[Senate Hearing 118-629]
[From the U.S. Government Publishing Office]
S. Hrg. 118-629
AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2025
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HEARINGS
before a
SUBCOMMITTEE OF THE
COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE
ONE HUNDRED EIGHTEENTH CONGRESS
SECOND SESSION
on
H.R. 9027/S. 4690
AN ACT MAKING APPROPRIATIONS FOR AGRICULTURE, RURAL DEVELOPMENT, FOOD
AND DRUG ADMINISTRATION, AND RELATED AGENCIES FOR THE FISCAL YEAR
ENDING SEPTEMBER 30, 2025, 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(S) NOT AVAILABLE IN TIFF FORMAT
Available via the World Wide Web: https://www.govinfo.gov
__________
______
U.S. GOVERNMENT PUBLISHING OFFICE
55-287 PDF WASHINGTON : 2025
COMMITTEE ON APPROPRIATIONS
PATTY MURRAY, Washington, Chairman
RICHARD J. DURBIN, Illinois SUSAN M. COLLINS, Maine, Vice
JACK REED, Rhode Island Chairman
JON TESTER, Montana MITCH McCONNELL, Kentucky
JEANNE SHAHEEN, New Hampshire LISA MURKOWSKI, Alaska
JEFF MERKLEY, Oregon LINDSEY GRAHAM, South Carolina
CHRISTOPHER A. COONS, Delaware JERRY MORAN, Kansas
BRIAN SCHATZ, Hawaii JOHN HOEVEN, North Dakota
TAMMY BALDWIN, Wisconsin JOHN BOOZMAN, Arkansas
CHRISTOPHER MURPHY, Connecticut SHELLEY MOORE CAPITO, West
JOE MANCHIN, West Virginia Virginia
CHRIS VAN HOLLEN, Maryland JOHN KENNEDY, Louisiana
MARTIN HEINRICH, New Mexico CINDY HYDE-SMITH, Mississippi
GARY PETERS, Michigan BILL HAGERTY, Tennessee
KYRSTEN SINEMA, Arizona KATIE BRITT, Alabama
MARCO RUBIO, Florida
DEB FISCHER, Nebraska
Evan Schatz, Staff Director
Elizabeth McDonnell, Minority Staff Director
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Subcommittee on Agriculture, Rural Development, Food and Drug
Administration, and Related Agencies
MARTIN HEINRICH, New Mexico, Chairman
JON TESTER, Montana JOHN HOEVEN, North Dakota, Ranking
JEFF MERKLEY, Oregon MITCH McCONNELL, Kentucky
TAMMY BALDWIN, Wisconsin SUSAN M. COLLINS, Maine (ex
JOE MANCHIN, West Virginia officio)
GARY PETERS, Michigan JERRY MORAN, Kansas
KYRSTEN SINEMA, Arizona CINDY HYDE-SMITH, Mississippi
DEB FISCHER, Nebraska
Professional Staff
Dianne Nellor
Rachel Erlebacher
Hannah Chauvin
Angela Caalim
Morgan Ulmer (Minority)
Daniel Mencher (Minority)
Alex Shultz (Minority)
C O N T E N T S
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hearings
Tuesday, April 16, 2024
Page
Department of Agriculture........................................ 1
Wednesday, May 8, 2024
Department of Health and Human Services: Food and Drug
Administration................................................. 31
back matter
List of Witnesses, Communications, and Prepared Statements....... 93
Subject Index:
Department of Agriculture.................................... 95
Department of Health and Human Services: Food and Drug
Administration............................................. 95
AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2025
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TUESDAY, APRIL 16, 2024
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
The subcommittee met, pursuant to notice, at 10:03 a.m. in
Room SR-124, Dirksen Senate Office Building, Hon. Martin
Heinrich (chairman) presiding.
Present: Senators Heinrich, Manchin, Hoeven, Moran, Hyde-
Smith, and Fischer.
DEPARTMENT OF AGRICULTURE
STATEMENT OF HON. TOM VILSACK, SECRETARY
ACCOMPANIED BY:
MR. CHRIS NELSON, ASSOCIATE BUDGET DIRECTOR
opening statement of senator martin heinrich
Senator Heinrich. The Agricultural Appropriations
subcommittee is now called to order.
And I would like to begin by welcoming Secretary Vilsack.
Joining the Secretary is Mr. Chris Nelson, Associate Budget
Director for the Department of Agriculture.
We welcome you both here today. And there is no doubt that
fiscal year 2024 presented us with many challenges. We had to
make some tough decisions, but I made sure we maintained our
support for United States Department of Agriculture (USDA)'s
vital programs that support American families, farmers, and
producers in rural communities. I am not going to sugarcoat
things; fiscal year 2025 will come with its own set of
complications that we must navigate together, Mr. Secretary.
While we are under austere spending constraints, this
subcommittee must ensure that USDA has the resources that you
need to fulfill your broad and critical mission. The programs
and activities of this Department affect nearly every American,
from farmers and rural communities to children and families who
depend on programs like Special Supplemental Nutrition Program
for Women and Children (WIC) and Supplemental Nutrition
Assistance Program (SNAP), to put healthy and nutritious food
on the table.
The President's budget request for USDA totals $25.1
billion, which is an increase of $2 billion. I am pleased that
this budget request maintains our focus on providing tools to
producers in rural communities to become part of our overall
effort to solve climate change. Of particular importance to me
is supporting our conservation programs to help producers be
good stewards of our land. We know these programs are vital to
managing lands and combating climate change.
While the fiscal year 2024 Budget Bill did not provide all
the funding for conservation that I would have liked, I am
pleased to see the budget restore these important programs. And
I will certainly do everything I can to ensure that
conservation is a priority in the fiscal year 2025 Bill. And it
calls for increased research and management of Per- and
polyfluoroalkyl substances (PFAS) contamination in the
agriculture sector, which has impacted many farmers in my home
state of New Mexico. I look forward to discussing these
initiatives and how this subcommittee can play a role in this
critical issue.
We also know that affordable housing has become a major
challenge, especially in rural areas. This budget includes
needed increases and innovative policy proposals to grow our
affordable housing stock in rural communities. This is
absolutely essential if we want to ensure that all Americans
can access a safe and affordable place to call home.
Another issue of great importance to both of us is ensuring
all of our children can receive healthy and nutritious food.
Without this, our children cannot learn effectively or thrive.
I am proud we were able to fully fund WIC last year, and
continue the fruit and vegetable voucher. This will continue to
be a priority of mine as we start this fiscal year 2025
process.
It is clear that USDA has many ambitious goals, and I look
forward to a robust discussion today. And I want to reiterate
my support for drafting a bipartisan bill this year, and look
forward to working with the Ranking Member, and all the members
of this committee.
And with that, I will turn to our ranking member, Senator
Hoeven, for any statement that he has this morning.
statement of senator john hoeven
Senator Hoeven. Thanks, Chairman. Thanks for your work. And
also, I was pleased that we were able to move our
Appropriations Bill for 2024 across the finish line. Albeit 6
months late, but again I think it was a good work product, and
I appreciate working with you on it. And obviously, we are
already into 2025 as we need to be, but it is important we get
it done. And I sure hope we can get it done, you know, closer
to on time, but very important that we do get it done. And that
takes a lot of bipartisan work.
Mr. Secretary, thank you for being here today, thank you
for your work, you know, for many years on behalf of
Agriculture. It is incredibly important. And as they say, now
more important than ever, appreciate you being here today.
Now every single American benefits every single day from
good farm policy. And think about it. And we need to talk about
it because so many folks now don't have that nexus to the farm
that they once had. Some of us come out of an Agriculture (AG)
background, some of us are still involved--as a matter of fact,
we have two cattle ranchers on our panel here, so they not only
know it, they live it. But certainly, Jerry and I come from
farm country, Kansas, and North Dakota, and Iowa.
