[Senate Hearing 119-061]
[From the U.S. Government Publishing Office]
S. Hrg. 119-061
AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2026
=======================================================================
HEARINGS
before a
SUBCOMMITTEE OF THE
COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE
ONE HUNDRED NINETEENTH CONGRESS
FIRST SESSION
on
H.R. 4121/S. 2256
AN ACT MAKING APPROPRIATIONS FOR AGRICULTURE, RURAL DEVELOPMENT, FOOD
AND DRUG ADMINISTRATION, AND RELATED AGENCIES FOR THE FISCAL YEAR
ENDING SEPTEMBER 30, 2026, AND FOR OTHER PURPOSES
__________
Department of Agriculture
Department of Health and Human Services: Food and Drug Administration
__________
Printed for the use of the Committee on Appropriations
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Available via the World Wide Web: https://www.govinfo.gov
__________
U.S. GOVERNMENT PUBLISHING OFFICE
60-249 PDF WASHINGTON : 2026
COMMITTEE ON APPROPRIATIONS
SUSAN M. COLLINS, Maine, Chair
MITCH McCONNELL, Kentucky PATTY MURRAY, Washington, Vice
LISA MURKOWSKI, Alaska Chair
LINDSEY GRAHAM, South Carolina RICHARD J. DURBIN, Illinois
JERRY MORAN, Kansas JACK REED, Rhode Island
JOHN HOEVEN, North Dakota JEANNE SHAHEEN, New Hampshire
JOHN BOOZMAN, Arkansas JEFF MERKLEY, Oregon
SHELLEY MOORE CAPITO, West Virginia CHRISTOPHER A. COONS, Delaware
JOHN KENNEDY, Louisiana BRIAN SCHATZ, Hawaii
CINDY HYDE-SMITH, Mississippi TAMMY BALDWIN, Wisconsin
BILL HAGERTY, Tennessee CHRISTOPHER MURPHY, Connecticut
KATIE BOYD BRITT, Alabama CHRIS VAN HOLLEN, Maryland
MARKWAYNE MULLIN, Oklahoma MARTIN HEINRICH, New Mexico
DEB FISCHER, Nebraska GARY C. PETERS, Michigan
MIKE ROUNDS, South Dakota KIRSTEN E. GILLIBRAND, New York
JON OSSOFF, Georgia
Elizabeth McDonnell, Staff Director
Evan Schatz, Minority Staff Director
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Subcommittee on Agriculture, Rural Development, Food and Drug
Administration, and Related Agencies
JOHN HOEVEN, North Dakota, Chairman
MITCH McCONNELL, Kentucky JEANNE SHAHEEN, New Hampshire,
SUSAN M. COLLINS, Maine (ex Ranking
officio) JEFF MERKLEY, Oregon
JERRY MORAN, Kansas TAMMY BALDWIN, Wisconsin
CINDY HYDE-SMITH, Mississippi MARTIN HEINRICH, New Mexico
DEB FISCHER, Nebraska GARY PETERS, Michigan
MARKWAYNE MULLIN, Oklahoma KIRSTEN E. GILLIBRAND, New York
MIKE ROUNDS, South Dakota JON OSSOFF, Georgia
Professional Staff
Morgan Ulmer
Macie Kelly
Lindsay Morris
Hart Clements (Minority)
Rachel Erlebacher (Minority)
Claire Wengrod (Minority)
C O N T E N T S
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hearings
Tuesday, May 6, 2025
Page
Department of Agriculture........................................ 1
Thursday, May 22, 2025
Department of Health and Human Services: Food and Drug
Administration................................................. 49
back matter
List of Witnesses, Communications, and Prepared Statements....... 117
Subject Index:
Department of Agriculture.................................... 119
Department of Health and Human Services: Food and Drug
Administration............................................. 119
AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2026
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TUESDAY, MAY 6, 2025
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
The subcommittee met at 10:35 a.m. in Room SD-124, Dirksen
Senate Office Building, Hon. John Hoeven (chairman) presiding.
Present: Senators Hoeven, Collins, Moran, Hyde-Smith,
Fischer, Shaheen, Murray, Merkley, Baldwin, Heinrich, Peters,
and Ossoff.
DEPARTMENT OF AGRICULTURE
STATEMENT OF HON. BROOKE L. ROLLINS, SECRETARY
opening statement of senator john hoeven
Senator Hoeven. We will call this meeting of the Ag
Appropriations Subcommittee to order.
And I want to begin by thanking Secretary of Agriculture,
Brooke Rollins, for being here today. We appreciate you being
here. We also appreciate you getting out and about around the
country, as you have, and getting a chance to meet with our
great farmers and ranchers in our respective states. So thanks
so much for that as well.
I am very pleased to be joined by Senator Jeanne Shaheen.
As you can tell, she is very young, but she and I were actually
governors together.
Senator Shaheen. We were both very young. Yes.
Senator Hoeven. Starting about 25 years ago, when she was a
teenager and I was not as old as I am now. And so we have had
an opportunity to work together as governors, and we work
together on various appropriations committees, like Homeland
Security, and others. And I just want to welcome her in this
new role as the Ranking Member on the Ag Appropriations
Committee, and just express how much I appreciate her and
working with her; so welcome, and really good to have you on
the committee.
Also, we are joined by our Chairman of the Full
Appropriations Committee, who also, we have worked together a
long time, and she is providing a strong leadership for the
Appropriations Committee and doing everything in her power to
see that we get back to regular order.
And so I would pause here for just a minute and ask if our
Chairman would like to make a few comments. Chairman Collins.
statement of senator susan collins
Senator Collins. I just want to say that I am absolutely
delighted that Senator Hoeven is chair of this committee and
that Senator Shaheen is the vice chair. That means this
subcommittee is in very good hands.
And we welcome the Secretary.
Senator Hoeven. Thank you, Chairman.
Again, Secretary, thanks for being here today. We
appreciate you, and appreciate you being here right away to
talk about this Ag Appropriations Budget. You had a great
chance out in North Dakota, and I know you have been to other
states as well, to see what our farmers and ranchers are doing
out there, firsthand. But I know you really don't--that is not
new to you, having grown up on a ranch, which is incredibly
important that you have that background, and then having gone
to Texas A&M, an Ag school.
Secretary Rollins. Well said. Thank you.
Senator Hoeven. And a very good one at that.
Secretary Rollins. Thanks.
Senator Hoeven. And they play reasonably good football,
too, last I checked.
Secretary Rollins. Until November, but yes.
Senator Hoeven. Yes. Well, again, we are pleased that you
are getting out and about like you are, and that you are with
us here today.
Secretary Rollins. Thank you.
Senator Hoeven. Obviously, our farmers and ranchers across
the country are dealing with a lot of challenges right now.
They always deal with challenges, whether it is markets,
whether it is prices, and certainly always the weather, none of
which they control. So it is vitally important that we do a
good job for them in our farm program, but also in the things
that we do here in the Ag Appropriations Committee, as well as
the countercyclical safety net, and the other things that we
think of, crop insurance, that our farmers and ranchers need
every day to stay in business.
And we can't, as you and I talked about before, we have in
agriculture about 16 million people that work either directly
or indirectly in agriculture. We have a system of small
businesses out there in farming and ranching, family-based
small businesses that produce the highest quality, lowest cost
food supply in the world that benefits every single American
every single day.
And we, as Americans, spend less on our food and have the
best food, and the best choice, and we spend less as a percent
of our budget than pretty much any developed country in the
world, brought to us by our family farms and ranches. And that
we can't take that for granted.
Secretary Rollins. Yes.
Senator Hoeven. There is so much concentration in so many
industries, and we have to recognize that it is not by accident
that we have this great system. And so good farm policy is so
important to keeping that, and it benefits every single
American. Well, you were out in our state. You saw North Dakota
State University and the incredible work that our land grant
universities do, like A&M, and many others.
But you also got to see the amazing new technology that is
coming with Precision Ag, Grand Farm, example that we showed
you out there of really leading the world with precision
agriculture, as well as the research, and so forth, that is
being done in tandem with land-grant universities through
National Institute of Food and Agriculture (NIFA), Agricultural
Research Service (ARS), your research function, and our farmers
and ranchers, which has revolutionized agriculture.
When I grew up in western North Dakota, we could grow a
couple row crops. Now our state grows 40 different crops, and
we lead the country in about 15 of them, which we try to rub
into South Dakota as often as we can, because they do great
stuff too, and we appreciate all of our ag states very much.
So again, that is what we are talking about here today. And
so the funding for these programs, and we talked to you about,
Farm Service Agency (FSA) and all these things, out on the
ground, we have got to make sure we are getting it done for our
farmers and our ranchers every single day. So we want to find
savings, we want to work with you to find savings, but we have
got to know that we are still going to deliver that service
that keeps those family businesses, those farms and ranchers
going every single day to the benefit of every single American.
So again, thanks for being here so much.
And I will turn to our ranking member, Senator Shaheen.
Secretary Rollins. Thank you, Senator.
statement of senator jeanne shaheen
Senator Shaheen. Thank you, Mr. Chairman. And I would just
echo your comments about how nice it is to work together again.
Thank you for those very nice remarks.
Secretary Rollins, thank you for coming before the
committee.
I think it is helpful as we think about questions today to
take stock of where we are and how we got here more than 100
days into this administration, because we all know that our
farmers, producers, and rural communities are no strangers to
uncertainty, the pressure from outside of their control, from
fluctuating commodity prices, to rising output costs, to a
rapidly changing climate and more extreme weather events.
But what I have heard from farmers in New Hampshire is that
the Federal Government has always been a critical partner that
our farmers could rely on. That is until now, sadly, because
what I have heard from farmers over the past 100 days of this
administration is that they are not sure they can trust the
Federal Government anymore. I have heard from farmers across
our state who no longer know if they can rely on the Federal
Government honoring a basic signed contract, and I have heard
in great detail from all kinds of farms in New Hampshire about
the hardship that this uncertainty, this delayed reimbursement
causes for their ability to run their businesses.
And as they say, in New England where the weather is very
problematic, anything that contributes to that uncertainty and
disruption is challenging. Rural communities can't be certain
if their small businesses and operations will survive the added
costs of tariffs on top of the other uncertainties, farmers
risk losing hard-fought market access due to President Trump's
trade war.
And I am sorry that we had not yet received the fiscal year
2026 Budget when we were preparing for this hearing, because
the limited information that I have seen to date has been
extremely disappointing. The proposed budget top lines released
last Friday fall well short of the President's purported
commitments to farmers and rural communities.
I don't believe that we support farmers by gutting research
that will boost yields and improve crop quality. And I don't
believe we put rural America on a path to thrive by slashing
core rural development programs, from housing, to water and
waste infrastructure, to energy assistance. And when grocery
prices are too high, we don't help families put food on the
table by undercutting vital nutrition programs. Yet, that is
exactly what this skinny budget would do.
I hope that we will have a chance to move forward with
bipartisan appropriations, with a serious nondefense
discretionary number that reflects the urgent needs that are
facing families and communities in New Hampshire and across
this country, because there are plenty of places where we can
work together to ensure that these programs deliver for
producers in rural America, from investing in our rural
communities and boosting the rural housing supply, to
supporting programs that help local food systems thrive, to
investing in cutting-edge research that will allow our farmers
and ranchers to feed our nation and the world.
So again, I appreciate your being here today, Secretary
Rollins, and I look forward to the discussion.
Thank you, Chair Hoeven.
Secretary Rollins. Thank you.
Senator Hoeven. Thank you, Senator Sheehan. At this point,
we would turn to you, Secretary Rollins, for your opening
comments.
summary statement of hon. brooke rollins
Secretary Rollins. Great. Thank you, Chairman Collins,
Chairman Hoeven, Vice Chair Murray, Ranking Member Sheehan, and
distinguished members of this subcommittee. I am so grateful
for the opportunity to appear before you to share what we have
accomplished at USDA in the last 100 days, but also to answer
your questions on the President's budget request and the
priorities moving forward.
When farmers prosper, rural America prospers, and I want to
thank you all for your shared bipartisan commitment to that
effort in ensuring that our farmers, and our ranchers, and our
rural communities thrive.
During my confirmation hearing, which some of you attended,
not all, I quoted Thomas Jefferson's 1787 letter to George
Washington in which he wrote, ``Agriculture is our wisest
pursuit because it will, in the end, contribute most to real
wealth, to good morals, and to happiness.'' I have had the
distinct privilege of serving American farmers and ranchers for
the past 82 days, and I can tell you our farmers continue to
embody every single day the ideals that Thomas Jefferson
described over two centuries ago, and serving as their champion
continues to be my greatest honor.
We at the Department of Agriculture have wasted no time in
implementing President Trump's bold policy agenda. The
President's fiscal year 2026 discretionary budget that we are
talking about today identifies the priorities of our
administration with the same degree of prudence and frugality
our family farmers practice when they draft their annual
budgets. Let me touch on a few highlights of the last 82 days
and then turn it back to you, Mr. Chairman.
Upon taking office, I was tasked by President Trump to
lower the cost of eggs in the short term, and also to provide
farmers with resources that are needed to combat the avian
influenza in the long term.
In February, at the direction of President Trump, we
announced a five-point plan to meet this challenge head on, and
I am proud to report that since that plan was introduced, the
wholesale price of eggs has decreased 56 percent, with the
retail price following. In taking this position, I fully
understood that American agriculture was facing one of the most
economically challenging times in our country's history.
For generations, American producers and consumers enjoyed
the fruits of an agricultural trade surplus, but under the last
4 years, that surplus went from zero--or that trade deficit
went from zero to a nearly $50 billion trade deficit, and the
newest numbers coming in are actually significantly more than
that.
President Trump and I know this problem will not solve
itself. That is why he is taking action, bold action, which I
am sure we are going to talk about today, to address our
imbalanced trade commitments, and I am working tirelessly to
promote American agricultural products on the world stage.
In April, USDA launched our agricultural trade promotion
programs for fiscal year 2026 and is currently accepting
applications for four export market development programs. As
part of this effort, I will be traveling to seven countries in
the next few months. The first trip begins Sunday when I head
to the UK, where I will be making sure our trading partners
know that American agriculture is the crown jewel of American
production.
And in fact, Chairman Hoeven, I have to leave here at noon
because the Secretary of Agriculture from Mexico has just
landed here in Washington, and I am going to meet and talk with
him momentarily as soon as we finish.
We are also streamlining unnecessary regulations and
cutting red tape for agricultural producers and industries so
that they can continue to do what they do best, and that is to
every day feed, fuel, and clothe America and our world.
To that end, my team and I have sought to eliminate waste,
fraud, and abuse in all USDA programs, including the SNAP
improper payments, fraud, and programs that fail to fulfill the
USDA mission of putting farmers first. Our team is meeting
daily with our partners at the Department of Government
Efficiency, with DOGE, which again I am sure we will get into,
to ensure that we are doing right by the American taxpayer
while also protecting critical USDA programs.
What is also of paramount importance at the United States
Department of Agriculture is our mission to make America
healthy again. We have been taking major steps to fulfill this
mandate by accepting SNAP waivers and working alongside our
country's great governors, both Republican and Democrat, as we
move that project forward.
The Make America Healthy Again (MAHA) movement at USDA has
also supported major, major voluntary changes to make food
healthier, including just last week the International Dairy
Foods Association's most recent announcement related to dyes in
school lunch dairy products. We are also working around the
clock to address major threats to our farmers and our ranchers,
including the new world screw worm, which would devastate our
cattle industry in this country.
Alongside Secretary of State, Marco Rubio, and Deputy
Secretary of State Christopher Landau, we were pleased to share
just last week that we have negotiated a deal with the
Government of Mexico to allow the best preventative tools we
have to land our response aircraft in Mexico without further
hindrance, additionally working to ensure that Mexico abides by
the 1944 Water Treaty, providing the water it owes to our ag
producers in America.
Finally, and again, just a quick summary of the last 82
days: Just last week, alongside Senator Rounds and some other
great Americans, we stood with Charles and Heather Maude, a
South Dakota cattle family, fifth-generation cattle ranching
family who operates small cattle and hogs, who endured a
senseless, politically motivated prosecution over 25 acres of
forest land that had had a fence line on it for almost 100
years.
The criminal charges against the family were dropped last
week, and to prevent further injustices against our farmers and
our ranchers, we launched a portal for farmers and ranchers to
tell us their stories, if they, too, are being treated in a
similar situation as to the Maudes.
And since we launched that a week ago, Thursday, so I guess
just four or five days ago now, we have had over 100 farmers
and ranchers reply and move their stories into our portal. So
we are already following up on that.
Again, during my first 82 days, as the Secretary of
Agriculture, we have visited 15 states. If we have not visited
yours yet, we are coming very, very soon. I have attended over
100 events, given dozens and dozens of keynote speeches, and
met with nearly 1,000 farmers and ranchers across this great
country, both here in Washington and out in the states.
We will continue to build based on their feedback, based on
their hard work, and based on reconstituting, rebuilding, and
revivifying the United States Department of Agriculture to
better serve our customers.
American ag does not rest, and I can assure you that under
my tenure, neither will the U.S. Department of Ag. I am proud
to be at the helm of the People's Department, as President
Lincoln so aptly launched and said in the 1860s, I am proud to
be at the Department, I am proud to be at the table with
President Trump, and I am so proud to be fighting for the most
American of all Americans, and that is our farmers, and our
ranchers, and our agriculture communities.
Thank you so much.
[The statement follows:]
Prepared Statement of Hon. Brooke Rollins
Chairman Hoeven, Ranking Member Shaheen, and distinguished members
of this subcommittee, I appreciate the opportunity to appear before you
to present on the U.S. Department of Agriculture (USDA) and what we've
accomplished since President Trump took office. President Dwight D.
Eisenhower said, ``Farming looks mighty easy when your plow is a
pencil, and you're a thousand miles from the corn field.'' I can assure
you, being a part of agriculture and visiting with the people who tend
the land and our Nation's livestock every day, farming isn't easy. I am
proud of the work we are doing at USDA. Making Agriculture Great Again
means promoting efficiencies, cutting regulatory red tape, and
refocusing the mission to expand market opportunities for farmers
rather than promoting programs that only satisfy the special interests
of Washington D.C., bureaucrats who have never set foot in a field or
pasture.
For far too long, the hardworking Americans who feed, fuel, and
clothe the world were left on the sidelines. Farmers and Ranchers now
have a seat at the table. We have had an action- packed first one
hundred days of the Trump Administration, affirming the bold leadership
of President Donald J. Trump. I've visited 15 States, attended or held
over one hundred events, and have visited with hundreds of different
agricultural stakeholders. In the first one hundred days we have
reprioritized American Agriculture.
Since my first day, we have been intensely focused on tackling the
avian influenza crisis. It was my very first briefing at USDA and I
fully understand the importance of animal health issues and the effects
they have not just on ranchers and producers, but on everyday
consumers. In February, at the direction of President Trump, we
announced a five-pronged plan to curb avian influenza to protect
producers and lower egg prices for all Americans. A plan which has been
applauded by agriculture and government leaders across the country.
Today, a dozen eggs at wholesale cost less than half of what they did
at the end of February. The expansion of biosecurity assessments
available to commercial poultry producers has also been successful. I
am happy to report that, since I've taken office, we have completed
over four hundred wildlife biosecurity assessments and biosecurity
incentive-focused assessments combined. As this program expands, we
expect these results to continue to impress. We also know that America
thrives when it innovates. That's why we have such hope for the up to
one hundred million dollars announced as a funding opportunity to
explore prevention, therapeutics, research, and potential vaccine
candidates to protect poultry from avian influenza. These projects
should give us new and innovative tools to use to keep the virus away,
protect producers, and keep prices low for consumers.
While much of the public attention has been on avian influenza, we
are also working around the clock to address the other threats to our
farmers and ranchers, including New World screwworm. This pest feeds on
livestock and could seriously jeopardize our food supply and create an
economic impact of well over a billion dollars if it enters through our
southern border. This devastating pest started spreading north through
Central America under Joe Biden's failed leadership. Under President
Trump, we are working to drive this pest south, out of Mexico by using
proven sterile insect technology. This approach has been successful in
previous eradication efforts, and it remains the most effective
strategy to protect our domestic industry from this devastating pest.
To address the ongoing spread of New World screwworm I recently sent a
letter to my counterpart in Mexico demanding Mexico eliminate
impediments to aircraft operations and landings that were impairing the
U.S. response, which was successful, and we are now landing the planes
we need to.
On the eve of a nearly fifty-billion-dollar agricultural trade
deficit, USDA is not sitting idle, but taking action to move our
industry back to becoming a net exporter. USDA's Trade and Foreign
Agricultural Affairs is well positioned to help producers gain new
market access opportunities. Since President Trump took office, USDA's
Foreign Agricultural Service has expanded access to foreign markets for
U.S. agricultural products. Panama partially opened its pork import
quota mechanism, which will allow an estimated additional thirty
million dollars in U.S. pork product exports. South Africa also
restored market access for U.S. microwave popcorn shipments, valued at
two to three million dollars. USDA conducted two trade missions to
Thailand and Guatemala and hosted USA Pavilions at six global trade
shows with a combined total of two hundred and eighty-two million
dollars in projected exports. In the last 2 months, FAS has worked with
India to reduce India's tariff on U.S. bourbon imports by fifty
percent, resulting in a likely two million dollar increase in distilled
spirits exports to India in 2025. We worked with Japan to lift the
mandatory aflatoxin testing requirements on U.S. almonds, resulting in
a likely eight to 10 percent increase of U.S. almond exports to Japan
annually.
Looking ahead, USDA will continue its efforts to improve foreign
market access for U.S. producers and address the agricultural trade
deficit. In April, USDA launched agricultural trade promotion programs
for fiscal year 2026 and is accepting applications for four export
market development programs totaling over two hundred and fifty million
dollars. I will also visit seven countries in the next 6 months:
Vietnam, Japan, India, Peru, Brazil, Italy, and the United Kingdom.
Together with the U.S. Trade Representative, we will build new markets,
expand current markets, and hold existing trading partners accountable
to ensure trade is fair and reciprocal and that the competitive
position of U.S. agriculture reaches new heights. USDA is committed to
leveling the playing field by identifying unfair imports, breaking down
export barriers, tackling non-tariff sanitary and phytosanitary
obstacles, advocating for lower foreign tariffs on U.S. agricultural
exports, and diversifying foreign markets for U.S. exports. USDA is
dedicated to an America First policy, ensuring that every action USDA
takes overseas makes America safer, stronger, and more prosperous.
On March 19, ahead of its statutory deadline, we issued 10 billion
dollars in economic assistance for farmers and ranchers through the
FSA-administered Emergency Commodity Assistance Program which was
passed by congress in December of 2025. The program has been extremely
efficient, paying farmers within three business days of an application
submission. A note of thanks to all of you for your unwavering support
for producers in times of economic crisis by passing that legislation.
USDA is working to soon roll out its Congressionally authorized
Supplemental Disaster Relief, over 20 billion dollars. On April 22,
USDA dispersed three hundred and forty million Congressionally mandated
disaster dollars across thirty-one States to deliver relief to farmers,
ranchers and rural communities impacted by natural disasters such as
hurricanes and wildfires that have caused devastation across the
country. We are also making sure these programs are offering the most
effective assistance where needed and not duplicating and wasting
taxpayer money.
There is a very public, yet very important endeavor to make America
healthy again through the President's Executive Order No. 14212. It is
no secret diet-related, chronic disease is plaguing American families,
including a substantial portion of children and adolescents from low-
income households. At the direction of President Trump, I, along with
relevant stakeholders, will continue to explore ways to encourage
better health through the Make America Healthy Again Commission. In
talking to Governors, many States are interested in testing innovative
solutions to our Nation's many health crises. I have made it clear, and
I will do so here, that I am open to these requests and look forward to
providing technical assistance and dialogue. There have been
significant developments on this around the country during State
legislative sessions, and we look forward to receiving State requests
to operate pilot programs to make the program more nutritious.
On February 13, upon my swearing in, I sent a letter to States and
Tribal, territory, and local government partners. I reminded them that
the mission of the Department's 16 nutrition programs is critical, but
that the American taxpayer expects their generosity to be valued and
for programs to be executed with integrity and accountability. The
letter noted a suite of guiding principles, each of which can serve as
catalysts for change, allowing the Department-and the American
taxpayer-to better serve vulnerable families and communities. It is
important to note, USDA spends four hundred and five million dollars a
day on nutrition programs. Furthermore, USDA issued guidance to all
State agencies directing them to enhance identity and immigration
verification practices when determining eligibility for the
Supplemental Nutrition Assistance Program (SNAP). This is to make
certain that SNAP benefits exclude any ineligible alien who entered the
United States illegally, or is otherwise unlawfully present in the U.S.
A recent Government Accountability Office (GAO) report indicated a
staggering 10 and a half billion dollars in improper SNAP payments were
made in fiscal year 2023 alone. This was about 12 percent of total SNAP
payments that year. The inadequate verification of an applicant's
identity and citizenship by States is specifically highlighted as
contributing to the improper payments of SNAP funds.
Under President Trump's leadership, we are streamlining unnecessary
regulations and cutting red tape for agricultural producers, and other
industries under the USDA purview, to allow them to feed, fuel, and
clothe the world. This includes making sweeping reforms to protect
national forests and boost domestic timber production, ending
regulations that have stifled energy and mineral development on Federal
lands so we may reaffirm America's role as a global energy powerhouse,
and reducing wildfire risk through public-private partnerships and many
other actions. I have been fortunate to spend time with our wildland
firefighters to thank them for their heroic service. I value their
perspectives and feedback, and I am proud of the work they do to save
lives and protect our beautiful homeland. We will continue to execute
President Trump's agenda to make America's forests healthy and
productive again.
In March, I announced new action to reduce burdens on the U.S. pork
and poultry industries, allowing for greater efficiency while
maintaining food safety standards. We are extending waivers allowing
existing establishments to maintain higher line speeds and are moving
towards rulemaking to make these standards permanent for more pork and
poultry plants. We have also withdrawn overly burdensome proposals
related to Salmonella in poultry as we reconsider more effective ways
to achieve public health objectives. These reforms will strengthen U.S.
food production, reduce costs for producers, and support a more
resilient supply chain-all without compromising food safety. It is also
important for farmers and ranchers to have access to timely, accurate,
and useful statistics to help make important decisions about their
operations; however, the Biden Administration ignored this directive
and cancelled the July Cattle Report and the County Estimates for Crops
and Livestock last year. I am so pleased to share that the National
Agricultural Statistics Service has reinstated these critical reports,
and they will be published later this year.
American agriculture began four centuries ago, when neighbors born
across an ocean came together in a New World to clear fields, build
homes, and plant crops on the edge of wilderness. That same spirit
animates us now. Our farmers who tend the fields do not rest from their
labor-neither do our ranchers and livestock producers who steward their
lands, herds, and flocks-and neither do the American mothers and
fathers who rely upon American agriculture to feed their families.
American agriculture does not rest-and neither will we at USDA. I'm
proud to be at the helm of the People's Department, at the table with
President Trump, and fighting for the most American of industries--
agriculture.
Senator Hoeven. Thank you, Secretary Rollins.
We will now start rounds of five-minute questions.
And I am going to defer to our Full Committee Chairman,
Senator Collins, to start that process.
Senator Collins. Thank you very much, Mr. Chairman.
Welcome, Secretary Rollins.
Secretary Rollins. Thank you.
Senator Collins. It is great to see you here today. When we
first met, we discussed Per-and Polyfluoroalkyl Substances
PFAS.
Secretary Rollins. Yes.
Senator Collins. Those are the toxic class of forever
chemicals that are being found in our soils, water, animal
feed, crops, and livestock. In Maine, the presence of PFAS and
wastewater sludge that was spread decades ago as a fertilizer
is preventing some of our family farmers from being able to
sell their products, causing them significant financial harm.
To support these affected farmers and to come up with
solutions, the University of Maine is undertaking research on
the presence of PFAS in agricultural land. To build upon this
work, I secured $17 million in fiscal year 2024 for the ARS and
the University of Maine to establish a new center of Excellence
for PFAS solutions, and the whole purpose is to help address
these very serious PFAS contamination in agriculture.
Madam Secretary, will you continue to support the
partnership between ARS and the University of Maine in
establishing this research center to help our farmers? And I
would note that the research that is being done there won't
just help the farmers in Maine, but across the nation.
Secretary Rollins. Across the country. Well, Madam
Chairman, as we discussed, this is an issue that is very close
to my family's heart. My mom, Helen Kerwin, is almost 78. She
is the youngest elected freshman to the Texas House of
Representatives in Texas history, and her number one issue is
PFAS. And she decided to run for a lot of reasons, but one of
those was, I believe it was the New York Times did an expose or
a big story, if you will, on a farm in Johnson County, Texas,
which is close to where we grew up and where my mom still
lives, rural Texas.
And she was so stunned by what had happened to these
farmers, and specifically through the PFAS contamination, it
had destroyed their lives. And so she became very, very
passionate about this particular issue. She is crushing it in
her first session in the Texas Legislature right now. And, in
fact, her very first bill that she will get a hearing on is her
PFAS Bill, and it will be tomorrow in Austin.
So I have been hearing a lot about this at the family
dinner table for quite some time now. But yes, we remain
committed to this research, very proud of that $7 million grant
to the Center for Excellence. And I think that, at least
according to my mom, who is amazing, raised my sisters and me,
by herself, she was a single mom, but at least according to my
mom, Maine leads the way in many respects on this important
issue for all of our farmers and our ranchers.
And I am excited to learn more. Perhaps even come visit the
center in Maine, see the work that they are doing firsthand,
and to continue to support it. So thank you for your leadership
on that.
Senator Collins. Thank you so much. And, in this case,
listening to your mother makes all the sense in the world.
Secretary Rollins. All the sense in the world. I need to
tell my four teenagers that.
Senator Collins. Yes. In late March, I wrote you a letter
detailing my concerns about USDA's delay in releasing some
program funds.
Secretary Rollins. Yes.
Senator Collins. I have heard from constituents who have
received grant award letters from USDA in the previous
administration, only to later receive letters from USDA
informing them that their grant funding is frozen. Now, this is
obviously very troubling to them. It creates a lot of
uncertainty. And we are a state that has lost 600 farms in the
past decade. And that is very troubling to me. I grew up in
Northern Maine. One of my first jobs was picking potatoes for a
farmer. And I am aware of how important that heritage is to our
state and to our food supply.
So we have seen a situation where farmers, landowners,
loggers, natural resource businesses that have applied for USDA
loans, still have no clarity on what decisions will be made.
And the timing of this funding is absolutely critical, because
as you know well, agricultural producers are making purchases
now for this year's crops, and processing facilities need to
order equipment for the summer and the fall harvest.
Local farm economies are fragile. And timing is really
important. So I know and appreciate that you have made some
significant strides in releasing program funding over the past
few weeks. Could you provide the subcommittee with an update on
Federal funding at USDA that remains frozen, and a time line
for when you plan to finish your reviews?
Secretary Rollins. I will, and I take to heart so sincerely
everything you have said. And I know many of you have reached
out during this process of frozen funds from both sides of the
aisle. And my goal is to respond immediately. Sometimes it is
at midnight. Sometimes it is at 5 a.m. But my goal is always to
respond and to be available. I have an amazing team. Kailee
Buller, is our chief of staff, she is here, Jen Tiller and a
few others that you all probably know well. And we are working
around the clock, going line, by line, by line. We are down to
the final 5 billion out of, I believe, almost 20 billion of
frozen funds. But $5 billion is a lot of money. And when you
think about that in terms of, you know, grant or contract and
moving that out quickly, we are very hopeful to keep moving
through that very, very quickly and have that done very soon.
But what I will say, and you all know this that have worked
with me, I am always available. So if there is one or a group
in particular that you want us to make sure we are getting to,
please just let me know. I know almost everybody here has my
cell phone number, maybe not a few of you, but I am always
available. Several of these guys have it too. So just call me
and just know we are doing our very, very, very best.
Some of the funding that we have pulled back and then
reopened, we have asked for reapplications to realign around
this President's priorities, which, of course, not
surprisingly, is not diversity, equity, and inclusion, or some
climate programs, but instead to reapply where the farmer would
receive, farmer or rancher would receive 65 percent of the
funding or more, that is another piece of this as well.
So we, again, are going line by line. We are working around
the clock. And believe me, we are on it. But please know to
always reach out if there is something specific. And I hear
you.
Senator Collins. Thank you very much.
Secretary Rollins. Thank you, Madam Chairman.
Senator Hoeven. Appreciate it.
Senator Sheehan.
Senator Shaheen. Thank you, Mr. Chairman. And just to
follow up on that. I referenced this in my opening statement,
but in New Hampshire USDA has frozen an $11 million RCPP award
for the Connecticut River Conservancy. It is a project that has
leveraged public-private partnerships for critical ecosystem
restoration across the watershed. And unfortunately, the
months'-long delay has slowed seasonal work, and it has driven
up the costs of the project.
Given that it is been more than 3 months since the
administration froze this program, when will USDA release the
funding?
Secretary Rollins. What is the name of it again?
Senator Shaheen. It is a Regional Conservation Partnership
Program (RCPP) award for the Connecticut River Conservancy, and
we are happy to follow up with whoever the appropriate person
is. And just to follow up on that, one of the things, as we
know, that Congress did at the end of last year was to pass
disaster funding, that included $220 million as a set-aside for
small farms in the six New England States, plus Hawaii and
Alaska. And we have got apple growers in New Hampshire who, in
2023, lost about 90 percent of their crop. Virtually all stone
crops were wiped out in that season. They have been waiting
desperately for the funding to be released from that emergency
supplemental.
Senator Tillis and I sent you a letter back in March
emphasizing the need to get this assistance out. So again,
along the lines of Senator Collins' question, can you provide
an update for when the remaining funds will be released, and
how we will ensure that the funding goes particularly to the
small farms in states like New Hampshire, where they are
desperately in need of some assistance?
Secretary Rollins. Yes, ma'am. I appreciate that. The
Emergency Commodity Assistance Program (ECAP) funding, the
economic assistance, of course, we were given a statutory
deadline of March 21st, I believe, when you all passed that, or
when it was passed in late last year. I think March 16th or
March 17th the portal opened, and it is a three-day turnaround
in most cases. I think we have already moved out, I don't have
the number in front of me, but of the $10 billion, almost $8
billion. You all correct me if I am wrong.
So we have actually moved almost all of that money out in,
I would argue, record speed, but maybe there have been a few
that we haven't. So please let us follow up on that.
I have got right in front of me, Madam Chairman, that in
your state we have moved out $395 million just into New
Hampshire to 17,476 of your producers in New Hampshire. So I
think we have done pretty well on that. But again, if there are
instances where you are not hearing those stories and that it
hasn't moved as quickly as we believe it has, please let us
know, and we will run that down.
On the disaster relief part of it, which is the additional
$20 billion, in the coming weeks, by the end of May, that
portal will open also. Obviously as part of that $20 billion
there was specific funding for the Mexican water issue in
Texas, and then of course up in the northeast where you are,
and I believe Alaska was the third specific instance. But we
are working with governors across the country. That was a
little more complicated than the ECAP, the disaster--or the
emergency relief payments; but we are really close, within a
matter of days, where we certainly by the end of this month,
that money will begin moving as well.
Senator Shaheen. Well, thank you. I appreciate that. As you
know, farming is very different in New England than it is in
the Midwest, and many states in the west, and anything that we
can do to be helpful in terms of getting information from out
farmers to make sure that they qualify for those programs,
please work with us.
Secretary Rollins. Absolutely. Yes.
Senator Shaheen. I also served on the Foreign Relations
Committee, and of the things the fiscal year 2026 Budget
Request eliminates, is the Food for Peace Program, and the
McGovern-Dole Food for Education Program. In 2023, those
programs provided over 1.1 million metric tons of U.S.-grown
commodities to people abroad.
For weeks earlier this year, more than 550 metric tons of
U.S.-grown rice, peas, wheat, beans, super cereal, and ready-
to-use therapeutic food sat at risk of spoilage in ports, on
ships, and in warehouses across the world, because of the
dismantling of USAID. We are tracking that more than 350 metric
tons of mixed commodities from American farmers are either
pending purchase or will not be purchased this year due to the
administration's terminations and delays.
So can you talk about what you are saying to farmers to
address this and how we are replacing that food that is so
desperately needed by people around the world?
Secretary Rollins. Yes. I will talk briefly about the
McGovern-Dole Program first. And I think it is important to
realize that that is a $240 million program, but our numbers
show only about $37 million of that is directly tied to
agriculture, which of course is what I am focused on. So as we
are looking to realign the government, to reorganize, to make
it more efficient for the American taxpayer, looking at
programs like McGovern-Dole, which obviously all these
government programs have a very worthy mission statement with
very wonderful intentions, but at the end of the day, are they
serving the American taxpayer who is funding them? And are we
providing and meeting the metrics of what the original intent
was?
And without knowing all the details of the McGovern-Dole
Program, for example, the fact that of a $240 million program,
only $37 million is being used regarding commodities, our
American farmer commodities. And I don't say $37 million isn't
a big number, and especially for our farmers and our ranchers,
but I think in the context of what the effort is to ensure that
everything we are doing is aligned with the best and highest
use of taxpayer dollars, and understanding that the layers of
bureaucracy, and the administration, and all of the money going
to lots of other places other than our ag community, that we
need a wholesale reapproach to all of it.
And that is what I realize, Senator, I will agree to
disagree on this, but that is what President Trump's vision is.
And while we are going through, it is never easy to change the
status quo. The easiest thing for us to do is just say: Oh. It
is great, and we don't want to make anyone mad, and let us just
keep moving forward and keep adding money to the programs. This
is what I believe the voters asked for and we will continue to
have these discussions.
So I hear you. It is something we are looking at every day,
and the Food for Peace Program as well. But programs like
McGovern-Dole, it is time to really take a deep look and see
what we are spending the money on, and if it is being
effective.
Senator Shaheen. I am out of time. And I appreciate what
you are saying. And I think most of us would agree that
examining the programs and being more efficient and effective
is something that we all support.
Secretary Rollins. Sure.
Senator Shaheen. But when we do it in a way that allows
millions of tons of food and medicine to rot because we have
cut off funding to ensure that that goes where it is supposed
to go, that is not efficient and effective.
Thank you, Mr. Chairman.
Senator Hoeven. Thank you, Ranking Member Sheehan.
Secretary, so at the end of the year we ended up with a 1
year extension of the Farm Bill because we did not have
agreement to update the countercyclical safety net like we need
to, which as you know we are working on very hard. But with
that 1 year extension we put in place $33.5 million (sic) in
emergency assistance, for the $10 million excuse me, $33.5
billion--for the $10 billion that is market conditions based we
put a number of conditions on it. One that you would provide
it--start providing it within 90 days, and you would follow a
format called WHIP+, which we put in statute back in 2017. You
did both.
Secretary Rollins. Yes.
Senator Hoeven. And you started dispersing, or started the
process of dispersing March 19th. I think of that 10- you are
probably closing on $7 billion. You have already dispersed
states, my state it is about $0.5 billion, I think. You already
referenced the Ranking Member and other states as well. That is
how we want to work with you. So I want to put right out front,
that is how we want to work between this subcommittee, and I
think Senator Boozman will tell you our Ag Committee, Full Ag
Committee and USDA.
So then I just want to step over now to the weather-based
$20 billion. What is your plan on that for getting it going,
and kind of the format so we know? We are getting questions on
that now from our producers.
Secretary Rollins. That is right. So we are within days of
announcing the application process. Of course, that is a little
more complicated because we don't have the specifics and it
isn't--yeah, as you mentioned in North Dakota, 15,794 of your
farmers and ranchers have received money through that first
tranche, through the first $10 billion, the emergency aid. On
the weather-related programs, that application opens in the
next week or two and we will be moving very, very quickly.
We realize that this is a long time coming and it is
related to disasters that happened a while ago, and so ensuring
that we get that out as quickly as we possibly can with the
team that we have in place. I am really proud of, I believe,
how efficiently and how quickly the team moved out that first
tranche. And I believe that you will see the same sort of
efficiency and effectiveness with the second tranche. So it is
within the coming weeks.
Senator Hoeven. And I know you have to wait until you get
the data from the different locations that had the weather
disasters. Like in our case, it was fires and ranchers, we lost
lives.
Secretary Rollins. Right.
Senator Hoeven. Not only cattle, but lives of people.
Secretary Rollins. Yeah.
Senator Hoeven. And so I know you have to wait to get that
data, but you are thinking within weeks, timeframe?
Secretary Rollins. Um-hum.
Senator Hoeven. Okay.
Secretary Rollins. By the end of the month, the
applications will be open, and we will be moving out. Now, we
have already moved out the $280 million to the Texas Department
of Agriculture for the water issue in South Texas with the
Mexicans, and so the ones that were specifically named in the
legislation that you all worked on so hard.
Senator Hoeven. Right.
Secretary Rollins. Those have already moved, those have
been moving for a little while. But this next round, the big
round, will be within the next few weeks.
Senator Hoeven. Yes. And that is what I was referring to.
Secretary Rollins. Yes.
Senator Hoeven. And that is, again, in line with what we
passed, and so I appreciate that very much. Restructuring USDA,
we all want to find waste, fraud, and abuse. We want to find
savings, efficiencies, reductions, clearly, here in D.C., I
think there is plenty of room for that in terms of reducing the
size and scope of the bureaucracy. One of the keys for us,
though, out on the ground, you and I have talked about it, and
I know you know this, is FSA.
Talk to me about how we make sure that we have those
frontline FSA officers or employees out there working directly
with our farmers and ranchers; that is, you know, key. So talk
about that. So again, yeah, we definitely--and we are seeing
the reductions in the bureaucracy. Again, we want to find
those, but we want the frontline folks out there, the hands-on
folks.
Secretary Rollins. I don't know, at least at USDA, if there
is any role more important than those frontline FSA offices,
and those remain a priority. Of course, right next to that is
our wildland firefighters as we are moving into wildfire
season, that is extremely important in being operationally
ready, which we are. Also, our Animal and Plant Health
Inspection Service (APHIS), our veterinarians, et cetera, those
are as important.
But the FSA operators that are managing and working with
our farmers and our ranchers every single day, it is not in our
plan to close any of those offices. There are 4,500, I think,
total across the country, which is a big number, but we are
also working to be, again, more efficient with online, et
cetera, technical assistance, et cetera, that in the future may
not rely so much on an on-the-ground presence.
But today we can't rip that rug out from underneath our
farmers and producers, and that remains a priority. I signed a
memorandum; I don't know, maybe last week, all the days are
running together, that put as a priority ensuring that those
offices are fully staffed. As I know we all in this room know,
often hiring in rural America is a little bit more difficult
because you just don't have the numbers of people.
But what I have told the team, and as we continue to focus
on rural prosperity moving forward, is that finding the men and
women out there, the patriotic Americans that are willing to
work around the clock. We already have a lot of that in the
FSA, but I think we can do better and more, so we will be
spending some good time on that moving forward.
Senator Hoeven. Thank you, Secretary.
Secretary Rollins. Thank you.
Senator Hoeven. Excuse me. Thank you.
And I am going to turn to our ranking member on the Full
Committee, Senator Murray.
