, and so that shows you were prepped for it.

01:13:04I'm asking you, what are you doing about bird flu?

01:13:06Just answer that, please.

01:13:07Don't give me a runaround about other stuff.

01:13:09We're doing a lot on bird flu.

01:13:10Don't use your prepared talking points.

01:13:13Tell me what are you doing to help us

01:13:15and protect the American people from bird flu.

01:13:16Please tell me that.

01:13:18We're doing a lot on bird flu.

01:13:19Please tell me that.

01:13:20That's why we're here.

01:13:21So look, when there is an antigenic shift

01:13:23that represents a epidemic threat,

01:13:26when there is human-to-human transmission,

01:13:29that strain that is involved

01:13:31in that human-to-human transition

01:13:32is the strain that we should be using

01:13:35to base any potential future vaccines.

01:13:38In the interim, as I said in my opening comments,

01:13:43delivering on a universal flu shot is one of our top goals,

01:13:47and there are two universal flu shots

01:13:49that are in development,

01:13:51and we are not in a receive-only mode with those developers.

01:13:54We are actively trying to partner with those individuals

01:13:57because it may be that you could come in

01:14:00for a single influenza vaccine

01:14:05or a two-dose strategy or something like that,

01:14:09and be immune for life

01:14:09against multiple different variants of influenza,

01:14:12including bird flu.

01:14:14And so early preclinical data in animal studies

01:14:17has shown some promise that a universal flu shot

01:14:20using a traditional vaccine platform

01:14:22can actually create antibodies

01:14:24to the current strain of bird flu.

01:14:26The question, of course, is,

01:14:28and I think this is really what you're getting at,

01:14:30is if we have a bird flu epidemic

01:14:33or even an outbreak in a human-to-human fashion,

01:14:36what strain is that gonna be?

01:14:37Because one thing we know for sure is

01:14:39it's not gonna be the strain that's circulating

01:14:41right now in millions of birds.

01:14:42So it is a huge priority for us, Senator.

01:14:45Good, thank you.

01:14:46Thank you, Mr. Chairman.

01:14:50Doctor, and in just one follow-up on the avian flu,

01:14:56I've spent quite a bit of time

01:14:58visiting with Secretary Brooke Rollins

01:15:01on that issue as well,

01:15:02and she put out a comprehensive plan to address it,

01:15:05and a very thoughtful plan,

01:15:06because, for example, the issue of inoculation is really,

01:15:10it's complicated, because if you inoculate chickens

01:15:12and then you got broilers

01:15:13and then you have trouble with export to Europe

01:15:15and all these kind of things.

01:15:16So I think she put out a comprehensive plan,

01:15:17but she did it very judiciously,

01:15:19because some of these things

01:15:20we still gotta figure out, right?

01:15:22So any comments you have in terms of working with her

01:15:25and understanding that this is, it's very complicated,

01:15:28and as doctors say, we wanna first do no harm,

01:15:32but address it in a comprehensive way.

01:15:34Would that be a fair evaluation,

01:15:36and what are your thoughts?

01:15:37100%, Secretary Rollins has been on top of this.

01:15:39She has been in communication

01:15:41with the emergency preparedness scientists at HHS

01:15:44and our FDA team, as well as people

01:15:47in the Office of Science Technology Policy

01:15:49to evaluate whether or not we should be

01:15:52mandating preemptive bird flu vaccines

01:15:58to chickens in the United States.

01:16:00Some countries have done it,

01:16:02and I think they made the right decision

01:16:03in saying that does not make sense at this time.

01:16:06Sometimes it represents messing with Mother Nature

01:16:11in ways that we may not foresee.

01:16:13It may drive mutant strains of the virus.

01:16:17So I think we need to be alert and ready,

01:16:21but at the same time, we need to wait

01:16:24until we see human-to-human transmission

01:16:27and see what that strain is

01:16:29before we develop a strain-specific vaccine.

01:16:33In the meantime, we can advance the universal flu shots

01:16:37that encompass those bird flu strains

01:16:40currently in circulation,

01:16:42provided that they are safe and effective.

01:16:44And not 100% of vaccines are wonderful.

01:16:48I love vaccines.

01:16:49I believe in vaccines.

01:16:50Vaccines save lives.

01:16:52Any death from a vaccine-preventable illness is a tragedy,

01:16:55but the anthrax vaccine was a disaster.

01:16:58The swine flu vaccine was a disaster.

01:17:00The rotavirus vaccine was removed from the market.

01:17:04We had a vaccine that we had to remove from the market

01:17:06a few weeks ago for a rare infectious disease

01:17:09in the United States.

01:17:11And when the data clearly shows

01:17:14that there's not broad safety,

01:17:16as we're commissioned by Congress to do,

01:17:18then we have to do our job.