But a lot of people figure food comes from the grocery
store, you know, and they don't have that nexus to the farmers
and ranchers that so many of us once had. And so it is really
important to understand that understand when we talk about
these farm programs, we are talking about keeping a network of
about 16 million people involved in agriculture across this
country both directly and indirectly.
A system that is primarily family farms and ranches, and
when you look at so many industries that have developed this
industry concentration to have that network is incredibly
important in and of itself, but didn't think of what it means
for every single American, highest quality, lowest cost food
supply in the world, with Americans spending less of their
disposable income on their food budget than any other developed
country in the world. Good grief, we can't take that for
granted.
And I know you know that, Mr. Secretary, and that is why it
is so important that as we talk about all these programs that
are in the Farm Bill, that we are very mindful of the programs
that that create that highest quality lowest cost food supply
because it benefits all these other programs. When we talk
about the nutrition program, or we talk about any of the other
aspects of what has become, you know, the largest part of the
Farm Bill, we have to understand that if we don't maintain that
system of family, farms, and ranches, and it is food, fuel, and
fiber now, as you well know, those costs are going to rise.
That affects every other aspect, not only of all of the
SNAP programs and everything else, it is going to cost more to
provide, and you won't be able to provide as much if we don't
sustain those farm programs that maintain that network of
family, farms, and ranches. It is truly the engine in the car.
And so we have to be mindful, as we look at this budget we have
to keep that absolutely in mind, and right now as you know,
again, our farmers and ranchers are facing real pressures they
are seeing commodity prices that they get go down at the same
time that their input costs are going up significantly.
When they look at their fuel cost, and of course that fuel
cost drives their fertilizer cost all their other inputs,
right, chemical, spray, everything they do, they are getting
squeezed this year, we are seeing a significant reduction in
farm income this year. Which is why it is so important we
maintain these programs.
Along that line, you may have seen that I, along with other
members of our AG Committee filed the Farmer Act which is
designed to increase support for crop insurance, the number one
risk management tool that our farmers and ranchers have. Also
the AG research I mean it is just critically important, not
only National Institute of Food and Agriculture (NIFA), the
industry-based AG research, as well as the Agricultural
Research Service (ARS), and they do a tremendous job continuing
to support Farm Service Agency (FSA), incredibly important we
have talked about that, that network out there, and having that
face-to-face, you know, they can't do it all, they can do a lot
on the Internet, but having that face-to-face is incredibly
important.
And you know, and we will talk about it here today, we are
seeing real pressures on this budget in terms of things like
WIC, and some of these other programs, increase of more than a
$1 billion last year, I think a $700 million proposed increase
this year. You know, we have got to talk about that a little
bit, and determine how we are going to handle some of these
costs, again while maintaining that safety net, that
countercyclical safety net for our farmers and ranchers, in
this great system of agriculture, so diverse.
I mean every state in the country I think. Boozman has been
on a challenge to find a state, if there is one, that isn't
involved in agriculture, because he is going to every single
state in the country. And he was up in Alaska, and I said well
maybe, you know, maybe you finally found one up there that
doesn't, but there is something about seaweed, or kelp, or
something that they are doing up there. So I think it is safe
to say all 50 states have agriculture.
With that, again, thanks for being here today we appreciate it
Mr. Secretary. Thanks, Chairman,
Senator Heinrich. Mr. Secretary.
summary statement of hon. tom vilsack
Secretary Vilsack. Mr. Chairman, Senator Hoeven, and
Members of the Committee, thank you very much for the
opportunity to be here this morning.
Each year the Department of Agriculture puts out a Rural
Development at a Glance, an opportunity to take a look at the
rural economy, and determine how things are going. This year's
edition of that report has some positive news.
It appears that rural employment is now down, now back to
pre-pandemic levels; it appears that the poverty rate is
significantly reduced, the unemployment rate is at an historic
low in rural America, and in fact we have actually seen a
reduction in counties that have been characterized as
persistently poor. These are counties that have experienced a
poverty rate of 20 percent or more for over 30 years. We had a
net reduction of 29 counties out of 260 that have left that
characterization.
I raise this just simply to put a focus on the importance
of investing in the Rural Partnership Network which is included
in our budget. The chairman indicated the importance of
housing, and making sure that we continue to support our
housing programs. And I would also encourage you as you look at
congressionally directed spending in the community facility
program that you do so with an eye on those areas of persistent
poverty so that we can continue the momentum that we have seen
in the last couple of years.
I appreciate Senator Hoeven's comments about research,
clearly, we need to continue to look at ways in which we can
focus on things like PFAS, Highly Pathogenic Avian Influenza
(HBAI), and some of the other challenges that are faced out in
the countryside, I appreciate the opportunity to acquaint the
committee with the challenges of our ARS facilities,
particularly in Beltsville, the need for significant investment
there, and the importance of containing and retaining the
flexibility within the Commodity Credit Corporation (CCC), in
order to allow us to respond to situations that crop up from
time to time.
The most recent example, fertilizer. We are now in the
process of funding at least 42 projects that are helping to
tamp down the cost and increase in fertilizer. We should also
point out that after 3 years of record farm income, the best
farm income that we have had in at least 50 years, or maybe
ever we, and as Senator Hoeven indicated, are seeing income
rates that will likely be closer to historic norms.
We are also seeing, as well, an aging nature of our farm
population, and I bring to the attention of the committee
concerns that I have about the loss of farms and the loss of
farmland. In 1981, Secretary Bergland, as he was leaving
office, expressed concern about the changes that we had made in
the way in which we supported agriculture from a supply
management system to a more market orientation. He expressed
concerns that this might result in a significant reduction in
farms and farmland. He was absolutely right.
Since he issued that report, we have lost 544,970 farms.
Now, to give you a sense of how many farms that is, that is all
the farms that exist today in North Dakota, South Dakota,
Minnesota, Wisconsin, Illinois, Iowa, Nebraska, Colorado,
Missouri, and Oklahoma. We have lost 151 million acres of
farmland. That is land that was in farming that is no longer in
farming. That is the entire landmass of Florida, Georgia, North
Carolina, South Carolina, Maryland, and a good part of
Virginia.
I don't think anybody on this Committee, and I don't think
anybody in this Congress, in the Senate, or the House, or in
this Federal Government believes that that is an appropriate
direction for agriculture, which is why we have, for the first
time, put together a comprehensive effort to provide support
for small- and mid-sized farming operations, in addition to the
extraordinarily important productive agriculture that Senator
Hoeven alluded to.
We are creating opportunities for value-added products
through climate-smart agriculture. We are creating the
opportunity for farmers to generate additional income by the
sale, if you will, of the environmental results that only
farmers can obtain because they have the land that can
sequester carbon. They have the operations that can reduce
greenhouse gas emissions below net zero, and they have the
opportunity to participate in ecosystem service markets, a new
stream of income for farm families.
They have the opportunity to convert agricultural waste
into a wide variety of bioproducts, the most exciting of which
is sustainable aviation fuel that I think we are going to see
an explosion of over the course of the next several years,
another income source, another commodity, if you will.
We have the ability to take renewable energy, and not only
reduce costs on the farm, but also utilize that renewable
energy to create a new revenue stream for farmers as well, as
they work with their elected co-op, as they work with local
facilities to provide less expensive, renewably produced
energy. Another commodity, if you will, another income source.
And also sponsoring and supporting local and regional food
systems, the ability to expand processing capacity owned and
operated independently of the large processing facilities. We
have done over close to 400 investments in expanded processing
opportunities across the United States, additional investments
at the state level, to shore up the supply chain, to create
opportunities for non-meat and poultry processing as well. And
the reason we do this is because when you go to the grocery
store and you put a dollar on the counter, Senator Hoeven is
absolutely right, it is the less expensive, as a percentage of
income that we spend on food than anybody else in the world.