Secretary Rollins. Good morning.
Senator Murray. Good morning. And thank you very much,
Chair Hoeven. I look forward to working with you and with our
new ranking member, Senator Shaheen, in her new role as the two
of you lead this committee. It is a really critical one.
Secretary Rollins, thank you for being here. Let me be
really frank with you. The very mission of USDA is under
incredible threat from this administration. We are seeing
dedicated researchers and experts who are being pushed out the
door. Research, safety efforts have been put on hold, funds
that Congress passed have been frozen and canceled by this
administration, and nearly $17 billion in investments are now
being held up at USDA.
That to me is really unacceptable and needs to change. We
are seeing our food banks with less, increased prices at the
grocery store. We are seeing Forest Service personnel who have
been fired. They respond to our wildfires, we need them.
Experts working on avian flu gone, and my farmers are extremely
concerned about these illegal funding freezes and the illegal
tariffs that are impacting them.
We also know that 15,000 employees have been pushed out,
that is more than 15 percent of your Department. We know USDA
cannot help farmers or communities without the people and the
resources that it needs, which is really to me why this
arbitrary workforce cuts combined with the sweeping cuts that
President Trump proposed in the new budget that we just got is
really alarming.
Secretary Rollins, let me just say to you, this committee
needs a lot more information about how your Department is
spending this funding that Congress provided earlier this year,
and the fiscal year 2025 spend plan that you submitted last
year, required by law, part of the Continuing Resolution, just
isn't satisfactory. We need to have that information in order
to write our appropriations bills.
And I just want you to know I expect you to work with
members on both sides of this aisle to provide the details so
we understand how you are spending money, and what is actually
needed in the coming year. That is what I really want you to
know and why I especially wanted to be here today.
But I do have some questions for you, because in Washington
State, my home state and across the country, these abrupt
terminations and resignations of ARS scientists and support
staff have really gutted some of our vital agricultural
research programs overnight. This is really undermining years
of progress, research on plant diseases, making crops more
resilient, extreme weather, that work is really fundamental to
our farmers, and they are deeply worried about that being gone.
I know that many of the ARS scientists have been
reinstated. Essential support staff has not. So will you commit
to taking steps to reinstate the ARS support staff and
stabilize these research units across the country?
Secretary Rollins. Well, there was a lot in that, Senator.
So I will try to talk really quickly and answer as much as I
can. And then please, reach out to me directly, and we can
always have this conversation anytime. I don't think you were
in here, but I have had long conversations with members on both
sides of the aisle about all of this in the last couple of
months, so I welcome that conversation anytime.
The first thing I want to say is the 15,000 number it is
less than 15 percent of our total workforce. I realize that is
still a very, very big number, but I think it is important to
realize in the context that every year, USDA, through
attrition, loses between 8,000 and 10,000 employees, so as a
massive government agency.
Senator Murray. But they are refilled.
Secretary Rollins. Well, and that is what we are looking to
refill, the frontliners that is what I was talking about right
now. So whether it is FSA, APHIS, the wildland firefighters,
those are, through a memorandum I just signed, we are actively
looking and recruiting to fill those positions that are
integral to the efforts and the key frontlines.
Senator Murray. So you let people go and you are looking
for new people to fill the positions that they had experience
in?
Secretary Rollins. We are having those discussions right
now. We are working with all of you around the country in your
states. We believe our firefighters are operationally ready for
wildfire season. Our FSA offices, we are looking, you know, we
are making things more efficient, but bringing on new people
that could potentially bring and be a game changer in those
offices.
But by the way, the people that you are talking about, the
15,000, those are all deferred resignations. None of those
people were fired. So if they want to come back and if they
were in a key position, then we would love to have that
conversation.
The other thing in the second round of Deferred Resignation
Program (DRPs), which just happened about, I don't know, a
couple of weeks ago, we did not accept the DRPs of employees
that were in those key positions that I outlined, that a few of
them, I think we had several hundred that said, all right, we
are going to take it. And we said, no, those are, your role is
too important right now. We are not going to accept it.
So we are very intentionally approaching this. Have we done
it perfectly? No. Any type of whole scale change and big effort
to basically realign an entire government agency is difficult.
And we know that. And we know that it hasn't been perfect. But
we are working every day to solve for a lot of this. And I
think we are making a lot of really good progress.
Senator Murray. Okay. You didn't answer my question
specifically on ARS scientists, research, the support staff.
Secretary Rollins. Well, what I would love if you or your
team could get us exactly what you are talking about, who you
are talking about, and where you are talking about it. Because
we have been, like I say, line by line, keeping the staff in
place where we believe it is of utmost importance and aligns
with the Agency's mission in areas where we don't believe we
haven't been as focused on that. But again, that is a
conversation I would so welcome to understand exactly where and
what that looks like.
Senator Murray. That is important. But this is on record.
And so one of my concerns is that you let people go however you
want to characterize it, who knew these jobs, and now you are
looking for people to fill these jobs because now we know how
essential they are, that doesn't seem to me to be very
efficient.
But I need to ask you about nutrition programs in my last
minute here.
Secretary Rollins. Sure.
Senator Murray. Because we have about 134,000 people in
Washington State, 7 million people nationwide who rely on
Women, Infants, and Children (WIC) Program. It provides, as you
know, essential nutrition support to moms and kids during the
earliest, most vulnerable stages of life. It is one of the most
effective programs that we have. It has always received
bipartisan support on this committee, it is glaringly absent
from the President's budget request.
WIC, Supplemental. Nutrition Assistance Program (SNAP),
Commodity Supplemental Food Program (CSFP), these are really
key, important programs for seniors. They are not optional.
They are essential programs that feed moms and babies and the
elderly. So I wanted to ask you, do you fully support funding
WIC; yes or no?
Secretary Rollins. Well, okay, so are you talking about the
Local Food for Schools Cooperative Agreement Program (LFS) and
Local Food Purchase Assistance (LFPA) contracts that were
canceled, or SNAP?
Senator Murray. I am talking about the budget that came
over to us on Friday.
Secretary Rollins. WIC is fully funded. SNAP is, so that is
why I am confused by your question. I am sorry, Senator.
Senator Murray. Well, in our looking at this, it is absent.
I am happy to get the information to you. But this, for this
committee, I know it is something we have always supported on a
bipartisan basis. It is something we need to continue.
Secretary Rollins. Yeah. WIC is fully funded. I am happy to
talk SNAP or some of the other cuts, but.
Senator Murray. Yeah, WIC, it is eliminated in the budget
that the President sent on Friday.
Senator Shaheen. We also thought that, so.
Secretary Rollins. We will clarify that and get that right
back to you. I know there had been some realigning in SNAP and
in some of the food banks, et cetera, that is kind of where we
have been talking and focusing on.
Senator Murray. The President--for the committee members,
the President sent over his budget on Friday. It does eliminate
WIC in it. So we obviously need to have better information from
the administration.
Senator Hoeven. Our understanding is that--I mean, number
one, we fully funded WIC in the last go around in the CR, as
you know, Senator. And our understanding is just in the skinny
budget, it just wasn't included. It is funded for this year.
Secretary Rollins. Yeah, it is funded.
Senator Hoeven. This is the skinny budget. There are things
we don't have yet. So that, at least, was our understanding.
Secretary Rollins. It is fully funded.
Senator Murray. That would be interesting to see in
writing.
Secretary Rollins. You are welcome.
Senator Hoeven. Thank you, Senator Murray.
Secretary Rollins. Thank you, Senator Murray.
Senator Hoeven. Let me turn to Senator Moran.
Senator Moran. Chairman, thank you. Thank you to you and
Senator Shaheen.
Secretary, welcome. Thank you for coming to Kansas,
although you came when I had the flu.
Secretary Rollins. We missed you.
Senator Moran. Please come back.
Secretary Rollins. Yes. I know.
Senator Moran. On a day that is not 16 below zero, and we
will show you a different side of our state. I want to talk a
bit before I get to a couple other topics, about Food for
Peace. Senator Hoeven and I, when we saw what was happening
with Food for Peace at USAID and the State Department, we
introduced legislation to transfer the authority to manage and
operate Food for Peace to the Department of Agriculture.
It was my understanding that both OMB and the Department of
Agriculture, your Department, responded to that idea favorably.
And I am anxious to have you tell me what it is that I and my
colleagues ought to be doing to keep providing the commodities
that we grow in the United States to people who are starving
around the globe, and is this something you are still
interested in acquiring?
Secretary Rollins. Yes. And it is my understanding this
program was started in Kansas; is that right?
Senator Moran. That is true.
Secretary Rollins. Yes. The Great State of Kansas, with
about 150 farmers who came together and came up with the
program. So not surprisingly, I don't want to get ahead of my
boss, and certainly Secretary Rubio and I have had very initial
conversations about it.
Senator Moran. And I would add. I also understood that
Secretary Rubio was willing or capable of sharing that
responsibility or giving you that responsibility.
Secretary Rollins. Yeah. We have had really great
conversations about it. Obviously, we will follow your lead,
and if in fact this is the will of Congress, I think we would
be very willing to take that on if that was your direction and
would be excited to partner on that.
Senator Moran. And to the elimination of McGovern-Dole,
which we call in Kansas Dole-McGovern, the elimination of that
program is not an indication of the lack of interest in the
Department of Agriculture making available American-grown
commodities to people who are hungry around the globe; is that
true?
Secretary Rollins. That is true. Thank you for that
clarification. That is really important.
Senator Moran. In the conversation that you have had about
employees at USDA and the efforts to right-size, downsize,
whatever the right words are, the Department, let me highlight
for you the importance of FSA and NRCS employees in county
offices across the state of Kansas and around the country, I
assume. And it was particularly troublesome when those on
probation were those who were eliminated. We love the
circumstance when a young man or woman out of college, returns
home, goes to work for USDA in a county office. We do not have
sufficient personnel in those county offices today.
Secretary Rollins. Right.
Senator Moran. But we particularly love when they are
somebody who is in their 20s, they come home, and they raise a
family in a small county of Kansas. And so would you pay
particular attention to trying to make certain that county
offices where farmers sit across the table from USDA employees
and have a conversation about--certainly about the farm
programs and conservation programs takes place, that is
different than ever trying to do that on a computer.
Secretary Rollins. That is right.
Senator Moran. So what would you tell me about your
commitment to that?
Secretary Rollins. Well, I think it is of paramount
importance. And you think about what USDA who we are called to
serve, the initial intention of the Agency, of course, in the
founding of our country, we had the original four agencies,
Treasury, Defense, the Attorney General, and Justice and then
just a few years later, a couple decades later, Interior was
added, and right after that was Agriculture.
So this goes back to almost the founding of our country,
and certainly we take that very, very, very seriously. In
President Lincoln's best vision and his intention in founding
this agency, it was to have that on-the-ground support for our
farmers and our ranchers.
So as President Trump is working to make America great
again and restore prosperity across our country, my role in
that is to ensure that rural America sees a level of prosperity
that perhaps they haven't seen in our lifetimes. And there is a
lot that goes into that formula, right, there is a lot we have
got to do. We have got to get government off the back of our
people. We have got to cut taxes.
Senator Moran. Let me ask you one more question.
Secretary Rollins. We have got to deregulate but, yes, the
FSA remains at the very top of that list.
Senator Moran. Thank you. And I do appreciate having
employees return to the office to work, it is as important as
well.
Secretary Rollins. Yes. That is an important part, too,
yes.
Senator Moran. I had mentioned to you when we visited about
the National Bio Ag Facility that is in Kansas, it is the
replacement for Plum Island, we had this conversation when you
were in my office before the confirmation.
Secretary Rollins. Yes.
Senator Moran. I want to just highlight, because I have one
second left, but I want to highlight that facility, that
institution, and ask you to either tell me or get me a report
on National Bio and Agro-Defense Facility (NBAF) operational
status as of today?
Secretary Rollins. I think it is a huge asset, and it is an
important asset to the greater good of the country. And as we
talked about in your office that day, a couple of months ago
now, my commitment in fulfilling Congress' intent has not
changed. And so I think, Senator, you and I can just make sure
you need to send me reports if you are hearing anything
different. But we are committed to ensuring that that facility
moves forward in a way that best serves all of America and,
frankly, the world. It is a really important asset.
Senator Moran. Thank you, Secretary.
Secretary Rollins. Thank you, Senator.
Senator Hoeven. Senator Baldwin.
Senator Baldwin. Thank you, Mr. Chairman.
Secretary Rollins. Good morning.
Senator Baldwin. Secretary Rollins, thank you for joining
us today.
Secretary Rollins. Thank you.
Senator Baldwin. The Dairy Business Innovation Initiative
has delivered critical and high-impact support to small dairy
farms and businesses in Wisconsin and across the country. Since
its inclusion in the 2018 Farm Bill, the program has helped
producers expand their product lines, access new markets, and
modernize their operations. In Wisconsin, these small-dollar
grants have made a real difference in helping expand a globally
respected dairy industry.
As we consider additional funding for USDA in 2026, I am
really deeply concerned about the treatment of the Dairy
Business Innovation Initiative under this administration.
Congress has secured funds annually in statute in the
bipartisan annual appropriation bills, and they were promised
to farmers by the USDA. Yet over 400 dairy businesses had
nearly $30 million on the chopping block due to a Diversity,
Equity, and Inclusion Executive Order issued by President Trump
this February. I hope we don't confuse diversity and
biodiversity, as important issues.
But I appreciated the opportunity to discuss this with you
personally, and you know, the need to issue these funds to
Wisconsin and other farmers expeditiously, especially when
their margins are already incredibly slim. But I still have
concerns. How are you planning to restore Congress' confidence
in USDA's ability to implement and fund programs required by
statute, like the Dairy Business Innovation Initiative? And how
will you ensure the Agency's communication to farmers and small
businesses can be relied upon when they make real-time
investment decisions in their operations based on awards?
Secretary Rollins. Well, I appreciate that question. And on
my second trip, it wasn't to your beautiful state, but it was
to Kansas, as we talked about. I think Senator Moran stepped
out. But we talked about--we actually visited a major dairy
operation and have since visited half a dozen more in
Pennsylvania and several other states. So I look forward to
coming to Wisconsin and seeing the operation there.
The program you are talking about is not frozen. I think
after we spoke, we looked into that. But I want to make sure
that is clear from your understanding as well.
Senator Baldwin. It is.
Secretary Rollins. So that is moving forward.
Senator Baldwin. After my intervention and our
conversation, the funds were released. But that was still, you
know, people make expenditures in reliance of an award that
they have gotten.
Secretary Rollins. I understand. It was maybe a 30-day
delay, and I apologize for that. Any delay, I think, on a
worthy program, especially with our dairy farmers is, one day
is one day too many. I know you understand.
Senator Baldwin. There was uncertainty of whether they were
ever going to get the funds.
Secretary Rollins. That is fair.
Senator Baldwin. Let me move on to another one that you
have already referenced briefly. I was really deeply concerned
when the USDA abruptly cut funding to critical food assistance
programs in March, including the Local Food Purchase Assistance
Program and the Emergency Food Assistance Program (TEFAP).
In 2024, through the TEFAP program, Wisconsin distributed
over 21 million pounds of food, serving over 618,000
households. Hunger Task Force in Milwaukee had about $615,000
worth of food they expected to help feed people during this
summer, halted by the Trump administration.
And Wisconsin farmers and producers worked tirelessly to
grow food that feeds hungry children and stocks our local food
pantries. And the decision to cancel these vital programs only
hurts families trying to put food on the table and the
Wisconsin farmers who produce it.
So Secretary Rollins, will you reinstate these critical
food assistance programs in fiscal year 2026?
Secretary Rollins. So let us talk about that for a second.
First of all, those were COVID-era programs. They were never
meant to go forever and ever. This is part of the problem
with--and again, not Democrat or Republican, but any
government, in general, you put an era program in, and then it
literally never goes away, which, by the way, is not fair to
taxpayers. But let me answer your question directly.
Senator Baldwin. Well, I would also argue that the
situation of hunger for----
Secretary Rollins. Well, that is what I was going to--may I
respond to that part of it? So specifically to Wisconsin, your
program in Wisconsin, aside from what was pulled back, still
has $1.2 million left sitting in a bank account, out of $8.1
million in your Local Food Purchase Assistance Program. You
also had your state, not you, Senator, but your state asked for
a contract extension because they couldn't spend the money fast
enough. Your tribes have 500,000 left out of 700,000.
Senator Baldwin. I think you are confusing the programs,
because the local food assistance purchased that creates
opportunities for local farms to produce fresh produce.
Secretary Rollins: I am not.
Secretary Rollins. That is the LFPA.
Senator Baldwin. Some of these others, you know, get canned
commodities, et cetera. I visited several food banks in
Wisconsin.
Secretary Rollins. I am talking about the LFPA, Senator.
Senator Baldwin. Right now and we have 200 to 300 farms
that were engaged in this, and this was an expected customer
that they no longer have.
Secretary Rollins. But, Senator, it was an era--it was
COVID-era program that, by the way, you still have millions of
dollars left, right, that you can use to pay those farmers.
Senator Baldwin. The need is still there.
Secretary Rollins. That is the point. Most of that--a lot
of that money was never spent, you couldn't spend it fast
enough, that is not fair to the taxpayers. Do you know USDA
spends $400 million a day on nutrition and food programs, just
USDA? That is aside from this food bank. There is plenty of
money in the system. We just have to be better about how we are
spending it.
So I hear you. But I think that it is important to look at
where this money is sitting, how it is being spent, and making
sure that we are using the taxpayer dollars effectively. But
thank you.
Senator Hoeven. Senator Fischer.
Senator Fischer. Thank you, Mr. Chairman.
Secretary Rollins, it is so good to see you here today.
Thank you.
Secretary Rollins. Thank you.
Senator Fischer. I share your desire to realign and
reprioritize resources across USDA to put our ranchers and our
farmers first. This is especially important for USDA's
Agricultural Research Service to ensure that we are funding
innovative and high-impact research that benefits our farmers
and ranchers. I have been working to secure funding for an ARS
facility that is focused on innovative, precision agriculture
research that is co-located at the University of Nebraska-
Lincoln.
And I look forward to continuing to work with you on that
facility to ensure we can have high-impact, high-priority
research taking place there. You have also talked about having
more USDA's workforce located closer to the people that they
serve.
Secretary Rollins. Yes.
Senator Fischer. And while no official announcements have
been made, I think this would be a great step, and I know
Nebraska would be a great location to relocate parts of USDA,
like the Ag Research Service, giving our proximity to a number
of strong land-grant institutions, lower cost of living, and
strong existing relationship with the Agency at the facilities
I mentioned beforehand.
Can you talk about your plans for relocating parts of USDA
to the heartland, and how do you anticipate relocation efforts
could save taxpayer dollars and create greater efficiencies for
the Agency itself?
Secretary Rollins. We are very close, I will say, in the
coming weeks you will hear a lot more about these plans, and I
have really--I am so grateful because I have gotten a lot of
feedback from you and from others about potential locations
around the country. What I am most excited about in this
realignment, though, is exactly how you outlined it, Senator,
that we have to move--this is a customer-service-oriented
agency; and why do we have so many people in Washington, D.C.?
And then you bring the force part into that, and then the
nutrition into that, and it just doesn't make as much sense. It
will also be cheaper for the taxpayer, and the customer service
agent will be closer to the people that they serve. So we are
very in the weeds on that today, and an announcement is
forthcoming.
Senator Fischer. I appreciated your comments to Senator
Moran about the FSA and keeping those local offices open. I am
very well aware in rural communities across my state how
important it is that farmers have that in-person access. And
while we may be using technology in many areas, there still, I
think, at this point in time, needs to be that face-to-face
contact.
Secretary Rollins. I agree.
Senator Fischer. So thank you for that as well. In
Nebraska, we are also so proud of the work that is being done
at USDA's Meat Animal Research Center at Clay Center. That is a
strong relationship that the Center has with our livestock
producers in the state.
Last month, both Nebraska cattlemen and Nebraska pork
producers talked to me about how they valued the research that
is being done there. The President's budget does call for cuts
to ARS funding, but I think it is also important for us to make
sure that the dollars that we do spend on research and
facilities gets stretched as far as it can. Due to
overregulation, you have touched on that in some of your
answers, a lot of burdensome contracting requirements out
there, simple maintenance and upkeep costs end up costing
sometimes three to four times more than they should.
And this is especially true for unique research centers
like U.S. Meat Animal Research Center (USMARC) at Clay Center,
who operate--they are working farms, they are working ranches,
they handle livestock on a daily basis.
So would you agree that research done in collaboration with
the livestock industry at USMARC's Working Farm and Ranch is
important? And would your team work with mine to ensure that
the improvements that we make to ARS facilities don't end up
dramatically costing more than it would for the private sector
to operate those?
Secretary Rollins. I will, Senator. And I appreciate that
and the great research that happens in Nebraska. A quick note
on ARS, while we are decreasing the budget, it is $2.1 billion
currently under the President's budget from Friday. It goes
down to $1.9 billion. that is about a 7.5 percent decrease, and
that is really focused on just some facilities that are way
behind on repair and just out of date, and not meeting the
mark, obviously not yours in Nebraska. So that is a very
targeted decrease in funding that shouldn't affect, we remain
highly, highly focused on the priorities of ARS and ensuring
those are funded.
Senator Fischer. You know, I hope you can also look at that
overregulation that we have with contracting that I mentioned,
because a lot of times just those really simple maintenance, it
does end up costing more, and more, and more, where if we can,
you always hear about government regulation and how burdensome
it is, and there is some good examples that we need to get rid
of those good examples and make sure that we are dealing with
common sense and in the real world to meet those lower costs
that should be available.
Secretary Rollins. And the most important thing you can do
is send us, have your team send us those examples, and we will
get on it right away.
Senator Fischer. Great.
Secretary Rollins. Thank you, Senator.
Senator Fischer. Thank you, Madam Secretary.
Senator Hoeven. Senator Heinrich.
Senator Heinrich. Thank you, Chairman.
Secretary, the Iron Fire is currently burning in the Gila
National Forest, and you and I have talked about the Silver
City Dispatch Center, which is in charge of coordinating the
response between air assets and frontline firefighters in the
Southwest. It is still among the dispatch centers that DOGE is
seeking to close. And in our conversations, you assured me that
you would seek to keep this dispatch center open, that you
would designate it mission critical. Talk to me about what you
are doing to make good on that promise?
Secretary Rollins. Yeah, we have been in conversations with
GSA on that, Senator, and certainly as we have many hands
working across the Trump administration to deliver on our
promise for a more effective and efficient government, we agree
that this is important, and especially as wildfire season is
heating up, ensuring that we are operationally ready at every
turn in your state and in other states that are highly affected
by that. So we remain focused on that. And if you hear
something different, please call me.
Senator Heinrich. Let us return to something that you
discussed with my colleague from Wisconsin. The local Food
Purchasing Assistance and Local Food for Schools programs, in
my view, are two of the best, and they may be COVID programs,
but they are two of the best examples of using American-grown
produce to produce healthier outcomes in our students. To me,
that is making America healthy again.
You have canceled both of those contracts, even though
those contracts were signed and farmers had bought supplies for
planting based on those contracts. So what would you say to
both the producers and the schools who made financial decisions
based on those commitments?
Secretary Rollins. Well, I would love, Senator--the first
thing I will say is could you send me specific information on
that, because that would be really helpful. We have talked a
lot in broad strokes, but if I could see the details. In New
Mexico, you still have $1.5 million of the last tranche left
out of 6 million.
Senator Heinrich. I can't speak to what the state is doing,
and we will be happy to run that to ground. But the people I am
hearing from are, literally, the schools and the producers who
were impacted, the growers.
Secretary Rollins. Yeah. I would love to get more details
on that and what that looks like. Again, it is a COVID-era
program. The other side of this, and I want to make sure you
have got plenty of time to ask your other questions, but the
other side of this as far as the local nutritious farms, et
cetera, I mean, I think that is a massive push.
I think it is important we remain prioritized on that. But
again, the $400 million a day we spend at USDA on nutrition,
just on nutrition, I believe sincerely that we will be able to
check a lot of those boxes without continuing a program that
was supposed to end at the end of COVID and that, in fact, most
states still have a lot of money left in the bank. They haven't
been able to spend it.
Senator Heinrich. My colleague from Kansas mentioned Food
for Peace and McGovern-Dole. These programs have provided life-
saving, American-grown food to people around the world. I have
literally met with mothers and children who relied on American
food aid for their survival. So I appreciate that you have had
initial discussions with Secretary Rubio about these programs,
but what I saw two weeks ago with several of my Republican
colleagues on the ground at a refugee camp, was kids who were
on fractional rations, who didn't have enough calories per day
to thrive.
So what are we doing to fill the gap between the historic
commitment of those programs and whatever that replaces them,
in the meantime, when the impact is kids who are not getting
enough to eat?
Secretary Rollins. And you are talking specifically on the
international programs. Yes, that is a great conversation. We
continue to talk about it. The President has been very clear
that we have to ensure that our kids here in America that are
hungry, that we are serving, obviously they are the priority.
It doesn't mean that we don't care about or want to move out
our American farmers' produce, and we should, and commodities
across the world, but really focusing here in America first.
But secondly, understanding what those programs are, which
I talked a little bit about with the back and forth with
Senator Baldwin, I think--it may have been Senator Murray. But
how important and effective those are, where we are spending
the money, how it is being spent, and what that looks like.
Senator Heinrich. I think you will get a lot of support
from this committee to go after overhead, excess overhead.
Secretary Rollins. Yes.
Senator Heinrich. I think we have to check too many boxes,
and there are a lot of entities that have gotten good at
running those contracts because they can check those boxes. But
what we saw on the ground was kids who had malaria and other
diseases because they simply didn't have enough food to eat,
because commitments we made were not being made good on.
Secretary Rollins. Well, I would love more details on that.
That would help me understand, in fact, where it was you all
went, and then my commitment to you is to study that. And you
know, my heart is with what you are saying, but again we,
putting America first, understanding how we are feeding our
children, and we haven't had a MAHA discussion yet, but if we
do, we can talk a little bit more about that, is important.
But also understanding that, again, the mission and that
the intention of these programs are always good, it is how we
are effectuating them and putting them into play and really
looking at that closely.
Senator Hoeven. Thanks. Senator Hyde-Smith.
Senator Hyde-Smith. Thank you, Mr. Chairman, and thank you,
Ranking Member. And thank you, Madam Secretary, for being here.
Secretary Rollins. Thank you, Senator.
Senator Hyde-Smith. I am thrilled to have you there. I
think you have already proven to be a great Secretary of
Agriculture, my hat is off to you, the challenges that you are
facing in reorganization and a new administration is a tall
drink of water.
Secretary Rollins. Yes.
Senator Hyde-Smith. And I certainly want to be helpful any
way I can, and I can attest to those 5 a.m. texts, that I don't
know when you sleep. But there is so many challenges out there.
Secretary Rollins. There are.
Senator Hyde-Smith. And of course, as the former Head of
the Mississippi Department of Agriculture, I know all the
players. And getting the calls I am getting now on the concerns
that you are desperately trying to address is very much
appreciated.
Secretary Rollins. Thank you.
Senator Hyde-Smith. Because there is a lot of glaring
concerns that we have to take a look at. And I just admire the
speed that you are tackling this and the tasks that you have in
front of you. And before I go to the questions, and I know that
this is about the 2026 Budget Request, but before I go into
these questions. I just want to say this to everybody in the
room. Congress needs to address the outdated and inadequate
safety nets that is in the Farm Bill during the budget
reconciliation process.
Secretary Rollins. Right.
Senator Hyde-Smith. There is a lot of farmers in
Mississippi and across this country that are not going to be
able to continue unless we do address this. It is so concerning
for me. And addressing one aspect of the Farm Bill, SNAP, in
reconciliation without making improvements to the farm safety
net, it will make it extremely difficult to pass a Farm Bill,
but it is so critical.
So American farmers, as you well know, desperately want a
new and improved Farm Bill. And I think it is our job to
improve the Farm Bill. So let us give that to them by
addressing the safety net and reconciliation. I can't scream
that enough. Like I said, I know this is about the budget, but
that is so critically important that we do this now.
I want to just commend you on how efficiently and fast the
Department got out the 10 billion in disaster aid Congress
passed in December to help commodity producers cope with the
unbelievable input and cost and the depressed commodity prices.
You were excellent at doing that. And I have had my farmers
call and thank me for that. But through the USDA's Emergency
Commodity Assistance Program (ECAP) that you have referenced,
you know, many farmers are able to farm this crop this year
that, literally, they would not be able to otherwise.
Secretary Rollins. Yes.
Senator Hyde-Smith. When I have bankers come to me and say,
we are not going to finance your farmers next year without
something, it was that critical. And it was not sounding the
alarm; it was just pure fact is what we were dealing with.
Secretary Rollins. Yes.
Senator Hyde-Smith. So thank you for that. But when can we
expect USDA to distribute the remaining disaster funds for 2023
and 2024 for the weather-related losses? That is the questions
that we are being asked right now; if you could address that?
Secretary Rollins. Yes, ma'am. And I appreciate all the
good words. And just quickly, it is the team sitting over my
right shoulder and the people back at USDA that literally
worked seven days a week, 18- 20-hour days to get that first
tranche of funding out. And I am so grateful to them and the
unbelievable amount of time and effort they put into it. They
are putting that same amount of time and effort into this now
second tranche on the disaster relief.
The portal should open within a matter of weeks, before the
end of the month, to allow those grant applications to begin
being processed, our goal is timely, efficient, and turn it
around quickly. With the first tranche, that first $10 billion,
the ECAP, we were turning it in two to three days, which I
believe is unprecedented for any government program, but
certainly for USDA.
Senator Hyde-Smith. We had four.
Secretary Rollins. And our goal is to have the same sort of
speed, timeliness, and hopefully effectiveness on the second
tranche as well.
Senator Hyde-Smith. And thank you for that. And there is no
doubt that you are not going to accomplish that because you
have done so well so far. And we have talked about the FSA
county levels, and the staffing, and the decisions that have
been made, but again, as I hear from all of my producers and so
many throughout the country, we know that some of this is so
necessary and it is going to benefit us in the long run. It is
kind of like cleaning out a closet. You dread doing it, and you
get everything out, and it is just stuff everywhere until you
get it sorted and organized and put back.
Secretary Rollins. That is an amazing metaphor, but I can
completely understand and appreciate.
Senator Hyde-Smith. Yes, we have four children. We can
clean out closets.
Secretary Rollins. Yes, we can.
Senator Hyde-Smith. Because that is where we are.
Secretary Rollins. Yes, ma'am.
Senator Hyde-Smith. And to get it organized, put in the
proper place.
Secretary Rollins. Right.
Senator Hyde-Smith. But to get to the end of, you know, the
conclusions, is it being spent properly? And are we doing the
most that we can to make it efficient? So my question is just,
it is so critically important that support continues to reach
these producers. And can we just ask that you work with the
subcommittee on doing that?
Secretary Rollins. Absolutely. And it brings up a bigger
question, I think, Senator, that the average age of the farmer
is 58. That is a whole other hearing for another time, how we
reverse that trend. But I think it goes to not to cast any of
us, you know, around that age or older, aspersions at any of
us, but that, you know, moving to online is important at some
point.
But that is my point. It isn't today. And especially with
all the challenges and the headwinds against our producers, we
have to keep those front liners in place as we are moving these
projects out.
Senator Hyde-Smith. Well, you have an unbelievable task
with a huge agency. But I just want you to know you have got my
support. I have been on the frontlines. I have been there. And
I am very, very pleased with what you are doing and the
direction you are headed.
Secretary Rollins. Thank you.
Senator Hyde-Smith. And thank you for being willing to do
it.
Secretary Rollins. Thank you, Senator. Thank you.
Senator Hoeven. Senator Peters.
Senator Peters. Thank you, Mr. Chairman.
Secretary Rollins. Good morning.
Senator Peters. Secretary Rollins, good to see you again.
Secretary Rollins. You, too.
Senator Peters. And welcome to the committee.
Secretary Rollins. Thanks.
Senator Peters. Secretary, as part of the 2018 Farm Bill,
Congress passed the PAWS Act legislation, which I authored to
establish a grant program to provide shelter options for
domestic violence survivors with companion animals. Research
had found that up to 84 percent of women entering domestic
violence shelters reported that their partners had threatened,
abused, or had killed the family pet, used that as a source of
intimidation for these survivors.
In fact, nearly half the survivors report that they have
stayed with their abuser longer, sometimes months, sometimes
years, because of fear of what would happen to that beloved
part of their family. PAWS funding is a priority that I pushed
throughout my time on this committee and in the Senate. And it
is a line item that I hope to see in the President's budget
once we receive the details.
So my question for you, Secretary Rollins, is would you be
willing to support this important issue, and certainly I would
hope to count on you to get that continuing support that
survivors have been able to get these last few years.
Secretary Rollins. Senator, if we could follow up and have
a longer conversation, I would welcome that opportunity. This
is the first I have heard of it, so I don't want to commit
without knowing more. But I really appreciate your leadership
and your quiet, steady hand in all of this, and I would love to
have a longer conversation about that.
Senator Peters. Great. We will follow up with you and your
team.
Secretary Rollins. Yeah, it would be great.
Senator Peters. I will be happy to do that. In my home
state of Michigan, food and agriculture is the second largest
contributor to our state's economy. Everybody thinks about
manufacturing and making cars. We do that really well, but ag
is incredibly important. And specialty crop industries are the
biggest part of that equation. That is why I have long fought
for strong, consistent funding for the APHIS Specialty Crop
Pest Program. And that is also why I am so alarmed by some of
the recent reports that more than 1,300 APHIS employees have
accepted the deferred resignation option.
So my question for you, Madam Secretary, is how will your
Agency continue to meet its responsibilities after such a major
reduction in staffing?
Secretary Rollins. Well, it is a really important question,
and one that I have been talking about quite a bit in media. I
think that while we are moving through the reduction in force,
one point that I made, Senator, I don't know if you were in the
room, that while 15,000 of our employees of 106,000 staffed
agencies, a little less than 15 percent have accepted the
deferred resignation program, our typical attrition is between
8,000 and 10,000. Now, obviously, this is a significant jump
from that, but it is one that I believe is manageable.
I signed a memorandum a few weeks ago at USDA putting our
key areas, such as APHIS, such as wildland firefighting, such
as FSA offices, at the very top of the list. So as we have lost
important employees as part of this process, we are out
recruiting and ensuring that they become and are prioritized as
we rehire, realign, and reorganize the Agency.
Senator Peters. Okay. Well, I look forward to working with
you on that as well.
Secretary Rollins. Yes, sir.
Senator Peters. It is a major concern for us. As you know,
public investment in agricultural research has decreased since
2002. While we have seen competitors such as China surge in
their research efforts, they have now far surpassed U.S.
investment in agricultural research as well as development. And
given the critical importance of food security, to national
security, China competitiveness in this context I think is of
utmost importance for us to keep an eye on. That is why I am
frustrated to see that the President's budget calls for hefty
cuts in ag research funding.
So my question for you, Madam Secretary is, is ag research
a priority for this administration? And if so, how do you
square that with this year's budget request?
Secretary Rollins. Obviously, the research is a key
component of this, of the work at USDA. In this budget
discussion, we are just talking about the discretionary
funding, which is about 30 billion of our total $200-plus
billion annual budget, so at about 20 percent total is what we
are discussing today. In total of that, the research part of it
in the budget that came out Friday went from $2.1 billion down
to $1.9 billion. So while it is a cut, it is not a massive cut.
It is a 7 percent cut, and it is very much focused on outdated
facilities.
So as we continue the high priority and the focus on the
important research, I believe that none of that will be
compromised, Senator. If you see something different on the
ground in Michigan or across the country, would you please flag
it for us, because it shouldn't affect the key, most important
parts of the research.
Senator Peters. Great. Well, thank you for that.
Thank you, Mr. Chairman.
Secretary Rollins. Thank you, Senator. Good to see you.
Senator Hoeven. Senator Ossoff.
Secretary Rollins. Good morning.
Senator Ossoff. Thank you, Mr. Chairman.
Good morning, Madam Secretary.
Secretary Rollins. Good morning.
Senator Ossoff. Thank you for joining us. I want to follow
up on hurricane disaster assistance, key, key priority for
farmers in Georgia, Madam Secretary. It is worth noting that
after Hurricane Michael in 2018, it took the Congress the
better part of a year to pass disaster assistance. We worked
together across the aisle here to get it done after Hurricane
Helene in less than 90 days.
Here is a quote from Arren Moses, owner of Moses Pecan in
Uvalda, Georgia, ``We lost almost our entire 2024 pecan crop
when Hurricane Helene hit our orchards. We lost the majority of
our mature pecan trees, which will set our farms' production
back for years. We were thankful that Congress approved
disaster assistance funding at the end of last year, but it is
critical that these funds get to those that need help.''
Here is a quote from Chris Hopkins, a cotton producer in
Toombs County, he said that ``The storm has created a void due
to loss of yield and quality as well as cost of cleanup that
has become untenable to a first-generation operation like
mine.''
When can farmers in Georgia expect that hurricane relief,
which we passed timely in Congress, to be out the door?
Secretary Rollins. Yeah. And first of all, thank you for
that. That relief was passed very quickly and very impressively
at the end of last year, and so we have been tracking it very,
very closely. I have visited Georgia. Hopefully next time I
will see you. I have visited some of those peanut farmers
especially. I have seen the devastation firsthand. It is
heartbreaking to witness it. I had mentioned earlier, but it is
good to keep repeating it, that within a matter of weeks, the
portal will open on those grant applications. Under ECAP which
was the first tranche, that first 10 billion that went out for
emergency assistance.
Senator Ossoff. That is the economic assistance.
Secretary Rollins. That is right.
Senator Ossoff. I am referring to the disaster assistance.
Secretary Rollins. I understand, but I just want to use
that as an explanation of how we are going to be also doing the
second tranche, which is the disaster. We, on March 17th,
announced it. On March 20th, funds were moving out and into
farmers' bank accounts.
Senator Ossoff. When will the portal be open for disaster
assistance?
Secretary Rollins. By the end of the month, hopefully in
the next week.
Senator Ossoff. And how will that impact states that are
using a block grant arrangement with USDA?
Secretary Rollins. Well, that is a state-by-state question,
so I will be happy to follow up with Tyler Harper, your Ag
Commissioner, who I know is tracking this very, very closely,
and I ensure that we both understand----
Senator Ossoff. When do you expect those discussions with
the state to be resolved?
Secretary Rollins. Well, again, there are 50 states. We are
talking to all of them. When we open that portal, hopefully it
moves almost immediately. We have already moved the 280 million
that was outlined in that disaster relief into Texas. Because
it was outlined, it was obviously easier than, the open book on
the rest of the states. But it will move very, very quickly.
Senator Ossoff. Because time is of the essence.
Secretary Rollins. Then would you please let me know?
Senator Ossoff. Yes, I will.
Secretary Rollins. And we will do everything we can.
Senator Ossoff. Madam Secretary, are you familiar with the
Local Foods for Schools Program?
Secretary Rollins. Yes, sir.
Senator Ossoff. So here is a few quotes from my
constituents, this is from Scott Richardson of the Dawson
County School District: ``Local Foods for Schools Program has
transformed our ability to bring healthy, fresh, and locally
grown fruits and vegetables to our students. Prior to the LFS,
purchasing from local farmers was often cost prohibitive.''
Here is a quote from Parrish Akins, he owns a family farm
in Nashville, Georgia. Mr. Akins said, this program, quote,
``Has allowed our farming operation to capture some of the
profits, which in the past would have gone to another member of
the supply chain, and has allowed us to increase our
revenues.''
Here is Colquitt County School Nutrition Office,
``Purchasing local foods has significantly enriched our school
community by providing fresher, healthier meal options for
students.''
Here is Atlanta Neighborhood Charter School Nutrition, ``We
bought some Georgia shrimp from a guy who has been in the
shrimp industry since he was a teenager.''
In Brunswick, Crisp County School Nutrition, ``Through the
Local Food for Schools Program, we were able to establish
reliable and stable local food sources.'' This is a program, of
course, that helps Georgia farmers sell food to Georgia
schools. Why did you cancel the program?
Secretary Rollins. Well, let us talk about Georgia for a
second.
Senator Ossoff. I have 50 seconds left, so I just want to
know about the----
Secretary Rollins. Well, that is a big question. You have
got to give me a little bit more time.
Senator Ossoff. You can take your time, but I want to know
why you canceled the program.
Secretary Rollins. Well, we canceled the program. It was a
COVID-era program, first of all. Second of all, the money was
not being spent. In the current tranche, your state has $2
million of $7 million left in the account. You are asking for
contract extensions because you cannot spend the money quickly
enough. The food for the FPA and the LFPA, we have got $10
million of $20 million left, so you have got money in the bank.
Senator Ossoff. Why rather than tailor the program did you
cancel it?
Secretary Rollins. It is not a good use of taxpayer funds
when you have got taxpayer dollars.
Senator Ossoff. Well, my constituents believe that it
Constituents, the farmers----
Secretary Rollins. Well, I would love to talk to your
constituents, I wonder if they know that the State of Georgia
has not moved that money out, we just can't continue that.
Senator Ossoff. Constituents, the farmers--Will you please
provide to the committee an economic justification for the
outright cancellation of that program?
Secretary Rollins. An economic justification for the
outright cancellation of the COVID-era program that was due to
end, yes, we will do that.
Senator Ossoff. Of the Local Food for Schools program that
the constituents enjoy and rely on?
Secretary Rollins. Yes, we will be happy to do that, sir.
Senator Ossoff. Thank you, Madam Secretary.
Secretary Rollins. Thank you.
Senator Hoeven. Senator Merkley.
Secretary Rollins. Good morning.
Senator Merkley. Thank you, Mr. Chairman.
And welcome.
Secretary Rollins. Thank you.
Senator Merkley. So agricultural research is very important
in the State of Oregon. We have such varied types of
agricultural activity. Just to give you an example, in
Corvallis the work is done on sudden oak death, which has a
huge threat to our nursery stock industry but also a huge
threat, potentially, to our timber. In Pendleton, the research
being done on drought-resistant dry land wheat varieties is
essential. In Burns, the research on how to reseed grasses that
are beneficial to cattle after a fire, rather than having cheap
grass take over, is essential.
Secretary Rollins. Sure.
Senator Merkley. So we were shocked when all these
scientists were fired. We lobbied like hell to get them back.
We got them back, thank you very much. But I am very concerned
about the proposed cut of 160 million to research in the
proposed budget.
Can you ensure, or can you assure the farmers and all the
ranchers in all these different places in Oregon that the
research will go on in a vibrant and significant way? Not only
for these reasons, that is just a short list, I mean, we have
invasive flies affecting the berries.
Secretary Rollins. Right.
Senator Merkley. You know, we have warmer conditions in the
ocean affecting our shellfish. Can you assure us that we are
not going to end up without this essential research being done?
Secretary Rollins. Yes, sir. And I really appreciate this
question, Senator. So the ARS portion of USDA has a $2.1
billion budget. The President's budget suggests, as you
mentioned, the $160 million decrease. That takes us down to
1.9. That is about a 7 percent decrease, so it is not, you
know, as big as maybe it is being made out to be in the press.