01:17:20And there is concern by producers

01:17:22in terms of if you start inoculating some of the flock,

01:17:25then you actually have the disease in the flock,

01:17:26but then if you're still keeping that flock,

01:17:29then does the disease spread.

01:17:32Also, as I say, depending on whether they're layers

01:17:34or they're broilers, that makes,

01:17:36so there's a lot that goes into this,

01:17:38and it's a really complicated,

01:17:40very important we address it,

01:17:41but a really complicated issue.

01:17:42And that's why I'm pleased that you and Brooke

01:17:44are working together in the way that you are on it.

01:17:47Thank you, Senator.

01:17:48Yeah, I want to ask about AI,

01:17:51and I don't mean AI as we talked about on the ranch.

01:17:54I mean artificial intelligence.

01:17:57And talk to me, I hear so much about what AI is going to do

01:18:03in every field, but certainly in medicine.

01:18:06Just give me some of your thoughts

01:18:09on not only how we should be using it

01:18:15and what it will do for us,

01:18:17but how we make sure that we don't get ourselves

01:18:20into a problem with it.

01:18:22Well, we spend a lot of time thinking about cybersecurity

01:18:25and proprietary information.

01:18:28We don't want a situation where AI

01:18:31is stealing proprietary information,

01:18:34and we don't want to expose ourselves to any cyber risks,

01:18:38which is why we have ensured that the AI

01:18:41that we're using to summarize clinical data

01:18:43and background information for our scientific reviewers

01:18:46lives in a very secure space, and the reviewers love it.

01:18:49And it's not just AI to assist in the scientific reviews.

01:18:53We're using AI to identify

01:18:55where we should be concentrating our food inspections.

01:18:58And it turns out the AI can sometimes figure out

01:19:01pattern recognition faster than we can as human beings.

01:19:06And we'd like to use this also to address the issue

01:19:10of illegal vapes coming into our border.

01:19:13Okay.

01:19:14And how do we make sure it doesn't get off

01:19:16and running on us and we have problems?

01:19:20We have to keep an eye on it, always.

01:19:22I mean, we cannot have blind trust in anything,

01:19:24which is why all the areas where we are using AI

01:19:27currently at the FDA, we also have a human being

01:19:31reviewing the information and having full access

01:19:33to the underlying data.

01:19:35Okay.

01:19:36Thank you, doctor.

01:19:37Ranking member Sheen.

01:19:39Yes, I just have a couple more questions.

01:19:42One is, again, apropos the need to address

01:19:49type one diabetes.

01:19:50One of the things that Senator Collins and I have worked on

01:19:53is a more efficient pathway for biosimilar drug approvals

01:19:59that are currently lacking competition.

01:20:02So can you give us an update

01:20:04on what you think is happening in that arena

01:20:08and whether there's any reason to hope

01:20:10that that's gonna get expedited

01:20:13and if there are any other approvals

01:20:15or anything that you need at the FDA

01:20:18to ensure that that is being addressed

01:20:22in a way that allows those biosimilars to come to market?

01:20:26Well, thank you, Senator.

01:20:27This is a very important topic

01:20:29that directly relates to drug prices for everyday Americans.

01:20:33And there's a reason why when you watch the news now,

01:20:36you're basically watching people dancing in the fields

01:20:42and singing with these drug ads nonstop

01:20:45in the commercial breaks

01:20:46because they are so expensive

01:20:49and so the companies have figured out

01:20:51that if they can get a few people

01:20:53to shake their doctor down

01:20:56to prescribe one of these drugs to them

01:20:59or I guess somehow let their doctor know

01:21:02that they're a candidate,

01:21:03it might be a little insulting to the doctor

01:21:05that they don't already know it, in my opinion,

01:21:07but that's why these ads are running nonstop.

01:21:09And so there are low-cost biosimilars

01:21:13that can be made available by the FDA,

01:21:15approved by the FDA,

01:21:16and that process is too slow, in my opinion.

01:21:19We have to look at whether or not

01:21:21we really need to require confirmatory trials

01:21:24for each biosimilar.

01:21:26I mean, we don't do that for generics

01:21:29with regular branded pills.

01:21:31We don't say, well, you make a generic

01:21:33with the same molecular structure,

01:21:35go out and do a confirmatory trial.

01:21:37I think we need to look at that.

01:21:39There's a bill I believe that Senator Rand Paul

01:21:41is putting forward to take a look at that.

01:21:43And then finally, we can look at whether or not

01:21:46we can sort of approve a class of interchangeable drugs,

01:21:51that is that they're very similar in the class

01:21:54and so an interchangeability provision

01:21:56could help create more incentives

01:21:58because we want to incentivize companies

01:22:00to make safe biosimilars.

01:22:02I agree.

01:22:04You mentioned in your opening statement

01:22:06the seizure of vaping products from China.

01:22:10One of the things that I've been concerned about

01:22:12for a very long time is the increased use

01:22:15of vaping by young people.