But the reality is the farmer only gets anywhere from 15 to
20 cents of that dollar. When you sell directly to your
customer, as many farmers are beginning to do, they get 50 to
75 cents of every food dollar. So it is an opportunity for us
to expand the income base for small- and mid-size farming
operations, to begin the process of slowing down, and
ultimately reversing the loss of farms and farm families.
I am excited about this budget because it does contain
additional tools at FSA to provide assistance and help to
farmers who might be struggling. We are looking at increasing
the microloan limit, looking at ways in which we perhaps
provide less experience requirements in order to access some of
our larger loan programs, increasing the ownership loan limits
so that we have access for small- and mid-size producers to
expand their operation, more flexibility in the amount of down
payment that they may be required to provide, and the way in
which it is financed, and more opportunity to provide some
degree of relief in the form of debt forgiveness, or loan
servicing, and allowing a refinancing of debt.
I look forward to the questions from this committee, but I
think this is a pivotal time. Senator Hoeven mentioned the Farm
Bill; obviously, we are anxious to work with the Congress to
get that Farm Bill done. But I think it is going to be
important for us to focus, in addition to productive
agricultural--production agriculture, on agriculture that also
benefits and increases income streams for small- and mid-sized
farmers because that is important to rural America.
[The statement follows:]
Prepared Statement of Hon. Thomas J. Vilsack
Thank you, Chair Heinrich, Ranking Member Hoeven, and distinguished
members of this subcommittee, for the opportunity to come before you
today to discuss the Administration's priorities for the Department of
Agriculture (USDA) and to provide you an overview of the 2025
President's Budget.
USDA's work touches every community, and nearly every landscape,
across the entire country. Since our founding, the ``People's
Department'' has provided safety nets to farmers, nutrition assistance
to some of our country's most vulnerable citizens, support for
renewable clean energy, firefighters to keep our communities safe, food
safety inspections-and much, much more. It is an honor to lead this
department, and I am excited to share with you some of the progress we
have made to support America's farmers and ranchers, create opportunity
in rural areas, and improve USDA's processes and customer service.
Through the FY 2025 Budget, the Biden-Harris Administration and
USDA have embraced a path where the future of American agriculture is
secure and where there is greater equity and economic opportunity for
agricultural and rural communities. We are now seeing farm income
mirroring the stronger economy that President Biden and his economic
team have advanced coming out of the pandemic. Farm income over the
2021-2023 period represented the highest level of farm income in the
last 50 years. We saw that the bulk of that income has been driven by
the market, namely high commodity prices and the three highest years on
record for agricultural exports, and not by farm safety net payments.
And while the first farm income forecast of 2024 indicates net farm
income this year will return to prior levels that are slightly below
these historic levels for farm income, this forecast underscores the
critical importance of USDA's ongoing work to help foster prosperity
for producers and the communities they love by supporting an economy
that grows from the bottom up and the middle out, and by creating new
market opportunities that promote competition in the marketplace. At
the end of the day, a strong farm economy inarguably contributes to a
strong rural economy and makes rural communities a more attractive
place to live--and we are doing everything within our control to focus
our efforts on enhancing economic resiliency.
As we look forward to FY2025, USDA will continue to focus on
policies that add value for farms of every shape and every size as well
as ensuring the policies are designed for the real needs of rural
America. This includes recognizing the undeniable challenges of climate
change and addressing the need for greater equity in our food system.
We will continue to draw strength from the USDA Equity Commission final
recommendations\1\, because they are a roadmap for ensuring USDA lives
up to its name as the People's Department for everyone. There is
nothing more foundational to a country's security and stability than
its food supply; an inclusive agriculture and rural life is necessary
if we want to create more opportunity in this country.
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\1\ USDA Equity Commission. (2024). Final Report 2024:
Recommendations made to the U.S. Department of Agriculture to Advance
equity for all. https://www.usda.gov/equity- commission/reports
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The 2025 USDA President's Budget recognizes the investment Congress
has made available through the American Rescue Plan Act (ARPA),
Bipartisan Infrastructure Law (BIL), and Inflation Reduction Act (IRA).
This investment has allowed USDA to create, not diminish, opportunities
for rural communities as well as invest in farmers, ranchers, and small
businesses. USDA is delivering on these investments, and the 2025
Budget continues to confront challenges, rebuild the rural economy, and
support a new, innovative approach to the future of agriculture. A
strong agriculture sector is key to strong rural communities,
supporting over 22 million people and 10 percent of jobs in the
economy, providing access to essential services like housing,
healthcare facilities, and fast reliable internet; it's how we ensure
there's safe, nutritious, affordable food on the table for everyone,
supporting the more than 10.2 percent of Americans that experience food
insecurity\2\; it's how we support and protect forests, grasslands, and
farms--nearly 50 percent of this nation's total land mass; and it's how
we provide for the communities that depend on them. The proposals in
this budget will address these challenges and spur new job creation and
opportunities in rural America; support a stronger nutrition safety
net; build resilience in the food supply chain and restore America's
advantage in agriculture; and leverage USDA's expertise to address
climate change.
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\2\ USDA, Economic Research Service using data from U.S. Department
of Commerce, Bureau of the Census, 2021 Current Population Survey Food
Security Supplement. https://www.ers.usda.gov/topics/food-nutrition-
assistance/food-security-in-the-u-s/key-statistics-graphics/
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The 2025 USDA President's Budget request totals $213.3 billion, of
which $181.7 billion is mandatory funding and $31.6 billion is
discretionary funding to continue advancing the vision to create an
equitable and climate-smart food and agriculture economy that protects
and improves the health, nutrition, and quality of life of all
Americans.
rebuilding rural america
The Biden-Harris Administration's historic investments in
infrastructure and new market opportunities have provided USDA with a
powerful set of tools for restructuring our food and agriculture
economy so small- and mid-sized producers are able to access
opportunities to maintain and grow, catalyzing strong rural economies
where people have the opportunity and tools they need to build a good
life in the communities they love.
It has been said that Rural Development (RD) can build a town from
the ground up. However, over the last decade, RD's portfolio has
increased 85 percent, but its staffing levels decreased by 30 percent.
Recruiting and retaining staff is a critical component in our ability
to meet the growing priorities in areas that have a direct effect on
our ability to be sustainable, relevant, and results- oriented in
delivering much-needed programs and services across rural America. USDA
is committed to ensuring we have sufficient levels of RD staff to
deliver these vital programs by requesting $881 million for S&E.
Affordable housing has been a long-standing problem for low-income
residents in rural communities, one that is exacerbated by low energy
efficiency of the aging housing stock which means higher costs to
families. The 2025 Budget requests $1.25 billion for the Section 502
Single Family Housing (SFH) Direct Loan program that will provide over
5,000 low and very-low income rural residents the dream of home
ownership. The Budget also provides $1.69 billion in budget authority
for Rental Assistance (RA) to renew 270,158 existing contracts,
ensuring that these very low income tenants can continue to live in
decent, safe and affordable housing. In addition, the Budget continues
to request the authority to decouple rental assistance from USDA
financed properties to allow USDA financed properties the option to
continue to offer affordable rents when projects reach loan maturity.
For paid off properties that do not decouple, the Budget continues to
include $20 million within the HUD Tenant Protection Vouchers, which
provides a fully portable voucher for the tenant, reduces duplication
across Federal programs, and allows USDA to focus more on its priority
mission of preservation.