And that specifically is focused on closing outdated facilities
around the country that have nothing to do with the different
issues that are being researched that are outlined.
So yes, we can commit to ensure that the robust body of
research that is so important to our agriculture producers
continues. And I look forward to working with you. And if you
hear anything differently, please call me direct.
Senator Merkley. Are there any outdated facilities that you
think are outdated in Oregon?
Secretary Rollins. I do not believe so, but we will follow
up on that.
Senator Merkley. Okay. Thank you.
Secretary Rollins. Thank you.
Senator Merkley. Because I don't know of it, I have
visited, I think, all of them, and they are incredibly
important.
Secretary Rollins. We will follow up on that today, sir.
Senator Merkley. Okay. I want to turn to the question about
the funding to decrease, essentially, the challenge of food
insecurity. And we have one in six kids in Oregon who are
facing that insecurity, which basically means they are going
hungry. And so the suspension of the Commodity Credit
Corporation payments to food assistance programs, including
TEFAP, have really been shocking. I don't think President Trump
campaigned on: I am going to help increase the number of hungry
kids. So what is going on there with that?
Secretary Rollins. Well, and let me pull up the Oregon
numbers just so you are aware. So again, USDA spends about,
$400 million a day on nutrition programs. That is a stunning
number. The specific program you are talking about, sir, to
answer your question, was a COVID-era program that, at the
time, probably made a tremendous amount of sense but never was
meant to continue indefinitely.
And specifically to Oregon, of the $2 million under the LFS
program and the $7 million under the LFPA, Oregon has $330,000
left in the first and $5 million left in the second. Almost
every state was asking for contract extensions because they
couldn't spend the money quickly enough. So I think it just
goes to the balance we have to strike every single day on
ensuring that every taxpayer dollar is spent to the best and
highest use.
And it was the decision of our President and this
administration that perhaps that COVID-era program had
fulfilled its purpose. But we can still continue to make sure
that we are supporting our farmers and getting nutritious foods
into the schools and into the food banks, but through different
and other programs.
Senator Merkley. You know, I guess I would like to have you
look at this from the perspective: Is there a current need that
needs to be addressed, whether or not it was originated under
COVID or not? I have visited those food banks. I have seen the
high increase in demand, which, it is kind of scary to see how
that need has grown. I have the estimate from the Oregon Food
Bank that the changes that are currently happening under the
credit corporation, the suspension, will reduce their ability
to provide about three million meals, 2.88 they said, three
million meals.
It seems like a pretty significant impact to an ongoing
problem, regardless of whether the program was created under
COVID. So could you just take a look at that in more detail?
Secretary Rollins. I will.
Senator Merkley. All of those numbers you provided, I did
not catch if one of those was a TEFAP number?
Secretary Rollins. Yes, sir.
Senator Merkley. Okay. Because I know that has been the top
priority of the Oregon Food Bank, is being able to move produce
around the state, which had been very helpful to our farmers in
one place that have a surplus, or grocery stores that have a
surplus, they are donating it, but it has to be moved to where
it is needed, and it has to move in a timely fashion so it
doesn't rot.
Secretary Rollins. Right.
Senator Merkley. And all the vegetables and so forth. So I
see that five minutes have vanished, and my stack of another
ten questions are ongoing.
Secretary Rollins. Well, I am always available. So I
welcome a phone call. Just, you know, call me anytime, and we
will be so happy to walk through any of this with you.
Senator Merkley. Thank you. Thank you very much.
Secretary Rollins. Yeah, thank you, Senator. Nice to meet
you.
Senator Hoeven. Secretary, we know you have a time line. We
certainly want you visiting with the Mexican Ambassador. We
will go to close up.
Let me turn to Ranking Member Shaheen for her final
comment.
Secretary Rollins. Yeah. And Senator Shaheen, if you have
any other questions, we can, we can go a few more minutes.
Senator Shaheen. Well, I just wanted to clarify what
Senator Murray and I think we were asking you about with
respect to the WIC Program which, as you pointed out, is not
mentioned at all in the skinny budget. And what also is not
mentioned is the cash value benefit for fruits and vegetables.
So what we wanted to know from you is whether you would support
fully funding WIC, including that cash benefit?
Secretary Rollins. If you do not mind, I would like to take
a good look at it, since it wasn't in this particular round. I
haven't spent the time on it, but obviously this administration
believes that WIC is very important.
Secretary Kennedy and I have had conversations about it
pretty extensively already. So the more that I can learn and be
in contact with you all, I would welcome that.
Senator Shaheen. We would appreciate your getting back to
us on whether you support both aspects of the WIC Program. The
other thing I just wanted to clarify is, I was not quite clear
where you got the numbers of money that has gone out to New
Hampshire and the number of recipients, because when we check
the online dashboard, New Hampshire has received 24,000 only,
of the $10 billion in economic disaster assistance that was
provided in the December supplemental, and the dashboard states
that 51 applications have been approved. So I am not sure where
those numbers came from, but they are a lot higher than any
numbers I have ever heard related to the agricultural sector in
New Hampshire.
Secretary Rollins. So you know what, Senator, my apologies,
it looks like there was a typo on yours--you and South Dakota
are exactly the same on this sheet. And we know that those are
two very different states, so my sincere, sincere apologies.
This is unacceptable. It will not happen again. And we will
make sure and get it right, and today we will follow up. Now, I
do not know we will get this up today.
Senator Shaheen. Thank you. And actually, the numbers are
not as big a concern for me as making sure that the funding
goes to the people who need it in New Hampshire.
Secretary Rollins. Yes, ma'am.
Senator Shaheen. That is the concern.
Secretary Rollins. We will follow up with your team today
on that and make sure you have the up-to-date numbers.
Senator Hoeven. Yeah. And I can add there. Again, I think
that is weather-related, which you will have coming out. We put
a number of different components in there.
Secretary Rollins. Right.
Senator Hoeven. So I think, Senator Shaheen, correct me if
I am wrong. You just want to make sure in that weather
component they are cognizant of the language you talked about
with the allocation specifically regarding small farms; is that
right?
Senator Shaheen. Well, the $220 million set aside for the
eight states for New England is a concern.
Senator Hoeven. Yes.
Secretary Rollins. Yes.
Senator Shaheen. But the other concern is the halt on
funding and the applications that have been submitted for all
of the assistance programs. Thank you.
Secretary Rollins. Yeah. We will get direct information on
that.
Senator Shaheen. Mr. Chairman, yes.
Senator Hoeven. Right. There were like five different
pieces to that, and so I think she is referring to a piece that
was weather-related, separate from the market conditions base--
the 10 billion-base that we talked about.
Secretary Rollins. That is right.
Senator Hoeven. I think that is the confusion.
Secretary Rollins. We will fix that. Yes, ma'am.
Senator Hoeven. So I will follow up with her on that. And
again, from what I have seen, you are following very well what
we laid out in that emergency assistance, and we appreciate it
in getting this squared away.
Secretary Rollins. Thank you.
Senator Hoeven. Just final couple comments or questions.
Any update on tariff agreement timelines?
Secretary Rollins. Yes. I don't want to speak for Secretary
Lutnick, Secretary Bessent, or our U.S. Trade Rep, Jamieson
Greer, or the President, but we are exceedingly close to having
significant announcements that of anyone that will be impacted,
no one will be impacted positively more than our agriculture
industry, as these announcements begin to roll out very
quickly.
Senator Hoeven. And we think weeks, not months?
Secretary Rollins. Oh yes. That is right.
Senator Hoeven. Yes.
Secretary Rollins. That is exactly right, within week/
weeks.
Senator Hoeven. Yeah. Okay. And then there was some
discussion regarding ARS restructuring, those kind of things.
Obviously, the policy centers, you have got one at A&M, FAPRI,
NDSU, Nebraska, Omaha, we are going to want to be involved in
that very closely with you, very important, as well as the NIFA
funding. So those are things that we are going to want to talk
to you about closely more.
Secretary Rollins. We would welcome that.
Senator Hoeven. Critically important.
Secretary Rollins. Yes. Thank you.
Senator Hoeven. Yeah. And then, just anything else that you
want to add for the record, Secretary, before we adjourn?
Secretary Rollins. I would just say that I really, really
appreciate the opportunity. This is my first hearing, other
than the confirmation hearing. And I have been--you know,
obviously there are some differences of opinion, and we can
agree to disagree, but the agriculture side of this effort, we
are all in this together. And I think even on the other side of
the aisle, you know, understanding that every one of our
elected officials on both sides really want what is best for
our ag producers, and our farmers, and our ranchers.
And I know you know this, Senator Hoeven; and Senator
Shaheen, you may not yet, but I am always available. And I just
want this to be a productive conversation and productive 4
years where we can hopefully get these farmers and ranchers
back to a place of prosperity, and where they are not worrying
about losing their farm every single year. So that is my goal,
and I look forward to working across party lines to do that.
Senator Hoeven. Well again, Secretary, thank you for being
here.
Secretary Rollins. Well, easy. Thank you. And I should not
say that before the questions come in, but we will do that. And
one other thing for you all to know too, we are working really
hard on the letters to make sure we are timely on responding to
letters. We have gotten about 140 since I took office about 80
days ago, and we have responded to more than half of those to
date. And we have responded to everyone on this committee. So I
feel really good, and we are way understaffed. So I think that
we will be able to be much more timely, moving forward. And
that is really important to me as well.
ADDITIONAL COMMITTEE QUESTIONS
Senator Hoeven. Questions for the record are due by next
Tuesday, May 13th. And we would appreciate responses back from
USDA within 30 days.
Questions Submitted to Hon. Brooke Rollins
Questions Submitted by Senator John Hoeven
Question. On May 16, I was informed of a round of terminations of
the McGovern-Dole Food for Education grants; some of which were mid-way
through a multi-year program. The FY2025 bill provided $240 million to
this program, which is the largest global donor to school feeding
efforts. The program provides U.S. agricultural commodities, funding,
and technical assistance to reduce hunger, support nutrition, and
improve literacy, primary education and training around the world. The
McGovern-Dole Program supports domestic agricultural producers,
advances U.S. diplomatic interests, and has received bipartisan support
since 2002. Can you provide details such as which programs were
terminated and the justification for termination?
Answer.In line with President Trump's January 20, 2025, Executive
Order: Reevaluating and Realigning United States Foreign Aid, USDA
terminated the below 17 McGovern-Dole projects that do not align with
the foreign assistance objectives of the Department. USDA continues to
maintain 30 active McGovern-Dole projects in 22 countries, and the FY25
Notice of Funding Opportunity for the program was posted on May 9.
------------------------------------------------------------------------
FY Country Organization
------------------------------------------------------------------------
FY19............................ Uzbekistan Mercy Corps
FY19............................ Togo CRS
FY20............................ Guatemala CRS
FY20............................ Honduras CRS
FY20............................ Mali CRS
FY21............................ Benin CRS
FY21............................ Burkina Faso CRS
FY21............................ Kyrgyzstan Mercy Corps
FY21............................ Laos CRS
FY21............................ Sierra Leone CRS
FY22............................ Burundi CRS
FY22............................ Lesotho CRS
FY22............................ Madagascar CRS
FY22............................ Timor-Leste CARE
FY23............................ Nepal WFP
FY23............................ Nicaragua Project Concern
Int'l
FY24............................ Guinea-Bissau CRS
------------------------------------------------------------------------
______
Questions Submitted by Senator Cindy Hyde-Smith
Question. USDA Watershed and Flood Prevention Operations
administered by the Natural Resources Conservation Service (NRCS) are
vital to rural Mississippi. Local sponsoring organizations throughout
Mississippi are working constantly to prevent flood, erosion, and
sedimentation damage in various watersheds--all of which affect
conservation, water disposal, and land utilization. Should Congress
provide funding for NRCS watershed operations above the FY2026 budget
request, are you confident that the Department could effectively put
those additional funds to good use?
Answer. NRCS is committed to supporting the technical and financial
assistance needs of local sponsoring organizations who have watershed
flooding, erosion and sedimentation concerns using funds provided to
the Watershed and Flood Prevention Operations program.
Question. I was pleased to see that the FY26 USDA budget request
calls for increased funding for the Food Safety and Inspection Service
(FSIS). Since USDA assumed responsibility over catfish inspection,
along with meat, poultry and egg products, the import of products
containing substances that could be harmful to human health has
declined. But USDA can do more to stop foreign countries, like Vietnam,
from sending us catfish grown in unsanitary conditions and treated with
chemicals not approved for U.S. aquaculture. With any additional
funding provided for FSIS in FY26, will you work to make sure USDA
catfish inspections are strengthened to the maximum--especially for
imports from known violators?
Answer. FSIS is committed to ensuring foreign suppliers meet the
same rigorous food safety standards as domestic catfish producers. USDA
will also continue working with the Department of Commerce and across
the Trump administration to ensure our producers have a level playing
field with our trading partners, including for our catfish producers.
Question. USDA administers the National Veterinary Stockpile (NVS),
a repository of materiel that can support State-based outbreaks of
livestock infectious disease. The unabated threat from H5N1 avian
influenza necessitates that those responding to these outbreaks have
access to effective personal protective equipment (PPE). It also
necessitates even more robust preparedness for any mutation of the
virus that could be especially virulent and transmissible to people.
This latter scenario would require significant levels of PPE to ensure
the safety of all animal agriculture workers and outbreak response
personnel. Can you please report back on the following: What specific
PPE supplies have the USDA stockpiled in the NVS? What planning
scenarios are these assets tied to? How many critical personnel could
be supported by this PPE in these scenarios? Have you coordinated with
the Department of Health and Human Services to plan for leveraging PPE
assets in the Strategic National Stockpile in the event of an emergency
that exceeds the assets in the NVS?
Answer. The PPE in the NVS includes goggles, disposable coveralls,
respirators, gloves, boot covers, and bouffant caps. The NVS is
designed to maintain sufficient amounts of countermeasures capable of
deployment against the most damaging animal diseases within 24 hours.
USDA is committed to working with our partners across the Federal
Government and routinely communicates with other agencies to ensure the
best outcomes in the event of large-scale emergencies.
______
Questions Submitted by Senator Mike Rounds
Question. As you know, Highly Pathogenic Avian Influenza (HPAI)
continues to devastate producers in South Dakota. While farmers in my
state are taking proactive steps to protect poultry and dairy
populations, the presence of migratory birds continues to exacerbate
the spread of HPAI. These circumstances have led many producers to
support the development of an HPAI vaccine.
Secretary Rollins, it was encouraging to see USDA support the
conditional approval of an avian flu vaccine for poultry. Do you
believe the USDA Agricultural Research Service (ARS) has the necessary
resources to support the development of additional HPAI vaccine
candidates?
Answer. ARS is fully committed to providing the necessary resources
to combat HPAI through detection, biosecurity, and vaccine development
and testing. Several vaccines against the currently circulating viruses
for chickens have been tested by ARS and licensed by the USDA Center
for Veterinary Biologics. ARS is currently receiving congressionally
appropriated funding for poultry vaccine development and approaches,
such as mass vaccination of birds and vaccines that enable
differentiating infected from vaccinated animals (DIVA vaccines).
For other species (cattle, small ruminants, and swine), ARS
received additional Commodity Credit Corporation funding through an
interagency agreement with APHIS. These additional resources support
foundational research on species-specific animal models and vaccine
testing, thereby enhancing our knowledge and understanding of a disease
previously unknown in these species.
Question. Secretary Rollins, South Dakota ranch families work
tirelessly to produce the safest, highest quality and most affordable
beef in the world. Yet as you know, foreign animal disease threats have
the ability to halt the U.S. beef trade. Unfortunately, the previous
administration lifted a long-standing ban on Paraguayan beef imports.
Secretary Rollins, does USDA's Animal and Plant Health Inspection
Service (APHIS) currently have the necessary resources to effectively
combat foreign animal diseases such as Foot and Mouth Disease (FMD) or
New World Screwworm?
Answer. Yes, APHIS currently has the resources needed to combat
foreign animal diseases and will continue to reassess needs as
warranted.
Question. For too long, American producers have been forced to
compete with lower quality foreign beef that falsely bears the 'Product
of USA' label. I previously introduced the USA Beef Act to make certain
the ``Product of USA'' label is only applied to beef derived from
livestock raised and slaughtered in the United States. Since this time,
USDA has implemented this change through rulemaking.
Secretary Rollins, with USDA set to implement this rule next year,
can you confirm whether the Food Safety and Inspection Service (FSIS)
will be fully prepared to administer the voluntary ``Product of USA''
labeling program?
Answer. USDA is thoroughly reviewing significant rules put in place
by the previous administration, such as the voluntary ``Product of the
USA'' labeling program. FSIS will continue to review stakeholder and
Congressional input as this review is ongoing.
Question. USDA's Rural Utilities Service (RUS) provides critical
financing to electric cooperatives across rural America, enabling many
small South Dakota communities to upgrade their rural electric
infrastructure. While the agency has traditionally worked well with
rural leaders, cooperatives in my state have recently encountered
lengthy delays due to RUS environmental reviews-a problem that
originated during the previous administration.
Secretary Rollins, will you work to help resolve these bureaucratic
delays and make sure that appropriated RUS funding is disbursed
promptly to rural electric cooperatives?
Answer. RUS has been working to identify process improvements to
streamline reviews to ensure compliance with the National Environmental
Policy Act. We have already implemented emergency procedures to comply
with Executive Order EO 14156, Declaring a National Emergency. USDA is
actively participating with other Federal agencies to comply with EO
14154, Unleashing American Energy, by identifying and adopting agency
level implementing regulations to expedite permitting approvals and
meet deadlines established in the Fiscal Responsibility Act of 2023
(Public Law 118-5).
______
Questions Submitted by Senator Jeanne Shaheen
Question. There are several Regional Conservation Partnership
Program awards in New Hampshire that have been disrupted by this
administration's funding freezes. The pauses and failure to provide
clear communication to grantees about the review have injected
unnecessary uncertainty in the process and delayed key seasonal work.
Given that it has been more than 3 months since the administration
froze this program and many others, when will USDA release the funding
and allow RCPP projects to proceed?
Answer. On June 11, USDA notified all RCPP partners of the status
of their project.
Question. More than 12,000 women, infants and children in New
Hampshire rely on the WIC program for healthy food, breastfeeding
support and nutrition education. An important part of this program is
the WIC Cash Value Benefit, which helps participants afford the level
of fresh fruits and vegetables each month recommended by the National
Academies of Sciences, Engineering and Medicine. Do you agree that
failing to fully fund the fruit and vegetable cash value voucher
undermines the nutritional quality of the WIC program?
Answer. I appreciate the value of the Special Supplemental
Nutrition Program for Women, Infants, and Children (WIC) to pregnant
and postpartum mothers and their children. WIC has a proven track
record of improving children's health by providing access to
supplemental foods, nutrition education, and health referrals. It
allows health- conscious food purchases that are adjusted according to
participants' life stage nutritional needs. The President's Budget
would continue to ensure WIC participants receive nutritious
supplemental foods--including support for purchasing fresh fruits and
vegetables--to promote healthy eating habits and improved health
outcomes.
Question. The Snow Telemetry Network (SNOTEL) has been providing
western States with vital measurements of snow accumulation and snow
melt prediction data for decades. In recent years, this Committee
provided additional funding to expand the SNOTEL program to the
Northeast-this data will be key for the region to better understand
flood potential, water supplies and the effects on seasonal businesses.
Do you commit to continuing the SNOTEL expansion to the Northeast? What
resources are needed in Fiscal Year 2026 to keep the expansion on track
and what benchmarks does NRCS hope to reach over the course of the next
year?
Answer. As our new Administration continues to evaluate all USDA
agency programs to identify opportunities to reduce inefficiencies, and
enhance customer service, especially to agricultural producers, NRCS is
currently focused on protecting our historical investments in the Snow
Survey and Water Supply Forecasting Program. We will continue to
collaborate with other federal, State and local agencies to develop and
encourage use of new techniques, improving data collection and
processing. Additionally, NRCS is evaluating a request for a no cost
extension of the existing Cooperative Agreement with the Northeast Snow
Survey Feasibility Study partners to accomplish the following
benchmarks though Fiscal Year 2026:
--Summary report on interest holder engagement process and outcomes
to share with interest holders.
--Summary report of snow monitoring in northern New England and New
York to share with NRCS colleagues and interest holders.
--Systems Engineering plan linking network objectives to data
products, processing workflow, measurement specifications, and
spatial design.
Question. New England experiences significant weather variability,
including historically dry and historically wet years over the last
decade. For many small and diversified operations in New Hampshire,
protected agriculture systems are critical to reducing weather
exposure, limiting damage from pests and diseases and helping farmers
extend their growing seasons. There is an opportunity for ARS to do
further research into optimal uses of these systems, and there are
ready partners like the University of New Hampshire who have done
related extension work.
Will you work with me on expanding investments in research relating
to protected agriculture?
Answer. If ARS is provided with funding from Congress to support
research relating to protected agriculture, I look forward to working
with you and ARS leadership to find ways to work with ready partners to
conduct this research.
Question. In Fiscal Year 2024, this Committee created a pilot
program to add an additional tool to preserve the rural affordable
housing portfolio. Do you commit to continuing to pursue and providing
the committee with regular updates regarding the Multifamily Housing
decoupling pilot? How many staff will be dedicated to affordable
housing preservation, and how many properties does RD plan to offer
decoupled rental assistance agreements to in Fiscal Year 2026?
Answer. We will ensure sufficient staff are dedicated to affordable
housing preservation to meet the statutory requirements. In Fiscal Year
2026 there are 52 units initially eligible for the pilot, with 1,209
units eligible for preservation through the pilot program.
Question. In October 2023, the Government Accountability Office
released a report titled ``Sugar Program: Alternative Methods for
Implementing Import Restrictions Could Increase Effectiveness''. GAO
made recommendations on improving the trade aspects of the program, and
USDA and USTR stated that they concurred with the recommendations.
Career officials at USDA communicated to stakeholders that policy
announcements to implement the GAO recommendations would be initiated
within 18 months of the report's release. When will USDA announce
policies to initiate implementation of the GAO recommendations?
Answer. USDA remains in close coordination with the Office of the
United States Trade Representative as it implements its GAO
recommendation. In 2024, USDA concurred with GAO's recommendation for
USDA to evaluate the effectiveness of the WTO raw sugar tariff rate
quota allocation methods. USDA committed to providing USTR an
evaluation report within 2 years and expects to share this evaluation
in 2025; USDA will inform GAO once the report has been shared to close
out its recommendation.
______
Questions Submitted by Senator Jeff Merkley
Question. According to the Oregon Food Bank, 1 in 8 people and 1 in
6 kids in Oregon and Southwest Washington are going hungry. However,
earlier this year, the USDA announced that it would suspend Commodity
Credit Corporation payments to food assistance programs, including the
Emergency Food Assistance Program (TEFAP). As a result, this year,
Oregon food banks will be unable to provide 2.88 million meals. How
many fewer meals will be delivered as a result of the decision to spend
Commodity Credit Corporation payments?
Do you agree that suspending CCC payments to food assistance
programs has resulted in more individuals going hungry?
Answer. USDA spends roughly $400 million per day across its 16
nutrition programs. Currently, one in four Americans will participate
in a USDA Food and Nutrition Service Program at some point over the
course of the year. Taxpayers generously fund these programs to help
ensure that no children, in Oregon or any other state, go hungry. We
owe it to taxpayers to ensure these programs are effective and
accountable. And with these nutrition programs and the Section 32
market support program in place, USDA remains focused on its core
mission: supporting agricultural markets and ensuring access to
nutritious food. The Department will continue to use its procurement
authority to support producers and consumers where appropriate, and
ensure families continue to have access to affordable and abundant
food.
Question. When will Commodity Credit Corporation (CCC) payments to
food assistance programs resume?
Answer. USDA continues to purchase food for TEFAP, with more than
$669 million spent in Fiscal Year 2025, as of May 14, 2025, to connect
families to food. Additionally, since March 27, 2025, USDA has
announced $328 million in available fruits, vegetables, tree nuts,
Atlantic groundfish, canned pears, dried sweet cherries, great northern
beans, and Pacific pink shrimp made possible through Section 32
purchases. These foods go directly to food banks and other charitable
organizations.
Question. At the hearing, you stated that the proposed $159 million
decrease for the Agricultural Research Service is ``specifically
focused on closing outdated facilities around the country that have
nothing to do with the different issues that are being researched...
yes, we can commit to ensure that the robust body of research that is
so important to our agriculture producers continues.'' You also
committed to following up with me to assure that no facilities in
Oregon were targeted for closure. Are any ARS units in Oregon proposed
for closure or consolidation?
Answer. The President's Budget does not propose the closure or
consolidation of any ARS units in Oregon.
Question. What facilities or ARS units are proposed for closure or
consolidation? Why?
Answer. The President's Budget proposes the closure of three
locations to support the Administration's priority of reducing the
Federal footprint. These include Newark, Delaware; Riverside,
California; and Urbana, Illinois. The research programs and resources
will be consolidated with other existing ARS laboratories and
locations.
Question. You stated clearly that the proposed funding cut to the
Agricultural Research Service would only be used to close outdated
facilities. This statement contradicts the President's so-called
``skinny budget,'' which States, ``The Budget reduces funding for
research sites across the Nation that have exceeded their ideal
lifespan and reduces funding for research projects that are not of the
highest national priority.'' Please clarify whether the U.S. Department
of Agriculture intends to cut funding for research projects. If so,
which projects does the Department intend to cut?
Answer. The President's Budget proposal for ARS terminates $145
million for Climate Science research and the Climate Hubs. These
activities are not aligned with the Administration's priorities.
Question. I am concerned with this administration's attempt to
withhold funds that were directly allocated for specific purposes by
Congress. For example, this administration initially froze the
Partnerships for Climate-Smart Commodities (PCSC) program which had
awarded grants to more than 130 agriculture projects across the
country, including in some of Oregon's most rural communities. Now, the
program has been rebranded by the Department of Agriculture and
possesses a different set of criteria for applicants to reapply for
funding. I have heard from ranchers in Oregon who received a PCSC grant
that has been terminated. They do not intend to reapply for the
rebranded program because they do not trust that the USDA will uphold
its commitments for funding and because they do not believe that the
USDA understands the time and resources it takes for small farms to
apply to Federal grants. How does USDA intend to maintain trust with
our farmers and ranchers while creating an environment of uncertainty
and pulling funding from critical projects in agricultural communities
across the country?
Answer. The Partnerships for Climate-Smart Commodities (PCSP)
program was established by the previous administration utilizing
discretionary authorities under the Commodity Credit Corporation
without funding direction or input from Congress. In creating the
Advancing Markets for Producers initiative, USDA will continue to
support farmers and encourage partners to ensure their projects are
farmer focused or re-apply to continue work that is aligned with the
priorities of this Administration.
Question. On May 5th I sent a letter to the U.S. Department of
Agriculture requesting that the Agricultural Marketing Service (AMS)
approve the Westcoast Seafood Processors request for a Section 32
purchase of Pacific pink shrimp. If approved, the Section 32 purchase
of Pacific pink shrimp would provide economic certainty to Oregon
fisheries and coastal communities in addition to providing much needed
relief in response to the impacts of this administration's tariff war.
Although the U.S. and EU have paused tariffs and retaliatory tariffs,
European customers cancelled their orders of American seafood products,
including up to 50% of the Oregonian pacific pink shrimp in response to
the President's announcement of tariffs. The pacific pink shrimp season
opened on April 2, 2025--leaving no time for the industry to find
alternative markets to offset the loss of consumers from the European
market. Will the Agricultural Marketing Service approve of the
Westcoast Seafood Processors request for a Section 32 purchase?
Answer. On May 23, AMS announced a Section 32 purchase of up to $16
million of Pacific Pink Shrimp.
Question. The Watershed and Flood Prevention Operations (WFPO)
Program--also known as PL-566--has been integral to agricultural
producers in the west to modernize their irrigation systems through
piping to respond to increased drought conditions. This program is ran
through USDA's Natural Resources Conservation Service (NRCS). During
the President's first term, a group of NRCS State Conservationists
developed a white paper proposing improvements to the PL-566 program to
streamline the approval of watershed plans and break ground on more
projects in a timely manner. In the years that followed, the
recommendations in this white paper were never fully adopted/
implemented by the agency. The President's ``Skinny'' Budget released
last week would provide $0 for WFPO, which specifically supported
multi-benefit projects in the West. Given the President's Budget
request calls for eliminating funds specifically for projects that
support Western farmers combat drought and implement multi-benefit
projects, how do you plan to maintain these activities at the agency?
Answer. There is permanent funding of $50 million provided annually
through the Farm Bill to support watershed projects. In addition, this
program received an enormous influx of funding through IIJA, which NRCS
is still working to obligate.
Question. Does the agency have plans to modernize the WFPO program
to facilitate multi- benefit projects? What steps will you be taking to
accomplish this modernization?
Answer. The NRCS WFPO program utilizes a continuous process
improvement strategy to prioritize changes related to Congressional
directions and local project sponsor feedback. Specifically, NRCS plans
to streamline:
--the Preliminary Investigation and Findings Report (PIFR)
development process,
--the Watershed Project Plan development, review and implementation
authorization process,
--and the development of Environmental Assessments or Environmental
Impact Statements for WFPO projects.
______
Questions Submitted by Senator Tammy Baldwin
biofuels
Question. What actions is USDA taking to ensure that EPA
understands the importance to US agriculture of quickly getting the
upcoming Renewable Volume Obligation rulemaking out the door that
includes biomass-based diesel volumes at 5.25 billion gallons and
implied ethanol volumes at no less than 15 billion gallons? When do you
expect the EPA proposal to be released?
Answer. USDA staff have been and will continue to be in
communication with EPA about rules that impact U.S. farmers and rural
communities. On June 13, the Environmental Protection Agency released
the Proposed Renewable Fuel Standards for 2026 and 2027 including a
proposed 15 billion gallons of conventional renewable fuels.
Question. Once volumes are set, they must not be undermined by
small refinery exemptions. What steps is USDA taking to ensure that EPA
and the White House understand the need for a careful and judicious
approach to any justified small refinery exemptions that ensures that
blending requirements are not reduced?
Answer. USDA staff have been and will continue to be in
communication with EPA about rules that impact U.S. farmers and rural
communities.
climate smart commodities
Question. On April 14, 2025, USDA announced cancellation of the
Partnership for Climate Smart Commodities program. The program had
funded 28 projects that had touch points and conservation enrollment
opportunities for Wisconsin producers as well as sizeable projects
focused on our State's vital dairy community. At the same time the
cancellation notice was provided USDA also announced the new
``Advancing Markets for Producers'' initiative. Could USDA please share
with the Committee:
--A breakdown (including funding allocations) of both terminated
projects as well as projects selected to continue;
--What if any modifications were required for projects selected to
continue;
--Specific details on Advancing Markets for Producers (AMP)
initiative, including but not limited to:
--Eligible applicants.
--AMP objectives and timelines.
--Size, scope and duration of projects sought through AMP.
--Application materials and deadlines.
--Expected Federal funding committed to AMP.
--Application review and grant awarding process.''
Answer. The Partnerships for Climate-Smart Commodities (PCSP)
program was established by the previous administration utilizing funds
under the Commodity Credit Corporation without funding direction or
input from congress. In creating the Advancing Markets for Producers
initiative, USDA will continue to support farmers and encourage
partners to ensure their projects are farmer focused or re-apply to
continue work that is aligned with the priorities of this
Administration.
organic concerns
Question. The Organic Agriculture Research and Extension Initiative
(OREI) and the Organic Transition Program (ORG) run under the National
Institute of Food and Agriculture (NIFA) are the only competitive grant
programs dedicated to organic agriculture research topics. We are
hearing from organic researchers across the country that OREI and ORG's
request for applications (RFA's) have been pulled from the NIFA
website. This is very concerning because under normal timelines, the
review process for both of these programs would be almost done at this
point. For OREI, which is Congressionally authorized and has permanent
and mandatory funding through the Farm Bill, we have also heard that
the Scientific Review Board has been disbanded. No Scientific Review
Board means no awards given out.
Can you confirm if the RFA's for the only two grant programs
dedicated to organic agriculture topics will be released soon? Lastly,
can you confirm if the Scientific Review Board for OREI has truly been
disbanded?
Answer. The RFAs for both programs (OREI and ORG) are currently
being reviewed and will be released in the near future.
Additionally, no scientific peer review panel for any NIFA program
has disbanded. To make the scientific peer review panel more efficient,
NIFA recently transitioned to using a ``panel chair'' selected from the
members of the scientific peer review panel to manage the review
process. This is a change from the previous ``panel managers'' who were
recruited to serve as temporary Federal employees, and this recruitment
slowed down the review process.
Question. Federal funding freezes and Federal employee deferments
have crippled NIFA research projects as well as the in-house research
efforts at ARS. ARS and NIFA research projects require steady
monitoring and evaluation since they often revolve around organic
materials such as animals, crops, soil, and so on. Shuttering
agriculture research before their intended end date can risk spoiling
research results and the tax payer dollars spent to find agricultural
innovations.
What efforts is the USDA taking to protect ongoing research from
being sullied by the deferments and funding freeze?
Answer. USDA continues to work with stakeholders to ensure that
priority research continues by prioritizing their review and release.
Question. The Economic Research Service (ERS) States, ``it is
widely agreed that increased productivity, arising from innovation and
changes in technology, is the main contributor to economic growth in
U.S. agriculture.'' Increased agriculture productivity not only spurs
growth but makes our products more competitive domestically and abroad.
According to ERS, organic agriculture has grown by over 600% in the
last 20 years to become a more than $64 billion industry. However, less
than one percent of the Agriculture Research Service's (ARS) budget and
less than two percent of NIFA's budget goes towards organic farming
research. Meanwhile, ERS shows us having a more than 400% trade deficit
in organics.
If you believe ERS' original statement about productivity deriving
from innovation is true, what ways does the President's budget address
our organic farming research funding problem so our organic producers
can have the best innovation to better compete at home and abroad?
Answer. In addition to the two NIFA grants programs specific to
organic agriculture (OREI and ORG), NIFA will continue to accept
submission of proposals focusing on organic agriculture to other
relevant programs like Agriculture and Food Research Initiative (AFRI).
aphis staffing
Question. Recent reports indicate that USDA, and specifically
APHIS, is experiencing significant staffing changes, including
reductions in force (RIF) and delayed replacement practices (DRP).
These workforce losses raise serious concerns about APHIS's ability to
carry out its core functions, including disease detection and response,
permitting, and safeguarding animal and plant health. Specifically,
USDA does not have the personnel and resources to effectively manage
multiple threats simultaneously with the four active threats to animal
agriculture including the Highly Pathogenic Influenza (ongoing outbreak
in the USA and globally); New World Screwworm (active in Mexico); Foot
and Mouth Disease (active in many parts of the world, including recent
outbreaks in Germany, Hungary, and Slovakia); and African Swine Fever
(active on the island of Hispaniola).
What is the number of APHIS employees lost due to RIF, DRP, or
other budgetary cuts?
Answer. APHIS has not initiated any layoffs in recent months. All
APHIS employees were offered the opportunity to participate in DRP 1.0
and DRP 2.0. To date, 1,386, or approximately 17% of all APHIS
employees participated in the DRP and the program has closed. USDA has
not initiated a reduction in force (RIF).
Question. What part(s) of APHIS did they work for, and what were
their job titles and roles?
Answer. APHIS employees taking the DRP were from all APHIS programs
and support units and represent a wide range of positions.
Question. What are the impacts of employee losses on functionality?
Answer. APHIS has the resources needed to maintain mission critical
activities.
Question. Given the severe understaffing in USDA APHIS's travel
approval office-resulting in delayed approvals, reduced outreach
capacity, missed deadlines, and increased costs- what is the
Department's plan to address this issue, and what is the timeline for
implementation?
Answer. APHIS has the resources needed to maintain mission critical
activities, including mission critical travel.
national milk testing strategy
Question. Many States have agreed to participate but have yet to
begin testing as part of the NMTS.
Will all States be required to actively participate in the NMTS?
Answer. Though States are not required to actively participate in
the NMTS, 45 of the 48 continental States have enrolled in the program.
USDA's goal is to enroll the remaining States by 2026.
Question. How will USDA sustainably fund NMTS to protect food
security, trade, and animal agriculture over the next 2 years?
Answer. USDA will continue to use the CCC funding authorized by
Congress and dedicated to NMTS and reassess any additional needs as
warranted.
highly pathogenic avian influenza
Question. We understand the current CCC funds available to support
HPAI-related activities to be $490 million.
What will happen if the current funds are expended in the next wave
of HPAI outbreaks? Will the Secretary be requesting additional funds?
Answer. I will examine budgetary issues related to HPAI and report
to Congress as appropriate.
local food for schools (lfs) & local food purchase assistance program
Question. The abrupt end to LFS and LFPA, after agreements had been
signed for the second round, devastated farmers like Stacey and Tenzin
Botsford of Red Door Family Farm in Marathon County, Wisconsin. How
will you ensure farmers can trust this Administration and trust that a
signed contract with USDA is honored? Will you re-obligate FY25 funds?
Will you allow States to utilize FY26 funds?
Answer. Over $340 million is still available under existing
agreements for LFPA and LFS, and these programs will continue to be in
effect for the remainder of the period of performance. The period of
performance varies by agreement, but entities with agreements may
request extensions. Upon request, LFPA agreements may be extended
through December 2026 and LFS agreements may be extended through June
2026.
Question. It's imperative that USDA support local food market
channels through programs other than LFS, some of which the Secretary
pointed to during her testimony. How will the agency ensure that these
programs are strengthened, including fully funded and staffed? How will
the agency ensure that they are accessible to small- and medium-sized
operations, as well as beginning farmers?
Answer. I will continue to assess staffing needs to ensure mission
critical activities are carried out and will use the funding provided
by Congress to implement programs across the Department. I will also
continue to work with agencies to understand where opportunities and
challenges are for small and medium-sized operations and beginning
farmers.
______
Questions Submitted by Senator Martin Heinrich
Question. The New World Screwworm (NWS) is a serious threat to
cattle and wildlife in New Mexico and throughout the west.
What do you need from this committee to ensure that we not only
prevent the further spread of NWS but push it back south of the Darien
gap in Panama?
Answer. Sterile insect technology is one key tool of several we
have for fighting New World screwworm. Should the screwworm continue
moving north, having access to many more flies than the existing
production facility in Panama can produce will be important to protect
U.S. agriculture. We are exploring possible options for increasing our
capacity to produce these sterile insects, which could include a
domestic facility here in the United States.
Question. The President's budget decreases USDA's Rural Development
by $721 million, including the complete elimination of Community
Facilities Grants. These grants are in incredibly high demand and have
been critical to improving rural health and public safety. Many of
these grants are also specifically directed by Members of Congress, who
know their districts better than any bureaucrat in Washington DC. Is it
this Administration's position that rural communities don't need or
deserve these funds or that they should just be forced to fend for
themselves?
Answer. The Administration is fully supportive of the Community
Facilities program; the Budget proposes $1.2 billion in Community
Facilities Direct Loans level and $650 million in loan guarantees,
which will provide sufficient investment in rural infrastructure and is
expected to have a measurable impact by fostering competition based on
the program's point system and program design. Reducing Community
Facilities Grants accounts for $18 million of the $721 million in
decreases included for USDA Rural Development as part of the
President's FY26 Budget, and will have little impact. Funds that are
provided for these grants are 100 percent earmarked by Congress. This
has resulted in carryover funding of $569M in unspent funds at the
beginning of FY25, which could be seen as a waste of tax payer dollars.
Question. Some of this country's best wildlife and habitat
conservation work has been done through voluntary partnerships with
private landowners and has relied on NRCS Conservation Technical
Assistance. The Working Lands for Wildlife program and the Migratory
Big Game Initiative have been particularly successful. How do you plan
to support these programs and other critical conservation efforts with
a budget that completely eliminates Conservation Technical Assistance
funding?
Answer. The Budget eliminates discretionary funding for
conservation technical assistance because it has historically received
over a billion dollars in mandatory funding, in addition to funding at
the State and local levels. While funding has helped producers deploy
conservation practices on their lands, many have been forced to
participate in the program in order to comply with State environmental
regulations such as California's Irrigated Lands Regulatory Program,
which regulates agricultural runoff. These cost drivers should be
connected to the resource demands they impose.
Question. Chronic Wasting Disease is an untreatable disease found
in deer, elk, and moose that is always fatal. It has been detected in
34 States, including New Mexico. For years, the Animal and Plant Health
Inspection Service has partnered with state fish and wildlife agencies
to monitor and prevent the spread of Chronic Wasting Disease. Given the
impact of chronic wasting disease, why does your budget request
eliminate resources that would allow the USDA to continue its work to
reduce the impact of this disease?
Answer. Since 2021, APHIS has invested over $41 million for
projects to research, manage, and respond to CWD in conjunction with
State and Tribal partners. USDA will continue to make decisions to
accommodate the most pressing needs of the Department.
Question. There are approximately 321,370 people facing hunger due
to food insecurity in New Mexico, including at least 37,500 seniors.
For these seniors, the Commodity Supplemental Food Program funds local
food banks to access their next meal. You intend to completely
eliminate the $425 million Commodity Supplemental Food Program and
replace it with ``MAHA food boxes.'' How can these boxes be distributed
without utilizing the already well-established food bank networks
across the country?
Answer. All nutrition programs, old or new, should be oriented to
promote healthy choices and healthy outcomes for the families that
receive them. CSFP is a relatively small program, and it is crucial to
focus limited resources on nutrition programs that are universally
available to serve low-income populations, like SNAP. To promote
healthier foods and support American farmers, the Administration
envisions converting a portion of SNAP benefits into MAHA boxes. These
boxes will be filled with commodities sourced from domestic farmers and
distributed to American households. Current CSFP participants will be
eligible for MAHA boxes. I look forward to discussing this legislative
proposal in more detail in the future.
Question. As of March 2025, egg prices have continued to rise to a
whopping cost of $6.23 for a dozen eggs, according to the U.S. Bureau
of Labor Statistics. On February 7th, I asked what your plans were to
combat Highly Pathogenic Avian Influenza and lower egg and poultry
prices. You said you would use every tool at your disposal to eradicate
this disease--including vaccine research at the Agricultural Research
Service. But now, the President is proposing a $159 million cut to the
Agriculture Research Services. How can USDA carry out critical vaccine
research and fulfill its commitments to food affordability and animal
health while slashing funding to one of the very agencies tasked with
delivering on those goals?
Answer. The President's Budget does not reduce any research funding
for animal vaccine development and testing. Instead, it proposes an
increase of $51,221,000 to enhance efforts in protecting U.S.
agriculture and food from invasive pests and diseases, as well as to
develop advanced technologies that will improve animal and plant health
and production.
Specific to HPAI, ARS is currently receiving congressionally
appropriated funding for research in poultry and there are no proposed
funding reductions to these programs in the President's Budget. For
other species (cattle, small ruminants, and swine), ARS received
additional Commodity Credit Corporation funding through an interagency
agreement with APHIS. These additional resources support foundational
research on species-specific animal models and vaccine testing, thereby
enhancing our knowledge and understanding of a disease previously
unknown in these species.