01:22:18And the numbers have gone up dramatically

01:22:23in the last 10 years.

01:22:24And also the health impacts of that

01:22:27that we're not even, I think, fully aware of at this point.

01:22:32So can you talk about what more you're doing at the FDA

01:22:38and how you did that interdiction,

01:22:40who you're working with?

01:22:42Again, what more can be done

01:22:46to get those products off the market?

01:22:49Well, Senator, thank you for your interest in this topic.

01:22:52A lot, we can do a lot more.

01:22:53And I've realized that what's happening now

01:22:57is these illegal Chinese vaping products

01:22:59designed to attract children.

01:23:02They are video game vaping products

01:23:04with an inhalation port designed to addict young children

01:23:08so they can vape as they play these games.

01:23:11These fruit video game products that are so small,

01:23:15they have an inhalation port.

01:23:17What happens is these products that are banned in China

01:23:19and made in China show up in US ports.

01:23:22And what's been happening, I learned,

01:23:23is that they are set aside, the FDA looks at them,

01:23:26and then we say, well, you know what?

01:23:28These shouldn't be coming in our country.

01:23:30We'll put them back on the ship they came on.

01:23:32And then the ship goes to another US port

01:23:35and will come in through,

01:23:36basically, we're 100% porous.

01:23:38It's been a joke, and they've been laughing at us.

01:23:41And so we are gonna stop that.

01:23:43And we have incredible interest at DOJ,

01:23:46at Department of Homeland Security,

01:23:48and we are creating an endeavor

01:23:50that is gonna basically say,

01:23:52we're not gonna send them back anymore.

01:23:54We're gonna compensate or confiscate

01:23:55and seize these products

01:23:57because we've gotta get serious about them.

01:23:58These are designed to get kids addicted.

01:24:01And there are kids in America today

01:24:04who are addicted, they know they're addicted,

01:24:06they come from good families, they're good kids,

01:24:08and they can't stop.

01:24:10And that is something that we have to address.

01:24:13There are high schools in America now

01:24:15where kids are saying half of the kids in high school

01:24:18are addicted to these vaping products.

01:24:21So we cannot get burned again

01:24:22like we did on opioids and Vioxx and other things

01:24:26where the problem is so far down the road,

01:24:28it's hard to undo some of the tragedy.

01:24:30And so this is a top priority for this administration,

01:24:34for this president, for this secretary, and for me.

01:24:37Well, I agree.

01:24:38I think we oughta right out ban vaping products

01:24:42for anybody under a certain age, certainly.

01:24:47And one of the other things we need to do, as you know,

01:24:50is to get a treatment for people

01:24:52who are trying to get off vaping products

01:24:55because one of the other selling points that they use

01:24:58is that, well, it's a way to get cigarette users

01:25:03to stop smoking, they can vape,

01:25:05and the harmful impacts are not as serious.

01:25:09But I'm pleased to hear

01:25:12that you're doing everything possible.

01:25:15And I don't know if you, again,

01:25:17if this is an area where you need

01:25:18additional authorization or support,

01:25:22but I think there are a number of us in the Senate

01:25:24who are all in to try and address this

01:25:26because it is having a huge impact.

01:25:29I've been to those schools in New Hampshire

01:25:31where I've talked to students

01:25:33who have gotten hooked on vaping who can't get off

01:25:36and who don't have any aids to help them do that.

01:25:40So it's something that we've really gotta address.

01:25:42Thank you so much, Senator.

01:25:43And as you know, we confiscated today $34 million

01:25:48worth of illegal vaping products and e-cigarettes.

01:25:52And so that announcement is coming out today.

01:25:57Doctor, thanks for being here.

01:25:58Did you have anything else

01:25:59that you wanted to express for the record?

01:26:02I appreciate the input and the feedback.

01:26:04And look, I'm on a listening tour.

01:26:06We're gonna be traveling around the country,

01:26:08myself and some of the other FDA leaders,

01:26:10meeting with industry leaders, developers,

01:26:13inventors, scientists, academics.

01:26:17And we wanna hear how we can perform better.

01:26:20We don't claim to have all the answers.

01:26:22We don't claim to have the truth on health.

01:26:24But we do have a lot of intellectual curiosity.

01:26:28And we plan when we see something

01:26:30that needs action to take action.

01:26:32So I wanna thank you and this committee

01:26:34for the input that you've provided

01:26:35and made available to me.

01:26:37We appreciate you being here today.

01:26:38We look forward to having you back as well.

01:26:42Questions for the record are due by next Thursday,

01:26:45May 29th, and then we'd appreciate responses

01:26:50from FDA within 30 days.

01:26:53I can't wait.

01:26:54Again, thank you, appreciate it.

01:26:55Have a great day. Thank you, Senator.

01:26:57We are adjourned.

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