Improved connectivity through broadband access means rural
communities can offer robust business services, expand access to modern
healthcare, and improve education. The Broadband ReConnect Program
provides capital access for strengthening e-connectivity that broadens
economic opportunities and job creation in rural America. Thanks to the
President's Bipartisan Infrastructure Law, USDA has provided $2.26
billion to deploy broadband to people living and working in rural areas
across 35 States and Territories, which is expected to expand access to
137,366 households. The Budget requests $112.4 million in budget
authority for the Broadband ReConnect Program to provide service to
about 56,000 households. In addition, the Budget continues to include
$35 million for broadband grants to support new or improved broadband
access in communities with populations of up to 20,000.
Safe drinking water and sanitary waste disposal systems are key
elements to achieving a high quality of life for rural residents.
Across the country, there are millions of Americans that lack indoor
plumbing and millions more that live in homes that still have poisonous
lead pipes. The Budget supports nearly $1.4 billion in regular direct
loans and $50 million in guaranteed loans to support nearly 450 direct
and guaranteed loans for water and waste disposal facilities to provide
safe and sanitary water services. Overall, the Budget requests $785
million in budget authority, which supports a total program level of
nearly $2.1 billion for the water and waste disposal program. Of $785
million in budget authority, $639 million are for grant funding for
water and waste disposal projects, including grants targeted to
Colonias, Native Americans, and Alaska Native Villages.
The Farm Service Agency (FSA) Farm Loan Programs provide an
important safety net for producers, by providing a source of credit to
producers who commercial lenders may be unwilling to serve. USDA is
committed to ensuring that as we administer the Farm Loan Programs, we
can provide targeted assistance based on need, reaching everyone who is
eligible, and removing the bureaucratic burden on producers. The Budget
is projected to support over 32,000 loans to farmers and ranchers by
financing operating expenses and providing opportunities to acquire a
farm or keep an existing one. Building on efforts begun in the 2024
Budget to connect more producers with the financing they need for
successful farm operations, the 2025 Budget continues to propose
legislative changes to Farm Loan Programs to ensure more producers
would be able to get the financial assistance they need to keep farming
and keep the farm in the family. Specifically, the proposals will 1)
authorize Direct Farm Ownership loans to be used to refinance debt; 2)
make a technical correction to certain special program interest rate
requirements; 3) require preferred lenders to obtain FSA approval prior
to taking a foreclosure action; 4) expand the lifetime limitation on
debt forgiveness from $300,000 to $600,000; 5) authorize future loans
to those with previous debt forgiveness; 6) give the Secretary maximum
flexibility for applicant eligibility for emergency loans; 7) increase
the microloan limit from $50,000 to $100,000; 8) eliminate the number
of years that a borrower can apply for Direct Operating Loan or Direct
Farm Ownership loan; 9) revise beginning farmer definition to require
individuals of an entity to be beginning farmers without regard to
relationship; 10) reduce required farming experience for Direct Farm
Ownership Loans from 3 years to 1 year, with a waiver of experience for
those who have an established mentorship; 11) correct the historical
linkage for Farm Ownership down payment direct loan limit to match the
direct Farm Ownership loan limit; and 12) revise beginning farmer
lending targets required ``to the extent practicable.'' This suite of
changes expands access to farm loans to strengthen agriculture while
remaining budget neutral.
To improve equity in rural America, the Budget proposes $10 million
to expand the Rural Partners Network (RPN) initiative, improve
leveraging of USDA's extensive network of county-based offices, and
continue to help people and communities in high poverty counties.
Through RPN and collaboration with other USDA and Federal agencies, RD
has been able to improve its connection with rural stakeholders. This
work follows through a commitment the President made when he came to
office--we must invest in America's heartland in a meaningful way. It
is critical that we ensure that our rural and Tribal communities can
benefit from Federal investments as the Biden-Harris Administration
delivers unprecedented resources provided through ARPA, BIL, and IRA.
We can only expand this innovative work of RPN into more rural
communities and additional States if Congress builds on the progress
made over the last year and provides additional funding for RPN.
supporting nutrition for the nation
USDA's core nutrition programs are the most far-reaching, powerful
tools available that ensure all Americans, regardless of race,
ethnicity, or background, have access to healthy, affordable food.
Across America, one in four individuals is served by one of USDA's 16
nutrition assistance programs over the course of the year. The Budget
makes strategic investments to advance nutrition security through
education and evidence-based interventions, and to support the purchase
of nutritious and local foods.
We know that the Special Supplemental Nutrition Program for Women,
Infants, and Children (WIC) drives better health for infants and more
nutritious diets for children, and it is a key tool for addressing
disparities in maternal and child health outcomes. WIC serves about
half of all babies in the United States. The Budget includes $7.7
billion for WIC in 2025 to serve nearly 7 million low- income women,
infants, and children each month in 2025, up from 6.6 million in 2023.
This funding request reflects the longstanding bipartisan commitment to
serve all projected participants seeking WIC benefits. WIC
participation rose rapidly in 2023 across all eligible categories--
women, children and infants and further growth is expected in 2025. The
Food and Nutrition Service (FNS) is continuing to work to modernize the
program through outreach, improving the shopping experience,
modernizing technology and service delivery, expanding access to
farmers' markets and investing in the workforce.
The Supplemental Nutrition Assistance Program (SNAP) stretches the
food budget for many low- income people and research shows that
participation in SNAP reduces food insecurity and allows families to
have healthier diets. The Budget requests $123.3 billion for SNAP,
which will serve an estimated average of 41.9 million participants. The
Budget also includes $95 million for The Emergency Food Assistance
Program (TEFAP) administration to support soup kitchens and food banks
and $242 million for the Food Distribution Program on Indian
Reservations (FDPIR) to improve participant nutrition and provide
culturally appropriate foods for an estimated average of 80,000
participants.
Child Nutrition programs, including National School Lunch Program
(NSLP), the School Breakfast Program (SBP), the Summer Food Service
Program, the Child and Adult Care Food Program (CACFP) Fresh Fruit and
Vegetable Program, and Special Milk Program assist State and local
governments and private non-profit organizations in ensuring that meals
provided to children in schools and child and adult care programs meet
their nutritional needs, foster healthy eating habits, and safeguard
their health with a goal of reducing the number of overweight and obese
children. Summer is perhaps the most challenging time of the year for
children at risk of food insecurity because they lose access to daily
school meals, and some face structural barriers to accessing summer
meals through the traditional programs. To meet the nutritional needs
of children during the summer, this Budget requests nearly $3.3 billion
in funding to provide Summer EBT to the approximately 21.5 million
children that will participate in 2025. In addition to Summer EBT, USDA
administers a suite of child nutrition programs that provide
reimbursement to State and local governments for nutritious meals and
snacks served to children in schools, childcare institutions, summer
sites, and after school care programs. The Budget also requests nearly
$29 billion to serve a projected 5 billion lunches and snacks and 2.7
billion breakfasts in schools, 1.9 billion meals in child and adult
care food programs, and 281 million meals through the Summer Food
Service Program. The increases will strengthen integrity controls,
modernize food ordering and inventory management systems, and provide
critical staffing to enhance FNS's ability to provide technical
assistance and oversight of child nutrition programs.
creating more, new, and better markets
USDA works to create more options for producers and consumers and
improve the resiliency of our food supply chain. As we invest in new
solutions, we must create new and better markets for all producers and
consumers and promote a safe, healthy work environment for agricultural
workers. USDA is working to transform the food system, from how food is
produced to how it is purchased, in a fairer, more competitive, and
more resilient system. These investments will benefit consumers,
producers, and rural communities by providing more options, increasing
access, and creating new, more, and better markets for small and mid-
sized producers. The success of American agriculture hinges on
innovation and the development of new markets, both at home and abroad,
to ensure everyone has access to affordable nutritious food.