Question. With the ongoing threat of Highly Pathogenic Avian
Influenza, USDA's mission to monitor and mitigate this disease is more
critical than ever and yet, the Administration has sewn chaos
throughout the workforce, pushing more than 2,632 employees from the
Animal and Plant Health Inspection Service and the Agriculture Research
Services. What is your plan for replacing this institutional knowledge
and expertise essential to effectively dealing with and preventing
future avian flu outbreaks?
Answer. APHIS has not pushed employees out or initiated any
layoffs. APHIS and ARS employees were offered the opportunity to
participate in the Deferred Resignation Programs, DRP 1.0 and DRP 2.0.
Some APHIS job series were included in the Department's exemption from
the hiring freeze for public safety mission delivery. ARS has also been
able to use the exemption memo for filling key public safety positions.
I will continue to work to optimize delivery of the Agency's critical
mission to safeguard U.S. agriculture.
Question. On May 6, the Food and Nutrition Service (FNS) issued
guidance to States requiring them to share with the Federal Government
detailed records about more than 42 million past and current
Supplemental Nutrition Assistance Program (SNAP) participants,
including sensitive information such as names, dates of birth,
addresses, Social Security numbers, and the amount of food benefits
received. This information is protected by 7 U.S.C. 2020(e)(8)(A),
which allows States to share information only with ``persons directly
connected with the administration or enforcement'' of the Food and
Nutrition Act, regulations issued pursuant to the Food and Nutrition
Act, Federal assistance programs, or federally-assisted State programs.
The law also limits the subsequent use of the information disclosed to
such individuals ``only for such administration or enforcement.''
Please describe the individuals ``directly connected'' with
administration or enforcement who will have access to these records.
How will FNS ensure this information is disclosed only to the
individuals authorized under 7 U.S.C. 2020(e)(8)(A) and is not
disclosed to unauthorized individuals?
How will FNS ensure this information is used only for the purposes
allowable under 7 U.S.C. 2020(e)(8)(A) and is not used for unallowable
purposes?
How long will FNS store these sensitive records?
What is the total cost associated with implementing this guidance,
including collecting, protecting, storing, and analyzing these records?
What funding will FNS use for this purpose?
Answer. Due to pending litigation, USDA does not have any comment.
______
Questions Submitted by Senator Kirsten Gillibrand
Question. Since 1981, Puerto Rico has been excluded from the
Supplemental Nutrition Assistance Program (SNAP), resulting in the loss
of billions of dollars in aid and reduced nutrition benefits. Yet,
Puerto Ricans pay billions in Federal taxes every year, including $5
billion in 2023. Additionally, in 2022, the Food and Nutrition Service
of the USDA published a feasibility study in which it concluded that
Puerto Rico is ready to transition from the current Nutrition
Assistance Program (NAP) to the Supplemental Nutrition Assistance
Program (SNAP). I have legislation, the Puerto Rico Nutrition
Assistance Fairness Act, which would authorize the transition from NAP
to SNAP for Puerto Rico. Can you commit to working with my office to
provide technical assistance and necessary budget information that
would support development of this legislation and Puerto Rico's ability
to transition?
Answer. USDA is available to provide technical assistance as you
and your office draft legislation.
Question. The Community Eligibility Provision (CEP) for the
National School Lunch Program is widely utilized in New York State as
it reduces administrative burdens and helps to feed all students
breakfast and lunch. In 2023, USDA changed the minimum Identified
Student Percentage, or ISP, from 40 percent to 25 percent. This change
has helped many schools and students in New York and throughout the
country. Can you commit to maintaining the ISP at 25 percent, or if you
are planning to change the ISP, what level do you believe it should be?
Answer. States have a significant role in administering the
National School Lunch Program (NSLP) and are granted various
flexibilities to tailor its implementation to local needs and
circumstances. As I mentioned at my confirmation hearing, children are
suffering from diet-related chronic disease at unheard of rates. School
lunch is an important part of that conversation, because we should all
want it to be the best meal eaten, not just the best meal served. Like
the rest of the Administration, USDA is conducting a comprehensive
review of all rules from the previous administration to ensure they
follow the law, align with current Administration priorities, and find
opportunities to provide regulatory relief.
Question. During your confirmation hearing, you testified that
USDA's Special Supplemental Nutrition Program for Women, Infants, and
Children (WIC) is an important part of the safety net, and that you
hoped to learn more about the program in the weeks and days to come.
The President's Budget Request for Fiscal Year 2026 discussed at the
May 6 Agriculture subcommittee hearing is void of any mention of WIC.
Accordingly, can you give this subcommittee your support for fully
funding WIC in Fiscal Year 2026 so that no eligible mother or child
will be turned away from receiving nutritional support and having their
basic needs met?
Answer. The President's Budget would support all eligible women,
infants, and children who seek WIC benefits in 2026, and adjusts the
vegetables and fruits benefit allowing more women, infants, and
children access to the program and driving them towards better health
outcomes.
Question. More than 15,000 USDA staff have accepted the
administration's offer of deferred resignation, and we are expecting
Reductions in Force (RIFs) to eliminate more staff. The Plum Island
Animal Disease Center, a mile off the North Fork of Long Island in New
York, is transitioning its research mission to the National Bio and
Agro-Defense Facility (NBAF) in Manhattan, Kansas. Right now, the
Department of Homeland Security has an ongoing closure program that
also relies on NBAF coming online and mission transfer to occur. Will
the resignations and reductions-in-force affect this timeline, and can
you provide an update on the status, timeline, and next steps of
mission transfer from Plum Island to NBAF?
Answer. There have not been any reductions in force at USDA. The
standup of NBAF continues to be a priority, and voluntary resignations
at USDA will not negatively impact the mission transfer timeline.
Question. The President's Budget Request proposes to reduce funding
for formula grants. This formula funding in the form of capacity
grants, such as Smith-Lever capacity grants, goes to every single state
and their land-grant university and cooperative extension. Capacity
grants give each State flexibility to work on their State's
agricultural and rural priorities. How do you propose to maintain youth
and K-12 programs when a significant portion of that funding comes from
formula grants?
Answer. The President's Budget reduces funding for formula grants
because they generally do not achieve the same results as competitive
programs. The President's Budget protects funding to youth and K-12
programs such as 4-H clubs, Tribal colleges, and universities.
Additionally, NIFA will continue to accept submissions of education-
related proposals for competitive funding opportunities.
SUBCOMMITTEE RECESS
Senator Hoeven. With that, we are adjourned.
[Whereupon, at 12:14 p.m., Tuesday, May 6, the subcommittee
was recessed, to reconvene subject to the call of the Chair.]
AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2026
----------
THURSDAY, MAY 22, 2025
U.S. Senate
Subcommittee of the Committee on Appropriations
Washington, DC.
The subcommittee met at 10:40 a.m. in Room 124, Dirksen
Senate Office Building, Hon. John Hoeven (chairman) presiding.
Present: Senators Hoeven, Collins, Hyde-Smith, Shaheen,
Murray, Peters, and Ossoff.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
STATEMENT OF HON. DR. MARTIN A. MAKARY, M.D., M.P.H.,
COMMISSIONER
OPENING STATEMENT OF SENATOR JOHN HOEVEN
Senator Hoeven. Good morning. We'll call this hearing to
order. Dr. Makary, thanks for being here. We appreciate it very
much.
Dr. Makary. Thank you.
Senator Hoeven. I know it's a busy day for you, and so
appreciate you being here. And, of course, Ranking Member
Shaheen. Thank you. Look forward to working with you on this
Approap' Subcommittee. You and I have worked before on Approap'
Subcommittee, and so I'm pleased now we're--I have that
opportunity here with Ag.
Agriculture is incredibly important. My state, and I know
the ranking member's state, well, our great farmers and
ranchers do every single day affects every American every
single day with the highest quality, lowest cost food supply in
the world. And of all the developed countries, Americans spend
less their budget on food, and they have better choice and
better quality than any other country in the world. And we
can't take that for granted. And so, you'll, you'll find that
we're pretty strong advocates for our farmers and ranchers.
Dr. Makary. Great.
Senator Hoeven. We understand that your job at FDA is to
keep people safe whether it's primarily the drugs they eat, but
many food products obviously as well. I've appreciated the
conversations that we've had. And I must say, as I've told you
in our conversations, I think you've got an incredible record
in healthcare.
I certainly believe that John Hopkins is one of the finest
hospitals, medical centers in the country. I have direct
personal experience where I've taken family members to John
Hopkins, and I've been impressed not only with the quality of
healthcare, but with the culture of the people there and the
caring. And then not only your tenure there, but all that
you've accomplished is remarkable. And so, we appreciate your
willing to take on this public service, this incredibly,
incredibly important job.
In it, you're going to have to, of course, primarily make
sure that our food and drugs are safe, that the organization is
working as absolutely well as it can, which is why I appreciate
your background, not only in medicine, but in business.
Obviously, we're all trying to find savings across government
to address the debt and the deficit. I know you've been charged
with that task as well, but paramount, your job is safety. I
understand, of course, they'll be releasing the Make America
Healthy Again (MAHA) report today. You're looking at new ways
to do things. That's important. We need to do those kinds of
things.
At the same time, there are practical realities, which you
and I have talked about, that our farmers and ranchers face
every day producing that highest quality, low cost food supply
that I just referenced, that benefits every Americans every
single day.
So, whether it's the fertilizers, the pesticides, the
equipment, all the things that go into them producing that food
supply, they have to face the practical realities of operating
in a market that every day they don't control. They don't
control the weather, they don't control the prices, they don't
control trade agreements, and on and on it goes.
And when you look across our economy, so many industries
are a few big companies. A few big companies that run the whole
thing. I personally am not a fan of that. But when you look at
agriculture, 16 million people directly or indirectly involved
in agriculture, small family farms and businesses across this
country that have become quite sophisticated with precision Ag
and everything else. And we do it better than anybody in the
world and have higher standards. But that is what we have. And
I firmly believe that that's what Americans want to make sure
we have for long into the future.
So, I spent a little time on that in this opening
statement, because we have to be aware, you have to be aware of
how that works. And as we make changes, again, making sure we
do all we can for a healthy America, that we understand those
realities and the challenges that those people have, and that
we can't just take it for granted, and that we have to
understand and make sure that all of this works for everybody
on both sides of the equation.
So, with that, I'll turn to our Ranking Member, and I'm
going to have to ask to excuse myself to vote. I may miss some
of your opening statement, but I'll see if I can't get anything
that I miss via the written remarks, and then be back. Ranking
Member.
STATEMENT OF SENATOR JEANNE SHAHEEN
Senator Shaheen. Well, thanks very much, Chair Hoeven. And
let me just welcome, as you did, Commissioner Makary. Very nice
to have you here this morning. And I would echo the chair's
commitment to agriculture, and how important it is our farmers
are to our food supply and to the economy of this country.
It's a very different enterprise in New Hampshire with our
farms, because they are small family farms, but very important
to the state nevertheless. But of course, this morning, we're
here to talk about the role of the Food and Drug
Administration. Federal investment and stability in biomedical
innovation are vital not just for our competitiveness and
national security, but also for local economies, in New
Hampshire and across the country.
Right now, we have the earliest access to new cures and
treatments, and we attract the best talent from across the
globe because of the good paying jobs that are in emerging
research. Those jobs fuel our small towns and cities, including
in New Hampshire, where we have a growing industry in
biomedical companies.
It's very exciting to see the growth that's occurring in
our state. As we speak, they're developing cutting-edge cell
and gene therapies to cure terrible diseases like diabetes and
cancer. And I think when we met, we talked about some of the
work that's being done in New Hampshire, particularly at the
Advanced Regenerative Manufacturing Institute (ARMI).
But of course, to keep pioneering breakthroughs in curative
treatments, they need stability and predictability, something
this administration, sadly, has failed to provide so far. It's
more than just a lack of stability. I fear the very mission of
the FDA is at risk because of the actions of this
administration. More than 4,000 people have been pushed out of
FDA since January. The majority of those targeted by
probationary terminations and reductions in force that don't
seem to have any real analysis of who's important to keep and
who is not critical to the mission.
To date, this committee has not received key information on
where specifically these workforce cuts are happening across
centers and offices at the FDA, and that's information that we
need as we're going to write this budget. What I want to
emphasize is that it didn't really have to be that way. I think
there is bipartisan support to see how we make our government
agencies and departments more effective and efficient. But to
do that, we need to have a process that people understand or
are engaged in. And I fear that the process that's been done so
far is going to prove to be very wasteful to patients and
families in New Hampshire and across the country.
Scientists at the FDA have been fired along with support
staff who make their work possible, from those who assist with
product reviewers to those who quite literally keep the lights
on. Patients across this country are depending on the FDA, as
you know, to review medical products to ensure that new and
novel treatments are approved. And yet, reports now suggest
that medical product reviews have slowed, that essential
meetings have been postponed or canceled, and that deadlines
for user fee agreements have been missed.
And as Congress has provided the FDA with new authorities
and directives from the Tobacco Control Act, to the Food Safety
Modernization Act, to the Modernizing of Cosmetics Regulation
Act, the FDA has hired talented people who have gotten the work
done to keep the American people safe.
Going backwards, I think, is unacceptable. I'm seriously
concerned that the workforce cuts across the agency will harm
the progress that this committee has supported on a bipartisan
basis to ensure a strong FDA that supports innovative
treatments and gives families peace of mind that the drugs we
take, the food we eat, and the cosmetics we use are safe.
Now, moving on to the fiscal year 2026 budget, which is the
topic of this hearing. I wish we'd received and had a chance to
review the full President's budget request prior to this
hearing, though I would point out that that's not unique to
FDA. We haven't gotten the details of the budget in any other
Appropriations hearings that I've been part of. The FDA was not
mentioned in the preliminary budget materials we received three
weeks ago. So, we are sitting here today talking about a budget
that this committee has not received.
I'm disappointed to see the vast and drastic proposed cuts
to the Department of Health and Human Services, and my priority
is that the FDA has the resources that you need to carry out
the core missions of the agency. But without a budget, it's
hard for us to assume that the President's proposal will meet
those goals.
Now, in closing, the FDA at its core has an incredibly
hopeful mission. The agency has the power to bring hope and
comfort to millions of people by approving groundbreaking cures
and treatments developed here in America by the best scientific
minds in the world. So, I think, we, on this committee, stand
ready to be partners in this effort.
And I with that, Commissioner Makary, I appreciate your
being here today, again, and I look forward to hearing your
statement, and to the discussion that we will have with members
of the committee about your budget proposals. Thank you.
SUMMARY STATEMENT OF HON. DR. MARTIN A. MAKARY
Dr. Makary. Thank you, Chair Hoeven, and thank you Ranking
Member Shaheen, and members of the subcommittee. Thank you for
having me here to testify on the FDA budget for 2026.
The Trump Administration is proposing a $6.8 billion budget
for the FDA, including $3.2 billion in budget authority and 3.6
billion in user fees for fiscal year 2026. This allows us to
take the necessary steps to support the Make America Healthy
Again agenda, as we have already been busy implementing.
Now, I've been at the FDA for about seven weeks, and I'm
proud of the early progress we've made working to remove all
nine petroleum-based food diets from the U.S. food supply,
eliminating unnecessary animal testing requirements for drugs.
We approved a new blood test for Alzheimer's, which could help
enable more early treatment. For the pharmaceutical
manufacturing facilities overseas that the FDA inspects, there
has been a routine of using scheduled inspections, which in my
opinion, are no inspections at all. They're a joke, and we are
moving towards surprise inspections.
We don't allow FDA inspectors anymore to accept limo rides
from the pharmaceutical manufacturing companies that they are
there to inspect. I'm amazed at some of the stuff that I'm
learning when I look under the hood. We've begun taking action
against new challenges such as gas station heroin, and
childhood vaping with illegal Chinese vaping products.
Our borders have been far too porous. Working with the
Trump Administration's reenergized Customs and Border
Protection, we're not wasting any time. Today, we are
announcing the seizure of nearly 2 million illegal vaping
products from China. Last week, we announced plans to withdraw
from the market, chewable, ingestible fluoride tablets,
currently prescribed to six-month-old babies.
And this week we published in the New England Journal of
Medicine, our framework for Covid vaccine booster regulation,
so that developers and companies can see what we're thinking
and have predictability. And we are planning to bring back gold
standard science and common sense.
We also have to modernize. On Day 1 of me being on the job,
I actively began an effort to organize to use AI for our
scientific reviewers to make their jobs easier. Well, two weeks
ago, we just announced our first AI-assisted review with the
latest generation AI technology. One reviewer said that what
normally took him two to three days, the AI did in six minutes.
I've set an aggressive goal of June 30th to have AI-
assisted scientific reviews help our reviewers agency-wide, and
we're going to be ahead of schedule and under budget on meeting
that aggressive goal. The goal is to reduce the paperwork
burden of reviewers, which is tremendous, so that we can
deliver more cures and meaningful treatments to the American
people faster.
That's been the first seven weeks of my job at the FDA.
Here are other important goals I have for the FDA, and we're
already hard at work on them. Healthier food for children, a
universal flu shot, meaningful treatments for ALS, Parkinson's
and other neurodegenerative disorders, treatments for rare
diseases, cancer therapies that are so powerful a tumor is
eliminated without the need for surgery or chemo. That's not a
theoretical, that something we've already seen.
And one of my highest priorities is to ensure that we are
not wasting any time in evaluating novel treatments for PTSD.
Many of our brave veterans served in unnecessary wars, and we
owe it to them. I've not yet hit the two-month mark, so I'm
doing a lot of listening. I appreciate all of your input, but
one question we must ask is why does it take over 10 years for
a new drug to come to market?
My team and I are working very actively to examine the
approval process in all of its details so we can try to figure
out how to deliver more cures, and meaningful treatments, and
devices faster and in a more user-friendly way for developers
without cutting any corners on the scientific review and
independence.
We're also committed to President Trump's promise to lower
drug prices at the FDA. We can help by bringing more low-cost
generics and biosimilars to market among many other strategies
we're exploring.
In conclusion, the FDA is filled with an enormously
talented and committed group of employees representing, in my
opinion, one of the greatest brands in the world. It's my duty
to make sure that everybody central to the core mission has all
the resources they need to do their job well.
So, I look forward to answering your questions. Thank you.
[The statement follows:]
Prepared Statement of Hon. Dr. Martin A. Makary, M.D.
Chairman Hoeven, Ranking Member Shaheen, and Members of the
subcommittee, thank you for the opportunity to appear before you today
to discuss the President's Fiscal Year 2026 Budget request for the Food
and Drug Administration (FDA or the Agency). I would like to start by
thanking the subcommittee for your continued support of FDA. The Agency
greatly appreciates the Committee's sustained commitment to our mission
and providing vital resources which have been critical for FDA's
protection of the public health, and we look forward to continuing to
work with you to further address critical issues impacting the health
and wellbeing of Americans.
Looking ahead to FY 2026, we will embrace President Trump and
Secretary Robert F. Kennedy's Make America Healthy Again (MAHA) agenda
by restoring trust in our food system, prioritizing public health, and
strengthening national nutrition and food safety. America is facing an
unprecedented chronic disease crisis, with heart disease, diabetes, and
obesity affecting millions of lives. Meanwhile, food safety failures,
contamination events, and formula shortages have exposed systemic
weaknesses in our food and nutrition infrastructure. The FY 2026 budget
directly supports the MAHA agenda by ensuring safety of the United
States food supply, investing in nutrition, preventing food safety
failures and infant formula contamination and shortages, and ensuring
appropriations needed to meet certain spending triggers for user fee
programs.
In my first 6 weeks or so at FDA, I have worked to make sure the
reviewers and inspectors have what they need to help protect the public
health of the American people. FDA will not go through a significant
reorganization, we will be centralizing and streamlining shared
functions that were previously duplicated throughout the centers and
offices, such as IT, communications, and operations. In addition, we
are exploring and moving to quickly implement where AI and novel
technology can help reduce workload as a tool for the expert scientists
and inspectors at the FDA. The initial response from the review staff
has been very positive, and I look forward to building on this
experience and expanding it throughout the centers at FDA.
The funding requested in the President's FY 2026 Budget includes
critical elements to safeguard public health and the food supply for
the American people. Our FY 2026 budget requests $6.8 billion,
including $3.2 billion in budget authority and $3.6 billion in user
fees. This includes an 11.5% reduction in budget authority compared to
the current fiscal year, improving efficiency while still increasing
investments in areas that are critical for the American people.
make america healthy again
FDA serves a critical role in supporting the Administration's
extensive efforts to protect the food supply, protect against chronic
disease, remove any dangerous chemicals and additives from foods, and
address any shortages of critical foods such as infant formula.
FDA is committed to radical transparency to give Americans the
latest information about the food ingredients they are eating and their
effects--in alignment with both MAHA and FDA's mission. The Agency is
leading efforts to protect the U.S. food supply to combat the growing
risks associated with some chemical additives used in food, expand
Closer to Zero efforts to reduce toxic elements, such as arsenic, from
foods consumed by infants and young children, reduce sodium and added
sugars, and provide new forms of nutrition labeling to better inform
consumers about the foods they consume.
FDA will also expand a new pilot grant program to help schools
transition to safer and healthier foods, as well as address failures in
inspecting high-risk facilities, strengthen import oversight, reduce
foodborne disease outbreak response times, and decrease the number of
associated illnesses. This includes supporting advancements in
technology to rapidly identify and combat food borne pathogens, such as
Salmonella, E. coli, and Listeria. FDA will also continue its
commitment to supporting the safety, nutritional quality, and
availability of infant formula; maintaining and expanding laboratory
capabilities; and supporting cooperative agreements, grants, and
contracts in support of federal-state initiatives. FDA and its
regulatory partners have a shared mission to ensure the food Americans
eat is safe. This mission can only be achieved by fully leveraging
resources, expertise, and capabilities as part of an integrated food
safety system.
continuity of user fee funding for medical devices
FDA's user fee agreements are negotiated with regulated industry
and implemented when Congress authorizes the user fees. Under the
Medical Device User Fee Amendments (MDUFA), for FDA to collect and use
the medical product user fees, a certain amount of non-user fee
appropriations must be appropriated by Congress and spent by FDA on the
application review process (known as the ``non-user fee spending
trigger''). The FY 2026 President's Budget intends to meet non-user fee
spending triggers, including an $8.2 million increase for FDA's medical
device program non-user fee spending trigger and to meet the goals and
commitments under MDUFA V.
conclusion
FDA believes the funding in the FY 2026 President's Budget will
enable the Agency to operate more efficiently, while addressing
critical public health and safety priorities, in particular restoring
trust in our food system and prioritizing public health. FDA looks
forward to working with the subcommittee to address these critical
issues and improve the health and wellbeing of Americans. Once again, I
thank the subcommittee for your continued support, and I look forward
to our continued collaboration. I am happy to answer your questions.
Senator Shaheen [presiding]. Thank you very much, Dr.
Makary. We're honored to have the chair of the Appropriations
Committee, Senator Collins, with us. And Senator Collins,
Senator Hoeven went to vote, so he turned the gavel over to me.
So, I will turn it over to you.
Senator Collins. Thank you very much, Temporary Chair.
[Laughter.]
Senator Collins. But it's been an honor to work with you on
so many issues that we care about in this space, including Type
1 diabetes in particular. Doctor, I appreciated hearing your
comments this morning. Americans have relied on the FDA for
more than a century to ensure that their medicines are both
safe and effective. Recognizing that America biotech leads the
world in innovation, we in Congress have taken a number of
actions to ensure that FDA's rigorous regulatory review keeps
pace with the speed of science and solves problems in areas
where we don't have cures, or effective treatments, or a means
of prevention.
Recent staffing changes at the FDA appear to have affected
the balance between innovation and regulatory review. From what
I'm hearing, I'm particularly concerned about the downstream
impact of delays on patients suffering from debilitating rare
diseases like ataxia and birth syndrome, as well as more common
terrible diseases like ALS, which you mentioned Alzheimer's and
other neurodegenerative diseases.
As I mentioned, Senator Shaheen and I'm sorry, I am out of
it today, apparently.
Senator Shaheen. It was a late night and early morning.
Senator Collins. We have worked together on Type 1 diabetes
for many years. We're encouraged by what's going on in STEM
therapy and immunotherapy in that area. And today, you,
yourself, talked about the need for more efficient regulatory
pathways and innovative treatments for rare life-threatening
diseases, particularly when there are no major safety issues
and existing treatments, or either don't exist, or they're
limited.
So, what I'm hearing is there's a real slow down in FDA,
and that's not what you were committing to today, but that's
what I'm hearing. The reality is, there are a number of rare
disease new drug applications that have been pending at FDA for
some time.
What specifically is FDA doing under your leadership to
accelerate getting new treatments for rare diseases to patients
safely and as soon as possible, particularly since we have
developed these accelerated pathways, particularly for those
patients, for which there are no treatment options now.
Dr. Makary. Good to see you, Senator Collins. I share in
your interest in this topic because I have cared for people
with rare diseases and rare cancers, and it is the worst
feeling in the world to have to break bad news. And when people
say, is there anything out there to be--to not have anything to
respond with is a very difficult position.
So, we need to customize the regulatory process to the
condition being treated. And so, if it is a rare condition, we
have to drop our randomized control trial requirements in some
instances. I will say, however, that the trains are running on
time at the FDA. There have been no staffing changes that have
changed any approval schedules. We are on track to meet all of
our Prescription Drug User Fee Act (PDUFA) targets.
There are on occasion, every year, essentially every year,
a couple drugs that are very complex, where the career
scientists ask for more time, either to convene an advisory
committee to weigh in or to design a very unique specific
randomized trial.
So, in reference to one of the products that you had
mentioned, I had gotten briefed and was assured that there was
no delays related to staffing. These were additional time
because of the complexity of the early data. And the staff
truly believe career scientists truly believed they needed a
few more weeks. And I thought, we're on track to meet our PDUFA
targets. They believe we're completely on track to meet our
PDUFA targets if they took a few more weeks. And I thought that
was reasonable.
The trains are running on time. The food inspectors are
doing their job. We have 12 food labs. There's no backlog at
the food labs. The cuts that you referenced and Senator Shaheen
referenced were to things like this 2,600: This is at the FDA
2,600 HR staff, Contract staff, and budget staff. Now, I think
that's too much. And we, they, they were part of the reduction
in force. In total, about 1,800, almost 1,900 people were
involved in the reduction in force. And I think a lot of that
is consolidation.
Just to be clear; there were no reductions in scientific
reviewers as a part of the reduction in force, and we're
actually hiring scientists because there's normally turnover
with our scientific staff. And I hope the AI and the other
tools will help make their jobs more efficient.
Senator Collins. Well, I am hearing something entirely
different. So, I will convey directly to you the concerns that
I'm hearing since Dr. Peter Marks was removed from his
position. And it is disheartening for patients with serious
diseases, as you know very, very well from your clinical
practice for which I know you are a dedicated physician, but it
is disheartening when it appears that a new treatment or drug
is on the horizon and then FDA says, no, we need three more
months. We need three more months. We need three more months
over and over again, despite the years that have gone into
developing a particular treatment for an illness that has no
treatment.
And, again, that's why we work so hard to establish these
accelerated pathways. So, I'll be in further touch with you. I
don't disagree with the need to look at the staffing of FDA and
to make sure that as much of it as possible is going into the
process that speeds food inspection, new drugs to the American
people, sensible regulation and guidance on diet, lifestyle
factors. All of that is extremely important. So, it's not that
I object to looking at that, but I don't want it to come at the
expense of drugs that are desperately needed. Thank you.
Dr. Makary. Thank you, Senator. I will just say that the
person, the scientist replacing Peter Marks is outstanding. And
I would say, take a close look at his credentials. He has
published over 540 peer-reviewed scientific articles. He's a
professor from UCSF, trained at the National Cancer Institute.
He's a scientific genius.
So, I've rejected the idea that there's only one scientist
in the world that can run Center for Biologics Evaluation and
Research [CBER] well, and I think we need fresh new ideas. The
new scientist replaced Peter Marks, 42-year-old. He brings a
fresh new perspective, and it will not change our approach to
rare diseases, or the predictability that people need in the
market and development investment space to know that they need
to continue to invest in those technologies.
Senator Collins. I look forward to meeting him. Thank you.
Dr. Makary. Thank you.
Senator Hoeven [presiding]. Thank you, Madam Chair.
Appreciate you being here. Doctor, you came into roughly a
19,000-person agency. Your budget top line is about 3 percent
less. But there's been estimates as high as potentially 4,000
reduction in force, voluntary or actual rifs.
Where are you on that, and how's it going? You and I've
again talked about this before. I was--you know, at that time,
you know, we talked about how once you got in there and had
more time, you were going to obviously have a better analysis
of what your needs are and where you're at with the personnel
situation. So, go through that for us, will you?
Dr. Makary. Sure. So, there have been about nearly 1,900
people involved in the reduction in force. Roughly, another
1,200-plus involved in the early retirement package. We are
hiring scientists to replace scientists that may have left for
an early retirement, but no scientific reviewer or inspector
was cut as a part of the reduction in force.
Now, any discussion of the reduction in force, I believe,
deserves one important fact of context which is always omitted
in the media coverage. And that is in 2007, the FDA had not a
little over 9,000 employees, and a few months ago was 19,000.
So, there was a 100 percent increase in the number of employees
at the FDA over the last 15, 16 years. And that is how we get
2,600 HR people, contracts and budget people, at the agency.
380 communications positions, we're now down to about 160.
They're doing a good job, 160 people. That covers a lot of
the communication work. Did we need 125 travel coordinators and
travel offices in each center, or 13 strategy offices at the
FDA? A lot of this reorganization is smart, and it's being
smart with taxpayer dollars because I personally believe when
this institution here, U.S. Congress is spending $2 trillion
more than we have as a country, it is driving inflation, which
is a backhanded tax on the poor.
And that is the harsh reality. It doesn't affect people of
wealth like myself. It affects the 50 percent of Americans that
have less than $500 of cash on hand. And they are forgotten
when we spend too much money and we drive inflation. And that's
why I support many of these reductions in force, where it makes
sense.
Senator Hoeven. Okay. But you also get fee agreements from,
you know, drug companies that want to get new drugs to the
market. And so, you have to be able to staff that so that you
bring in that fee revenue, which of course is not a cost to the
taxpayer. So, I agree with you. Yeah, we need to find better
ways to do things. We need to find savings, and that's good.
But talk to us how you're making sure that you manage things. I
mean, again, paramount to your mission of safety, as we talked
about on the front end. I know you understand that. You're a
doctor, took the Hippocratic Oath.
But those fee agreements make it more complicated, but they
bring in revenue. Talk about that, as well as making sure we
get these new drugs to the market as safely and efficiently as
possible, because that ultimately saves lives.
Dr. Makary. Yes, Senator. So, thank you for that question.
And, again, I want to reassure the public to see through the
headlines, and to know that the trains are running on time at
the FDA, and we're on track to meet all of our user fee targets
as an agency. And we need the staff to help with the user fee
management. And that's why I've made sure that we have the
appropriate staff to make sure that we can report on our user
fees and sort of service conductors in managing the user fee
targets.
Now, look, I'm a surgeon, and so the reductions in force
are never perfect. So, I've done everything humanly possible
since I've gotten there to try to make sure we heal and
reorganize appropriately. We have brought back some people, and
my job is to make sure that the scientists, and inspectors,
that the law enforcement officials at FDA have all the
resources they need to do their job well.
Senator Hoeven. Okay. I think I'm going to give you a short
question to save my long. Well, now I'm going to go with the
longer one. I'm going to probably run over my time a little
bit, ranking member, so I'll beg your indulgence and certainly
return the favor. The MAHA Commissions coming out with their
report, I think pretty much right after this hearing.
Dr. Makary. Yeah, noon.
Senator Hoeven. Yeah. So, if you want to kind of give us
all the details right now, that's great, and just get a jump on
things.
[Laughter.]
Senator Hoeven. But guessing that you might not, you do
need to talk to us about it in that, as I laid out my opening
statement, this committee has jurisdiction both in regard to
all of your funding at FDA, but also USDA for our farmers and
ranchers. And we have to address both.
So, I know you're coming out, you know, the Department of
Health and Human Services (HHS) writ large, is coming out with
this MAHA study plan today. But as I said in my opening, we're
very concerned not only how that's going to affect the American
consumers, but also how that's going to affect agriculture. And
as you know, agriculture goes--I mean, they're regulated like
everybody else. In fact, in my opinion, they're overregulated
like everybody else.
And so, you know, with this report coming out, I get y'all
are going to be working very hard to make sure it's
scientifically-based and all that. But a lot of what our
farmers and ranchers in producing that food supply have had to
do, that's all scientifically-based, too, heavily regulated.
And there's been years, and years, and years of that analysis
and regulation done, and a heck of a lot of expertise.
So, how do you approach that in this plan of action, and
the analysis that you're doing, and so forth, and the studies
you're doing to make sure that that's adequately included in
terms of your evaluation, and the results and the
recommendations that you make?
Dr. Makary. Well, Senator, you shouldn't be concerned about
the MAHA report. It is simply information. And it's important
information about health written by people who have excellent
citations, and are representing the many scientists that have
been waving a flag in the air for many years saying, ``Hey,
look at root causes.''
We have the sickest, most disabled, most medicated, most
obese population in the history of the world. Half our nation's
kids are sick. And why are they sick? Because when the immune
system, or some inflammatory response is reacting to the many
different chemicals that go down their GI tract, the immune--
they feel, blah, they don't feel well. And so, we have got to
look at root causes.
Now, there's no single chemical in the food supply that is
accounting for a root cause for the driving our chronic disease
epidemic, but I think everything has to be on the table. We,
for example, at the FDA, just convened, two days ago, a round
table on talc. Now, talc has been identified as a cancer-
causing agent. It's been removed from baby powder.
There have been 30 studies saying that talc may cause
ovarian cancer in women with a high odds ratio in statistical
significance. International cancer bodies have warned about the
cancer-causing effect and the mechanism of talc. And so, it's
been removed from baby powder. But do you know kids are eating
talc every day? It's in candy. You take chewing gum and the
white powder on there, people think it's sugar. Sometimes, it's
talc. Talc is in our food supply. Kids are eating talc.
And it's not just in food, it's in medicines. The number 1,
3, 9 and 10 most common medications in the United States have
talc on it. Why? Because it's a lubricant. It's just the way
we've been doing business. It's a lubricant in the machines
when it's mass produced. Well, there's a low-cost alternative
that is generally considered to be safe.
This is the--we're not fighting anybody here. We're trying
to bring the latest scientific information to inform good
decisions. And I think you're going to be pleased with the MAHA
Commission report. It puts at the forefront of our discussions
of health many issues that sciences have been talking about for
years.
Never in my oncology meetings do we talk about the root
causes of cancer. Cancer's going up in kids, young people under
age 50. It's everyone's scratching their heads. You get a
diagnosis, they come to Johns Hopkins, we would look at them
and parents would say, ``What could possibly cause this?''
Well, guess what? We don't talk about any of this in our
national conferences. That is what the MAHA Commission report's
going to talk about.
What have we been talking about? Insulin, chemotherapy,
CAR-T therapy, radiation, sophisticated operations. We have got
to talk about food and chemicals, not just chemo and insulin.
And so, this MAHA Commission is going to put front and center
as a setting our research priorities, setting a national
conversation, setting our own internal goals so that we're
going to deliver in another 100 days from today some of what
we're going to do.
The MAHA Commission report is a diagnosis. And I think we
have to do something differently. We have a healthcare system
that's breaking the budget, that's resulting in inflation,
that's burdening businesses. That's the number one cause of
household bankruptcy in the United States; is medical bills.
And no one is talking about the root cause. And that is the
health of the population that is actively deteriorating right
in front of our eyes.
And so, we've got to move from a reactionary healthcare
system where we're playing whack-a-mole with all these
treatments in the hospital and late stages, and be proactive
and actually talk about the root causes, and why we don't see
some of these problems in other countries. I think this report
is going to be the cornerstone of a broader discussion, and
there's no one single ingredient that's going to be vilified.
Senator Hoeven. So, after the report comes out, after we do
some work on your budget, we're going to want you to come back
and talk to us. Are you going to be willing to do that?
Dr. Makary. Of course. I'd love to talk.
Senator Hoeven. Good. Thank you very much. Ranking Member
Shaheen.
Senator Shaheen. Well, thank you, Chair Hoeven. And I
certainly agree with you that we ought to focus on the root
causes of what's causing diseases. And I've been trying for
years to get to change the sugar subsidy system that we have
that encourages sugar to be added to our food supply in so many
ways. But so far there hasn't been the political will to do
that.
So, one of the things that I would urge you to do, Chair
Hoeven suggested that we would like to have you come back and
talk about this. I hope that there will be more of an effort to
engage Congress in the changes that you're talking about making
than there was in the cuts that were made.
Because again, I think there's a lot of appetite to try and
look at how we do things better. But boy, there's not an
appetite to have one person and a DOGE Commission go around and
make all these decisions without engaging Congress, because so
much of that has not only been not well received, it's been
outright illegal.
That's not your problem. But I hope as you think about
looking at the changes that we need to make to get at root
causes, that you will come back and engage with us on what
you're proposing because there's a lot of expertise on this
committee, and I'm sure a lot of ideas for what we ought do
better, too.
But I want to go back to diabetes, one of the most
expensive chronic illnesses we have. It's one that you and I
talked about. Senator Collins and I have done a lot of work as
co-chairs of the Diabetes Caucus on this. As I explained to
you, for me, it's not just a policy issue, it's a personal
issue. I have a granddaughter with Type 1, so I know the
struggles that the community has had, and many of those with
the FDA before you got here.
But they have been real. And one of the issues right now
that I'm hearing from the diabetes community is about C-
peptide, which is a marker of the body's own insulin
production. It's emerging as a potentially more accurate tool
for measuring how well a person cells are functioning. However,
the FDA does not currently recognize C-peptide as a validated
surrogate endpoint. Meaning, that the community has to use
other endpoints that are less--many people believe less
accurate. So, will you commit to reviewing C-peptide as a
validated surrogate endpoint?
Dr. Makary. I'm happy to, Senator. I love C-peptide. I'm a
pancreatic specialist. And so, I don't understand why it would
not be recognized. It is a naturally occurring hormone that is
an indicator of the physiologic health of the pancreas. So,
I'll take a look at that for you. Happy to.
Senator Shaheen. Good, thank you. I hope we can stay in
touch on that. In the last couple of days, there have been a
lot of news reports about the COVID-19 vaccine. I would think
that one of the real accomplishments of the first Trump
Administration was the development of the COVID-19 vaccine. I
would think people would be very proud of that effort.
And so, I was surprised to hear about the FDA's
announcement earlier this week that would limit access to
COVID-19 boosters. And it seems like the announcement would
take away people's ability to make that choice on their own by
limiting it to only people 65 or at high risk.
So, can you help us understand why that decision was made,
and why people who may think that that booster would be helpful
to them will no longer be available?
Dr. Makary. Happy to. It's been four to 5 years since we've
had a randomized controlled trial. And so, we don't know the
right number of boosters that a healthy American should take.
What is that number? Is it two, like the MMR vaccine? Is it two
or three, like HPV or hepatitis B? Or is it 80? Do we believe
in giving 80 mRNA shots to a healthy girl born today in her
average lifespan of 80 years? Is that the right answer?
That has been a theory that the repeat booster strategy in
healthy individuals is the correct evidence-based strategy, but
there's been no data to support it. So, we are doing our job to
say that if we are going to approve a Covid vaccine for
younger, healthy Americans, we'd like to see some clinical
trial data, given that it's a much different population from 5
years ago.
There's broad ubiquitous population-based immunity, and
there's also a different virus circulating. And this is a new
vaccine formulation that creates a new protein in the body.
Should we blindly rubber stamp a vaccine that creates a new
protein in the body every year for the rest of our lives, for
the next 100 years? I don't think so.
And so, that's why we published in the New England Journal
of Medicine this week, a framework for sensible Covid vaccine
booster regulation in the United States that uses an age-
stratified approach. And really, honestly, we are catching up
with the rest of the world. Some of the rest of the world has
been laughing at us using this blind strategy.
We're now switching to a scientific strategy. The UK only
recommends Covid boosters and people 75 years of age and high-
risk. France, 80 years of age and high risk. I don't think we
should be pushing this on healthy 6-year-old girls without any
evidence every year for the rest of their lives. And so, that's
why we've outlined this framework. And by the way, the vaccine
manufacturers put out positive statements about the framework
because I believe they like predictability.
Senator Shaheen. Well, so I understand that rationale. Do
you have a timetable for when you expect to have the trials
done and a decision made about the future?
Dr. Makary. When the companies present trials to us, and in
the case of high risk, our New England Journal paper outlines
how they can seek clinical trial data after approval in high-
risk populations. But it's up to the companies to present data
to us. It's always been that way where the FDA reviews clinical
trial data that companies present, and we make a decision about
safe and effective.
We have been suspending that role for the last 4 years with
Covid boosters. And so, we're saying this is a reasonable time
to check in and look at clinical trial data given how different
it is. By the way, America doesn't want Covid boosters----
Senator Shaheen. But I assume--I'm sorry to interrupt, but
I'm out of time. Actually, I assume that you're talking to some
of those companies so you have some idea of their level of
interest in coming back to do those clinical trials and what
they may be thinking about in terms of a timeframe.
Dr. Makary. Look, some of these companies made $100 billion
in the Covid booster. They can afford to run a clinical trial
and they have time to run a clinical trial. The VRBPAC meeting
meets later today to pick a strain. So, there's time and
there's money. We're setting a well common-sense framework.
Senator Shaheen. Yes, but I get.
Dr. Makary. Eighty-five percent of healthcare workers----
Senator Shaheen. Are you talking about--are we talking
about 6 months, 1 year, 5 years, 10 years? I'm just trying to
get some ideas so that when people call our office and ask,
when I run into people and say, well, ``How come I can't get
the Covid booster?'' That we can give them some kind of an
answer for what they can expect.
Dr. Makary. Eighty-five percent of healthcare workers said
no to the last Covid boosters. You're not suggesting that we
blindly approve Covid boosters each year without clinical trial
data?
Senator Shaheen. You're not listening to me, Dr. Makary.
Dr. Makary. Is that what you're----
Senator Shaheen. I'm not asking for a blind approval. I'm
saying that I understand the argument you're making. What I'm
asking you is, do you have any timeframe for when you think
this might happen? And I'm sure you're talking to
pharmaceutical companies so that they might have some idea so
that we can just answer questions from the public. Part of what
I'm objecting to here is that all of these decisions are being
made without engaging the public, and I think that's a problem.
Dr. Makary. The public has said no to Covid boosters.
Seventy percent of the public has not gotten a Covid booster,
and they don't trust us because there's no----
Senator Shaheen. You're still not answering my question,
though. Do you not have any idea?
Dr. Makary. The timeframe is reasonable, and it is amicable
to what the industry thinks is they can do. And so, we've had
these conversations and we do with industry. I can't share
individual product conversations with manufacturer, but they
think that the timeframes that we've outlined are reasonable
and we think they're reasonable.
Senator Shaheen. But you still haven't said what they might
be.
Dr. Makary. Well, there's plenty of time between now and
the fall, and so there's plenty.
Senator Shaheen. So, you're looking--you think it's going
to be more of a short-term timeline.
Dr. Makary. In the high-risk group.
Senator Shaheen. This is not a trick question. I'm not
trying to trick you here. I'm just trying to get some answers.
Dr. Makary. And I'm not trying to not answer your question.
It's just different for each age group. For young, healthy
individuals, we have a different timeframe from the high-risk
community where we are approving the Covid--well, I shouldn't
say we are because we haven't reviewed all the data, and all
the applications are not in.
But for high-risk individuals, we do have a framework now
by which they can run the trials after the approval in high-
risk individuals throughout the Covid season. And then
Americans will know it either works or doesn't work. So, it's
roughly a year. It's roughly a year. In Operation Warp Speed,
they ran that Phase 3 clinical trial over the summer. And if
they want to do the same thing, there's plenty of time, in my
opinion.
Senator Shaheen. Thank you.
Dr. Makary. Thanks.
Senator Shaheen [presiding]. Senator Hyde-Smith.
Senator Hyde-Smith. Thank you very much. And thank you, Dr.
Makary, for being here and joining us on the Hill today. We've
discussed the issue of chemical abortion before. However, I'd
like to revisit the topic in light of new data published last
month by the Ethics and Public Policy Center. This data reveals
a much higher risk from the abortion drug, mifepristone, than
previously acknowledged.
And this raises the questions whether it's time to
reconsider the broadly unrestricted access to the drug. It
makes me question if the FDA should reinstate the original
safeguards in order to protect vulnerable women and minors from
experiencing the horrible adverse and life-threatening
complications that could follow the chemical abortion regimen.
First, let me summarize the new data. In April, 2025,
researchers from Ethics and Public Policy Center and the
Foundation of the Restoration of America reviewed the outcomes
of 865,000-plus drug induced abortions from 2017 to 2023. These
abortions occurred after the FDA in 2016 removed the
requirement for doctors to report non-fatal but adverse
complications. The data shows 94,605 serious adverse events
proving conclusively that more than 1 out of 10 women are put
at risk by the mifepristone.
This real-world rate is 20 times greater than the rate the
FDA used when it originally approved the drug. Specifically,
this status shows that, their words, ``10.93 percent of women
experience sepsis, infection, hemorrhaging, or other serious
adverse events within 45 days following the chemical
abortion.''
If serious complications have increased as safety rules
have been loosened over the last 25 years, then logically, it
makes sense to bring those safety protections back. At the very
least, the FDA should restore the original safety requirements
from 2000 under its risk evaluation and mitigation strategies.
How do you view this new data, and will the FDA be taking
this new data into consideration and commit to restoring
common-sense protections, like requiring an in-person doctor
visit before women can actually access mifepristone?
Dr. Makary. Thank you, Senator Hyde-Smith, and good to see
you again. I think a lot of people are asking those questions.
And so, I did see those top line results that you referenced,
and we are going to take a look at those data as they become
available. There is no peer-reviewed publication, and the
underlying data set is not available. But when it does become
available, we're going to take a hard look at it. Thank you.
Senator Hyde-Smith. Thank you. I would appreciate that
very, very much.
Dr. Makary. Thank you.
Senator Hoeven. Senator Ossoff.
Senator Ossoff. Thank you, Mr. Chairman. And Dr. Makary,
good to see you.
Dr. Makary. Good to see you.
Senator Ossoff. Thank you for joining us. I was pleased to
see that the secretary has made the safety of infant formula a
priority for the Department. Is that correct?
Dr. Makary. That's right. And the FDA will be convening the
world experts on infant formula on June 4th, and we're going to
be having a robust discussion because parents want infant
formula options with a better supply chain, without added sugar
and seed oils.
Senator Ossoff. Did you see a recent consumer report study
which found that of 41 tested infant formulas more than 30 were
found to have potentially dangerous levels of lead?
Dr. Makary. Yeah. Heavy metals in infant formula is
something that's getting a lot of attention, as it should. And
so that is part of Operation Stork Speed to take a hard look at
that. And it is one of the priorities of our infant formula
roundtable at the FDA on June 4th.
Senator Ossoff. And it's the Human Foods Division of your
agency responsible for infant formula safety, at least in large
part. Yes?
Dr. Makary. Yes.
Senator Ossoff. I'm trying to make sure I understand some
of the relevant personnel decisions given the concern that
families in Georgia have about the safety of infant formula,
the safety of the food supply. James Jones, the Deputy
Commissioner for Human Foods, submitted a resignation letter
February 17th, included the quote, ``The indiscriminate firing
of 89 staff in the Human Foods Program is beyond shortsighted.
The foods program staff at FDA is the envy of the world in its
technical, professional, and ethical standards.''
It goes on, ``The employees fired this past weekend are the
most recent hires, and generally come to Federal service with
the most recent education and represent the future of the
agency. They included staff with highly technical expertise in
nutrition, infant formula, food safety response, and even 10
chemical safety staff hired to review potentially unsafe
ingredients in our food supply.''
That was February 17th. You were asked on April 17th
whether any of the personnel reductions had included personnel
responsible for food safety or infant formula safety. You said,
``There were no cuts to scientists, or reviewers, or
inspectors. Absolutely none.''
You were asked on April 23rd on CNN and said again, ``There
were no cuts to scientists, or inspectors. But then just two
days later, an HHS spokesperson confirmed that, in fact,
scientists had been fired and that you were scrambling to
rehire them. Is that--did you in fact say on April 23rd,
``There were no cuts to scientists or inspectors?'' Just before
we get into the details, is that an accurate quote?
Dr. Makary. No scientific reviewer was cut as a part of the
reduction in force.
Senator Ossoff. But you said there were no cuts to
scientists or inspectors. Didn't you say that?
Dr. Makary. My understanding whether there was--that there
were no cuts to the scientific staff, but specifically, the
scientific reviewers is what I was referring to.
Senator Ossoff. But you said there were--it's a very
straightforward question. You said there were no cuts to
scientists or inspectors. Correct?
Dr. Makary. Scientific reviewers is what I was referring
to, that's the vast majority of scientists there.
Senator Ossoff. But you said----
Dr. Makary. Jim Jones is an economist.
Senator Ossoff. Five days before you had said there were no
cuts to scientists. You said that right?
Dr. Makary. I was referring to scientific reviewers. There
are a couple----
Senator Ossoff. But scientists had been fired. Correct?
Dr. Makary. There have been a couple. There have been
research scientists in some labs that have been doing some
research. Some of that research is good, some of it is not
good. And so there have been no cuts to scientific reviewers.
Senator Ossoff. And, in fact, scientists who study the
safety of infant formula had been fired. Correct?
Dr. Makary. I'm not aware of any scientists studying infant
formula that----
Senator Ossoff. Well, here's the reporting in the New York
Times, which says the HHS spokesman said those employees called
back had been inadvertently fired, and the decision to rehire
specialists on outbreaks of food-related illnesses and those
who study the safety of products like infant formula.
So, is this reporting accurate? Had, in fact, scientists
who study outbreaks of food-related illnesses and the safety of
infant formula been fired?
Dr. Makary. The reason it's not accurate, it's Senator, is
that people were not fired. They were scheduled for the
reduction in force. And when I--this was before I got there.
When I got there, we did an assessment. And so, some of those
individuals out of the 19,000 were restored. Jim Jones was an
economist, and he was upset about the DOGE cuts. So, he self-
doged. I didn't--he was not fired. I wish he would've stayed.
Senator Ossoff. Have all scientists responsible for food
safety and infant formula safety been rehired or reinstated?
Dr. Makary. Look, we have not reduced in force the
scientific review staff. I know where you're going with this.
We're not allowed to----
Senator Ossoff. I'm trying to clarity on statements. You
said there were no cuts to scientists, and then the HHS
spokesperson said, actually there were cuts to scientists and
now we're trying to rehire them. I mean, so it gives the
impression you're not sure about the personnel actions ongoing
in your own agency.
Dr. Makary. Again, No one was cut in the reduction of
force.
Senator Ossoff. And that's information from your testimony
here today.
Dr. Makary. They were scheduled for the reduction in the
future, down the road. It has not happened yet. So, the people
scheduled to be cut. We did a review and found some research
scientists--when I made those statements, it was very specific.
I was very clear. We're talking about scientific reviewers
because the trains have to run on time. And if you're concerned
about backlog.
Senator Ossoff. My time is up. You were very specific. You
said there were no cuts to scientists. And then five days
later, ``There were no cuts to scientists.'' Those are your
direct quotes. ``There were no cuts to scientists,'' but there
were cuts to scientists. Right?
Dr. Makary. No, there were no cuts to scientists because
people were scheduled for the reduction in force down in the
future. And the people scheduled were reevaluated and we
restored a couple research scientists, and I was referring not
only to them, but to to the scientific reviewers.
Senator Ossoff. How many scientists responsible for
preventing outbreaks of food-related illnesses and the safety
of infant formula have been restored or reinstated?
Dr. Makary. There were no scientists that were in charge of
preventing outbreaks that were part of reduction.
Senator Ossoff. I didn't say in charge.
Dr. Makary. But, I mean, this is the problem in government.
Somebody has a fancy sounding name like infant formula safety,
and no one can ever touch them even if they're not doing their
job.
Senator Ossoff. Okay. Say, how about this? I'll send you so
that you can get accurate information to the committee. I'll
send you some very detailed questions about this and you'll
respond in full. Yes?
Dr. Makary. Yes. Just keep in mind, the agency was half its
size in 2007.
Senator Ossoff. But you'll respond in full----
Dr. Makary. We didn't have outbreaks and rampages, and food
outbreaks----
Senator Ossoff. But we had a huge infant formula safety
crisis in this country just a few years ago. Do you recall
that?
Dr. Makary. That was because of several problems
including----
Senator Ossoff. So, you will respond in full to the
questions that I send you.
Dr. Makary. I'm always happy to respond in full to you,
Senator.
Senator Ossoff. Thank you so much, Dr. Makary. Thank you.
Senator Hoeven. Doctor, I know that that you're working on
Operation Stork speed, speaking of baby formula, that Secretary
Kennedy's already talked about Operation Stork Speed, which
goes right to this issue. Yes. And you're already working on
it, made it a priority. Would you like to address that?
Dr. Makary. We're working hard on it, and that's why we're
convening the world's experts. And the part of the problem with
infant formula that the Senator is alluding to, which is a real
problem, is that the FDA has been so rigid in the way it
evaluates infant formula.
Basically, we have for decades said you have to follow this
recipe because we as the government know exactly what infants
need and you can't deviate from this recipe. And guess what?
They got added sugar on there and seed oils. And there's been
no innovation in infant formula practically since 1998 when we
saw the last change in infant formula on the monograph recipe,
with the exception of selenium that was added. Basically, no
innovation in, in infant formula since 1998.
And so that's what we're working to fix. That is one of the
underlying problems. The more innovation, the more competitors
that can come to market, the more predictability with the
regulatory process, the better products. We're going to see
more options for moms that want infant formula that's safe, low
on heavy metals without seed oil, without added sugar. And that
is, I think, going to help also lower prices and increase the
supply chain.
Senator Hoeven. And, of course, moms know, but there needs
to be a choice in that baby formula so that you've got the
product you need for your child.
Dr. Makary. Absolutely. We're all about choice.
Senator Hoeven. And so, there's a lot to it, and again, I
commend you for--and the secretary for making that a priority.
And I do like the name Operation Stork Speed. That's a great
name. I don't know if you came up with it or the secretary, but
it's a good one.
Dr. Makary. I did not, but I'll pass all along to the
person that did that.
Senator Hoeven. You liked it. And the other thing is this
seems like a timely thing to say because the senior Senator
from the State of Michigan just showed up, and he and I
actually have legislation on baby formula, bipartisan
legislation.
I don't know if you had a chance to look at it yet, but I
would ask that you work with us on it because it goes to some
of these very same things. And I think we worked very hard to
make it very practical, actually reflecting some of the things
you just talked about; how do we make sure safe, but we
innovate and have choice.
Dr. Makary. It's great legislation, Senator. Thank you for
working on it.
Senator Hoeven. That was the right answer. I've got another
question, but I'm going to turn to Senator Murray before I ask
my final question, and then of course, Senator Peters. Senator
Murray.
Senator Murray. Thank you very much, Chair Hoeven. Look
forward to working with you on this really important committee.
You know, Commissioner Makary, the FDA has a really
important job to do. Lives literally are at stake. And that
work requires the utmost diligence, and care, and commitment to
following the science and upholding FDA's gold standard. We all
expect to walk into the drugstore and know that what we are
buying has passed a safety and efficacy standard. And we have
to be assured of that, and we have to be assured that the
work's been done, that we don't have to question that.
So, I don't think it's careful leadership when you do mass
fire 1 in 5 people across FDA only to, frantically, then bring
some back because you didn't stop and think two seconds about
whether those jobs were actually important. We really, Mr.
Chairman, cannot cheap out on the FDA and expect to maintain
that gold standard. That means that people know that drugs are
safe.
We can't just cut, and cut, and hope nobody gets sick when
you're slow to issue a recall, or hope no one needs that
medicine that had its approval delayed, or hope there isn't
another infant formula issue while your staff are getting
fired, or getting rehired, or wherever they are.
This work really takes investments. This committee knows
that, and it expects expert staff, like the people that have
been shoved out the door. Drug approvals are already getting
delayed. Food and drug safety inspections are lagging behind.
We are going in the wrong direction fast.
We still have yet to see from you a full budget request.
That is unacceptable. You are now testifying that the budget
proposes to slash FDA by more than 11 percent. That's actually
news to all of us. And I'll tell you right now, it is not going
to fly. It's reckless and it's not going to happen as long as I
have anything to say about it.
Now, Commissioner Makary, when it comes to your mass firing
of FDA employees in April, you said, ``I can tell you there
were no cuts to scientists or inspectors.'' Well, that is not
true. I think Senator Ossoff covered that. And I think the
point here is that all of this firing and rehiring, I don't see
how that's efficient. Frankly, it kind of shows that you don't
know what you're doing and you're breaking things in the
process here.
And so let me ask you a question, and hopefully it is an
easy one for you. Does it save taxpayer dollars to fire staff
who work in centers that are fully funded by user fees, not
taxpayer dollars, yes or no?
Dr. Makary. Nice to see you again, Senator Murray. You
asked me to do an assessment of the staff when I came here for
my confirmation hearing and, and I hear that you're criticizing
me for bringing back some individuals after the cuts that I was
not a part of.
Senator Murray. No, I'm saying that's good. I'm just saying
in the long run, this has been very inefficient. But my
question to you is not about that. And I know you've covered it
with several other members. So, does it save taxpayer dollars
to fire staff who work in centers that are fully funded by user
fees, not taxpayer dollars. Is that efficient? Does it save
much?
Dr. Makary. The cuts were to HR, IT, communications. There
were 2,600 HR staff----
Senator Murray. But they're funded by user fees.
Dr. Makary. In part.
Senator Murray. It's not saving anymore.
Dr. Makary. In part.
Senator Murray. Well, the many of the staff you fired were
in centers that are actually fully funded by user fees. You
know that. Correct?
Dr. Makary. So, if we have 2,600 HR people, do you want me
to not make any cuts to that number?
Senator Murray. No. I'm asking you a specific question
about the centers that are fully funded by user fees.
Dr. Makary. That's one center. It's the tobacco center.
Senator Murray. Okay, well, let me just say----
Dr. Makary. You said we can't just keep cut and cut. We
can't keep hiring and hiring. The agency doubled since 2007.
So, let me ask you, what is the right number of employees?
Senator Murray. No. You're here to answer my questions and
I'm going to ask some more. Without critical support staff you
fired, inspectors cannot plan their trips. They cannot do their
jobs. I want to ask you; what percent of planned inspections
has FDA missed since those April 1st firings?
Dr. Makary. In the 12 labs that we have that evaluate food
products in the food inspection realm, there are no--as of last
week, I just did a check. There are no backlogs. They're
running at 100 percent efficiency. There are no drug approval
delays despite the--you know, what people want to attribute.
Senator Murray. Well, that is not what I have been told. I
have been told, and I would like you to go back and check and
report back to us because we know that some of the planned
inspections at these--that supposed to take place have been
missed. And to me, why that's so important, if there is not
inspections, the public doesn't have the information that they
need. I am going to run out of time, so I want to move on.
Dr. Makary. There are no cuts to inspectors, Senator.
Senator Murray. Will you go back and check for me, please?
Dr. Makary. Absolutely.
Senator Murray. I understand. And, by the way, inspectors
are one thing, but if you don't have this support staff to make
sure that they know where the
Dr. Makary. But 2,600 HR staff and procurement staff?
Senator Murray. Okay. I understand that the Freedom of
Information Act [FOIA] staff producing documents related to
ongoing litigation by the Children's Health Defense, Secretary
Kennedy's organization, were shielded from the rif, while other
FOIA staff who are responsible for FOIA responses and other FDA
centers were targeted for termination. Is that true?
Dr. Makary. That's not true, Senator. We are have our FOIA
staff. They continue to work at the FDA. I've made sure that
all the FOIA staff at the FDA are doing their job. We are also
using AI to reduce the burden on that staff.
Senator Murray. Well, for the record, my understanding is
that the Children's Health Defense FOIA staff were not fired
when other ones were, all the FOIA staff were there. And that
seems like a real conflict of interest to me, considering that
the secretary's extensive history with that organization,
Children's Health Defense, and his goal to remove
authorizations for vaccines. So, I just want that on record.
Dr. Makary. It's not true.
Senator Murray. Well----
Dr. Makary. All FOIA staff are in place.
Senator Murray. Okay. So, if a study came out saying that
people who took a certain medication experience a certain rate
of ``serious adverse effects'', but the study's authors refuse
to say what they were counting as an adverse event, would that
raise serious questions for you about the study's validity?
Dr. Makary. Yes, Senator. So, I have the natural
inquisition of a scientist that's done a lot of research. So, I
would want to see the underlying data. Yes.
Senator Murray. Okay. Well, I am of course talking about
the sham study from the Ethics and Public Policy Center. It's
an anti-abortion group. It's bankrolled by extremists. They
fought to overturn Roe v. Wade. And this study, if you can call
it that, is unsound and has been widely panned by medical
experts.
But days after its release, you and Secretary Kennedy are
now suggesting that we need a complete review on the safety of
mifepristone. Now, to be clear, mifepristone has been proven
safe and effective in more than 100 studies over three decades.
And the people that are now pushing that bogus study and saying
that mifepristone is dangerous for women, are the exact same
people who think that abortion is never necessary to save a
woman's life, and that 10-year-olds should somehow be forced
into childbirth.
I believe that this administration is laying the groundwork
to rip away access to medication abortion across the country.
This has not gotten enough attention. And I know you'd prefer
to keep it that way, but I want you to know I'm not going to
let that happen.
Dr. Makary. I have not seen that study, Senator, and you
have not seen that study. So, how can you call it a sham, bogus
study? Neither of us have seen the study, the underlying data,
or the methodology.
Senator Murray. Actually, that's not true. But I will say
this, Mr. Chairman, we have a lot of differences here. I know
you came before this committee to present your side of the
story, but I am very clear that laying off people, cutting
budgets is not going to improve the safety and efficacy that we
count on when we go to the drugstore to get our drugs. And I
know that sham studies that try to prove a point that came from
a political group, is not going to tell the public that they
can count on the medications they count on.
Thank you, Mr. Chairman. I yield back.
Senator Hoeven. Senator Peters.
Senator Peters. Thank you, Chairman Hoeven. And thank you
for talking about infant formula and talking about our bill
specifically. And thank you for eliciting a response from our
witness that we both really appreciate. So, thank you for doing
that.
Dr. Makary, as when I was chair of Homeland Security and
Governmental Affairs, we did a study looking at persistent drug
shortages throughout the country and found that a lot of us,
because we're overreliant on foreign sources for those
supplies, and many of the precursors are, as you know, all
overseas.
And in fact, in that study when I put it out, I said it's
pretty clear based on these challenges with the supply chain,
that when there is a pandemic, we're going to find ourselves in
a very difficult position. Six months later, that academic
study became reality as we dealt with the pandemic and
certainly saw that we had highly efficient supply chains, but
they were not resilient.
And I remain concerned that the FDA does not have the
visibility it needs into essential medicine supply chains from
the key ingredients needed for manufacturing our drug products,
to the distribution to the patients, and hospitals, and
pharmacies. And these blind spots clearly limit our ability to
accurately assess national security risk, including our over
dependence on China, in particular, for many critical inputs.
So, last week, I reintroduced the MAPS Act with several of
my bipartisan colleagues, which would address this critical gap
by requiring HHS through public-private partnerships to
essentially map out the medical supply chains using data
analysis, and to assess all the threats and vulnerability.
So, my question for you is, do you agree that this is a
significant concern? And if so, will you commit to work when we
pass this legislation to make this a reality?
Dr. Makary. Senator Peters, I love this topic. It's so
important. I'm glad you're raising it. I've written about it in
a book in 2019. I've written about it in the Journal of the
American Medical Association. I felt like no one has been
paying attention. I warned about exactly what happened at the
beginning of Covid, and it happened.
So, I am totally aligned with you that this is an important
issue. I think there are root causes that we've not been
talking about that we need to talk about. I mean, we can get
out a ruler and map out, you know, the supply chains, and I'm
not opposed to that exercise, but the underlying problem is
that manufacturing has moved overseas.
And it's not just one or two things. It is most of what we
use in anesthesia to perform surgery. It is most antibiotics.
It is most of these cutting-edge therapies is the vast majority
of generic drugs. And so, I totally am in support of President
Trump's agenda here to bring manufacturing back to the United
States.
And we've already had a tremendous amount of success. There
are companies announcing moving manufacturing in the United
States. We're creating incentives, we're removing regulation.
And this is a national security issue. So, I am 100 percent
with you on this.
Senator Peters. Very good. In April, FDA reported
suspending programs to improve testing for potential bird flu
virus contamination of milk, cheese, and pet food because of
the mass layoffs that occurred. We know that the bird flu virus
can kill pets who eat contaminated raw pet food, and it can
pose a real danger to humans who also consume unpasteurized
dairy products.
As you know, the more people and animals who get infected
with bird flu the more opportunities there are for the virus to
mutate. And I'm really worried that we only may be a couple,
and it's not just me, others are worried that there may be a
couple of mutations away from having another--potentially a
pandemic.
So, my question for you, sir, is with the continued spread
of bird flu in the country and the significant personnel
disruptions at FDA food safety programs, could you tell me on
the committee specifically what the FDA is currently doing to
ensure our food is free from bird flu contamination?
Dr. Makary. Well, first of all, that story was debunked by
The Washington Post. It was the normal procurement pause to
recalibrate the equipment. And so, when that happened, people
who were trying to make us look bad, sometimes internally,
sometimes externally, said, aha, there were layoffs, and
there's a pause in some of the milk inspection, and therefore
the cuts may have been related to this, or were related to
this, and that's going to affect food safety.
No. It was a normally scheduled pause to recalibrate
equipment. It went through its normal schedule, and it is back
up and running, and it's normally done to recalibrate the
equipment. The cuts were to 380 communications people. What's
the right number of communications people for the FDA? Not 380.
125 travel coordinators, 13 strategy offices, 2,600 HR people,
and budget and procurement people. So, I mean, are we not
supposed to address some of this redundancy?
Senator Peters. My question is, what exactly are you doing
to safeguard our food supply and to safeguard to people from
bird flu? So, that was the question. I think you're prepared
for a different question and you gave the answer to the
different question. But the question is suggested specifically
what you're doing, please.
Dr. Makary. You suggested the cuts increased our risk of
bird flu, and I firmly reject that that's not true. And the
inspection trains are running on time.
Senator Peters. I think I said personnel disruptions, so.
Dr. Makary. There's no personnel disruptions involved.
Senator Peters. There are no personnel disruption----
Dr. Makary. No calibration facility that was written about.
Senator Peters. So, there are no personnel disruptions
related to your work on bird flu. Is that what you're telling
this committee?
Dr. Makary. What I'm saying is the story that you
referenced was saying that our milk calibration facility paused
because of disruptions.
Senator Peters. I don't remember--I don't think I cited a
particular article. I don't know where you--obviously, you're
prepared. You may not--you're prepared for a question that I
didn't ask. That's fine.
Dr. Makary. No, I mean, you referenced it.
Senator Peters. You probably gave a good answer to a
question that I didn't ask. And so, it shows you were prepped
for it. I'm asking you, what are you doing about bird flu? Just
answer that. Please don't give a runaround about other stuff.
Dr. Makary. Doing a lot on bird flu.
Senator Peters. Don't use your prepared talking points.
Tell me, what are you doing to help us and protect the American
people from bird flu? Please tell me that?
Dr. Makary. We're doing a lot on bird flu.
Senator Peters. Please tell me that. That's why we're here.
Dr. Makary. We got--so look, when there is an antigenic
shift that represents an epidemic threat, when there is human-
to-human transmission, that strain that is involved in that
human-to-human transition is the strain that we should be using
to base any potential future vaccines.
And in the interim, as I said in my opening comments,
delivering on a universal flu shot is one of our top goals. And
there are two universal flu shots that are in development. And
we are not in a receive-only mode with those developers. We are
actively trying to partner with those individuals because it
may be that you could come in for a single birch, a single
influenza vaccine, or a two-dose strategy, or something like
that and be immune for life against multiple different variants
of influenza, including bird flu.
And so, early preclinical data in animal studies has shown
some promise that a universal flu shot using a traditional
vaccine platform can actually create antibodies to the current
strain of bird flu. The question, of course is, and I think
this is really what you're getting at, is if we have a bird flu
epidemic or even an outbreak in a human-to-human fashion, what
strain is that going to be? Because one thing we know for sure
is it's not going to be the strain that's circulating right now
in millions of birds. So, it is a huge priority for us,
Senator.
Senator Peters. Good. Thank you.
Dr. Makary. Thank you.
Senator Peters. Thank you, Mr. Chairman.
Senator Hoeven. Doctor, and in just one follow-up on the
avian flu. I've spent quite a bit of time visiting with
Secretary Brooke Rollins on that issue as well. And she put out
a comprehensive plan to address it and a very thoughtful plan
because, for example, the issue of inoculation is really
complicated because if you inoculate chickens, and then you got
broilers, and then you have trouble with export to Europe and
all these kinds of things.
Dr. Makary. Yes.
Senator Hoeven. So, I think she put out a comprehensive
plan, but she did it very judiciously because some of these
things we still got to figure out. Right? So, any comments you
have in terms of working with her and understanding that this
it's very complicated, and as doctors say, we want to first do
no harm but address it in a comprehensive way? Would that be a,
a fair evaluation, and what are your thoughts?
Dr. Makary. 100 percent. Secretary Rollins has been on top
of this, she has been in communication with the emergency
preparedness scientists at HHS and our FDA team, as well as
people in the Office of Science Technology Policy to evaluate
whether or not we should be mandating preemptive bird flu
vaccines to chickens in the United States.
Some countries have done it, and I think they made the
right decision in saying that does not make sense at this time.
Sometimes, it represents messing with mother nature in ways
that we may not foresee. It may drive mutant strains of the
virus. So, I think we need to be alert and ready. But at the
same time, we need to wait until we see human-to-human
transmission, and see what that strain is before we develop a
strain specific vaccine.
And in the meantime, we can advance the universal flu shots
that encompass those bird flu strains currently in circulation,
provided that they are safe and effective. And, you know, not
100 percent of vaccines are wonderful. I love vaccines. I
believe in vaccines. Vaccines save lives. Any death from a
vaccine-preventable illness is a tragedy.
But the anthrax vaccine was a disaster. The swine flu
vaccine was a disaster. The rotavirus vaccine was removed from
the market. We had a vaccine that we had to remove from the
market a few weeks ago for a rare infectious disease in the
United States. And when the data clearly shows that there's not
broad safety as we're commissioned by Congress to do, then we
have to do our job.
Senator Hoeven. And there is concern by producers in terms
of, if you start inoculating some of the flock, then you
actually have the disease in the flock. But then if you're
still, you know, keeping that flock, then does the disease
spread also, as I say, depending on whether they're layers or
they're broilers. That makes--so there's a lot that that goes
into this, and it's a really complicated. Very important we
address it, but a really complicated issue.
And that's why I'm pleased that you and Brooke are working
together in the way that you are on it.
Dr. Makary. Thank you, Senator.
Senator Hoeven. Yeah. I want to ask about AI, and I don't
mean AI as we talked about on the ranch. This I mean artificial
intelligence. And, you know, talk to me--I hear so much about
what AI's going to do in every field, but certainly in
medicine. Just give me, you know, some of your thoughts on not
only how we should be using it and what it will do for us, but
how we make sure that we don't get ourselves into a problem
with it.
Dr. Makary. Well, we spend a lot of time thinking about
cybersecurity and proprietary information. We don't want a
situation where AI is stealing proprietary information. And we
don't want to expose ourselves to any cyber risks, which is why
we have ensured that the AI that we're using to summarize
clinical data and background information for our scientific
reviewers lives in a very secure space. And the reviewers love
it.
And it's not just AI to assist in the scientific reviews.
We're using AI to identify where we should be concentrating our
food inspections. And it turns out the AI can sometimes figure
out pattern recognition faster than, you know, we can as human
beings. And we'd like to use this also to address the issue of
illegal vapes coming into our border.
Senator Hoeven. Okay. And how do we make sure it doesn't
get off and running on us and we have problems?
Dr. Makary. We have to keep an eye on it always. I mean, we
cannot have blind trust in anything, which is why all the areas
where we are using AI currently at the FDA, we also have a
human being reviewing the information and having full access to
the underlying data.
Senator Hoeven. Okay. Thank you, Doctor. Ranking Member
Shaheen.
Senator Shaheen. Yes. I just have a couple more questions.
One is, again, apropos the need to address Type 1 diabetes. One
of the things that Senator Collins and I have worked on is a
more efficient pathway for biosimilar drug approvals that are
currently lacking competition.
So, can you give us an update on what you think is
happening in that arena and whether there's any reason to hope
that that's going to get expedited, and if there are any other
approvals or anything that you need at the FDA to ensure that
that is being addressed in a way that allows those biosimilars
to come to market?
Dr. Makary. Well, thank you, Senator. This is a very
important topic that directly relates to drug prices for
everyday Americans. And there's a reason why when you watch the
news now, you're basically watching, you know, people dancing
in the fields and singing with these drug ads nonstop in the
commercial breaks because they're so expensive.
And so, the companies have figured out that if they can get
a few people to, you know, shake their doctor down to prescribe
one of these drugs to them, or I guess somehow let their doctor
know that they're a candidate--it might be a little insulting
to the doctor that they don't already know it, in my opinion.
But that's why these ads are running nonstop.
And so, there are low cost biosimilars that can be made
available by the FDA, approved by the FDA, and that process is
too slow, in my opinion. We have to look at whether or not we
really need to require confirmatory trials for each biosimilar.
I mean, we don't do that for generics with regular branded
pills. We don't say, ``Well, you make a generic with the same
molecular structure, go out and do a confirmatory trial.'' I
think we need to look at that.
There's a bill, I believe, that Senator Rand Paul is
putting forward to take a look at that. And then finally, we
can look at whether or not we can sort of approve a class of
interchangeable drugs that they're very similar in the class.
And so, an interchangeability provision could help create more
incentives because we want to incentivize companies to make
safe biosimilars.
Senator Shaheen. I agree. You mentioned in your opening
statement the seizure of vaping products from China. One of the
things that I've been concerned about for a very long time is
the increased use of vaping by young people. And the numbers
have gone up dramatically in the last 10 years, and also the
health impacts of that we're not even, I think, fully aware of
at this point.
So, can you talk about what more you're doing at the FDA,
and how you did that interdiction, who you're working with,
again what more can be done to get those products off the
market?
Dr. Makary. Well, Senator, thank you for your interest in
this topic. We can do a lot more. And I've realized that what's
happening now is these illegal Chinese vaping products designed
to attract children, they are video game vaping products with
an inhalation port designed to addict young children so they
can vape as they play these games. These fruit video game
products that are so small, they have an inhalation port.
What happens is these products that are banned in China,
and made in China, show up in U.S. ports. And what's been
happening, I learned, is that they are set aside, the FDA looks
at them, and then we say, ``Well, you know what? These are
shouldn't be coming in our country. We'll put them back on the
ship they came on, and then the ship goes to another U.S. port
and will come in through. Basically, we're 100 percent porous.
It's been a joke, and they've been laughing at us, and so
we are going to stop that. And we have incredible interest at
DOJ, at Department of Homeland Security, and we are creating an
endeavor that is going to basically say we're not going to send
them back anymore. We're going to confiscate and seize these
products because we've got to get serious about them.
These are designed to get kids addicted, and there are kids
in America today who are addicted. They know they're addicted.
They come from good families, they're good kids, and they can't
stop. And that is something that we have to address. There are
high schools in America now where kids are saying half of the
kids in high school are addicted to these vaping products.
So, we cannot get burned, again, like we did on opioids,
and Vioxx, and other things where the problem is so far down
the road it's hard to undo some of the tragedy. And so, this is
a top priority for this administration, for this President, for
this secretary, and for me.
Senator Shaheen. Well, I agree. I think we ought to right
out ban vaping products for anybody under a certain age,
certainly. And one of the other things we need to do, as you
know, is to get a treatment for people who are trying to get
off vaping products. Because one of the other selling points
that they use is that, well, it's a way to get cigarette users
to stop smoking. They can vape and the harmful impacts are not
as serious.
But I'm pleased to hear that you're doing everything
possible. And I don't know if you, again, if this is an area
where you need additional authorization or support, but I think
there are a number of us in the Senate who are all in to try
and address this because it is having a huge impact.
I've been to those schools in New Hampshire where I've
talked to students who have gotten hooked on vaping, who can't
get off, and who don't have any aids to help them do that. So,
it's something that we've really got to address.
Dr. Makary. Thank you so much, Senator. And as you know, we
confiscated today $34 million worth of illegal vaping products
and e-cigarettes. And so that announcement is coming out today.
Senator Shaheen. Thank you.
Dr. Makary. Thank you.
Senator Hoeven. Doctor, thanks for being here. Did you have
anything else that you wanted to express for the record before
we wrap?
Dr. Makary. I appreciate the input and the feedback. And,
look, I'm on a listening tour. We're going to be traveling
around the country, myself and some of the other FDA leaders,
meeting with industry leaders, developers, inventors,
scientists, academics, and we want to hear how we can perform
better.
We don't claim to have all the answers. We don't claim to
have the truth on health, but we do have a lot of intellectual
curiosity, and we plan when we see something that needs action
to take action. So, I want to thank you and this committee for
the input that you've provided and made available to me.
ADDITIONAL COMMITTEE QUESTIONS
Senator Hoeven. We appreciate you being here today. We look
forward to having you back as well. Questions for the record
are due by next Thursday, May 29th. And then, we'd appreciate
responses from FDA within 30 days, so.
Dr. Makary. I can't wait.
Questions Submitted to Hon. Dr. Martin A. Makary
Questions Submitted by Senator John Hoeven
maha commission report
Question. The Make American Healthy Again (MAHA) Commission report
was made public the day of our hearing. This subcommittee has a special
interest in the recommendations in the report as we are at the
intersection of food and health with jurisdiction over both the FDA and
the USDA. I am curious about the next stage in the process for the MAHA
Commission, which will entail the publication of a strategy to build
upon the report which is due by August of this year.
Can you speak to the MAHA report and how you believe it will impact
your work at the FDA? Will you work closely with the USDA on the next
phase of the MAHA Commission Strategy development to ensure our farmers
will continue to enjoy support for their work providing the fresh
fruit, vegetables and other dietary staples that are important to
ensuring the health and nourishment of all Americans?
Answer. On April 22, the U.S. Department of Health and Human
Services and U.S. Food and Drug Administration (FDA) announced new
measures to work with industry to phase out all petroleum-based
synthetic dyes from the Nation's food supply-a significant milestone in
the administration's initiative to Make America Healthy Again. The FDA
is taking a number of actions, including:
--Initiating the process to revoke authorization for two petroleum-
based food colorings-Citrus Red No. 2 and Orange B.
--Working with industry to phase out the use of six remaining
petroleum-based dyes-FD&C Green No. 3, FD&C Red No. 40, FD&C
Yellow No. 5, FD&C Yellow No. 6, FD&C Blue No. 1, and FD&C Blue
No. 2-from the food supply by the end of next year.
--Partnering with the National Institutes of Health (NIH) to conduct
comprehensive research on how food additives impact children's
health and development. In partnership with the NIH Nutrition
Regulatory Science and Research Program, the FDA will enhance
nutrition and food-related research to better inform regulatory
decisions.
--The FDA fast-tracked the review of calcium phosphate, Galdieria
extract blue, gardenia blue, butterfly pea flower extract,
which are color additives derived from natural sources. The
agency is also taking steps to issue guidance and provide
regulatory flexibilities to industries.
Lastly, FDA has and will continue to collaborate with USDA on a
variety of cross-cutting work related to the MAHA Commission Report.
human foods program
Question. As I mentioned in my opening statement, the FDA regulates
80 percent of our Nation's food supply. We know that there have been
staffing changes and reductions at the Human Food Program this year. We
have also heard of the possibility of changes in FDA's food inspections
that would lead to a decrease in FDA's direct involvement. I assume
this would lead to more support of state inspectors, which are more
cost effective.
Can you speak to your vision for FDA's food regulation and
inspections for the next year?
Answer. The President's proposed budget for Fiscal Year 2026
includes a plan to shift responsibility for many routine food facility
inspections from FDA to State agencies. This shift is part of a larger
proposal to enhance FDA's efficiency. As part of the plan, FDA and
state co-regulators would work in a coordinated framework, sharing data
and responsibilities to ensure coverage of regulatory responsibilities
in a jurisdiction. It is anticipated that each State would have a
unique distribution of work based on its capacity and capability, while
FDA would focus on areas where its national scope and specialized
expertise would be most impactful. This proposed framework will reduce
duplication and streamline work planning between FDA and state co-
regulators, as well as provide more complete food safety coverage and
optimize resource utilization at both the State and Federal levels.
From a training perspective, FDA's Partnership for Regulatory
Education and Training (PRET) program helps enable States to have more
qualified personnel to conduct inspections. PRET is designed to assist
State, local, Tribal, territorial and military (SLTTM) partners by
equipping them to independently deliver training courses. By enhancing
training capabilities and strengthening regulatory capacity across all
levels, FDA is reinforcing our collective commitment to safeguarding
public health. PRET offers an opportunity to empower jurisdictions to
meet their own training needs while using FDA-designed course materials
and utilizing FDA-trained qualified instructors from the SLTTM's own
staff.
ai product reviews
Question. I noted your recent announcements around the use of AI at
the FDA; including the hiring of the FDA's first Chief AI Officer and
the completion of the first AI assisted product review, with the goal
of scaling widespread use of AI in reviews at the agency by July. I am
curious if you can discuss parameters of the rollout.
Specifically, can you touch on the safeguards you have in place
that will protect proprietary information and ensure accuracy?
Answer. In June 2025, FDA deployed the generative AI Tool, Elsa,
across the entire Agency. Elsa's development team was comprised of
experts from every Center. Currently, we have approximately 11,400
users of Elsa, with 6,000-7,000 weekly active users, making it one of
our most utilized applications. Elsa is an FDA-wide solution that can
be employed to help with tasks in every Center/Office. The system
supports diverse functions, from administrative tasks to Freedom of
Information Act requests and human resources needs. We also expanded
accessibility by developing mobile capabilities specifically for field
investigators. In addition to Elsa, FDA is currently compiling the 2025
annual HHS AI use case inventory in accordance with Executive Order
13960, ``Promoting the Use of Trustworthy Artificial Intelligence in
the Federal Government.'' FDA's 2024 use case list may be found here:
AI Use Cases Inventory HHS.gov.
Regarding cybersecurity and information security measures, Elsa
operates within the most robust security framework available to Federal
agencies. The system is deployed in a FedRAMP/FISMA High environment,
which represents the highest level of Federal cybersecurity standards.
Our key security measures include comprehensive data protection
protocols. The system is also not connected to the internet and
operates securely behind the FDA firewall, allowing our staff to input
FDA confidential information safely while maintaining the highest
security standards. We maintain strict access controls, including user
profile restrictions and the ability to create locked-down, user-
specific document libraries. Staff can upload documents and data during
individual chat sessions, and this information remains within that
specific session and user context, preventing unauthorized access or
data sharing. Additionally, we maintain rigorous vendor management
protocols with our cloud solution providers and AI vendors, ensuring
they meet all Federal security requirements while providing us with
access to the latest modeling capabilities within our secure
environment.
Question. Can you discuss how FDA reviewers are being trained, and
any cost or savings this may bring to the agency?
Answer. Since Elsa's launch on June 2, 2025, over 6,290 FDA staff
have completed initial training, and currently, we maintain 6-7,000
weekly active users out of approximately 11,400 total users Agency-
wide. This makes Elsa one of our most utilized applications outside of
standard Microsoft Office products.
Our training approach is deliberately structured and progressive.
We have conducted extensive trainings paired with multiple office hours
and video recordings, and to date, over 6,290 staff have attended
training sessions. Our approach focuses heavily on prompt engineering--
teaching users to craft specific, effective queries rather than relying
on generic interactions. As new features and models are released, staff
will be required to attend trainings to unlock such additional AI
models and features. This ensures we have a process to continually
train and reinforce the proper use of these tools as they advance.
Some administrative tasks that previously required days to weeks of
work can now be completed in fractions of the time, representing
significant labor cost savings across our large user base. For example,
analyzing public docket comments for high-level themes could normally
require days of efforts from several staff members, however, through
Elsa such themes can now be identified more efficiently.
The system development and deployment occurred in 2-3 weeks using
existing FDA staff with minimal contractor support, demonstrating
relatively low implementation costs. Our training investment is
generating returns through accelerated adoption and more effective
utilization of AI capabilities across diverse Agency functions,
including assisting staff in drafting warning letters, processing
meeting transcripts, and supporting various aspects of our review
processes.
FDA maintains rigorous mechanisms to ensure regulatory compliance
and protection of sensitive information. All users are trained that
Elsa is a supportive tool, not a decision-maker, and that they must
verify all outputs through our established multiple levels of review.
We maintain structured processes with extensive oversight, ensuring
that AI-assisted work still meets our rigorous scientific and
regulatory standards. Users learn to utilize feedback mechanisms,
including rating systems that help our development team understand
usage patterns and improve the system.
Finally, we have implemented features in our system such that when
users are interacting with Document Libraries, Elsa is forced to read
prompts in the context of those documents and cite relevant documents,
significantly limiting the likelihood that Elsa hallucinates
information or references. Regardless, FDA staff are required to
validate sources and information in every instance.
We also plan to provide Center leadership with information about
usage patterns, enabling them to understand how their teams are
utilizing the tools and ensure appropriate application within their
specific regulatory contexts. Finally, we maintain currency with the
latest AI capabilities, while ensuring all updates meet our security
and functionality requirements. We recently upgraded from Claude 3.5 to
Claude 4.0 within our secure environment, demonstrating our commitment
to providing staff with cutting-edge tools while maintaining the
highest security standards.