Despite record-breaking farm income in recent years, typically
about 7 percent of U.S. farms receive 85 percent of overall farm
income, which means 93 percent of our farms share only 15 percent of
farm income. We also know that over half of farm households had
negative farm income, and 84 percent of farm families obtain most of
their income from off the farm. On top of this, farmers are receiving
less of the food dollar today than ever before. It's obvious that the
system needs to be revisited to find a way to create a system that
benefits small and mid-sized farms, expands opportunity, and values
their products.
To do so, USDA is increasing market opportunities for producers to
sell their products. We are strengthening local and regional food
systems and providing producers with more options to market their
products. The Budget invests over $383 million in supporting new supply
chains and markets that uplift small and mid-sized farmers through
programs such as the Local Agriculture Market Program, Farmers Market
and Local Food Production, and Transportation and Market Development,
through Agriculture and Food Research Initiative (AFRI) grants and the
Gus Schumacher Nutrition Incentive Program at the National Institute of
Food and Agriculture (NIFA), as well as through Farmers Market
Nutrition Programs at FNS. Investments will also help strengthen supply
chain resiliency by improving access to and encouraging consumption of
locally grown foods, shortening the food supply chain by supporting
direct farmer-to-consumer transactions.
Last year marked the 10th anniversary of the Farm to School Grant
Program at FNS, which has awarded more than 1,100 projects totaling
more than $85 million and reaching more than 28 million students in
nearly 63,000 schools. These grants play an important role in expanding
USDA's farm to school efforts across the country and strengthening the
school meal programs. Funded projects increase the amount of local
foods served through child nutrition programs and help educate children
about where their food comes from. These efforts make school meal
programs more resilient in the face of recent supply chain disruptions
by building connections within local communities while also creating
healthier school food environments and improving student health
behaviors. This program also allows producers, large or small, to have
additional market opportunities in their own backyard and a chance for
their commodities to nourish children in their community. The Budget
requests $12 million in the Farm to School Grant funding in addition to
$5 million in permanent funding to assist in making local food and
agricultural education available to child nutrition program
participants.
The Budget supports investments to assist in transitioning away
from fossil fuels while creating manufacturing jobs across rural
America by creating market opportunities in the bio-based economy. The
Sustainable Aviation Fuel (SAF) Grand Challenge, in partnership with
Department of Energy and Department of Transportation, is meeting the
demand to reduce cost, enhance sustainability, and expand SAF
production which currently has a high demand. USDA is committed to
continuing investments and building expertise in sustainable crop and
other biomass production system and supply chains; investing in
biomanufacturing capability, workforce development, and community and
individual education; and providing outreach and technology transfer to
producer's processors. USDA ensures farmers, foresters, small
businesses, and rural economies benefit from these opportunities with
attention to cost, quality, and quantity of agricultural-based
feedstock for producing SAF.
One way USDA promotes the creation and expansion of rural
businesses, by providing additional access to capital, which helps to
diversify the rural economy, is through the B&I Guaranteed Loan
Program. The Budget supports $2.3 billion in Business and Industry
(B&I) loan guarantees, which bolsters the availability of private
credit by guaranteeing loans made by lenders to rural businesses. At
the average loan level of $7 million, this request will support more
than 300 loans. This program improves the economic health of rural
communities by increasing access to business capital through loan
guarantees that enable commercial lenders to provide affordable
financing for businesses in eligible rural areas.
research and innovation
This pivotal moment calls for additional investment in research and
innovation that influence every program we implement at USDA.
Agricultural research has a return on investment of $17 for every $1
invested. Between 1948 and 2019, total agricultural output in the
United States grew by 142 percent. This rise was not due to increases
in agricultural land or labor; in fact, both inputs declined over the
period. The productivity stemmed from the adoption of a whole suite of
innovations and technology transfer in crop and livestock breeding,
nutrient use, pest management, farm practices, and farm equipment and
structures. These innovations are the fruits of publicly funded
agricultural research and development that often have a less-told
story, but we live and reap the benefits of these investments every
single day. Production agriculture requires constant innovation and
adaptation as farmers and ranchers pursue climate-smart solutions to
extreme weather, rural businesses seek new markets, and underserved
communities seek trusted partners to tackle systemic concerns.
The Budget proposes a $3.8 billion investment in our research,
education, and economics programs. The Budget includes discretionary
funding of $1.7 billion for NIFA of which $475 million is for the
Agriculture and Food Research Initiative (AFRI). Demand for AFRI's
competitive funds grows annually and the awards focus on promoting
enhanced profitability and productivity in U.S. agriculture, food and
nutrition security, and boosting rural prosperity through a circular
economy with support for clean energy technologies, climate-smart
agriculture and forestry, and education and workforce development. An
additional $1.8 billion for the Agricultural Research Service (ARS)
includes increases from 2023 of $17 million in support of the Cancer
Moonshot, $13 million for the operations and maintenance of the new
National Bio and Agro-Defense Facility, $13 million for climate science
and monitoring greenhouse gas emissions from agriculture, and $17
million for additional high priority investments. These funds enable
ARS to find solutions to agricultural problems that affect Americans
every day from field to table. This is done through the delivery of
cutting-edge, scientific tools and innovative solutions for American
farmers, producers, industry, and communities to support the
nourishment and well-being of all people; sustain our Nation's
agroecosystems and natural resources; and ensure the economic
competitiveness and excellence of our agriculture.
Science and research are our best defenses to protect our resources
against the climate crisis. The changes in our environment have allowed
invasive plants, pests, and diseases to move around the world more
easily and become established in new areas. Without the tools and
sufficient resources to protect ourselves against invasive species and
safeguard the health, welfare, and value of American agriculture and
natural resources, our farmers and our economy will suffer.
tackling the climate crisis
Producers and land managers across the country are experiencing
real and increasing threats from climate change that have serious
implications-not just for farmers, ranchers, and forest landowners- but
also for surrounding communities and all Americans. In 2022, nearly 80
percent of the western region experienced extreme drought, wildfires
burned over 7.6 million acres of our forestland, and communities across
the country are dealing with the impacts of severe flooding and record
snow fall exacerbated by climate change. Agriculture has a critical
role in delivering climate change solutions and our Nations farmers,
ranchers, and foresters are already leading the way through the
adoption of voluntary and farmer friendly incentive-based climate-smart
agricultural and forestry practices.
Through the Conservation Technical Assistance (CTA) Program, the
Natural Resources Conservation Service (NRCS) provides landowners and
managers with the knowledge and tools they need to develop conservation
plans to implement specific conservation practices needed to improve
farm operations and conserve, restore and maintain the natural
resources on their lands. The Budget requests $985 million for Private
Lands Conservation Operation, of which almost $870 million is for the
CTA program. An additional $30 million in CTA funding will be used to
continue Equity Conservation Cooperative Agreements, which support
historically underserved farmers and ranchers with climate-smart
agriculture and forestry, will bring in additional new customers to
work with NRCS. In 2022, NRCS offered $50 million in funding for Equity
Conservation Cooperative Agreements. Two-hundred fifty applications
were received requesting $202 million, of which 117 agreements were
funded for $49 million. In 2023, NRCS offered $70 million in funding.
Three hundred applications were received requesting $210 million, of
which 139 were selected for funding for $69.2 million.
The Budget supports the USDA Climate Hubs, a cross departmental
effort to provide technical assistance in tackling the climate crisis,
expanding USDA's ability to develop and deliver science- based, region-
specific information and technologies. The Budget requests an
additional $14 million from 2023 for the Climate Hubs to support the
adoption of climate-smart practices. Investments will assist farmers,
ranchers, and foresters make region specific climate-informed decisions
and provide technical assistance to implement those decisions.
rebuilding usda through diversity, equity, and inclusion
Building a better USDA means bringing people of all backgrounds and
lived experiences to be a part of a healthy, safe, and inclusive
workplace. This includes ensuring we are recruiting the best and the
brightest across our great country, and investing in our employees
through recognition, wellness programs, and support to our employees.