Question. Will the use of AI have effects on staffing levels?
Answer. Our current focus is on Human-in-the-loop capabilities to
support our workforce and not on replacing staff functions with AI.
inspections
Question. Inspections are important to promote domestic
manufacturing. In addition to modernizing the foreign inspection
process, there are steps that could be taken to address avoidable
inefficiencies that impact the time and expense of product reviews.
Inspections are a critical step in the safety assessment and the
approval process. They need to be thorough and complete while at the
same time being accurate and rationale, particularly given the reliance
on contract manufacturing sites, which can be spread across multiple
buildings and with distinct products.
Can you share with the committee your plan to modernize
inspections, and commit to working with Congress to identify and
address improvements to current practices?
Answer. FDA has focused on more efficient and timely inspections
and comprehensive but succinct inspection reports, as well as
additional technological tools to assist in modernization. Together
these approaches should allow for an increase in the number of
inspections performed and allow broader coverage of industry.
The Agency is also utilizing remote assessment tools and other
alternative inspectional tools to gather information and records in
advance of or in lieu of inspections. This allows FDA to leverage such
information and records to focus subsequent inspections or to forgo the
need for inspection in certain cases, as appropriate, e.g., if the
information in the reviewed records is sufficient for the agency's
purposes. FDA is also using our authority under section 704(a)(4) of
the FD&C Act, as recently amended by Congress, to require provision of
records or other information in advance of or in lieu of an inspection.
Question. Will you commit to reporting back to the committee on how
many inspection issues have led to delayed approvals in the form of
Complete Response Letters (CRLs), particularly noting those cases in
which the inspection issue that resulted in the delay is ultimately
determined to be a non-issue or is unrelated to the product that was
delayed?
Answer. The focus of current good manufacturing practice (CGMP)
inspections is on system-wide controls that ensure manufacturing
processes consistently produce quality drugs. FDA will use information
gathered from inspections to assess an establishment's compliance with
CGMP requirements, including, among other things, evaluating the
effectiveness of the establishment's quality system.
FDA provides information on inspections, including the median time
to start a pre-approval inspection (PAI) and the number of facilities
that failed to address inspection issues leading to application
Complete Response Letters (CRLs) for new drug applications (NDAs) and
abbreviated new drug applications (ANDAs), in the publicly available
FDARA 902 report. The number and type (e.g. PAI, surveillance, for-
cause) of inspections resulting in Official Action Indicated (OAI)
classifications is documented, but a categorical breakdown of the type
requested pertaining to CRL reasons is not available with current
systems.
fda it infrastructure
Question. Please provide details on FDA's IT modernization roadmap,
including timelines, risk mitigation strategies, and how the agency
plans to maintain continuity of operations during any system
transitions.
Answer. The FDA has developed a roadmap to consolidate the agency's
mission critical applications across all centers. The consolidation
focuses on data intake systems, regulatory workflow management
platforms, publishing platforms, and the aggregated data platforms. The
implementation follows a three-phase timeline approach spanning
calendar years 2025-2028, with the agency currently in the first phase
which began in May 2025.
The first phase, spanning May 2025 through October 2025 (6 months),
focuses on foundational setup beginning with the launch of frequent
adverse event data publishing to provide more timely post-market data
to the public, followed by the initiation of historical data
digitization to enhance knowledge sources and cross-center system
consolidation planning, including the deployment of the AI platform
Elsa 2.0 and Adverse Event Monitoring (AEM) capabilities alongside five
additional foundational initiatives.
The second phase, covering November 2025 through October 26 (12
months), concentrates on core transformation activities, including the
completion of adverse event system consolidation from seven (7)
separate databases into one (1) unified system that supports downstream
regulatory reviews, analytics, reporting, and data mining functions
without operational interruption. This phase also includes the
deployment of more real-time sentinel capabilities, the launch of
parallel real-time review processes for early-phase clinical trials,
and the implementation of comprehensive real-time surveillance
capabilities.
The third and final phase, planned for November 2026 through April
2028 (18 months), achieves full integration by completing historical
data digitization, establishing full cross-center system integration,
and scaling real-time review capabilities from early-phase trials to
include late-phase trials, thereby creating a comprehensive and timely
regulatory framework.
The consolidation effort employs an approach that minimizes the
risk by maintaining all existing applications, systems, platforms, and
resources in their current operational state until successful
implementation, testing, and migration to the consolidated platform is
completed. Each initiative involves representatives from every center,
including both business subject matter experts and technical personnel,
to ensure ownership of business and IT operations and to provide input
on proposed changes before any code base modifications occur. Business
continuity is ensured through embedded change management teams within
each center that provide hands-on training and various training
modalities to ensure smooth transitions without major disruptions.
Additionally, comprehensive backup plans maintain systems in their
current operational state as contingency measures, ensuring that
critical regulatory functions continue uninterrupted throughout the
transformation process.
Question. Please provide the committee with an update on the
current review process for reviewing contracts at FDA, including:
How long is it currently taking FDA to process procurement
contracts?
Answer. The time to process procurement actions, receipt to
contract award generally takes 2-3 months.
Question. How is HHS ensuring that FDA contract governance adheres
to best practices in procurement, risk management, and operational
resilience?
Answer. HHS is ensuring FDA contract governance adheres to best
practices in procurement, risk management, and operational resilience
through implementation of the Administration's priorities. Through HHS,
the FDA is implementing changes to the Federal Acquisition Regulation
(FAR) as part of the President's Executive Order (EO), ``Restoring
Common Sense to Federal Procurement'' (EO 14275), through the
Revolutionary FAR Overhaul \1\ (RFO). HHS' oversight of FDA's
acquisition activities helps ensure the FDA realizes the goals of the
RFO: faster acquisitions, greater competition, and better results.
---------------------------------------------------------------------------
\1\ https://www.acquisition.gov/far-overhaul
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Additionally, HHS has enabled the FDA to be flexible and innovative
in adopting best practices, risk management, and operational resilience
through promotion of the HHS ``Acquisition Innovation Program,'' which
is transforming ``the department's acquisition process through
fostering a culture of innovation, streamlining procedures, and
piloting new approaches to deliver best value to the taxpayer.'' In
particular, HHS has provided ``streamlined acquisition efficiencies to
assist the HHS contracting workforce with year-end actions . . . [and]
low-risk efficiencies that are easy to implement to ensure successful
execution of FY25 year-end requirements,'' such as streamlined
acquisition planning, small business-related reviews, and strategic
sourcing opportunities (HHS Acquisition Alert 2025-07). The FDA is
implementing many of these approaches to effectively support the FDA,
including the Department of Homeland Security's Procurement Innovation
Lab's (PIL) source selection techniques.
Question. What internal controls are in place to prevent potential
bottlenecks during the contract approval process?
Answer. Controls include standardized review timelines, designated
approval authorities at each organizational level, and systematic
tracking mechanisms that monitor contract progress through each stage
of the approval workflow. Additionally, the Agency maintains escalation
procedures and regular communication protocols between contracting
officers, program officials, and FDA leadership to identify and resolve
any delays that may arise during the contract approval process.
Question. Building off the progress in genomic medicine/rare
disease--Congress has spent decades providing regulatory tools and
encouraging their use, from innovative trial designs to expedited
programs, surrogate endpoints, and real-world evidence. In your efforts
to build a more efficient FDA that upholds the world's ``gold
standard,'' it is imperative that FDA makes full use of the tools that
Congress has provided in applying that standard. This is especially
important for patients with serious rare diseases where randomized
controlled trials may not be possible.
What does the Administration intend to do to ensure we are able to
advance the field of cell and gene therapy, and will this
Administration continue to support the full use of regulatory tools
Congress has provided, including accelerated approval and single arm
trials when placebo controls are not possible, in order to speed the
delivery of these life-changing treatments to patients?
Answer. The FDA is committed to advancing cell and gene therapy
development and making full use of the regulatory tools Congress has
provided, particularly for rare diseases where traditional trial
designs may not be feasible.
The FDA is actively implementing several key initiatives to support
cell and gene therapy advancement. The Agency has established the
Support for Clinical Trials Advancing Rare Disease Therapeutics (START)
Pilot Program for CBER and CDER, which provides enhanced communication
between sponsors and FDA staff to address product-specific development
issues more efficiently. This program specifically targets gene and
cellular therapies for serious rare diseases, offering frequent advice
and regular informal communication to help move development programs
forward more quickly. Additionally, FDA has launched the Rare Disease
Innovation Hub that will leverage expertise across the Agency to
advance regulatory science on critical issues including novel
endpoints, biomarker development, and innovative trial designs.
Regarding the use of regulatory flexibilities that Congress has
provided, FDA explicitly confirms its commitment to applying these
tools appropriately. These flexibilities include accelerated approval
based on surrogate endpoints that are reasonably likely to predict
clinical benefit, reliance on a single adequate and well-controlled
trial with confirmatory evidence instead of requiring two trials, use
of natural history study data as external control data, use of novel
trial designs, and use of novel statistical methodologies.
The FDA also continues to support the Rare Disease Endpoint
Advancement (RDEA) Pilot Program, a joint CBER and CDER initiative
designed to support novel endpoint efficacy development for drugs that
treat rare diseases by providing a mechanism for sponsors to
collaborate with FDA throughout the efficacy endpoint development
process. The Agency emphasizes that it considers all relevant statutory
authorities and available flexibilities when making decisions
appropriate to each particular rare disease and therapeutic product,
and ensuring that the tools Congress has provided are being utilized
effectively to benefit patients with serious rare diseases who have
limited treatment options.
rare diseases require innovative approaches to drug development and
regulation
Question. Dr. Makary, you have previously articulated the
challenges in rare disease drug development, stating that for
debilitating, life-threatening rare conditions, ``you can't expect
companies to do a randomized controlled trial'' because it would ``kill
investment in those innovative ideas.'' You also spoke about the need
to ``customize the approval process to the condition'' and uphold
``gold standard science.'' I was encouraged by your statements because
Congress has provided FDA with a wide array of regulatory tools to do
just that, and these tools are especially important for rare diseases
that are complex and challenge traditional approaches to drug
development.
As you work towards building a more modern, efficient FDA, how will
you ensure that your vision for customized approaches to regulation and
gold standard science is implemented at the review level? Can we count
on FDA under your leadership to fully leverage all the tools Congress
has provided to apply innovative regulatory approaches beyond just
focusing on randomized controlled trials--especially in rare diseases
where such traditional approaches may not be possible?
Answer. FDA currently has numerous programs (e.g., accelerated
approval, breakthrough therapy designation, fast track designation, and
priority review) to help speed the availability of drugs intended to
treat patients with serious and life-threatening diseases, while at the
same time meeting appropriate safety and effectiveness standards and
facilitating the collection of scientific data that is relevant and
reliable.
FDA also focuses significant resources on rare disease drug
development and initiatives to help bring safe and effective treatments
to rare disease patients. These initiatives include:
--Rare Disease Innovation Hub \2\: In July 2024, FDA announced the
creation of the Hub to serve as a point of collaboration and
connectivity between CBER and CDER with the goal of ultimately
improving outcomes for patients with rare diseases.
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\2\ https://www.fda.gov/industry/medical-products-rare-diseases-
and-conditions/fda-rare-disease-innovation-hub
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--CDER's Accelerating Rare disease Cures (ARC) Program \3\: In May
2022, CDER launched the ARC Program with a vision to speed and
increase the development of safe and effective treatment
options to address the unmet needs of patients with rare
diseases.
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\3\ https://www.fda.gov/about-fda/center-drug-evaluation-and-
research-cder/accelerating-rare-disease-cures-arc-program
---------------------------------------------------------------------------
--CBER/CDER START Pilot Program \4\: FDA's CBER and CDER initiated
the Support for clinical Trials Advancing Rare disease
Therapeutics (START) Pilot Program to help further accelerate
the development of novel drug and biological products for rare
diseases.
---------------------------------------------------------------------------
\4\ https://www.fda.gov/science-research/clinical-trials-and-human-
subject-protection/support-clinical-trials-advancing-rare-disease-
therapeutics-start-pilot-program
---------------------------------------------------------------------------
--Rare Disease Endpoint Advancement (RDEA) Pilot Program \5\: This
pilot is a PDUFA VII commitment designed to support novel
efficacy endpoint development for drugs that treat rare
diseases.
---------------------------------------------------------------------------
\5\ https://www.fda.gov/drugs/development-resources/rare-disease-
endpoint-advancement-pilot-program
---------------------------------------------------------------------------
--The Oncology Center of Excellence (OCE) Rare Cancers Program \6\:
This program is intended to promote the development of safe and
effective new drugs and biologics totreat patients with rare
cancers by engaging with multiple internal and external groups
involved in rare cancer drug development, including patient
groups, academia, industry, etc., and holding various workshops
for pediatric cancers, rare cancers and ultra-rare cancer tumor
indications. Importantly, the OCE has applied regulatory
flexibility in many rare cancer drug approvals, including
acceptance of the use of single arm trials where appropriate,
one adequate and well controlled trial under accelerated
approval, use of master protocols and seamless trial designs,
etc.
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\6\ https://www.fda.gov/about-fda/oncology-center-excellence/oce-
rare-cancers-program
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threats to us biotech's future investment and global competitiveness
Question. The National Security Commission on Emerging
Biotechnology recently issued a report on the impact of emerging
biotechnology on national security. The Commission's conclusion was a
clear warning--the U.S. risks permanently forfeiting its position as
the global leader in biotechnology if supportive action is not taken in
the next few years. I am concerned that the US can fall behind
competitors like China, which has been investing in biotech for the
last two decades in an attempt to overtake the U.S. in this area.
What actions can the Administration take to restore the confidence
and predictability needed in the regulatory process to ensure the
viability of U.S. biotech, and what is this Administration's broader
plan to preserve and defend our standing as the global leader in
biotech and ensure that Americans have access to innovative, lifesaving
treatments?
Answer. To preserve America's competitive edge in biotechnology,
FDA is taking action across our product areas, including some notable
examples below, to increase regulatory predictability, accelerate
review timelines, and foster greater industry collaboration.
The FDA recognizes that drug developers and capital markets alike
want predictability. To that end, FDA published more than 200 complete
response letters (CRLs) to provide significantly greater insight into
the FDA's decision-making and the most common deficiencies cited that
sponsors must address before their application is approved. The Agency
plans to publish additional CRLs from our archives.
The Agency also recently announced its Commissioner's National
Priority Voucher (CNPV) program. The new voucher may be redeemed by
drug developers to participate in a novel priority program by the FDA
that shortens its review time from approximately 10-12 months to 1-2
months following a sponsor's final drug application submission.
Additionally, the Commissioner recently launched a six-city
listening tour to gather direct input from biotechnology and
pharmaceutical leaders on how FDA can modernize its regulatory
framework to better support innovation and patient access to safe and
effective therapies.
Lastly, FDA has streamlined its procedures for oversight of foods
and animals developed using biotechnology and recently implemented a
Voluntary Premarket Meeting process to help certain foods from genome
edited plants reach the market much more quickly. This approach
continues to protect public health and promote transparency while
reducing FDA's regulatory timeline from months to weeks for these kinds
of products.
Taken together, the US system generally, and FDA procedures in
particular, have enabled the marketing of more biotechnology-derived
food and animal products in the US than anywhere else in the world.
staffing at fda
Question. Can you confirm the number of current FDA staff and how
that compares to 2024?
--Have these staff losses affected certain offices, centers, or
divisions more than others? If so, which?
--How many of these staff reductions were funded by user fees versus
annual appropriations?
--Is the agency currently meeting its PDUFA-mandated review
timelines, including for applications granted priority review
or for those targeting rare diseases?
--What steps are you taking to ensure that the FDA has the staff it
needs to review applications within the statutorily mandated
timeline?
Answer. The table below shows the staff on board as of December 31,
2024, and May 22, 2025. The May 22, 2025, numbers exclude individuals
that remain on administrative leave with anticipated departures due to
DRP and pending RIF actions.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Grand
As Of CBER CDER CDRH CTP CVM HFP OC OII Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
12/31/2024........................................... 1373 5655 2192 1183 698 1966 3148 2983 19198
5/22/2025............................................ 1304 5388 2017 1078 634 1801 2769 2825 17816
Change (%)........................................... 5.03% -4.72% -8.12% -8.88% -9.17% -8.39% -12.04% -5.30% -7.20%
--------------------------------------------------------------------------------------------------------------------------------------------------------
As demonstrated in the table above, the reductions range from
approximately 18% to 23% by Center. The Office of the Commissioner is
an outlier at 27.54%, reflective of the focus of the RIF actions on
administrative, non-scientific positions without direct roles in the
reviews, inspections, and investigations.
52% of FTEs who left the FDA during the time frame above were
funded by user fees.
FDA continues to meet all of its user fee-related timelines, and
therapeutics for rare diseases is a significant priority for the
Agency. As in the past, FDA is monitoring and assessing organizational
hiring needs to respond according to hiring authority guidelines, so
that the Agency can continue to review applications within the
statutorily mandated timelines.
vaccine regulatory framework
Question. The Advisory Committee on Immunization Practices (ACIP)
is an independent body of clinical experts that provides guidance with
regard to vaccines Last month, the ACIP met and made several
recommendations that are still pending review by HHS. Can you provide
any timeline or update as to when HHS will consider the ACIP
recommendations?
Answer. The Advisory Committee on Immunization Practices is an
advisory committee of the Centers for Disease Control and Prevention
(CDC). FDA recommends reaching out to CDC for further information.
benzodiazepines
Question. Commissioner Makary, recent media investigations have
underscored the severe risks of the benzo (benzodiazepines) class of
drugs-including dependency, cognitive decline, and fatal withdrawal
complications-prompting many patients and providers to seek safer
alternatives. In the last 2 years the Committee has asked FDA to report
back on this topic.
Given that the FDA and DEA are currently collaborating on an
analysis to determine whether to deschedule or reschedule newer DORA
class insomnia medications, will you prioritize this analysis?
Answer. Under the Controlled Substances Act (CSA), drug scheduling
is an effort coordinated between the Drug Enforcement Administration
(DEA) and the Department of Health and Human Services (HHS), where a
final scheduling action is taken by DEA. Generally, FDA, on behalf of
the Secretary of HHS, performs the medical and scientific evaluation of
substances for control under the CSA, pursuant to provisions under 21
U.S.C. 811(a-c). According to an April 11, 2024, opinion from the
Department of Justice Office of Legal Counsel, such scientific and
medical determinations from HHS ``must be binding [on DEA] until
issuance of a notice of proposed rulemaking"; once formal rulemaking
has commenced, DEA must continue to accord ``significant deference'' to
those determinations. As such, we acknowledge our significant and
important role in evaluating the science to support the scheduling
process. However, the Agency notes that DEA is the Federal agency that
takes final scheduling actions under the CSA, including any potential
descheduling or rescheduling of DORA class substances (suvorexant,
lemborexant, and daridorexant).
alternative methods for testing
Question. As you know, the FDA issued a Roadmap to reduce animal
testing.
Please provide an update on the agency's plans and timeline
regarding this initiative?
Answer. Our Roadmap, released before the hearing on April 10, 2025,
outlines an approach for FDA to reduce toxicity testing in animals in
the next 3 years:
1. Explore Pre-existing International Data.
2. Encourage sponsors to submit new approach methodologies (NAM)
data in parallel with animal data to build a repository of experience.
3. Develop an open-access repository with a comprehensive
collection of international drug toxicity data from animals and humans.
4. Reduce the routine 6-month primate toxicology testing for
monoclonal antibodies (mAbs) that show no concerning signals in 1-month
studies plus NAM tests to 3 months.
5. Reduction in animal toxicity testing timeframes for other drug
categories.
6. Changes in toxicity testing will be tracked and quantified on a
bi-annual basis.
Following the release of the roadmap, FDA and NIH held workshop on
July 7 titled, ``FDA & NIH Workshop on Reducing Animal Testing''. The
workshop discussed how the FDA and NIH can collaborate to reduce the
animal testing currently performed for new drugs and other products.
In addition, over the coming year, the FDA aims to launch a pilot
program allowing select monoclonal antibody developers to use a
primarily non-animal-based testing strategy, under close FDA
consultation. Findings from an accompanying pilot study will inform
broader policy changes and guidance updates expected to roll out in
phases.
foreign inspections
Question. Commissioner Makary, as you know many generic drugs used
in the U.S. are manufactured overseas, particularly in India and China.
I'm hopeful we can onshore more of this activity. In the interim, we
still have to ensure those who depend on these medications can trust
that they are safe and effective when they are imported.
How will the FDA ensure that it will be able to sustain its foreign
inspection schedule?
Answer. FDA has resumed the recruitment and hiring of new
investigators. Training our new and existing workforce of Investigators
who conduct inspections remains a priority. FDA is committed to the
continuous assessment and implementation of various training
improvements, standardization efforts, and evaluations in efforts to
support the development of the inspectorate and contribute to the
completion of planned foreign inspections. Emerging training focusing
on unique aspects of foreign inspections will help ensure that the time
to prepare for foreign inspection work is minimized, thereby
facilitating an aggressive foreign inspection schedule.
regulatory review timelines
Question. Commissioner Makary, many small biotech firms have
stressed that the predictability and speed of FDA regulatory engagement
is critical to their investment decisions. Can you give us your
assurance that regulatory review times and processes will not be
significantly impacted by any staffing changes at the agency?
Answer. One of my highest priorities is to ensure that the U.S.
continues to be at the leader in biotechnology innovation and to get
these cutting-edge therapies to the American public quickly. For this
reason, we made sure that there were no RIFs of reviewers of medical
products and others serving in critical roles to support FDA's mission
and operations. The Agency continues to meet its review goals under the
user fee agreements and we anticipate continuing to do so. In fact, we
have recently undertaken a number of new initiatives to make reviews
more efficient in an effort to further reduce current review times,
including for products targeting rare diseases.
Dr. Makary, you have previously stated, ``our number one goal is
delivering cures and meaningful treatment and healthier foods for
Americans.'' Smoking cessation therapies have been approved for decades
but it has been almost 20 years since a new smoking cessation therapy
has been approved.
Question. Under your leadership, how can the Center for Drug
Evaluation and Research (CDER) help Americans be more effective in
their efforts to quit smoking with new, safe and more effective smoking
cessation therapies?
Answer. FDA recognizes there is an unmet need for novel therapies
particularly for individuals who have not been able to quit smoking
despite available therapies.
We are encouraging development of novel smoking cessation drug
therapies that show benefit over existing products by providing
recommendations on how to qualify expedited development pathways such
as fast track, breakthrough, and priority review.
In May 2023, CDER finalized the draft guidance Smoking Cessation
and Related Indications: Developing Nicotine Replacement Therapy [NRT]
Drug Products. The NRT Guidance provides recommendations for applicants
to make NRT development easier, efficient, and streamlined:
--Clarifying recommendations for companies that seek approval for a
product that alters the route of administration compared to
approved NRT drug products, e.g., products with pulmonary route
of administration rather than an oral route of administration.
--Explaining when simplified efficacy study requirements may be used
(e.g., recommending a 4-week study as the minimum period of
efficacy ascertainment)
--Clearly outlining the abbreviated review pathways available for NRT
products, including how to use FDA's previous findings of
safety and how already approved NRT products and published
literature can be leveraged.
--Encouraging sponsors to consider expedited development and review
pathways, as well as providing details on how to qualify.
In addition, because the data are so strong in demonstrating that
quitting smoking can lower a person's chance of having lung disease,
heart disease, and certain types of cancer, drug products that have
been demonstrated to be effective for cessation can be approved with
labeling claims regarding these benefits without additional data
supporting benefit of the particular product on these outcomes.
To support the majority of smokers who wish to quit and to increase
utilization of cessation products and interventions, FDA and the
National Institutes of Health (NIH) are collaborating to identify
opportunities for the development of novel therapies, support
innovative trial designs, and facilitate product development for
smoking cessation therapies. Opportunities for innovation exist in many
areas including collaboration with researchers to help identify novel
targets, use of innovative clinical trial design and conduct, inclusion
of individuals underrepresented in research, developing a better
understanding of quit failures and relapse, and utilizing FDA's
expedited programs for medical product development.
To this end, FDA held a joint public meeting with NIH to discuss
innovations in development of smoking cessation products. The overall
goal of the meeting was to stimulate novel product development to
reduce rates of smoking and related chronic illnesses. Input gathered
from that meeting will help inform future guidance for industry on
development of non-nicotine containing drug products for smoking
cessation.
Question. A recent study published in JAMA Oncology looked at the
impact of smoking after a cancer diagnosis and concluded that evidence-
based smoking cessation treatment within 6 months following a cancer
diagnosis maximizes survival benefit, supporting smoking cessation as
an important early clinical intervention for patients after being
diagnosed with cancer, yet, the current smoking cessation toolkit
hasn't changed in nearly two decades. Under your leadership, how will
you ensure that all patients, including cancer patients, have the best
chance for the most optimal treatment outcomes, including for patients
for whom it is critical they are more effective in their attempts to
quit smoking?
Answer. Nicotine is a highly addictive substance, making nicotine
dependence a very challenging condition to treat. The reasons for low
success quit rates include multiple factors unrelated to availability
of safe and effective smoking cessation products, such as weight gain,
lack of access to effective therapies due to financial hardship,
exposure to other smokers and secondhand smoke, loss of an ability to
manage stress, and comorbid alcohol and other substance use disorders.
Unfortunately, less than one-third of smokers who try to quit use
counseling and FDA-approved smoking cessation drug products, which is
one potential area for intervention. Although many national oncology
organizations have emphasized the importance of smoking cessation
treatment in comprehensive cancer care, use of FDA-approved smoking
cessation products remains low in cancer patients as well. Among cancer
patients, lack of access to smoking cessation therapies has been
identified as a barrier to use. That is why we have worked to improve
access by making so many of these products available in the
nonprescription setting via the prescription to nonprescription switch
pathway, making these products accessible to consumers without the need
to see a healthcare provider.
Specifically, FDA has issued a final guidance intended to assist
sponsors in the clinical development of nicotine replacement therapy
(NRT) drug products intended to help cigarette smokers stop smoking.
That guidance, Smoking Cessation and Related Indications: Developing
Nicotine Replacement Therapy Drug Products, provides recommendations to
assist sponsors in getting novel therapies directly in the hands of
consumers, in the nonprescription setting, without going through
development as a prescription product first. This pathway could be
especially meaningful for cancer patients who seek timely access to
supportive care treatments and who wish to reduce the burden of
additional physician visits. In the guidance, we provide
recommendations for developing over-the-counter (OTC) NRT products,
which can reduce potential hurdles for access, and recommendations for
sponsors to help get novel products over the goal line for approval. It
also describes potential abbreviated pathways available for NRT
products, including how to use FDA's previous findings of safety and
how already approved NRT products and published literature can be
leveraged. Finally, the NRT Guidance encourages sponsors to consider
expedited development and review pathways and provides recommendations
on how to qualify for this review.
Question. What opportunities do you see for innovation in smoking
cessation therapies to be part of the administration's work to Make
America Healthy Again?
Answer. As part of broader national efforts to reduce the burden of
chronic conditions, such as Chronic Obstructive Pulmonary Disease
(COPD), heart disease, and cancer, there is growing interest in
advancing innovative approaches to smoking cessation. FDA's 2023 NRT
guidance, discussed in the response to Question 16A encourages
development of novel nicotine replacement therapies by providing
recommendations for applicants to make NRT development easier,
efficient, and streamlined.
Question. In October 2024, the Food and Drug Administration and the
National Institutes of Health held a joint public meeting on smoking
cessation, at which several patient and public health organizations
underscored the detrimental impact smoking continues to have on the
health of Americans and the importance of prioritizing innovations in
smoking cessation therapies. What opportunities do you see to ensure
FDA does not accept the status quo and the Center for Drug Evaluation
and Research (CDER) approaches the risk-benefit considerations for
nicotine replacement therapies in a manner that reflects the realities
of how hard it is to quit and the unmet need for patients who continue
to fail in their quit attempts?
Answer. Please see FDA's response to previously question.
Question. Cigarette smoking and secondhand smoke exposure account
for nearly half a million deaths in the United States each year.
Smoking-related death and disease cost the United States $600 billion
each year and contribute to significant health challenges. Reducing
smoking is not only an urgent public health challenge for Americans,
but also an economic challenge for the health care system and American
taxpayers. What is the administration doing to advance innovation in
smoking cessation in order to offer Americans access to new therapies
that can help them succeed in their quit attempts and limit the toll
smoking-related health conditions take on the Medicare and Medicaid
programs, and most importantly, the patients served by these health
programs?
Answer. It is important to note that FDA does not develop drugs.
Historically, FDA has seen limited interest from sponsors in developing
nicotine replacement therapy products and we have not seen a recent
change. Please see FDA's response to Question 16A for information about
how FDA is attempting to encourage development novel smoking cessation
drug therapies.
compounding drugs
Question. In the Drug Quality and Security Act, Congress authorized
the FDA to identify drug formulations that are ``demonstrably difficult
to compound (DDC),'' to protect patients when the scientific evidence
demonstrates that the risks of compounding a particular drug outweigh
the benefits. Once added to the DDC list, it becomes unlawful to
compound.
Commissioner Makary, as you know, the FDA is authorized to limit
503A compounding of specific drug products and 503B compounding of
drugs and categories of drugs. In a March 2024 proposed rule, the FDA
described six criteria for evaluating whether a drug should be added to
the DDC list. I have heard concerns from constituents that the agency
may seek to use those criteria to ban entire categories of drugs from
503A compounding. This could negatively impact patients who rely on
compounded medications for a wide range of conditions, including when
drugs are on shortage.
Will you commit that you will not finalize any rule that exceeds
the agency's statutory authority under section 503A, including that
only individual drug products may be added to the 503A DDC list?
Answer. As you note, FDA issued a proposed rule, ``Drug Products or
Categories of Drug Products That Present Demonstrable Difficulties for
Compounding Under Sections 503A or 503B of the FD&C Act,'' in March
2024.
The Agency is currently reviewing public comments on the proposed
rule, including comments regarding the scope of the Agency's
authorities regarding the development of the DDC lists.
FDA plans to finalize the rule consistent with our authorities
under the FD&C Act.
regulatory review timelines
Question. Many individuals are accessing health information through
the use of digital tools, in addition to health care providers who are
using such tools to make treatment decisions. Prescription Drug-Use-
Related Software continues to play an increasing role in patient care
and it is important to have a consistent framework in place that takes
a modern approach to digital regulation. During the first Trump
Administration, FDA issued guidance to advance such a framework.
Dr. Makary, do you plan to advance and/or update the guidance
released during the first Trump Administration regarding the regulation
of Prescription Drug-Use-Related Software?
Answer. FDA is considering whether to prepare a final version or
issue another draft of the Regulatory Considerations for Prescription
Drug Use-Related Software (PDURS) draft guidance document. FDA will
continue to engage with stakeholders who are exploring PDURS and will
consider whether to issue or revise guidance based on stakeholder
feedback as appropriate and evolving regulatory considerations.
Phenobarbital--Phenobarbital, a schedule IV controlled substance,
is a barbiturate that can slow the activity of a user's brain and
nervous system. It is my understanding that phenobarbital in tablet
form is primarily for veterinary use, and the only use approved by FDA
is for the control of seizures associated with idiopathic epilepsy in
dogs. Despite FDA's approval in 2023, many animals are being treated
with unapproved phenobarbital drugs intended for human use.
I understand the FDA is aware of this issue and announced earlier
this year that in November, 2024 warning letters were issued to six
firms that were selling unapproved drugs that do not contain
phenobarbital and that claim to treat and control seizures in dogs.
Question. In addition, has the FDA considered sending letters to
companies prescribing or dispensing unapproved phenobarbital human
drugs in lieu of an approved veterinarian phenobarbital drug?
Answer. CVM published a CVM Update following the conditional
approval of Fidoquel-CA1 (phenobarbital tablets) for dogs on September
6, 2023, that included the statement, ``Unapproved phenobarbital
tablets from the human drug marketplace have historically been used in
veterinary medicine to help control seizures in dogs. Fidoquel-CA1 are
the only phenobarbital tablets that have received the agency's
conditional approval for safety, quality manufacturing and reasonable
expectation of effectiveness.'' CVM Updates are posted on our website
and are also sent to various stakeholders.
Question. Given that ``Dear Veterinarian Letters'' and ``Dear
Pharmacy Professional Letters,'' are issued by the FDA, has the agency
considered appropriately notifying veterinarians and pharmacists of the
availability of the FDA-approved phenobarbital drug for treatment of
their animal patients in lieu of unapproved phenobarbital preparations
intended for human use?
Answer.When CVM conditionally approved Fidoquel-CA1 (phenobarbital
tablets), a CVM Update was issued (FDA Conditionally Approves
Phenobarbital Tablets to Control Seizures in Dogs with Idiopathic
Epilepsy FDA). This CVM Update explains that Fidoquel-CA1 tablets are
the only phenobarbital tablets that have received the agency's
conditional approval for safety, quality manufacturing, and reasonable
expectation of effectiveness. The CVM Update further explains that
conditional approval allows an animal drug sponsor to legally market
its product after demonstrating that the drug is safe and manufactured
in accordance with full approval standards, and that there is a
reasonable expectation of effectiveness for use. At this time, CVM does
not intend to issue a ``Dear Veterinarian Letter'' or ``Dear Pharmacy
Professional Letter'' about Fidoquel-CA1, as this information is
already captured in the CVM Update. The sponsor of Fidoquel-CA1 was
encouraged to share the CVM update with veterinarians and pharmacy
professionals.
______
Questions Submitted by Senator Jerry Moran
Question. The Prescription Drug User Fee Act (PDUFA) was
established in 1992 to address concerns regarding delays in the FDA's
regulatory review of new medications for patients. Congress enacted
PDUFA as a bipartisan approach to ensure that the American public
receives the high-standard regulatory authority it deserves. PDUFA
performance goals are designed to enhance the efficiency and
effectiveness of the first cycle review process and minimize the number
of review cycles required for approval. Compared to its inception in
1992, significant progress has been made. However, despite the shared
commitment between the U.S. FDA and the regulated industry, recent
performance signals have raised concerns: 1) inconsistent first cycle
approval rates, 2) fewer priority reviews granted in 2024 compared to
the past 5 years, and 3) delayed responsiveness to meeting requests
from companies developing medications for patients. What specific
measures will be implemented to improve FDA performance?
Answer. FDA has worked and will continue to work diligently to meet
its PDUFA performance goals. The FDA responds to each of the
performance signals identified in this question:
The rate of first cycle approval is not a PDUFA performance goal;
however, PDUFA commitments negotiated between FDA and regulated
industry can contribute to greater first cycle approvals of marketing
applications. As published in CDER's New Drugs Approval Reports,
approvals of novel therapies in the first review cycle have
consistently been well above 50% for the past 4 years: 86% in 2021 (43
out of 50); 76% in 2022 (28 out of 37); 84% in 2023 (46 out of 55); and
74% in 2024 (37 out of 50). For 2025, CDER has approved 19 novel
therapies as of July 3, 2025, and 15 (79%) of these are first cycle
approvals. CBER's first cycle approvals were 89% in 2021 (8 out of 9);
100% in 2022 (12 total); 82% in 2023 (9 out of 11); and 90% in 2024 (9
out of 10).
The number of priority reviews granted is also not a PDUFA
commitment and instead reflects the type of marketing applications
submitted to the FDA. Priority review is granted only if the marketing
application meets the criteria for this expedited review program.
Similar to the data for first cycle reviews, this information is
provided in CDER's New Drugs Approval Reports, and the percentage of
novel drugs approved that were designated priority review has
consistently been above 50% for the past 4 years: 68% in 2021; 57% in
2022; 56% in 2023; and 56% in 2024. Of the 19 novel therapies approved
in 2025 thus far, 10 (53%) were priority reviews. Of CBER approved
products, there were high percentages of priority designated products:
78% in 2021; 75% in 2022; 73% in 2023; 70% in 2024.
Although neither of these above metrics is a PDUFA performance
goal, FDA's ability to consistently deliver in both of these areas is a
reflection of the extensive engagement between FDA and regulated
industry throughout drug development.
In regard to your third concern, providing a timely response to
meeting requests by either granting or denying the request is a PDUFA
performance goal. FDA has historically met or exceeded this goal for
most meeting types. To continue to maintain our PDUFA performance, FDA
is committed to hiring, training, and retaining quality scientific
staff across multiple disciplines.
Question. Complete Response Letters (CRLs) from the FDA for all
approved products have remained relatively constant since 2018, but the
proportion of those CRLs that can be attributed to manufacturing and
quality-related issues has increased substantially. CRLs can arise for
a wide range of issues, but with good, prompt communication between the
FDA and sponsors there can be opportunities to avoid CRL and achieve a
First Cycle Approval.
Given the increasing proportion of CRLs for manufacturing and
quality-related issues, what steps will FDA take to improve
communication with sponsors during the review and adjust the timing of
manufacturing inspections to reduce unnecessary CRLs and accelerate
patient access to innovative medicines?
Answer. Timely interactive communication with sponsors during drug
development is a core Agency activity and helps achieve the Agency's
mission to facilitate efficient and effective drug development
programs.
FDA publishes policy documents such as guidance documents,
compliance programs, and manuals of policies and procedures to
facilitate an applicant or manufacturer's understanding of requirements
and recommendations, and FDA business processes. This information
enables applicants and manufacturers to proactively understand and meet
pharmaceutical quality standards before submitting an application for
review.
After FDA receives an application, FDA's obligation is to manage
the review process and determine whether a submitted application meets
the legal and scientific requirements for approval of the product. To
increase the likelihood of first cycle approval, however, the
applicant's continued active involvement is important, especially in
responding to requests for additional information that may be prompted
by the ongoing reviews.
In addition, we have initiated a new program for Post-Warning
Letter Meetings (PWLM) regarding a facility's ongoing efforts to
remediate current good manufacturing practice (CGMP) deficiencies.
Beyond the User Fee Commitments on facility inspections/
evaluations, FDA has enhanced existing practices to provide earlier
communication to a sponsor or applicant when any facility inspection,
not just preapproval, may impact approvability to promote interaction
between sponsor/applicant and their manufacturing facility to attempt
to remediate the inspection observations prior to the application goal
dates.
To avoid first-cycle CRLs due to manufacturing and quality issues,
FDA continues to recommend that applicants/sponsors conduct due
diligence to audit their manufacturing facilities, ensure they are
meeting CGMP requirements that help protect patients and to provide
access to high quality, safe, and effective medicines. Leveraging pre-
submission meetings with the FDA and applying current FDA guidance and
advice to their submissions, can help alleviate challenges that occur
when a submission is of poor quality or does not incorporate
recommendations found in publicly available guidance.
FDA works with all sponsors to resolve issues and help speed
development of new products, while maintaining high, scientifically
based safety and efficacy standards.
Question. Considering the decrease in the percentage of novel drugs
approved first in the US from 86% in 2016 to 64% in 2023, what actions
will be taken to ensure the FDA has adequate resources to uphold its
high standards for regulatory review and enhance transparency in the
review process to accelerate American access to innovative, safe and
effective treatments?
Answer. The decrease in novel drugs approved first in the US is
likely attributable to multiple factors. Pharmaceutical companies'
decisions of where to first bring a novel drug to the market is likely
based on a variety of business considerations, most of which would be
beyond FDA's expertise and ability to opine on. It's also worth noting
that the proportion of first-in-class drugs has increased from 2023
(36%) to 2024 (48%), indicating that drugs with novel mechanisms of
action may be starting to represent a larger proportion of novel drug
approvals in the US.
FDA cannot comment publicly on specific drug development programs
or existing or potential applications of unapproved products. However,
FDA recognizes that drug developers and capital markets alike want
predictability. To that end, FDA published more than 200 letters, known
as complete response letters (CRLs). Many were issued in response to
applications submitted to the FDA for approval of novel drug or
biological products between 2020 and 2025. By making the CRLs
available, the public now has significantly greater insight into the
FDA's decision-making and the most common deficiencies cited that
sponsors must address before their application is approved. The Agency
is in the process of publishing additional CRLs from its archives and
is continuously exploring ways of providing the public with greater
transparency into its decision-making process.
Commissioner Makary, you should know that Kansas is home to part of
the Animal Health Corridor, which has more than 300 animal health
companies--the largest concentration in the world. The animal health
industry works with farmers and ranchers, government agencies, and
veterinarians to ensure the health and safety of animals, humans, and
the food supply. The Center for Veterinary Medicine (CVM) at FDA has
long been an agency operating independently with the unique mission to
review food, food additives, and drugs for animals to ensure they are
safe and effective for the market.
Question. How will FDA ensure the animal product review functions
at CVM can not only continue, but be improved?
Answer. CVM will continue to recruit scientific reviewers to
maintain essential staffing levels and specialized expertise to ensure
compliance with statutory and user fee goals. Integration of artificial
intelligence tools will help streamline current review processes,
furthering efficient review determinations for new animal drugs.
Question. What changes are needed at CVM to improve the review
process and allow more innovation to come to the market?
Answer. FDA believes that facilitating increased innovation is
critical to supporting the agriculture industry and others working to
support both human and animal health. The Agency has begun modernizing
its approaches, including through the use of artificial intelligence,
and it welcomes the opportunity to work with Congress on any approaches
that may be useful in improving these efforts.
Question. In March, HHS Secretary Kennedy directed the FDA to
explore rulemaking to revise the Substances Generally Recognized as
SAFE (GRAS) Final Rule to eliminate the self-affirmed GRAS pathway.
What is the current status of this directive?
Answer. We are pursuing the Secretary's directive and exploring
potential rulemaking to eliminate the self-affirmed GRAS pathway.
In the Spring 2025 Unified Agenda, FDA announced intent to publish
a proposed rule, that if finalized would amend the Generally Recognized
as Safe (GRAS) regulations in 21 CFR parts 170 and 570 to require the
mandatory submission of GRAS notices for the use of human and animal
food substances that are purported to be GRAS.
Question. If FDA were to eliminate this pathway, in part or whole,
what does the FDA view as an adequate replacement or alternative that
will not force food companies into a pipeline process that could be
subject to excessive delays?
Answer. To give a sense of the current baseline of FDA GRAS
reviews, the program currently completes review of an average of 85
human and animal foods GRAS notices per year. FDA's FY26 President's
Budget request proposes investing additional resources to support FDA's
capacity to assess the safety of exposure to chemicals in the food
supply, including meaningfully exploring closing the Generally
Recognized as Safe (GRAS) loophole and more quickly implementing a
framework for proactive, systematic, and risk-based reassessment of
chemicals used in food.
Further, the accessibility of certain information made available to
the public on FDA's website through the GRAS Notice Inventory as well
as publishing the Agency's determinations when a substance is deemed
not GRAS will continue to provide transparency to the industry to help
support GRAS submissions to the agency.
Question. How will FDA engage food producers, especially small
manufacturers, as they look for regulatory certainty?
Answer. FDA values transparency and public engagement and will
continue to engage with industry as we consider regulatory options for
improving the GRAS program. FDA is initiating rulemaking regarding the
voluntary GRAS notification program, and will issue a notice of
proposed rulemaking and invite public comment as part of that process.
Industry members looking to consult with FDA on pre-market
submissions can contact FDA's Office of Premarket and Additive Safety,
which operates the Voluntary GRAS Notification Program, at
[email protected] for human foods and animalfood-
[email protected]. for animal foods.
______
Questions Submitted by Senator Cindy Hyde-Smith
Question. Dr. Makary, you have discussed the importance of medical
innovation to improving the health of our Nation and made the comment
that drug development takes too long for many patients who are
suffering from diseases that have no current treatment.
During a recent media interview, you advocated for new regulatory
pathways for rare disease drugs, allowing for their conditional
approval based on a ``scientifically plausible mechanism.'' You stated
that in some instances, ``You can't expect the companies to do a
randomized, controlled trial; you'll kill innovation. You'll kill
investment in those innovative ideas,'' Makary said.
Can you give us examples of what you are doing to ensure that the
FDA under your leadership is moving quickly to advance new pathways for
rare disease?
Answer. FDA exercises appropriate regulatory discretion for rare
diseases to help safe and effective products come to market as quickly
as possible in accordance with the approval standards established by
law. We leverage numerous programs, tools, and resources, that serve to
speed the availability of products intended to treat patients with
serious and life-threatening diseases, while at the same time meeting
appropriate safety and effectiveness standards and facilitating the
collection of scientific data that is relevant and reliable. An example
of a new initiative we've launched that is intended in part to address
unmet medical needs, including drugs to treat or prevent rare diseases
is the Commissioner's National Priority Voucher (CNPV) Pilot Program.
Additional details can be found at the following website: https://
www.fda.gov/industry/commissioners-national-priority-voucher-cnpv-
pilot-program
We know that there are pending applications for rare diseases that
have either missed their PDUFA dates or have recently extended their
PDUFA dates.
Question. What are you doing to ensure your staff applies maximum
regulatory flexibility as required by the law and works urgently to
complete their reviews of rare disease applications on time, or even
early, to meet the urgent medical needs of patients who are waiting for
life-altering treatments).
Answer. See response to previously question.
Question. It's my understanding that FDA has an ongoing Unapproved
Drugs Initiative to remove and replace drugs that do not have the
required regulatory approval from the market. The Agency's website
States, ``FDA has taken hundreds of unapproved prescription drugs off
the market since 2006 and has executed multiple class actions announced
through Federal Register Notices''. FDA's guidance to industry
encourages manufacturers to seek FDA approval of these drugs and in
return, the Agency uses a risk-based approach to remove unapproved
drugs from the market that pose a risk to public health.
I am aware of a company who received approval for a phenobarbital
sodium product in November 2022, which marked the first, and only,
approval of phenobarbital for human use, yet thirty months later, the
Agency has not utilized its enforcement authority to remove the
unapproved drugs from the market. As explained to me, phenobarbital is
a controlled substance and many of the unapproved drugs contain
preservatives that the Agency has prohibited from use in products
administered to neonates because of known toxicity.
I am concerned the Agency's lack of action threatens the integrity
of the Agency's regulatory mission, discourages manufacturers from
making the significant investment to seek FDA approval, and poses
health risks to these patients. I am hopeful that under your leadership
the Agency will prioritize this important initiative.
Will you commit to reviewing this issue in a timely manner to
ensure patients are receiving the safest, and most effective drugs?
Answer. FDA approved Sezaby (phenobarbital sodium) in November 2022
solely for the treatment of neonatal seizures in term and pre-term
infants. Sezaby is the first FDA-approved phenobarbital sodium
injection product, and it is preservative-free. It is not approved for
use in adolescents or adults, and its labeling includes a boxed warning
that the product is only for short-term use.
There are a number of unapproved phenobarbital sodium injection
products currently on the market. These products generally are
indicated for use in the adult population as a sedative, hypnotic,
preanesthetic, or long-term anticonvulsant and for use in pediatric
patients as an anticonvulsant and sedative.
FDA exercises a risk-based approach to prioritizing enforcement
action regarding unapproved drugs. This involves considering all the
facts of a given circumstance and focusing on enforcement priorities
for drugs that pose the highest risk to public health without imposing
undue burden on patients or unnecessarily disrupting the availability
of medically necessary drugs on the market.
The Agency is currently reviewing a Citizen Petition regarding
unapproved phenobarbital sodium injection drugs, and will respond to
the Petition as soon as possible and post the response to the public
petition docket.
Question. A new study presented on Capitol Hill yesterday
highlights a critical gap: most healthcare professionals misunderstand
the risks of nicotine and remain unaware of the FDA's role in
authorizing smoke-free alternatives. They continue to equate nicotine
with cancer, despite evidence that it's the smoke- not nicotine-causing
disease. These misperceptions are preventing pivotal informed patient
counseling. This same study showed the overwhelming majority of
healthcare providers want clear, accurate guidance from FDA on
authorized smoke-free products so they can share this information with
their patients.
Will you commit to immediately prioritize educating the medical
community on the continuum of risk and the public health potential of
authorized smoke-free products?
Answer. FDA agrees that the medical community has a unique and
important role to play in the education of adults who use tobacco
products. FDA's CTP currently disseminates educational content
explaining that tobacco products exist on a continuum of risk, with
combustible products such as cigarettes being the most harmful. CTP's
``The Relative Risks of Tobacco Products'' webpage \7\ informs
consumers and stakeholders about tobacco product relative risk. CTP has
also published commentaries \8\ discussing evidence-based opportunities
for addressing misperceptions about tobacco product relative risks,
including the role of medical providers as trusted messengers of
relative risk messaging for adults.
---------------------------------------------------------------------------
\7\ https://www.fda.gov/tobacco-products/health-effects-tobacco-
use/relative-risks-tobacco-products
\8\ https://www.fda.gov/tobacco-products/ctp-newsroom/ctp-director-
co-authors-new-journal-commentary-relative-risks-tobacco-products
---------------------------------------------------------------------------
Question. Commissioner Makary, FDA places all tobacco and nicotine
products on a continuum of risk, with smoking being the most harmful.
Recent data shows that most medical professionals do not understand the
continuum of risk across nicotine products and often misperceive
nicotine- not smoke- as the main cause of tobacco related diseases.
Will you commit to educating the medical community on the relative
risks of tobacco and nicotine products, including FDA-authorized smoke
free alternatives?
Answer. See response to previously question.
Question. Skin cancer is the most common cancer in the United
States, affecting over five million Americans annually and resulting in
significant healthcare costs. Despite its prevalence, four out of five
cases of skin cancer can be prevented through sun-safe practices,
including the use of effective sunscreens. The United States has not
approved a new sunscreen active ingredient since the 1990s while our
peer countries have moved several generations ahead of the U.S. in
terms of sunscreen technologies.
Considering the preventable nature of skin cancer and the
importance of effective sunscreens, do you commit to utilizing your
budget to improve the approval process for new sunscreen active
ingredients to ensure that Americans have access to the most advanced
and effective sun protection products?
Answer. FDA is strongly committed to timely evaluation of any
industry submission requesting that FDA determine conditions under
which a new active ingredient is generally recognized as safe and
effective (GRASE) for use in sunscreens to enable that ingredient's use
in OTC monograph sunscreen products marketed in the U.S. Once an active
ingredient is included in the OTC sunscreen monograph (subject to an
exclusivity period afforded by section 505G of the FD&C Act, if
applicable), each sunscreen product that uses that ingredient can be
marketed without first being reviewed by FDA, so long as that product
conforms to the sunscreen monograph conditions and other general
requirements. This can make it easier for firms to introduce individual
sunscreen products to the market. The Agency has taken significant
steps to help advance the development of submissions that could support
a positive GRASE determination for use of new sunscreen active
ingredients. We will continue to dedicate resources to this goal as
well as to evaluation of any submissions industry makes.
______
Questions Submitted by Senator Jeanne Shaheen
Question. I am concerned about the workforce reductions at the FDA
and the impact they will have on the FDA's ability to complete
statutorily mandated functions of the Agency. Please provide responses
to the following questions:
--How many people are employed by the FDA as of May 29, 2025?
--How many people were employed by the FDA on January 19, 2025?
Answer.
------------------------------------------------------------------------
As of Jan 19, As of May 29,
Position Type 2025 2025
------------------------------------------------------------------------
Advisory Committee...................... 1785 1667
Civilian................................ 19166 17821
Commissioned Corps...................... 954 945
Total............................. 21905 20433
------------------------------------------------------------------------
probationary firings
Question. How many probationary staff were let go from the FDA
since January 20th, 2025? Please provide a total and breakdown by
Center.
--Of the probationary staff fired, how many were brought back?
--What were the factors used to determine which staff to bring back?
Answer. On 2/15/2025, the following probationary employees were
placed on administrative leave:
------------------------------------------------------------------------
Center/Office/Program Employees
------------------------------------------------------------------------
CDER.................................................... 13
CDRH.................................................... 229
CTP..................................................... 108
CVM..................................................... 41
HFP..................................................... 89
OC...................................................... 202
OII..................................................... 12
Total............................................. 694
------------------------------------------------------------------------
On 5/8/2025, the following probationary employees were terminated:
------------------------------------------------------------------------
Center/Office/Program Employees
------------------------------------------------------------------------
CDER.................................................... 1
CDRH.................................................... 28
CTP..................................................... 74
CVM..................................................... 18
HFP..................................................... 20
OC...................................................... 93
OII..................................................... 1
Total............................................. 235
------------------------------------------------------------------------
The following probationary employees were not terminated at the
time for the following reasons:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reason Not Terminated CDER CDRH CTP CVM HFP OC OII Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
Probationary Period Completed................................... 0 71 7 12 18 14 0 122
Data Correction--Not Probationary............................... 0 2 13 0 2 18 0 35
Leadership Determination........................................ 0 108 4 36 22 11 181
Resigned........................................................ 0 3 2 1 4 5 0 15
Remained on Admin Leave Pending RIF............................. 12 17 12 6 9 50 0 106
Total..................................................... 12 201 34 23 69 109 11 459
--------------------------------------------------------------------------------------------------------------------------------------------------------
Probationary employees restored due to leadership determination
were based upon mission requirements and the needs of the agency.
reductions in force (rif)
Question. How many people were let go because of the RIFs that
occurred on April 1, 2025? Please provide a total and breakdown the
RIFs by Center.
--Of the employees who were a part of the RIF, how many have been
brought back? Please breakdown by Center.
--What were the factors used to determine which staff to bring back?
Answer.
----------------------------------------------------------------------------------------------------------------
Data CBER CDER CDRH CTP CVM HFP OC OII Total
----------------------------------------------------------------------------------------------------------------
Positions impacted by RIF as of 193 825 233 220 148 256 415 170 2460
4/1/2025......................
Positions impacted by RIF 55 214 73 109 89 94 103 24 761
Rescissions as of 7/14/2025...
Positions impacted by RIF as of 133 593 167 165 113 65 333 144 1713
7/14/2025.....................
----------------------------------------------------------------------------------------------------------------
Rescission decisions were based upon impact analysis and impact to
mission.
deferred resignation program
Question. How many people at the FDA took the offer for the
Deferred Resignation Program? Please provide a total and breakdown by
Center.
--Were there staff at the FDA who sought to participate in the
Deferred Resignation Program but were not allowed to? If so,
what factors were used to determine which staff at the FDA
could participate in the Deferred Resignation Program?
Answer. Please see the below table. No eligible staff were
disallowed from participating in the deferred resignation program if
they indicated their interest to participate by the program deadline.
------------------------------------------------------------------------
DRP
COP Participants
------------------------------------------------------------------------
CBER.................................................... 24
CDER.................................................... 85
CDRH.................................................... 55
CTP..................................................... 21
CVM..................................................... 18
HFP..................................................... 51
OC...................................................... 102
OII..................................................... 100
Total............................................. 456
------------------------------------------------------------------------
early retirements
Question. How many people at the FDA have opted into the Voluntary
Early Retirement Authority or Voluntary Separation Incentive Program
since January 20, 2025? Please provide a total and a breakdown by
Center.
--How many people at the FDA combined early retirement authorities
with the Deferred Resignation Program?
Answer. See the below table for the number of individuals signed up
for the VERA and/or VSIP program after the DRP program was closed. As
part of the DRP program, 91 people indicated they were participating
under the VERA retirement authority.
------------------------------------------------------------------------
DRP
COP Participants
------------------------------------------------------------------------
CBER.................................................... 47
CDER.................................................... 112
CDRH.................................................... 72
CTP..................................................... 30
CVM..................................................... 34
HFP..................................................... 107
OC...................................................... 209
OII..................................................... 110
Total............................................. 721
------------------------------------------------------------------------
hiring
Question. You stated in your testimony that you are currently
hiring scientists and other staff. How many people and which positions
are you actively hiring for across the agency? Please provide a total
and breakdown by center or office as well as a complete list of
positions for which the agency has sought and received an exemption
from the Office of Personnel Management to the ongoing hiring freeze.
Please also share the links to positions the FDA is hiring for on USA
Jobs.
Answer. FDA has sought and received an exemption from OPM for 1,000
positions for reviewers, inspectors, and criminal investigators. FDA
plans to move forward with this hiring throughout the course of the
summer and fall. FDA will continue to provide updates to the Committee,
requested.
Question. What are you doing to ensure that all inspections move
ahead as planned and to improve the rate of attrition among inspectors?
How will that be reflected in the Fiscal Year 2026 budget request?
Answer. FDA continues to identify the highest priority inspectional
work and is taking steps to improve efficiencies in conducting
inspections. This includes using feedback mechanisms and working to
centralize and enhance key operational functions across the Agency,
empowering the Office of Inspections and Investigations (OII) to focus
more directly on its core mission-related work.
FDA has also resumed the recruitment and hiring of new
investigators. FDA is addressing attrition through various means,
including the use of hiring authorities and through improved training
processes.
OII and the Centers have ongoing collaborations to improve the
efficiency and effectiveness of investigator training, with the goal of
lessening the time for new investigators to begin conducting
independent inspections, while ensuring the FDA maintains its gold
standard for the quality of our inspection programs to protect public
health and safety. Through this training modernization effort, which
includes experiential learning and on the job training, early
engagement and meeting staff training needs will also lessen the risk
of attrition.
The FY 2026 President's Budget proposes funding levels for OII to
support all of these efforts.
Question. One known way to cure type 1 diabetes (T1D) is through
cell therapies, which replace destroyed beta cells with external cells
that make insulin and protect them so that they maintain function long-
term. The advancement of cell therapies holds immense promise for
transforming the lives of those with T1D and other diseases. However,
challenges and uncertainty in the therapy pipeline, including review
timeliness and insufficient patient and expert input, are causing
delays. What steps will you take to ensure cell therapies can reach the
T1D populations that need them without unnecessary delay?
Answer. FDA works with all sponsors to resolve issues and speed
development of new products, while maintaining high standards for
safety and efficacy that are based on science. Clinical holds for
Investigational New Drug applications (INDs) investigating Cell and
Gene Therapy (CGT) products for treating various diseases, including
Type 1 diabetes, have markedly decreased in the past few years. The
decline results from many factors, including outreach efforts to better
inform sponsors of IND content necessary to assess risks and address
safety issues, and internal Agency efforts to ensure timely review of
potential clinical hold issues, which enables sponsors to provide
missing/additional information when feasible.
FDA also works with patients and their advocates to ensure that the
patient voice is included in the regulatory process, and that reviewers
have access to the latest science. For example, to advance Type 1
diabetes products, CBER works with Breakthrough T1D (formerly the
Juvenile Diabetes Research Foundation) on an annual Cell Therapies
Educational Seminar series, where outside experts provide science-based
lectures on emerging technologies for the treatment of diabetes. Prior
to the 2023 approval of LANTIDRA (donislecel-jujn), a cellular therapy
product composed of purified allogeneic deceased donor pancreas derived
islets of Langerhans for the treatment of certain adults with Type I
diabetes, an FDA advisory committee meeting was held where the
committee and FDA reviewers considered testimony from patients who
participated in clinical studies for the product.
FDA remains committed to advancing the development of safe and
effective CGT products to treat serious or life-threatening conditions,
including various rare diseases, forms of cancer, and Type 1 diabetes.
When combined, FDA's scientific and patient-focused efforts increase
predictability in the regulatory process to support a robust CGT
product development pipeline.
Question. FDA participation in external scientific efforts that
advance development and review of new therapies is critical. Such pre-
competitive engagement guides the research to align with FDA
expectations in real time, keeps the FDA informed on the current state
of science, and makes future reviews more efficient. We've heard recent
reports that FDA staff have declined invitations to participate in such
external scientific efforts, citing bandwidth and the need to focus on
PDUFA activities. We've also heard that previously planned and
recurring events between the FDA and non-governmental organizations
have been cancelled by the agency. When will external engagement at
these types of events resume? What is the agency's policy on external
engagement?
Answer. For more than 100 years, the FDA has been working to carry
out our mission of promoting and protecting public health, and engaging
with the public and the scientific community is a key part of that
work. While there was a brief pause for certain types of engagements
and communications at the agency at the beginning of the new
administration, external engagements have resumed and remain a
priority. The commissioner also recently began a series of Expert
Panels to engage the public, media, and the scientific community on
important public health topics, which have been open to the public and
livestreamed. This initiative is part of the FDA's broader efforts to
apply rigorous, evidence-based standards to ingredient safety and
modernize regulatory oversight, thoroughly considering evolving science
and consumer health.
______
Questions Submitted by Senator Patty Murray
Question. In 2022, Congress passed the bipartisan Modernization of
Cosmetics Regulation Act (Moca) which finally empowered the FDA with
the tools it needs to better ensure cosmetic products are safe. MoCRA
passed over 2 years ago, and the FDA has not put out any Good
Manufacturing Practices for any cosmetic products. When does FDA expect
those to be finalized?
Answer. FDA has listed a proposed rule, ``Good Manufacturing
Practice for Cosmetic Product Facilities,'' on the Unified Agenda as a
long-term action.
Question. Do you have a timeline for finalization?
Answer. MoCRA established timeframes requiring the Secretary to
publish a proposed rule not later than 2 years after December 29, 2022,
which was on December 29, 2024, and to publish a final rule not later
than 3 years after December 29, 2022, which is on December 29, 2025.
Although the statutory date for publishing the proposed rule has
passed, FDA is prioritizing this rulemaking.
The Long-Term National Strategy to Increase the Resiliency of the
Infant Formula Market outlines several actions the FDA should be taking
to protect the integrity of the infant formula supply chain, including
taking measures to prevent contamination, and incentivizing new infant
formula manufacturers to enter the U.S. market.
Question. What are you doing to implement the recommendations
within the National Strategy to improve the integrity of infant formula
supply chain in the U.S.?
Answer. FDA has taken numerous steps to implement recommendations
in the Long-Term National Strategy to Increase the Resiliency of the
U.S. Infant Formula Market:
--In October 2024, FDA established the Office of Critical Foods to
oversee the regulation of critical foods (i.e., infant formula
and medical foods) and continues prioritizing staff hiring,
including having dedicated investigators to conduct infant
formula inspections. The FY 2026 President's Budget proposes
increased funding for infant formula work.
--FDA has worked to enhance infant formula supply diversity by
providing a pathway for domestic and foreign infant formula
manufacturers that were provided enforcement discretion to
continue marketing their products while they worked to meet all
FDA requirements. All the manufacturers participating in the
enforcement discretion transition pathway submitted their new
infant formula submissions, for a total of 12 new infant
formula products, consistent with FDA's timing expectations.
--FDA is enhancing post-market surveillance by taking the following
steps:
--Released draft guidance in December 2024 for infant formula
manufacturers on notifying the FDA of permanent
discontinuances or interruptions that are likely to lead to
a meaningful disruption in the U.S. supply.
--Engaging with infant formula manufacturers to monitor and assess
production levels, ingredient supply chains, and final
product distribution. FDA also monitors in-stock rates to
track product volume and variety, as well as sales data to
identify early signals of potential disruption.
--Working with industry to establish a system for voluntary
reporting of product samples that test positive for
Cronobacter or Salmonella.
--FDA collaborates with USDA's Special Supplemental Nutrition
Program for Woman, Infants, and Children (WIC) to help
ensure infant formula manufacturers meet evidence-based
standards while exploring enhanced contract flexibilities
during supply disruptions.
Question. How are you ensuring this work remains ongoing in light
of agency reorganization efforts, probationary firings, deferred
resignations, and RIFs?
Answer. FDA's Human Food Program is dedicated to and continues to
prioritize the work contained in the Long-Term National Strategy and
Operation Stork Speed. Overall, the functions outlined in the strategy
are all related to critical foods work and, therefore, were not
substantively affected by staff reductions. Additionally, despite the
Federal hiring freeze, we have been able to post some high-priority job
vacancies, one of which is the Director of the Office of Critical
Foods, who will be directly responsible for the oversight of infant
formula.
I am concerned that there was not a public search for the Director
of the Center for Biologics and that Title 21 hiring authority may have
been used. Title 21 was part of the landmark 21st Century Cures Act
that I championed, was intended to help the FDA bring experts on board
quickly and at relatively competitive salaries. Title 21 hiring
authorities were drafted as such to prevent the hiring of political
appointees.
Question. Can you confirm whether Dr. Prasad was hired under Title
21 and, if so, explain why a public search was not conducted, as has
been done for all of the other recent senior leadership positions at
the centers?
Answer. Following a nationwide search, Dr. Prasad was hired under
the Title 21 hiring authority as the best candidate available. Dr.
Prasad's extensive background as a medical practitioner, an author, and
in academia made him uniquely qualified for the critical position as
Director of the Center for Biologics Evaluation and Research. Given the
importance of this position, it was not in the public interest to leave
it vacant for many months. Title 21 allowed FDA to expedite the
recruitment process and more efficiently onboard Dr. Prasad, as the
Agency has done with other highly qualified experts in the past.
This approach aligns with the legislative intent of the 21st
Century Cures Act to help the FDA attract top talent quickly with
competitive salaries.
Question. If not hired under Title 21, what authority was used to
hire Dr. Prasad?
Answer. Dr. Prasad was hired under Title 21 hiring authority.
Question. Do you commit to doing public searches for the Center for
Drug Evaluation and Research and the Human Foods Program, who currently
have acting directors?
Answer. As of December 3, 2025, Dr. Tracey Beth Hoeg is the acting
Director of the Center for Drug Evaluation and Research. FDA has made a
permanent hire of Kyle Diamantes as the Deputy Commissioner for Human
Foods. Both are extremely qualified and have already provided great
contributions in support of public health.
Question. The FDA is now requiring Pfizer and Moderna to expand
warning labels of their COVID-19 vaccines to include risk of heart
inflammation in adolescents and young men ages 18 to 24. This was
determined after FDA's own analysis of insurance claims indicated an
increased incidence from the 2023-2024 formulations. Will FDA be
releasing this report and the data you used to determine this new
practice?
Answer. In a post-approval U.S. study \9\ funded and co-authored by
FDA, study authors noted that myocarditis and pericarditis is a known
complication of mRNA 9 vaccines, most frequently seen in adolescent and
young adult males 1 to 7 days following vaccination.
---------------------------------------------------------------------------
\9\ https://www.sciencedirect.com/science/article/pii/
S2589537024003882?via%3Dihub
---------------------------------------------------------------------------
Using data in a separate analysis, the estimated incidence rate of
myocarditis and pericarditis during the 1-7 days following
administration of the 2023-2024 formula of mRNA COVID-19 vaccines was
approximately 8 cases per million doses in individuals 6 months through
64 years of age, with the highest rate among males aged 12-24 years at
approximately 27 cases per million doses. These estimates do not
provide an analysis of or evidence of an increased risk over time in
any age group, but a standalone estimates of risk in the 1 to 7 days
following the 2023-2024 Formula of mRNA COVID-19 vaccines.
The BEST initiative conducts continuous monitoring and assessment
of the safety of vaccines, including the mRNA COVID-19 vaccines. These
safety studies include prespecified analyses that assess whether the
risk of an outcome is elevated and associated with vaccination, and
results can be found on the BEST. Results of the 2023-2024 formula mRNA
COVID-19 vaccine safety studies have been submitted for peer-reviewed
publication and are currently under review.
Question. As FDA Commissioner, you have talked about increasing the
transparency of the agency. Did you share the data mentioned in
Question 4 with outside experts to help the FDA make a decision about
including this risk on vaccine labels?
Answer. Information about myocarditis (inflammation of the heart
muscle) and pericarditis (inflammation of the lining outside the heart)
following vaccination with these mRNA COVID-19 vaccines has been
included in the labeling since 2021. FDA has considered presenting the
updated myocarditis/pericarditis data at a future Advisory Committee on
Immunization Practices meeting if the opportunity arises. FDA is also
evaluating the best way to disseminate these results.
Question. The FDA is essentially limiting COVID-19 vaccine
approvals to people 65 and older and those with underlying conditions,
because pharmaceutical companies are unlikely to conduct randomized
control trials of updated vaccine formulations each year, as your new
policy States they need to do. In alignment with your goal of
transparency, will you please share which outside experts reviewed FDA
recommendations on this policy change?
Answer. FDA notes that vaccine manufacturers have agreed to conduct
additional randomized controlled studies in individuals 50 to 65 years
of age without high-risk conditions and the Agency plans to review and
take appropriate action on applications for vaccines with 2025-26
COVID-19 vaccine formulations. Further, it has not been established
that updated vaccine formulations will be necessary each year in
perpetuity. Please refer to ``An Evidence-Based Approach to Covid-19
Vaccination'' in New England Journal of Medicine which was published
after discussion with the expert editorial staff of NEJM.
Question. Did any of the outside experts feel that this policy
change was unwarranted?
Answer. Please reference previously question.
Question. What ethical concerns about this policy change were
expressed?
Answer. Please reference previously question.
Question. What data did you present to outside experts to determine
that this policy was evidence-based?
Answer. Please reference previously question.
Question. The Make American Healthy Again Commission is
recommending that pesticides be reduced, as they are a driver of
chronic health conditions in American children. What process will you
create to start broad conversations with experts outside of the FDA to
determine next steps regarding pesticide use?
Answer. FDA will take the following steps regarding appropriate
pesticide use, including by engaging experts outside of the FDA as
appropriate: 1) monitor pesticide residues in the American diet through
compliance surveys and the FDA Total Diet Study while also providing
transparent reporting of that data to all applicable stakeholders,
including those in the US government; 2) coordinate with USDA and
States to inform data-driven policies; 3) as appropriate, provide
technical support to EPA in their role to reduce unnecessary or harmful
pesticide use; and 4) as appropriate, engage in any reforms to Federal
programs that favor traditional field crops over organic foods when and
if FDA is the appropriate agency to be engaged.
Question. How will you identify best practices for improving
childhood nutrition as a driver of childhood chronic disease?
Answer. Improving nutrition is one of the most effective public
health interventions for reducing diet-related chronic illnesses and
premature death. The vast majority of Americans, including children, do
not eat enough fruits, vegetables, dairy, seafood, whole grains, and
healthy oils. Researchers have estimated that more than half of
calories consumed by adults and children in the U.S. are from foods
considered to be ultra-processed, which are linked to increased risk of
negative health outcomes. There are many best practices that can and
are being implemented across the Federal Government to support
Americans in meeting recommendations for a healthy eating pattern. For
example, FDA is encouraging industry to make healthier foods and
helping provide nutrition information so that consumers can make
informed choices. Further, FDA recently updated the definition of the
``healthy'' content claim to help consumers identify foods that are
particularly useful as the foundation of a diet that is consistent with
dietary recommendations. We will continue to work with Federal partners
to research and identify best practices, including through FDA and the
National Institutes of Health's recently announced Nutrition Regulatory
Science Program.
Question. Will you work with USDA to ensure that the SNAP, WIC, and
the National School Lunch Program is fully funded so that children and
families have access to healthy food?
Answer. Reducing childhood chronic diseases is a priority for this
Administration and FDA. The U.S. Department of Agriculture (USDA) is
responsible for administering these programs and FDA regularly
collaborates with USDA and other Federal agencies on a variety of
nutrition programs and issues.
Question. What do you see as the biggest barrier to improving
childhood nutrition in the U.S. and what steps will you take to address
this?
Answer. While there are numerous factors that impact children's
health, improving nutrition is one of the most effective public health
interventions for reducing diet-related chronic illnesses. FDA is
committed to addressing the root causes of chronic disease through its
authorities, including by helping provide people with information and
tools to help support healthy food choices while improving the
nutritional quality of the food supply.
FDA is already moving forward with helping provide Americans with
'at-a-glance' information they can use to make better informed
nutritional decisions, including with its front-of-package nutrition
labeling work. FDA is also working with USDA and other Federal partners
to develop a definition for ultra-processed foods to support uniform
research and policies and provide increased transparency to consumers
about the food they eat. The FY 2026 President's Budget includes a
request to increase funding for FDA's nutrition work, including
expanding a new pilot program to help schools research nutrition and
transition to healthier foods to help ensure children in our Nation are
served nutritious, wholesome food that will set them up for a healthy
future.
Question. You recently held a virtual FDA Expert Panel on Talc.
Could you please share the takeaways from that panel, and what FDA's
next steps are related to address talc exposure?
Answer. As part of the Trump Administration's commitment to
transforming the future of American health care and restoring trust in
public health, the U.S. Food and Drug Administration held an
independent panel of scientific experts for a roundtable discussion in
a public forum on Tuesday, May 20, 2025. Using gold-standard science
and a transparent process, this historic roundtable set the public
standard for future roundtables, evaluating the safety and necessity of
talc as an additive in food, drug, and cosmetic products. The expert
panel, comprised of leaders in their respective fields, reviewed the
latest scientific evidence, evaluated potential health risks, explored
alternatives, and offered their recommendations for action. The Agency
will take a close look at the literature shared by the panel and re-
engage with stakeholders as questions emerge. Regarding additional
steps, FDA continues to prioritize this issue and is working toward
rulemaking.
Question. What process did the FDA use to determine who should be
on the Expert Panel?
Answer. The panel was designed to bring together experts with a
broad representation of perspectives to discuss the issue.
Question. You have indicated that you will soon hold an FDA
roundtable on menopause hormone replacement therapy. Could you please
share more details about these plans?
Answer. FDA will host the ``FDA Expert Panel on Menopause and
Hormone Replacement Therapy for Women'' on July 17, 2025, from 1:00--
3:00 ET. Panelists include Marty A. Makary, M.D., M.P.H., FDA
Commissioner and Sara Brenner M.D., M.P.H., FDA Principal Deputy
Commissioner. Additional panelists include those with expertise in
various aspects of menopausal health, including gynecological,
urological, cognitive, bone, and cardiovascular care. The purpose of
the meeting is to discuss the latest understanding of the benefits and
safety of menopause hormone therapy. The event will be live streamed
and can be viewed over the FDA's YouTube channel.\10\
---------------------------------------------------------------------------
\10\ https://www.youtube.com/user/USFoodandDrugAdmin
---------------------------------------------------------------------------
Question. Is the FDA going to be reviewing only hormonal treatments
for menopause, or will you also consider non-hormonal treatments?
Answer. The FDA Expert Panel discussion will focus on hormonal
treatments for conditions related to menopause. Regarding drugs to
treat menopausal symptoms more broadly, FDA considers development
programs and applications for hormonal and non-hormonal medications.
Question. What is the FDA currently doing to ensure that the
accelerated approval pathway is available for rare disease treatments?
Answer. FDA supports drug development through the accelerated
approval pathway in many ways. Sponsors are encouraged to communicate
with the Agency early in the drug development process concerning (1)
the potential eligibility of a drug for accelerated approval, (2)
proposed surrogate endpoints or intermediate clinical endpoints, (3)
clinical trial designs, and (4) the planning and conduct of
confirmatory trials. In addition, the Rare Disease Endpoint Advancement
Pilot Program is a PDUFA VII commitment designed to support novel
efficacy endpoint development for drugs that treat rare diseases.
FDA's recent initiatives also help facilitate the use of the
accelerated approval pathway for rare disease therapies. For example,
the Rare Disease Innovation Hub launched in 2024 serves as a point of
collaboration and connectivity between CBER and CDER with the goal of
ultimately improving outcomes for patients with rare diseases. The Hub
program is intended to support both internal alignment and
communication with the rare disease community on a variety of topics,
including guidance on surrogate endpoints and accelerated approval.
Communication with rare disease stakeholders is an important aspect of
facilitating rare disease product development.
Approximately 60-70% of drugs approved under the accelerated
approval pathway are oncology drugs, including drugs to treat rare
cancers. Quite often the appropriate regulatory pathway (e.g.,
traditional approval or accelerated approval) for drugs intended to
treat rare cancers is discussed early on in pivotal trial design.
______
Questions Submitted by Senator Jeff Merkley
Question. When Congress gave FDA the authority to oversee tobacco
products, it established an appropriately high bar for a new tobacco
product to enter the market. Under the standard established in the
Family Smoking Prevention and Tobacco Control Act, manufacturers must
provide strong evidence that the benefits of introducing a new tobacco
product to the market will outweigh the risks.
In reviewing applications for e-cigarettes in recent years, FDA has
determined that flavors pose an additional level of risk because they
are much more appealing to youth than tobacco-flavored products.
Because of this higher level of risk, FDA has required e-cigarette
manufacturers to show that a flavored e-cigarette will be more
effective at helping a smoker to stop smoking cigarettes than a
tobacco-flavored e-cigarette. A unanimous Supreme Court recently upheld
this requirement. The vast majority of e-cigarette applications for
flavored products have not been able to provide the evidence of a
benefit to smokers that outweighs the risk to kids.
Under your leadership, will FDA continue to require robust evidence
that the benefit of a flavored product in helping smokers quit is
sufficient to outweigh the demonstrated risk of the flavor to youth?
Answer. The Federal Food, Drug and Cosmetic Act (FD&C Act) requires
that FDA deny a premarket tobacco application (PMTA) where it finds
``there is a lack of a showing that permitting such tobacco product to
be marketed would be appropriate for the protection of the public
health.'' FDA is committed to its responsibility to protect public
health, follow the law, and carefully review the science presented in
each premarket application when determining if a product meets the
standard for marketing.
Flavors are an important consideration in the review of a PMTA
because of their impact on potential toxicity, consumer perceptions,
and health risks-especially to youth. The burden is on the applicant to
provide evidence to meet the public health standard provided by
Congress. FDA will continue to consider whether PMTAs for flavored e-
cigarette products contain evidence of an added benefit to adult
smokers, as compared to tobacco-flavored e-cigarette products, that
could outweigh the known and substantial risk of flavored e-cigarette
products to youth.
Question. Do you think the premarket review process is an important
way to keep e-cigarettes that are particularly appealing to young
people off the market?
Answer. Ensuring new tobacco products undergo premarket evaluation
by FDA is a critical part of the Agency's mission to protect the public
health, particularly for the youth, and to reduce tobacco-related
disease and death. As part of the evaluation of e-cigarettes, FDA
determines whether to authorize the marketing of a new product under
the ``appropriate for the protection of the public health'' standard
and will not authorize marketing if the applicant does not demonstrate
that the public health benefit outweighs the risk to non-users,
including youth.
Question. Earlier this year, dozens of staffers at the FDA's Center
for Tobacco Products (CTP) were placed on administrative leave,
including the Center's director. How many total FDA CTP employees have
lost their jobs? How many have lost their jobs as a result of:
--The recent reductions in force announced by the Department on March
27, 2025 (including transfers to other Federal agencies)?
--The termination of probationary employees?
--Other Administration efforts to reduce the Federal workforce (e.g.,
early retirement and Fork in the Road)?
Answer. Thus far, no CTP employees have been removed as a result of
the reduction in force, as they remain pending. 73 CTP probationary
employees were terminated. A total of 51 employees voluntarily left
their positions and made use of one of the incentive programs.
Question. For each office within FDA CTP (e.g., Office of the
Director, Office of Management, Office of Regulations, Office of
Science, Office of Health Communications and Education, and Office of
Compliance and Enforcement), how many people have been removed from
their positions and how many remain?
Answer.
----------------------------------------------------------------------------------------------------------------
Terminated Other
Row Labels (Probationary) Termination Retain
----------------------------------------------------------------------------------------------------------------
CTP............................................................. 73 3 924
OFFICE OF THE CENTER DIRECTOR................................... 27
OFFICE OF MANAGEMENT............................................ 2 19
OFFICE OF REGULATIONS........................................... 25
OFFICE OF SCIENCE............................................... 67 1 558
OFFICE OF HEALTH COMM & EDUCATION............................... 3 55
OFFICE OF COMPLIANCE & ENFORCEMEN............................... 4 240
----------------------------------------------------------------------------------------------------------------
Question. Which directors of offices within FDA CTP have been
removed from their positions, placed on administrative leave, or
transferred to other Federal agencies?
Answer. As of 7/26/2025, the Director for the Office of Science
within FDA CTP is on administrative leave pending reassignment to IHS.
In addition, the Director of the Center for Tobacco Products was
initially placed on administrative leave pending reassignment to IHS
but has since resigned.
Question. Does FDA CTP intend to spend the $712 million in tobacco
user fees authorized under the Family Smoking Prevention and Tobacco
Control Act and included in the FY 2025 Full-Year Continuing
Appropriations and Extensions Act (Public Law 119-4)? Please indicate
how CTP intends to spend its tobacco user fees for FY 2025, including,
but not limited to, dollars spent on premarket review, enforcement of
marketing and sales of illegal products, and Tobacco Centers of
Regulatory Science.
Answer. In FY 2025, CTP plans to spend $680M in the following
program areas:
------------------------------------------------------------------------
FY Planned
Program Area Spending
------------------------------------------------------------------------
Product Review, Scientific Research, and Research $277M
Infrastructure.....................................
Compliance and Enforcement.......................... $164M
Public Education Campaigns and Communications....... $80M
Leadership, Management Oversigt, and Administrative $37M
Services...........................................
Related Overheard Activities........................ $122M
Total Obligations:............................ $680M
------------------------------------------------------------------------
Please note that because most of CTP's tobacco regulatory
activities cut across product classes and programs, we do not track
spending by tobacco product class or for specific programs such as
premarket review or enforcement against illegally marketed products.
However, both PMTA review and Tobacco Centers of Regulatory Science
spending is captured in the Product Review, Scientific Research, and
Research and Research Infrastructure program area.
The Center's FY 2025 planned spending level is lower than its
annual user fee collection amount for the following reasons.
--As a result of litigation, CTP no longer has the statutory
authority to collect user fees from manufacturers and importers
of premium cigars. For FY25, this means that about $16M in user
fees will not be collected. When the litigation concludes, FDA
intends to consider what options are feasible and statutorily
authorized for reallocating the fees.
--Additionally, through the HHS cost efficiency initiative, CTP has
reduced planned acquisitions spending in FY 2025 by the
required $78.5 million. However, any unspent user fees in FY
2025 will be carried over and available to spend in FY 2026.
Question. What functions of CTP have been transferred to other
offices at FDA or to other agencies? To which offices or agencies were
they transferred?
Answer. None of CTP's functions have been transferred.
Question. What functions of CTP have been eliminated?
Answer. None of CTP's mission areas have been eliminated. The
Center continues to perform all of its programmatic functions.
______
Questions Submitted by Senator Gary Peters
Question. In response to questioning about FDA's suspension of
programs to improve testing for potential H5N1 contamination in
consumer products, including testing of milk, cheese and pet food, due
to mass layoffs, you testified that a Washington Post article
``debunked'' these concerns.
Please provide a copy of the Washington Post article you referenced
in your testimony.
Answer. As requested, the Washington Post article, titled ``FDA's
milk testing program pause is not cause for alarm, experts say'', can
be found at the following: https://www.washingtonpost.com/food/2025/04/
23/fda-milk-testing-program-paused/
Question. Has FDA suspended, scaled back, or changed any of its
programs to monitor and test for H5N1 since January 20, 2025? If so,
please explain FDA's actions and its reasoning for suspending, scaling
back, or changing any of these programs.
Answer. FDA programs to test for H5N1 in animal and human food have
not changed since January 20, 2025. A combination of FDA internal
laboratories, USDA's National Veterinary Services Laboratory, and FDA's
Veterinary Laboratory Investigation and Response Network are supporting
testing of animal and human food products for H5N1 virus.
You also testified that FDA suspending milk testing was due to a
``normally scheduled pause'' to ``recalibrate the equipment'' and that
it is ``back up and running.''
Question. Please provide the full schedule for the Interlaboratory
Comparison Exercise as it stood on April 1, 2025.
Answer. As of April 1, 2025, the HPAI Interlaboratory Comparison
Exercise (ICE) schedule was as follows:
Completed work:
Planning began in November 2024. Sample testing, including
stability, was completed in March 2025.
Scheduled work from April 1:
April 2025: Finalize instruction documents and training
materials for participating laboratories
April 28th 2025: Ship sample sets to laboratories
May 12th 2025: Laboratory results due
June 2nd 2025: Send preliminary report to laboratories
August 2025: Complete final report
Question. Please list all the entities that have or were scheduled
to participate in the Interlaboratory Comparison Exercise as of January
20, 2025, or later, including those from FDA's Veterinary Laboratory
Investigation and Response Network and food laboratories, the USDA's
National Animal Health Laboratory Network, and private industry.
Answer.43 laboratories have participated in the HPAI
Interlaboratory Comparison Exercise, as of January 20, 2025:
--21 state laboratories
--13 university laboratories
--2 private industry laboratories
--2 other government laboratories
--5 FDA Laboratories:
--FDA Arkansas Human and Animal Food Laboratory
--FDA San Francisco Human and Animal Food Laboratory
--FDA Denver Laboratory
--FDA New York Human and Animal Foods Laboratory
--FDA Atlanta Human and Animal Food Laboratory
Question. Please describe all quality assurance programs FDA is
currently carrying out with regards to identifying potential H5N1 virus
contamination in human or pet food.
Answer. FDA testing is performed in accordance with the ``FDA
Regulatory Testing Laboratory Manual of Quality Policies,'' which was
prepared to meet the requirements for the laboratories' accreditation
to the International Organization for Standardization/International
Electrotechnical Commission (ISO/IEC 17025:2017). FDA HPAI RT-qPCR
detection methodology incorporates internal amplification controls in
the qPCR reactions in addition to surrogate virus extraction controls
to establish confidence in laboratory results.
Question. Please list all staff positions within FDA's Human Food
Program as of January 20, 2025 and a corresponding description of each
position, including:
--The job or function the position relates to.
--Whether the position was filled on January 20, 2025.
--Whether there have been any changes to the staffing of the position
since January 20, 2025, and if so, describe the specific
change(s).
--Whether FDA has any plans to reduce or eliminate the position
within the next 24 months, and if so, what it may or will be
replaced with.
Answer. Below is a table noting each job function within HFP and
the number of positions within that function. Because staffing is fluid
and employees are hired, leave FDA, or move to other parts of the
Agency, staffing levels may change on a day-to-day basis. FDA currently
does not have plans to reduce or eliminate such positions within the
next 24 months.