Building a better America is about ensuring all have equal access to
USDA opportunities, which demands that we design and implement our
policies and programs with our diverse customers at the center. The
2025 Budget focuses on building a USDA that is a model employer and
great place to work, proposes investments that remove barriers to
accessing USDA programs, and addresses historic gaps with respect to
who benefits from USDA programming.
It's an honor and a privilege to have the dedicated and talented
staff of over 100,000 employees supporting USDA. However, the historic
lack of investment throughout the Department over the years has
resulted in a decline in staffing that we still struggle to recover
from and has meant that we have not had the necessary resources to
modernize critical IT systems or make other improvements to the way we
do business here in USDA in support of rural Americans. USDA
appreciates that Congress broadened the purpose of the Department's
Non-recurring Expense Fund to address both facilities and information
technology needs. For IT systems alone, USDA is projecting a FY 2025
need of at least $190 million for modernization of our platforms to
best serve the public accessing USDA programs. As USDA reimagines and
transforms the way it delivers its mission and services to the American
public, it must also invest in IT modernization to address
vulnerabilities in government legacy systems to ensure those services
are provided in an effective, efficient, and secure manner.
USDA is committed to not only hiring, developing, and advancing a
workforce that truly reflects America's rich and diverse
characteristics, but also to creating an inclusive workplace
environment so that everyone can rise to their highest potential and
flourish in supporting our mission. We are committed to making USDA the
best place to work so that we can attract and train the best and the
brightest in the field of agriculture. The need for growing the next
generation of professionals is timely and important and this funding is
aimed at attracting, inspiring, and retaining diverse and talented
students at eligible minority-serving institutions for careers in food,
agriculture, and related disciplines, with an emphasis on Federal
Government sector employment. The Budget requests $365 million directly
invested in Minority Serving Institution (MSI) programs to fight
against the historic inequity in access to higher education.
Partnerships with MSI programs support capacity building initiatives,
education, and pathways to employment for students and faculty and help
develop a strong pipeline of talented individuals for USDA and USDA
partner jobs. These capacity-building funds will bolster the impact of
the recently announced Inflation Reduction Act program ``From Learning
to Leading: Cultivating the Next Generation of Diverse Food and
Agriculture Professionals (NextGen)''. This historic $262.5 million
investment supports 33 projects across 24 States and competitively
established six HBCUs as NextGen lead institutions. NextGen projects
are led by HBCUs, TCUs, Alaska Native-serving Institutions and Native
Hawaiian-serving Institutions, HSIs, or institutions of higher
education located in the Insular Areas. Working with 60+ MSI partners,
projects will provide training and support to more than 20,000 future
food and agricultural leaders. These investments in future agricultural
leaders will help USDA attract the best and brightest to face the
growing challenges of the agricultural economy.
conclusion
If we are going to create an agriculture system that works for the
many and the most, I believe the answer is a holistic approach. Not one
focused just on bushels per acre, but one that also measures success as
rural families being able to pay their bills, preserving our lands, and
making their communities a place our children and grandchildren can
call home. Producers of all kinds should be able to make a living and
support their families through farming, not just those with the biggest
operations. As decision makers in USDA and Congress, we should use the
market, climate-based tools, and food systems to create new income
opportunities and value for producers and rural communities. This
budget is not a wish list; rather, it is a to do list to fulfill the
items that Congress and USDA have been talking about fixing for
decades. It is a plan for what we need to do to continue to get USDA
back on track and to help the U.S. outcompete the rest of the world.
USDA needs the support of this subcommittee and of Congress to make the
much-needed investments called for in the President's FY 2025 Budget. I
look forward to working with this subcommittee and to answering any
questions you may have about our budget proposals.
Senator Heinrich. Mr. Secretary, I appreciate your response
to my recent letter regarding ready-to-use therapeutic foods
(RUTF). Can you talk a little bit about what more the
Department can do to provide RUTFs as an option within the food
aid toolbox? What authorities you may need, and talk a little
bit about the incredible impact that ready-to-use therapeutic
foods can have on malnourished children?
READY TO USE THERAPUIC FOOD
Secretary Vilsack. I think, Mr. Chairman, the distinction
is between trying to address malnutrition as it exists today in
an emergency circumstance versus a longer-term commitment to
increase food security in nations that are challenged. Our
programs are primarily through the Food for Peace Program. Our
progress programs are primarily focused on the latter. USAID's
efforts are focused primarily on the former. So we work
collaboratively with USAID to ensure that our resources are
utilized in a proper way.
The use of CCC, in this particular circumstance, provided
us an opportunity to double down on the latter. But because of
the nature of the charter, the new CCC charter, we were not
able to, essentially, utilize any of those resources for the
packets. We are advised that because of what we are doing with
the CCC, we are creating greater flexibility within USAID, and
I would suspect and anticipate that in the very near future,
you are going to see a significant commitment from USAID on the
use of those packets.
So it is a combination, it is a partnership. I mean, I
think you could look at changing the CCC, but I think it is
probably better to adequately finance the Food for Peace and
Food for Progress programs and encourage USDA and USAID to
continue working collaboratively together.
BISON PRODUCTION
Senator Heinrich. Can you talk a little bit, give us a
little bit of an update on implementation of the two bison
production-related provisions that were in the fiscal year 24
Bill related both to inspection fees for processing and then
also production and marketing?
Secretary Vilsack. As Senator Hoeven pointed out, that bill
just passed recently, and so we are in the process of taking a
look at trying to better define what a Native American
establishment and institution is, so we know where that
resource and that assistance needs to be directed. We are
engaged in consultations this week and next week with tribes in
an effort to discuss self-determination as it relates to
processing, and as you know, we are investing resources under
the American Rescue Plan (ARP) in expanded processing capacity.
So I think you are going to continue to see us work
collaboratively with tribes. I think you are going to continue
to see us work in a way that will dovetail and parallel what we
do with states where we basically try, I think we can, to pick
up roughly 50 percent of the cost. I think you are going to see
that kind of arrangement discussed with the tribes, and
hopefully we reach a consensus on steps forward.
Senator Heinrich. Thank you. I was glad to see the Western
Water Framework announced by Natural Resources Conservation
Service (NRCS) last year. This as a foundation to build on, how
is USDA planning a sort of all-of-department approach to tackle
the western drought resilience challenges that we have from,
you know, large-scale upstream watershed restoration, all the
way down to small-scale on-the-farm kind of measures?
WESTERN DROUGHT RESILENCE
Secretary Vilsack. The Western Water and Working Lands
Initiative is an initiative focused on six strategies, thirteen
different ways in which we approach preserving groundwater,
surface water, focused on preserving rangeland, pastureland,
agricultural productivity, and the tools to do so.
In fiscal year 2023, we invested $1.9 billion across a
variety of programs within USDA. You saw aggressive use of
Environmental Quality Incentives Program, Conservation
Stewardship Program, Regional Conservation Partnership Program
(EQIP), (CSP), (RCPP) within the NRCS. You saw research being
conducted at ARS as well as grants in NIFA. So it is an
extensive effort on our part to try to address and to provide
tools for farmers, ranchers, and producers to be able to
address concerted issues.
And I think we work collaboratively with our partners in
the Federal Government, in an interagency effort focused on
everything from storage to more conservation and better
utilization of the scarce water resources we have.
Senator Heinrich. This will be my last question for you,
Mr. Secretary, and then I will turn it over to my colleague.
But we know affordable housing has become just such an enormous
challenge across my state and many states across the country.
Can you talk a little bit about how USDA is planning to
implement the decoupling of rental assistance from the
multifamily loan program that was included in the fiscal year
2024 bill?
RENTAL ASSISTANCE
Secretary Vilsack. First of all, I express appreciation for
the Senate and the House providing us this tool. We have
identified approximately 1,700 units between this year and next
fiscal year that will become available that could potentially
be incorporated in that program. I think you will see roughly
600 units this year, and 1,100 units, potentially, next year
depending upon what decisions you make in reference to a
decoupling. You have instructed us up to 1,000 units. We might
suggest maybe going to 1,700.
Senator Heinrich. Great, fantastic. Senator Hoeven.
Senator Hoeven. Secretary, I want to pick up on, you know,
the loss of farms concerns me greatly, that you referenced and
actually it is more than I realized. You and I have talked
about this before, but you brought it home pretty dramatically
in your opening comments. What is most effective, in your
opinion, to stem that tide?
LOSS OF FARMLAND
Secretary Vilsack. I think it is a combination. Senator, I
think first and foremost, you obviously have to have a safety
net to try to keep people on the farm, which goes to the loan
programs, it goes to crop insurance and the risk management
tools that you know so much about. But I think it is also
expanding markets.
I think it is important for these small- and mid-size
producers not to have a single commodity-based income stream. I
think they have to have a stream that is climate-related. I
think they have to have a stream that is ecosystem service-
related. I think we have to encourage more conversion of
agricultural waste into a variety of products instead of over-
application in many parts of the country.
I think we need to continue to strengthen our local and
regional food system, because they get a better bang for the
buck. I think we need to continue to look at concentration and
do what we can to provide more independently owned, maybe
farmer-owned processing. So it is a combination of safety net
and markets.
Senator Hoeven. So I agree, we work on all those things in
Iowa, and North Dakota, Kansas, across the country. So I agree
with those. In terms of crop insurance, the countercyclical
safety net crop insurance, are there some things that ought to
be included in those things as we look at the Farm Bill that
you think would go at this problem?
CROP INSURANCE
Secretary Vilsack. Well, I think we need to continue to
look for ways in which we can expand coverage, more products,
more crops basically being covered. There is still not
everything that is grown and raised in this country has the
same level or opportunity. We have had 12 new products and 50
modifications to existing policies. I think we need to do more
of that.
I think we do need to take--and you know there is a
conflicting set of messages coming out of this Capitol on crop
insurance, there is some who in your circumstances suggesting
an increase in commitment from the Federal Government so that
the farmers have to pay a little bit less for more coverage.
Then there are some folks on the House side who are suggesting
significant reductions in that safety net. I think we need
perhaps some consistency in the approach here, would be
helpful.
Senator Hoeven. Well, we prefer our approach.
Secretary Vilsack. Well, I am sure you do, but there are
166 Members of the House Republican Caucus that feel that crop
insurance should be cut.
Senator Hoeven. Well, it seems to me as we look at this
Farm Bill, crop insurance, countercyclical safety net, access
to credit, beginning farmer, those kind of programs, some of
the livestock programs, we actually want to make more
consistent and dependable, whether it is, you know, livestock
forage, livestock indemnity, emergency livestock assistance,
where you know, like the on the farm side it is more
dependable, these ranchers, particularly the smaller ranchers
the one starting up.
I think as we look at the Farm Bill, those things, we have
to take into account, those numbers that you just laid out, and
think about our programs and make sure we are getting the job
done.
Secretary Vilsack. You do, but I think if you only do
that----
Senator Hoeven. Not only that, yeah.
Secretary Vilsack. If that is all you do, that is not--that
is halfway.
Senator Hoeven. Right, which is why I asked you--we have
always had a surplus in AG trade, we have a deficit right now
in AG trade, back to your comment about markets, right?
Secretary Vilsack. Well, there is a reason for that.
Senator Hoeven. High dollar is one.
AGRICULTURAL TRADE
Secretary Vilsack. Well, high dollar, strong dollar no
doubt, the economy worldwide that is not as strong as the U.S.
economy, however, this is an interesting statistic, maybe it is
just coincidental, our trade deficit for the first 3 months of
fiscal year 2024 was $6 billion, bought $6 billion more than we
sold. China purchased $6 billion less.
Senator Hoeven. I knew that is where you were going, yeah,
coincidence no. Right?
Secretary Vilsack. Well, look, if you continually rap your
number one customer it is not surprising that your number one
customer would send you a signal about, hey, we are paying
attention. So what has to happen I think is a much more nuanced
and sophisticated conversation about China.
You know you mentioned family farms, what is at greater
risk, Chinese ownership of farmland, or the fact that Wall
Street and investment banks own a third of the largest farm
operations in the country, 50,000 farms or so, owned by
investors not by farm families; which is a greater risk?
Senator Hoeven. Let us say we do on the trade front but,
again, we do on the trade, I think there is both trade
barriers, and non-trade barriers, that we have got to knock
down, and we have got to be tougher there. What do we do?
Secretary Vilsack. I can give you a list of $20 million of
trade wins we have had, they are doubles and singles, they are
not home runs, but they are the cumulative impact and effect is
important. The Regional Agricultural Promotion Program (RAPP)
program that we initiated at the request of Senator Boozman and
Senator Stabenow, is important because it expands our
opportunity to diversify, more people, more presence, more
promotion, and more opportunities for trade missions, you are
going to see that. More emphasis in Africa, and Southeast Asia,
moving away from the overreliance on China, I think that is an
important consideration.
Senator Hoeven. Okay. Well, I have used my time up. I will
come back with some other questions in the next round. Thanks,
Mr. Chairman.
Senator Heinrich. Senator Fischer. That is what you get for
showing up on time.
Senator Fischer. Well, my colleagues here, I would love to
bump them. Senator Moran followed me, and before the gavel.
Senator Heinrich. Senator Moran.
Senator Fischer. So now you owe me, Jerry.
Senator Moran. So now, I didn't come out ahead on this
deal.
Secretary Vilsack, thank you. My expectation is that I need
a couple of rounds for questions, so I am happy to take this
beginning. First of all, I appreciate your leadership in
agriculture. I appreciate the relationship we have had for a
long time. I want to highlight the importance that I see in the
consideration and ultimate passage of a Farm Bill. I am
disappointed that there is a pause taking place and it seems to
be that there are those in the Senate who believe the current
Farm Bill is satisfactory, it meets their needs.
I also recognize the challenges that would exist in the
House in trying to pass a Farm Bill as well, so there is plenty
of responsibility here that needs to be met, but it is the
first time in, I don't know, I have been maybe through four
Farm Bills, been on the Conference Committee for two or three
of them. It is the first time that I have ever seen that we
voluntarily decide that we can't get a Farm Bill done.
And you outlined the challenges that producers face, and I
don't expect you to respond to this, but I did not want the
moment to pass without again asking the Senate leadership of
the AG Committee, and the leadership of the Senate, to
reemphasize and refocus on getting a Farm Bill done. I have a
lot of interest in trying to deal with drought and water issues
in the Farm Bill, conservation practices.
On the farm income, you predicted, the USDA predicted it
would be down 43 percent in the last 5 years since the last
Farm Bill input costs are dramatically rising, have risen, and
so I don't want us to walk away from this.
Mr. Secretary, about a year ago we were in Manhattan
Kansas, cut a ribbon on the National Agro-Bioscience Research
Facility, its importance becomes it is more evident all the
time? Would you update me and the committee on the transition
activities, and the mission transfer from Plum Island to
Manhattan?
NATIONAL AGRO-BIOSCIENCE RESEARCH FACILITY
Secretary Vilsack. The official transfer from the
Department of Home Homeland Security to USDA has occurred, and
we are in the process now of, as you say, moving select agents
and other matters from Plum Island to Manhattan, Kansas, and we
are doing this in a very thoughtful, and very careful, and a
very systematic way. I am pleased with the progress that we
have made so far. I anticipate more progress being made this
summer and this fall, and I think we are going to be
significantly operational by the end of this year.