As of January 20, 2025, HFP had the following 1,965 employees:
------------------------------------------------------------------------
Position Title Positions
------------------------------------------------------------------------
Acquisition Program Specialist.......................... 5
Acquisition Program Specialist Assistant Commissioner 1
For Par................................................
Acquisition Program Specialist Audiovisual Production 2
Special................................................
Acquisition Program Specialist Bio (Sensory- 1
Organoleptic)..........................................
Acquisition Program Specialist Biological Science Lab 1
Technic................................................
Acquisition Program Specialist Biological Science 2
Technician.............................................
Acquisition Program Specialist Biologist................ 176
Acquisition Program Specialist Biologist (Molecular).... 1
Acquisition Program Specialist Biologist (Senior Science 1
Advisor)...............................................
Acquisition Program Specialist Biologist (Reg Prog 1
Expert)................................................
Acquisition Program Specialist Branch Chief............. 7
Acquisition Program Specialist Branch Chief For Budget 1
Formulation............................................
Acquisition Program Specialist Branch Chief, Chemical 1
Contami................................................
Acquisition Program Specialist Branch Chief, Exposure 1
Assessm................................................
Acquisition Program Specialist Branch Chief, Supervisory 1
Phar...................................................
Acquisition Program Specialist Budget Analyst........... 10
Acquisition Program Specialist Business Analyst......... 1
Acquisition Program Specialist Business Information 1
Management.............................................
Acquisition Program Specialist Certification Control 1
Assistant..............................................
Acquisition Program Specialist Chemist.................. 240
Chemist (Industrial).................................... 1
Chemist (Investigative Analyst)......................... 1
Chemist (Quality Assurance Man)......................... 1
Chemist (Color Spec).................................... 1
Chemist (QA Manager).................................... 1
Chemist (Residue Testing)............................... 1
Chemist (Technology).................................... 1
Chemistry............................................... 1
Chief Critical Foods Officer............................ 1
Computer Scientist...................................... 2
Consumer Complaint Coordinator.......................... 7
Consumer Complaints Coordinator......................... 2
Consumer Safety Officer................................. 238
Consumer Safety Officer (Compl)......................... 1
Consumer Safety Officer (Milk).......................... 1
Consumer Safety Officer (Nation)........................ 1
Consumer Safety Officer (Program)....................... 1
Consumer Safety Officer (Retail......................... 21
Consumer Safety Officer (Shell)......................... 15
Consumer Safety Officer Product......................... 1
Consumer Safety Technician.............................. 1
CSO (National Standardization).......................... 1
Data Scientist.......................................... 2
Dep Dir For Animal Der Foods............................ 1
Dep Dir For Scientific Operation........................ 1
Deputy Commissioner For Human........................... 1
Deputy Director......................................... 1
Deputy Director For Plant Deri.......................... 1
Deputy Director ODSP.................................... 1
Deputy Director, Office Of Par.......................... 1
Deputy Director, Office Of Reg.......................... 1
Deputy Office Director.................................. 2
Deputy Office Director, Office.......................... 1
Dietitian/Nutritionist.................................. 1
Dir, Ne Regional Lab.................................... 1
Director Of The Office Of Diet.......................... 1
Director, DBP........................................... 1
Director, OARSA......................................... 1
Director, Office Of Core................................ 1
Director, Office Of Executive........................... 1
Director, Office Of Management.......................... 1
Director, Office Of Nutrition........................... 1
Director, Office Of Regulatory.......................... 1
Director, Southeast Food And F.......................... 1
Division Director, Analytical........................... 1
Division Director, DITM................................. 1
Division Director, DWM.................................. 1
Electronic Engineer..................................... 1
Electronics Technician.................................. 1
Emergency Response Specialist........................... 1
Entomologist............................................ 14
Epidemiologist.......................................... 16
Ethics Management Specialist............................ 1
Executive Assistant..................................... 2
FDA Liaison To CDC...................................... 1
Food Defense Science Program C.......................... 1
Food Technologist....................................... 9
Food Technologist....................................... 1
General Health Scientist................................ 4
Geneticist.............................................. 2
Geneticist (Research)................................... 1
Government Information Special.......................... 4
Health Communication Specialist......................... 3
Health Communications Spec.............................. 5
Health Communications Specialist........................ 2
Health Communications Specialist........................ 15
Health Informaticist.................................... 2
Health Science Policy Advisor........................... 1
Health Scientist........................................ 6
Health Scientist (Quality).............................. 1
Horticulturist.......................................... 3
Hydrologist............................................. 1
Industrial Hygienist.................................... 1
Industrial Property Management.......................... 1
Information Technology Special.......................... 2
Instructional Systems Specialist........................ 4
Interdisciplinary Scientist............................. 1
Interdisciplinary Scientist (B.......................... 1
International Policy Analyst............................ 6
Laboratory Support Assistant............................ 9
Laboratory Technician (Oa).............................. 1
Laboratory Worker....................................... 2
Lead Biologist.......................................... 13
Lead Chemist............................................ 19
Lead Consumer Safety Officer............................ 8
Lead Government Information Sp.......................... 2
Lead Management Analyst................................. 1
Lead Management And Program An.......................... 2
Lead Microbiologist..................................... 16
Lead Toxicologist....................................... 1
Legal Instruments Exam (Oa)............................. 2
Legal Instruments Examiner.............................. 1
Legal Technician (Oa)................................... 1
Management And Program Analyst.......................... 1
Management & Program Analyst............................ 1
Management Analyst...................................... 45
Management And Program Analysi.......................... 3
Management And Program Analyst.......................... 30
Management/Program Analyst.............................. 1
Management And Program Analyst.......................... 2
Mathematical Statistician............................... 10
Mathematician Statistician.............................. 2
Medical Officer......................................... 2
Mgt And Prog Analysis Officer........................... 1
Microbiologist.......................................... 1
Microbiologist.......................................... 156
Microbiologist (QSS).................................... 1
Microbiologist (Spec Asst To Lb......................... 1
Microbiologist.......................................... 2
Miscellaneous Administration A.......................... 1
Ntnl Food Sfty Edc Advisor.............................. 1
Nutritionist............................................ 8
Office Director......................................... 1
Office Director, Office Of Pri.......................... 1
Office Support Assistant................................ 1
Operations Research Analyst............................. 2
Pharmacologist.......................................... 1
Physical Science Technician............................. 3
Physical Scientist...................................... 1
Physician............................................... 3
Policy Advisor.......................................... 1
Policy Analyst.......................................... 29
Policy Analyst (International).......................... 3
Program Analyst......................................... 79
Program Analyst (International)......................... 2
Program Manager (Communication)......................... 1
Program Manager (Diversity, Eq)......................... 1
Program Specialist...................................... 9
Program Support Specialist.............................. 13
Project Coordinator..................................... 1
Project Manager......................................... 31
Project Officer......................................... 2
Project Specialist...................................... 8
Public Affairs Specialist............................... 9
Public Health Advisor................................... 4
Public Health Analyst................................... 2
Public Health Educator.................................. 5
Public Information Specialist........................... 1
Quality Assurance Manager............................... 1
Quality Assurance Specialist............................ 3
Quality Systems Specialist.............................. 2
Records & Info Management Spec.......................... 2
Regulations Analyst..................................... 1
Regulatory Counsel...................................... 14
Regulatory Health Information........................... 1
Regulatory Information Special.......................... 2
Regulatory Policy Analyst............................... 3
Research Biologist...................................... 28
Research Biologist (Bioinformatic)...................... 1
Research Chemical Engineer.............................. 2
Research Chemist........................................ 22
Research Entomologist................................... 1
Research Food Technologist.............................. 2
Research Microbiologist................................. 31
Research Microbiology................................... 1
Research Pharmacologist................................. 2
Safety And Occupational Health.......................... 1
Sample Evidence Specialist.............................. 13
SBRBPAS Expert.......................................... 5
SBRBPAS Expert (Parasitologist)......................... 1
SBRBPAS Expert (Microbiologist)......................... 1
Science Policy Analyst.................................. 1
Senior Advisor.......................................... 2
Senior Advisor For Compliance........................... 1
Senior Advisor For Intentional.......................... 1
Senior Advisor For Policy............................... 1
Senior Consumer Safety Officer.......................... 1
Senior Dietician........................................ 1
Senior Health Communication Sp.......................... 1
Senior Physician........................................ 3
Senior Policy Advisor................................... 8
Senior Policy Analyst................................... 5
Senior Project Manager.................................. 3
Senior Project Officer.................................. 1
Senior Regulatory Advisor............................... 1
Senior Regulatory Counsel............................... 3
Senior Regulatory Counsel For........................... 1
Senior Science Advisor.................................. 2
Senior Science Advisor For Bio.......................... 1
Senior Science Advisor For Eco.......................... 1
Senior Science Advisor For Foo.......................... 3
Senior Science Advisor For Glo.......................... 1
Senior Science Advisor For Int.......................... 1
Senior Science Advisor For Mil.......................... 1
Senior Science Advisor For Nut.......................... 2
Senior Science Advisor For Pro.......................... 1
Senior Science Advisor For Ris.......................... 1
Senior Science Advisor For Tox.......................... 2
Senior Staff Fellow..................................... 1
Senior Staff Fellow (Biologist)......................... 1
Sensory Expert Organoleptic............................. 1
Social Science Analyst.................................. 5
Social Scientist........................................ 2
Special Assistant....................................... 4
Staff Assistant......................................... 5
Staff Director.......................................... 4
Staff Fellow............................................ 24
Staff Fellow (Biologist)................................ 3
Staff Fellow (Consumer Safety........................... 1
Staff Fellow-Pharmacologist............................. 1
Statistician............................................ 1
Statistician............................................ 1
Strategic Communications Specialist..................... 1
Student Trainee......................................... 1
Supervisory Government Info Special..................... 1
Supervisory Consumer Safety O........................... 3
Supervisory Program Analyst............................. 1
Supervisory Project Specialist.......................... 2
Supervisory Biologist................................... 11
Supervisory Biologist (Integra)......................... 1
Supervisory Budget Analyst.............................. 3
Supervisory Chemist..................................... 43
Supervisory Consumer Safety Of.......................... 54
Supervisory Consumer Safety Off......................... 1
Supervisory Data Scientist.............................. 2
Supervisory Entomologist................................ 1
Supervisory Food Technologist........................... 2
Supervisory General Health Sci.......................... 2
Supervisory Geneticist.................................. 1
Supervisory Health Communication........................ 1
Supervisory Health Scientist............................ 1
Supervisory Information Commun.......................... 1
Supervisory Information Techno.......................... 2
Supervisory Management Analyst.......................... 6
Supervisory Management And Pro.......................... 7
Supervisory Management Liaison.......................... 1
Supervisory Management Officer.......................... 1
Supervisory Microbiologist.............................. 29
Supervisory Physician................................... 1
Supervisory Policy Advisor.............................. 1
Supervisory Project Specialist.......................... 1
Supervisory Public Health Educ.......................... 2
Supervisory Quality Assurance........................... 1
Supervisory Regulatory Counsel.......................... 3
Supervisory Regulatory Special.......................... 1
Supervisory Safety And Occupational..................... 1
Supervisory SBRBPAS Expert.............................. 1
Supervisory SBRBPAS Expert (Ch)......................... 1
Supervisory Science/Regulatory.......................... 1
Supervisory Toxicologist................................ 4
Supply Management Specialist............................ 1
Support Services Specialist............................. 4
Supervisory Facilities Res Specialist................... 1
Supervisory Consumer Safety Officer..................... 3
Supervisory Health Communications Spe................... 1
Supervisory Mathematical Statistician................... 1
Supervisory Mgmt And Prog Analyst....................... 2
Supervisory Microbiologist.............................. 2
Supervisory Program Manager............................. 1
Supervisory SBRBPAS Expert (Chemist).................... 3
Supervisory SBRBPAS Expert (Nutrition).................. 1
Supervisory Social Scientist............................ 1
Supervisory Training Specialist......................... 1
Supervisory Public Affairs Specialist................... 1
Survey Statistician..................................... 1
Technical Information Specialist........................ 6
Toxicologist............................................ 21
Training Administrator.................................. 1
Training Specialist..................................... 7
Vet Medical Officer (Pathology)......................... 1
Visiting Associate (Biologist).......................... 1
Visiting Scientist...................................... 1
Visual Information Specialist........................... 3
Writer-Editor........................................... 1
Total............................................. 1965
------------------------------------------------------------------------
Question. You testified that staffing cuts at FDA have not
increased the risks related to bird flu. Has FDA cut any staffing
positions or responsibilities related to bird flu since January 20,
2025?
--As of January 20, 2025, please list every position at FDA that has
responsibilities regarding H5N1/bird flu and, for each,
describe:
--The specific responsibilities related to H5N1/bird flu carried out
by the person in the position.
--Whether the position was filled on January 20, 2025.
--Whether there have been any changes to the staffing of the position
since January 20, 2025, and if so, describe the specific
change(s).
--Whether FDA has any plans to reduce or eliminate the position
within the next 24 months, and if so, what it may or will be
replaced with.
Answer. The reduction in force (RIF) has not had an impact on FDA's
activities related to H5N1. Upon my arrival at FDA, the Agency
undertook an evaluation of all positions to ensure that any jobs
critical to FDA's mission or operations were either not part of the RIF
or had the RIF rescinded. FDA currently does not have plans to reduce
or eliminate such within the next 24 months.
You testified that a potential future H5N1/bird flu vaccine should
be based on a strain showing an ``antigenic shift that represents a[n]
epidemic threat, when there is human-to-human transmission.''
Question. What evidence has FDA collected, obtained, or received to
date demonstrating that such an antigenic shift has occurred for H5N1?
Answer. In the United States, the Centers for Disease Control and
Prevention (CDC) is the lead for monitoring H5 avian influenza (bird
flu) activity in people. As of July 7, 2025, the CDC reported publicly
that there is no known person-to-person spread at this time in the
United States and the risk is low for the general public.
Question. Is FDA at any stage of evaluation for potential H5N1
vaccine candidates for humans? If so, please describe what vaccines are
being evaluated and which H5N1 strain(s) are being targeted.
Answer. FDA has approved three H5N1 vaccines for use in the U.S.
[Sanofi Pasteur Inc (2007), ID Biomedical Corporation of Quebec (2013),
and Seqirus, Inc. (2020). The vaccines manufactured by ID Biomedical
and Seqirus are approved for use in individuals 6 months of age and
older.
The vaccine manufactured by Sanofi is approved for use in
individuals 18 through 64 years of age.
As discussed during FDA's October 2024 Vaccines and Related
Biological Products Advisory Committee meeting,\11\ licensed vaccine
manufacturers have prepared candidate H5 influenza vaccines for A/
Astrakhan/3212/2020, which has a hemagglutinin that is closely related
antigenically to the HA of currently circulating H5 clade 2.3.4.4b
viruses. Clinical trials to evaluate immunogenicity and safety have
been initiated and FDA is working closely with these manufacturers to
evaluate the results. Information about these vaccines is available on
clinicaltrials.gov at https://clinicaltrials.gov/study/
NCT05975840?id=NCT05975840&rank=1 and https://clinicaltrials.gov/study/
NCT05874713?id=NCT05874713&rank=1.
---------------------------------------------------------------------------
\11\ https://www.fda.gov/media/182543/download
---------------------------------------------------------------------------
Question. Please provide any evidence FDA has that demonstrates a
``universal flu shot'' would be effective against H5N1 infection or
transmission in or among mammals. For the ``current strain of bird
flu'' you cited that such a universal vaccine may protect against,
please provide the specific H5N1 strain information.
Answer. The goal of developing a ``universal'' influenza vaccine
would be to provide protection against many or most clades and strains
of influenza and several experimental approaches are being actively
pursued by researchers and vaccine manufacturers. Some vaccine
candidates have demonstrated their potential for broad immunity in
animal models, but all are still in development.
In May, doctors at the Children's Hospital of Philadelphia
announced an incredible medical breakthrough--a baby born with a rare
genetic disorder appears to be largely cured thanks to personalized
gene therapy that uses CRISPR gene-editing technology. It took just 6
months from the time the baby was born to the doctors giving him the
first treatments--a speed only made possible by rapid FDA approval of
the novel therapy and knowledge learned from decades of robust Federal
funding for science. Please describe what FDA is currently or planning
on doing to ensure it has enough skilled personnel to help Americans
benefit from remarkable advancements in personalized medicine.
Question. How many FDA personnel (irrespective of hiring mechanism)
were assigned to reviewing, or consulting with outside stakeholders
(such as academia and industry) on, applications for novel gene/
personalized medicine therapies on January 20, 2025, and how many
personnel are so assigned as of May 22, 2025?
Answer. The Office of Therapeutic Products (OTP) within FDA's
Center for Biologics Evaluation and Research leads and oversees the
development of CGT products and other products. It should be noted that
many staff split their time between reviewing novel cell and gene
therapy (CGT) products and other products regulated by CBER. As such,
it is difficult to give a precise answer to the personnel assigned to
reviewing or consulting on such applications. However, as an
approximation, 366 employees were assigned to OTP on January 20, 2025,
and 349 employees were assigned to the office on May 22, 2025.
Question. Please list all FDA positions responsible for reviewing,
or consulting with outside stakeholders on, applications for novel
gene/personalized medicine therapies that are or will be impacted as
part of a reduction in force, deferred resignation, or early retirement
program.
Answer. As noted in Question 6A it is difficult to give a precise
answer to the personnel assigned to reviewing or consulting on such
applications. As of September 16, 2025, 4 OTP employees were part of
the deferred resignation program and 10 OTP employees took part in
early retirement programs. No OTP staff members involved in review of
CGT applications were subject to reduction in force.
Question. Please list all FDA positions responsible for reviewing,
or consulting with outside stakeholders on, applications for novel
gene/personalized medicine therapies that are or will be considered for
elimination. For each position, please describe whether the position
will be replaced by something else (for example, an AI tool) or
combined with another position(s).
Answer. FDA is working to retain and recruit reviewers for CGT
products and is not considering these positions for elimination or
replacement.
Question. Please describe the specific artificial intelligence (AI)
tools FDA is or will deploy as part of its regulatory and research
processes, including the entity or entities that developed or have some
level of ownership of the tool. For each AI tool:
--Please list which specific FDA components, programs, or offices
will be deploying it.
--Please describe what cybersecurity and information security
measures are or will be in place to safeguard intellectual
property and other proprietary information, confidential or
other privacy-related data, and any other sensitive information
or data.
--Please describe the training that FDA personnel have or will
receive before and while using the tool.
--Please describe what oversight FDA personnel will perform over the
output produced by the tool, to include ensuring quality
control, regulatory compliance, protection of privacy,
protection of intellectual property, etc.
Answer. In June 2025, FDA deployed the generative AI Tool, Elsa,
across the entire Agency. Elsa's development team was comprised of
experts from every Center. Currently, we have approximately 11,400
users of Elsa, with 6,000-7,000 weekly active users, making it one of
our most utilized applications. Elsa is an FDA-wide solution that can
be employed to help with tasks in every Center/Office. The system
supports diverse functions, from administrative tasks to Freedom of
Information Act requests and human resources needs. We also expanded
accessibility by developing mobile capabilities specifically for field
investigators. In addition to Elsa, FDA is currently compiling the 2025
annual HHS AI use case inventory in accordance with Executive Order
13960, ``Promoting the Use of Trustworthy Artificial Intelligence in
the Federal Government.'' FDA's 2024 use case list may be found here:
AI Use Cases Inventory HHS.gov.
Regarding cybersecurity and information security measures, Elsa
operates within the most robust security framework available to Federal
agencies. The system is deployed in a FedRAMP/FISMA High environment,
which represents the highest level of Federal cybersecurity standards.
Our key security measures include comprehensive data protection
protocols. The system is also not connected to the internet and
operates securely behind the FDA firewall, allowing our staff to input
FDA confidential information safely while maintaining the highest
security standards. We maintain strict access controls, including user
profile restrictions and the ability to create locked-down, user-
specific document libraries. Staff can upload documents and data during
individual chat sessions, and this information remains within that
specific session and user context, preventing unauthorized access or
data sharing. Additionally, we maintain rigorous vendor management
protocols with our cloud solution providers and AI vendors, ensuring
they meet all Federal security requirements while providing us with
access to the latest modeling capabilities within our secure
environment.
Our training approach is deliberately structured and progressive.
We have conducted extensive trainings, paired with multiple office
hours and video recordings. Our approach focuses heavily on prompt
engineering--teaching users to craft specific, effective queries rather
than relying on generic interactions. As new features and models are
released, staff will be required to attend trainings to unlock such
additional AI models and features. This ensures we have a process to
continually train and reinforce the proper use of these tools as they
advance.
FDA maintains rigorous mechanisms to ensure regulatory compliance
and protection of sensitive information. All users are trained that
Elsa is a supportive tool, not a decision-maker, and that they must
verify all outputs through our established multiple levels of review.
We maintain structured processes with extensive oversight, ensuring
that AI-assisted work still meets our rigorous scientific and
regulatory standards. Users learn to utilize feedback mechanisms,
including rating systems that help our development team understand
usage patterns and improve the system. Finally, we have implemented
features in our system such that when users are interacting with
Document Libraries, Elsa is forced to read prompts in the context of
those documents and cite relevant documents, significantly limiting the
likelihood that Elsa hallucinates information or references.
Regardless, FDA staff are required to validate sources and information
in every instance.
We also plan to provide Center leadership with information about
usage patterns, enabling them to understand how their teams are
utilizing the tools and ensure appropriate application within their
specific regulatory contexts. Finally, we maintain currency with the
latest AI capabilities, while ensuring all updates meet our security
and functionality requirements. We recently upgraded from Claude 3.5 to
Claude 4.0 within our secure environment, demonstrating our commitment
to providing staff with cutting-edge tools while maintaining the
highest security standards.
Question. Were algorithms used to make decisions about FDA's
staffing cuts? If so:
--Who created the algorithms FDA used to execute these staffing cuts?
Please identify the name, title, and affiliation of each
individual involved.
--Who at FDA reviewed the algorithm decisions about staffing cuts
prior to their execution?
--Who executed the staffing cuts and rehiring decisions at FDA?
Answer. FDA is not aware of algorithms used to make staffing
decisions. Decisions were made by the Principal Deputy Commissioner and
executed by the Chief Operating Officer.
An April 21, 2025, Brookings report raised concerns regarding the
lack of quality standards for active ingredient manufacturers of
semaglutide used in bulk compounding. The report found that a ``large
share'' of these manufacturers were based ``almost exclusively'' in
China, most had never been inspected by FDA, and many of those who had
been inspected ``had drug quality assurance violations.'' Reports also
raised concerns that FDA's staffing cuts may impact its ability to
conduct foreign drug inspections.
Question. What is FDA doing to ensure quality standards for bulk
semiglutide and that all drug products entering the U.S. are safe and
effective?
Answer. FDA reviews shipments of drugs offered for import to
determine whether they appear to comply with applicable standards and
are admissible into the U.S. FDA may detain and refuse products that
appear to be compliant products. The Agency's risk-based oversight has
enabled us to effectively identify potential violations and take
action, ultimately contributing to a more secure supply chain.
Surveillance inspections for registered active pharmaceutical
ingredient (API) and finished dosage form drug manufacturers are
prioritized by the CDER risk-based Site Selection Model (SSM). The SSM
uses risk factors, based on statutory requirements and emerging risks
to prioritize inspectional assignments from CDER-regulated sites.
On September 5, 2025, FDA established a ``green list'' import alert
to help stop potentially dangerous GLP-1 (glucagon-like peptide-1) API,
including semaglutide, from unverified foreign sources from entering
the U.S. market. This is part of the agency's steps to safeguard
consumers from GLP-1 active ingredients imported from overseas that
fail to meet applicable quality standards or are otherwise unlawful to
help ensure patient safety and a secure drug supply chain. The green
list includes GLP-1 API from suppliers the agency has evaluated (e.g.,
through establishment inspections or review of records requests) that
appear to be in compliance with the FDA's rigorous standards--standards
applicable to all API manufactured within or outside the U.S. The
agency will continue to work with state regulators, monitor the market,
and take enforcement actions as necessary to prevent unsafe or
fraudulent GLP-1 drugs from reaching U.S. consumers.
FDA actively monitors the internet to identify unsafe online
pharmacies and websites offering misbranded and/or illegally marketed
unapproved drugs for sale to U.S. consumers and has issued warning
letters seeking to stop and prevent the distribution of illegally
marketed GLP-1 drugs. For instance, FDA has issued warning letters to
companies, including compounding pharmacies and suppliers of active
pharmaceutical ingredients used in compounding, that have illegally
sold semaglutide, tirzepatide, or retatrutide drugs. FDA has urged
consumers not to purchase these products, which are of unknown quality
and may be harmful to their health. FDA's Office of Criminal
Investigations has also worked with the Department of Justice to bring
actions against parties for introducing unapproved and misbranded drugs
into interstate commerce, including GLP-1 drugs.
In the President's FY 2026 proposed Budget, FDA proposed that
Congress amend the FD&C Act to clearly require that the label and any
accompanying certificate of analysis for an API for use in drug
manufacturing, including human drug compounding, identify the name,
address, and unique facility identifier of the API's original
manufacturer. The original manufacturers of API are not always readily
identified in labeling, such as when the label only indicates the
repackager or distributor. This supply chain information is critical to
investigate quality and safety problems.
Question. Has FDA made any staffing cuts that would impact its
ability to carry out domestic and foreign drug manufacturing
inspections?
Answer. FDA's investigator positions were not included in the RIF
and the Agency continues to carry out inspections of both domestic and
foreign drug facilities. Notably, FDA has recently embarked on an
effort to increase the number of unannounced foreign facility
inspections.
Question. In addition to FDA's announcement that it will be
conducting unannounced foreign drug inspections, what specifically is
FDA doing to ensure its inspection workforce is sufficiently staffed
with experienced investigators to carry out quality inspections of both
active pharmaceutical ingredient (API) and finished dosage form (FDF)
manufacturing facilities to ensure products entering the U.S. meet
FDA's quality standards and Current Good Manufacturing Practices
(CGMPs)?
Answer. FDA notes that it has been conducting unannounced and
short-notice inspections of foreign drug manufacturing facilities for
several years and that we are now building on and significantly
expanding those efforts. In terms of staffing, the Agency has resumed
the recruitment and hiring of new investigators, including having
announced multiple vacancies for investigator positions in efforts to
hire additional inspectional staff.
Training our new and existing investigator workforce remains a
priority. In support of the Agency's mission to have the workforce
trained and operationally ready more quickly, the Office of Inspections
and Investigations (OII) Office of Training, Education, and Development
recently updated new Investigator training (aka Operational
Foundations) to support basic inspection training across all
commodities, and is exploring options for more effectively leveraging
technology (e.g., AI) and immersive learning to improve efficiency and
reduce the time to achieve the Independent Work qualification.
OII and the Center for Drug Evaluation and Research are
collaborating to continually enhance and improve the training content
and delivery to ensure that any staff conducting inspections on behalf
of the Agency are consistently trained and prepared to conduct high
quality inspections of both API and FDF drug manufacturing facilities.
______
Questions Submitted by Senator Kirsten Gillibrand
Question. In February, FDA announced the recall of Lyons ReadyCare
and Sysco Imperial frozen supplemental shakes. The recall is connected
with an outbreak of Listeria that has infected 42 people from 21
States, including New York, and has led to 41 hospitalizations and 14
deaths. As Ranking Member of the Special Committee on Aging, I am
concerned about this outbreak because the shakes were sold to
congregate care settings, such as nursing homes.
Although FDA closed its investigation into the Listeria outbreak, I
am concerned about how HHS cutbacks and efforts by the so-called
``Department of Government Efficiency'' may have impacted the
investigation. My Aging Committee staff reached out to FDA with a
series of questions on March 17, 2025. On March 27, HHS Secretary
Kennedy announced his ``reorganization'' of the Department of Health
and Human Services. On April 1, FDA informed my staff that the
individuals working on a response to my staff's questions ``are no
longer at FDA as of this morning'' and suggested that I reach out to
HHS directly for a response. Given this turn of events, I ask that you
answer the following questions:
How did staffing on the FDA team responding to the Listeria
outbreak change between January 20, 2025 and the conclusion of FDA's
investigation into the outbreak? Please provide information detailing:
Answer. HFP's Coordinated Outbreak Response and Evaluation team did
not experience any staffing changes during this time-period.
Question. The number of staff on the FDA team on January 20, 2025.
Answer. The response team is a multidisciplinary group composed of
six members.
Question. The number of staff on the FDA team when the Listeria
investigation was closed.
Answer. The response team consisted of six members when this
investigation was closed.
Question. The number of staff on the FDA team who accepted the
``deferred resignation'' scheme e-mailed by OPM to Federal employees on
January 28, 2025, or who accepted any subsequent buyout or deferred
resignation offers.
Answer. No members of the response team accepted the deferred
resignation program.
Question. The number of staff on the FDA team who were laid off or
fired between January 20, 2025 and the date when the Listeria
investigation was closed.
Answer. No members of the outbreak response team were laid off or
fired during the course of the investigation.
Question. What were the specific roles and duties of the staff on
the FDA team that responded to the Listeria outbreak who accepted the
January 28, 2025 deferred resignation scheme, or any subsequent buyout
or deferred resignation offers? Please also detail:
Answer. As stated above, no members of the response team left the
Agency during that time period.
Question. How those staff were involved in supporting the
investigation into the Listeria outbreak connected to frozen shakes.
Answer. As stated above, no members of the response team left the
Agency during that time period.
Question. What were the specific roles and duties of the staff on
the FDA team who responded to the Listeria outbreak who were laid off
or fired between January 20, 2025 and the date that FDA closed the
investigation into the Listeria outbreak? Please also detail:
Answer. As stated above, no members of the response team left the
Agency during that time period.
Question. How those staff were involved in supporting the
investigation into the Listeria outbreak connected to frozen shakes.
Answer. As stated above, no members of the response team left the
Agency during that time period.
Question. Please describe the role and duties of the FDA team that
responded to the Listeria outbreak in responding to other outbreaks of
foodborne illnesses.
Answer. FDA's Office of Coordinated Outbreak Response, Prevention,
& Emergency Preparedness (CORE+EP) has several specialized teams to
support outbreak detection and response. Once it is determined that a
multi-State outbreak of foodborne illnesses or series of adverse events
is likely due to an FDA-regulated human food, CORE+EP's Response Teams
lead the coordination of stopping the outbreak and preventing
additional illnesses.
Response Teams work directly with FDA field offices, FDA subject-
matter experts, CDC, and state partners on a response strategy. The
team coordinates investigations, inspections, sampling, and traces
product distribution. Close coordination among FDA, CDC, and State and
local regulatory, public health and agriculture departments is crucial
to stopping an outbreak.
Investigations coordinated by CORE+EP also inform follow-up
activities carried out by other offices and divisions of FDA. These
include, but are not limited to, follow-up inspections, continued risk
assessments, and development of prevention strategies.\12\
---------------------------------------------------------------------------
\12\ https://www.fda.gov/food/outbreaks-foodborne-illness/post-
outbreak-response-and-prevention-strategies-enhance-food-safety-
updated-january-17-2025
---------------------------------------------------------------------------
Question. How many staff on the FDA team does FDA anticipate laying
off or firing over the next year?
Answer. FDA does not anticipate any additional reductions in force.
During a March 14, 2025, call between my Aging Committee staff and
subject matter experts at FDA and CDC, it was noted that the Federal
Government supports State and local public health infrastructure that
plays a critical role in responding to outbreaks of foodborne
illnesses. That infrastructure includes State and local health
departments and laboratories that the Federal Government assists with
training and equipment. Please:
Question. Describe this State and local network in greater detail,
including how the network assists CDC and FDA as they investigate and
respond to outbreaks of foodborne illnesses.
Answer. FDA staff work in conjunction with CDC, State, and local
partners during foodborne illness investigations to leverage regulatory
authorities to effectuate the best public health outcome. This enables
all parties to rely on, coordinate with, and leverage one another's
work, data, and actions to meet the public health goal of a safe
national food supply.
State and local epidemiologists help track illnesses, interview
patients, identify outbreak sources and collect samples. State and
local health laboratories help analyze food, environmental, and
clinical samples. State and local partner agencies also help conduct
retail food inspections, produce inspections, manufactured food
inspections, and surveil the food supply for a variety of hazards. They
assist in finding the food that caused illnesses (traceback) and help
conduct root cause assessments to find the cause of food contamination;
or if they discover a hazard before an outbreak is detected or occurs,
they work with FDA to help prevent illnesses.
Question. Describe in specific detail how the Federal Government
supported this State and local network prior to January 20, 2025,
including through Federal funding and grants, technical assistance, and
training.
Answer. Prior to January 20, 2025, FDA provided support to State,
local, Tribal, and territorial (SLTT) agencies, universities, and
nonprofit organizations by routinely working directly with these
partners and funding cooperative agreement programs--federal awards
with substantial FDA involvement--that support personnel, supplies,
training, technical assistance, and equipment to support these
integrated response efforts. Further, FDA's Program Standards and Rapid
Response Team Technical Experts also support state partners with
technical assistance and training by participating in state-hosted
meetings, capturing and sharing best practices amongst program
participants, and facilitating national level training courses.
Question. Describe how Federal support for this network has changed
between January 20, 2025, and present, including:
--Any grants to State or local governments, public health agencies,
or laboratories that have been reduced or cancelled.
--Any Federal technical assistance or training for State or local
governments, public health agencies, or laboratories that have
been reduced in frequency or cancelled.
--Any other assistance, including with technology or equipment, to
State and local governments, public health agencies, or
laboratories that has been reduced or cancelled.
Answer. Since 2022, FDA allocated unspent dollars to increase
annual state partnerships funding from the $83 million appropriated by
Congress to $116 million. Given increasing inflationary costs and
changes implemented as part of the FDA's 2024 Agency-wide
reorganization, the Agency was no longer able to allocate this level of
additional funding beginning in FY 2025. FDA is in the process of
finalizing awards for FY 2025 and ensuring that resources are
prioritized to the highest public health priorities using the
Integrated Food Safety System (IFSS) Prioritization Model.
The FY 2026 President's Budget includes $33 million to restore the
previous level of enhanced state funding to $116 million. If
appropriated, this funding will support the expansion of current state
agreements for routine inspections of domestic food facilities to cover
all applicable domestic facilities, to the extent feasible. This
paradigm shift streamlines routine inspections through a transformative
oversight model that fosters enhanced collaboration between Federal and
State agencies and reduces redundancy.
______
Questions Submitted by Senator Jon Ossoff
Question. What is the total number of probationary and non-
probationary employees terminated from FDA's Human Foods Program since
Thursday, February 13, 2025? Please include the following information:
--The job titles of employees who have had their termination
finalized,
--The job titles of employees who have been scheduled to be
terminated and their pending termination date, and
--The number of probationary and non-probationary terminated workers,
from each office and center within the division, in raw
numbers, and as a percentage of each office's, center's, and
the division's total workforce.
Answer. All anticipated terminations within HFP have been finalized
as of 7/26/2025. There are no pending or scheduled terminations within
Human Foods Program (HFP).
Probationary and Non-Probationary Employee Terminations by COP
----------------------------------------------------------------------------------------------------------------
HFP Office Terminations % of HFP % of FDA
----------------------------------------------------------------------------------------------------------------
Human Foods Program................................. 0 0.00% 0.00%
Nutrition Center of Excellence...................... 0 0.00% 0.00%
Office of Communications, Education, and Engagement. 38 56.72% 0.18%
Office of Compliance and Enforcement................ 5 3.29% 0.02%
Office of Coordinated Outbreak Response, Evaluation, 1 1.61% 0.00%
and Emergency Preparedness.........................
Office of Executive Programs........................ 16 43.24% 0.08%
Office of Food Chemical Safety, Dietary Supplements, 7 3.74% 0.03%
and Innovation.....................................
Office of Integrated Food Safety System Partnerships 3 2.63% 0.01%
Office of Laboratory Operations and Applied Science. 15 1.93% 0.07%
Office of Microbiological Food Safety............... 14 8.97% 0.07%
Office of Policy and International Engagement....... 0 0.00% 0.00%
Office of Quality Assessment and Management......... 1 4.55% 0.00%
Office of Resource Management....................... 64 46.04% 0.31%
Office of Strategic Programs........................ 12 85.71% 0.06%
Office of Surveillance Strategy and Risk 8 8.42% 0.04%
Prioritization.....................................
Office of the Deputy Commissioner for Human Foods... 6 35.29% 0.03%
Total......................................... 190 .................. 0.91%
----------------------------------------------------------------------------------------------------------------
Question. On April 17th, you told Megyn Kelly ``there were no cuts
to scientists, reviewers or inspectors or law enforcement'' at FDA. On
April 23rd, you told Dana Bash ``there were no cuts to scientists or
inspectors.''
--Did you make those statements?
--Were those statements accurate?
Answer. There were no reductions in force (RIFs) for any reviewers,
investigators, or law enforcement personnel. In addition, following the
initial RIF decisions-which were made prior to my arrival at FDA-we
took a close look at mission impacts and rescinded RIF notices for any
employees who were in critical positions to the Agency's mission or
operations.
Question. A fact sheet circulated by HHS States that the
elimination of roles at FDA ``will not affect drug, medical device, or
food reviewers, nor will it impact inspectors.'' Please specify what is
meant by the elimination of 3,500 roles at FDA not ``affect[ing]
reviewers'' or ``impact[ing] reviewers.''
Answer. Please see the response to the above question.
Question. According to AgencyIQ reporting, over 200 employees
supporting the critical work of the Human Foods Program no longer have
active files in the U.S. Health and Human Services' (HHS) employee
database. Many of them had job titles listing occupations such as
Chemist, Biologist, and Microbiologist. On April 25, 2025, the New York
Times reported an HHS spokesperson reinstated employee who had been
``inadvertently fired because of inaccurate job classification codes.''
--Will you conduct a full evaluation of these positions to ensure
employees critical to safeguarding our Nation's food and
preventing food-related illness and death were not
``inadvertently'' fired or scheduled for termination? Will you
include each employee's duties, expertise, and past performance
in such analysis?
--If after such analysis, you determine certain employees should not
be reinstated or de-scheduled for termination, please provide
your rationale.
--If after such analysis, you determine certain employees were
critical for ensuring food safety, will you reinstate them?
Answer. After the HHS RIF, FDA reviewed impacts to FDA's mission
and rescinded RIF notices of positions critical to the Agency's
operations and mission areas.
Question. The FDA coordinates food surveillance activities with the
Centers for Disease Control and Prevention. How has this coordination
been impacted by the Reduction in Force and layoffs that have occurred
within both agencies since February 13, 2025?
Answer. FDA's Human Food Program is dedicated to-and continues to
prioritize-our foodborne illness surveillance work with CDC. These
functions were not significantly affected by the reduction in force.
For example, foodborne outbreak communications and the Outbreak
Investigation Table continue to be published to provide relevant,
timely, and actionable information to consumers and stakeholders.
Question. How has FDA evaluated the impact of the closure of the
food safety labs?
Answer. No food safety labs have been subjected to closure.
SUBCOMMITTEE RECESS
Senator Hoeven. Again, thank you. Appreciate it. Have a
great day.
Dr. Makary. Thank you, Senator.
Senator Hoeven. We are adjourned.
[Whereupon, at 12:06 p.m., Thursday, May 22, the
subcommittee was recessed, to reconvene subject to the call of
the Chair.]
LIST OF WITNESSES, COMMUNICATIONS, AND PREPARED STATEMENTS
----------
Page
Baldwin, Senator Tammy, U.S. Senator from Wisconsin, Questions
Submitted by...................................................
43.............................................................
Collins, Senator Susan, U.S. Senator from Maine, Statement of....
2..............................................................
Gillibrand, Senator Kirsten, U.S. Senator from New York,
Questions Submitted by
Heinrich, Senator Martin, U.S. Senator from Questions Submitted
by.............................................................
45.............................................................
Hoeven, Senator John, U.S. Senator from North Dakota:
Opening Statement of
Questions Submitted by
Hyde-Smith, Senator Cindy, U.S. Senator from Mississippi,
Questions Submitted by
Makary, Hon. Dr. Martin A., M.D., M.P.H., Commissioner,
Department of Health and Human Services, Food and Drug
Administration:
Prepared Statement of........................................
54.........................................................
Questions Submitted to.......................................
77.........................................................
Statement of.................................................
49.........................................................
Summary Statement of.........................................
52.........................................................
Merkley, Senator Jeff, U.S. Senator from Oregon, Questions
Submitted by
Moran, Senator Jerry, U.S. Senator from Kansas, Questions
Submitted by...................................................
89.............................................................
Murray, Senator Patty, U.S. Senator from Washington, Questions
Submitted by...................................................
97.............................................................
Ossoff, Senator Jon, U.S. Senator from Georgia, Questions
Submitted by...................................................
115............................................................
Peters, Senator Gary, U.S. Senator from Michigan, Questions
Submitted by...................................................
103............................................................
Rollins, Hon. Brooke L., Secretary, Department of Agriculture:
Prepared Statement of........................................
7..........................................................
Questions Submitted to.......................................
37.........................................................
Statement of.................................................
1..........................................................
Summary Statement of.........................................
4..........................................................
Rounds, Senator Mike, U.S. Senator from South Dakota, Questions
Submitted by...................................................
39.............................................................
Shaheen, Senator Jeanne, U.S. Senator from New Hampshire:
Questions Submitted by
Statement of
SUBJECT INDEX
----------
DEPARTMENT OF AGRICULTURE
Page
Additional Committee Questions...................................
37.............................................................
APHIS Staffing...................................................
44.............................................................
Biofuels.........................................................
43.............................................................
Climate Smart Commodities........................................
43.............................................................
Highly Pathogenic Avian Influenza................................
45.............................................................
Local Food for Schools (LFS) & Local Food Purchase Assistance
Program........................................................
45.............................................................
National Milk Testing Strategy...................................
45.............................................................
Organic Concerns.................................................
43.............................................................
__________
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
Additional Committee Questions...................................
77.............................................................
AI Product Reviews...............................................
78.............................................................
Alternative Methods for Testing..................................
85.............................................................
Benzodiazepines..................................................
84.............................................................
Compounding Drugs................................................
87.............................................................
Continuity of User Fee Funding for Medical Devices...............
55.............................................................
Deferred Resignation Program.....................................
95.............................................................
Early Retirements................................................
95.............................................................
FDA IT Infrastructure............................................
80.............................................................
Foreign Inspections..............................................
85.............................................................
Hiring...........................................................
96.............................................................
Human Foods Program..............................................
78.............................................................
Inspections......................................................
79.............................................................
MAHA Commission Report...........................................
77.............................................................
Make America Healthy Again.......................................
54.............................................................
Probationary Firings.............................................
94.............................................................
Rare Diseases Require Innovative Approaches to Drug Development
and Regulation.................................................
82.............................................................
Reductions In Force (RIF)........................................
94.............................................................
Regulatory Review timelines
Staffing at FDA..................................................
84.............................................................
Threats to US Biotech's Future Investment and Global
Competitiveness................................................
83.............................................................
Vaccine Regulatory Framework.....................................
84.............................................................
[all]