Senator Moran. Any challenges, workforce or otherwise that
you need help with?
Secretary Vilsack. Well, there is always the issue of
budget Senator, this is a state-of-the-art facility that is
unique, and so when things don't work, and you have to get them
fixed, or you have to get them repaired, or you have to get
them replaced. There is a significant expense because of the
level of security that we now have in this facility. But I am
confident that we have got the workforce that is dedicated to
the mission, and that we are going to help American agriculture
and the country.
Senator Moran. In fiscal year 2024 we appropriated the
President's request; we will work to do so in fiscal year '25.
Staying a bit on this topic, I recently visited with the Kansas
Department of Agriculture, its Secretary, and staff of the
Animal Health Commissioner, USDA Regional Veterinary Director,
and livestock producers throughout Kansas.
Mr. Secretary, what we are talking about is H5N1, and it
has spread to mammals; can Animal and Plant Health Inspection
Service (APHIS) through, either its contingency funds or
emergency response work with land grant and diagnostic labs
that have the expertise in livestock management and biodefense
to make funds available to research H5N1 that could either
treat infected animals or develop the therapies that stop the
spread, or mutation of the current strain?
H5N1
Secretary Vilsack. I think that work is already underway.
Senator Moran. With any success that you could report or
challenges you would face?
Secretary Vilsack. Well there are significant challenges
from a scientific perspective, but you know we are going to
continue to work on them, and we hope that within 12 to 18
months we are in a much better place than we are today. It is
going to take time, you have got to match the virus, if you are
looking at vaccines you got to match the vaccine to the virus,
you have to make sure that there are markers that can
distinguish, especially in poultry, between diseased birds and
vaccinated birds.
You have the trade implications, I mean it is a pretty
complicated question it doesn't lend itself to a five-minute
question and answer.
Senator Moran. I would be glad to have a long cup of coffee
with you.
Secretary Vilsack. Sure.
Senator Moran. On that topic, and then I will save my other
questions for the next round, if there is one. What is the
status of scientific study on the H5N1 threat to new mammals?
And what are you seeing in trade implications to date?
Secretary Vilsack. We have made a concerted effort to reach
out to our trading partners, and so far I think there has been
an understanding and appreciation for the amount of information
we have provided our trade partners, we have seen very little
restriction, if you will, a couple of countries expressing
concerns, but for the most part our trading partners understand
that we are on top of this, that we expect and anticipate our
dairy cows to recover, that our milk is safe, and that is very,
very low risk to people.
Senator Moran. We are going to continue to do a lot of
research on this, so that we understand and appreciate the
transition and transmission of this. We know that there is
heavy virus in the milk, we know that that milk when it is
pasteurized it is safe. But there may very well be a
circumstance and situation where we need to be ever vigilant,
in terms of biosecurity especially around the milking parlor,
in terms of having access to what may be virus filled milk that
in turn can be transitioned.
We also have facilities that are both poultry and dairy, we
want to make sure that the transport between those two is very
carefully thought through, because there can also be
biosecurity issues there.
Senator Moran. Kansas has become such a dairy state Mr.
Secretary. And thanks to Senator Fischer. Thank you Mr.
Chairman.
Senator Heinrich. Mr. Secretary, please keep all of us up
to speed on this issue, because it is something I think
everything single member of the committee is following.
We are going to continue the tradition of order of arrival.
So we are going to go with Senator Fischer, and then Senator
Hyde-Smith.
Senator Fischer. Thank you, Mr. Chairman.
Secretary, it is nice to see you again. In fiscal year 2024
I was glad to secure $25 million toward USDA's ARS National
Center for Resilience and Regenerative Precision Agriculture to
be collocated at the University of Nebraska-Lincoln. And I am
excited that we will be holding a groundbreaking in a few weeks
alongside some of your leadership at USDA, and I look forward
to continuing to work with USDA on that facility and to advance
that very important technology.
I also want to discuss the USDA Meat Animal Research Center
at Clay Center (USMARC), Nebraska. As you know, livestock is
the largest segment in the--for agriculture in Nebraska. I was
glad to see the budget request included a request for
additional employees at USMARC, in Clay Center. Your ARS budget
request also highlighted some of the important advancements
that USMARC has accomplished such as a development that could
protect cattle from Bovine Viral Diarrhea (BVD), which is
estimated to cause annual losses of $1 billion in the United
States alone.
So Mr. Secretary, could you discuss how that increase staff
at USMARC can help carry out research related to critical
livestock industry priorities including increased environmental
sustainability, improved production efficiencies, and optimized
use of natural resources?
MEAT ANIMAL RESEARCH CENTER
Secretary Vilsack. I think the easiest way for me to answer
that question is to suggest that we will approach these
challenges in the same way we approach all challenges relative
to agriculture, and that is in a cooperative and collaborative
way, working not just with the university, but also working
with those who are directly impacted and affected by the
research.
Critically important to any of this, is the cooperation of
producers, and producers are in the best position to inform us
as to where they think priorities should be, and we should be
responsive to those priorities, and the research should be
driven, in part, by virtue of those priorities. It should also
work in concert with the research that we are independently
investing in through our National Institute of Food and
Agriculture, as well as the private foundation that was
established in a previous Farm Bill.
So we have a comprehensive approach, a coordinated approach
so that we are not basically spending $2 when $1 will do. So I
think it is a collaborative approach, it is a cooperative
approach, and it is a comprehensive approach.
Senator Fischer. Have you seen that approach at Clay
Center, working with producers in Nebraska?
Secretary Vilsack. I have seen that in ARS facilities
across the United States. I haven't had the opportunity to
specifically visit that particular Center, but I would be
surprised if that is not the way in which they are approaching
their business, because that is the most successful way to do
their business.
Senator Fischer. I have heard very positive things about
the center obviously our AG producers, our beef producers are
extremely aware of the value that that Center has, not just for
the state of Nebraska, but across this country as well, so I
thank you for the interest there.
I also believe it is important to maximize the funding that
broadband programs are receiving, and to get Broadband to
unserved areas in order to do that I think it would make sense
that we have one data source that we can rely on about where
broadband is and where it is not.
Can you share how the USDA tried to promote a more
consistent challenge process comparing what is used by rural
utility service versus what is used by the Federal
Communications Commission (FCC), in connection with the
national broadband map, and has USDA considered measures to
improve transparency or challenges by publishing written
reason, decisions on those challenges?
BROADBAND ACCESS
Secretary Vilsack. When we received the resource under the
Bipartisan Infrastructure Law (BIL), the White House convened
the FCC, the Department of Commerce, and the USDA, and
expressed concern for collaboration and cooperation between the
three entities. We made the decision that we would try to get
our resources out under the ReConnect Program as quickly as
possible, which we have. We have obligated those resources. We
will continue to make announcements for the rest of this year,
where roughly 320 projects will be funded.
And the location, scope, and the nature of those projects
were provided to the FCC and the Department of Commerce so
they, in turn, could take that into consideration as they made
decisions concerning the allocation of a far greater amount of
money that they received. They, in turn, provide to the states
to encourage the states then to make the necessary changes to
ensure that we do, in fact, ultimately have access to decent
Broadband everywhere in the country.
Senator Fischer. Right. And you know, being able to have
that accurate mapping is extremely important, and that, again,
takes cooperation, collaboration not just from providers but
their customers as well to be make sure it is accurate.
Secretary Vilsack. You know, I think states were given an
opportunity to weigh in, and hopefully Governors understood the
importance of that, and I am sure they did.
Senator Fischer. Okay. Thank you.
Senator Heinrich. Senator Hyde-Smith.
Senator Hyde-Smith. Thank you, Mr. Chairman.
And thank you, Mr. Secretary, for being here. Good to see
you again. I first and foremost want to thank you so very much
for the work and helping me address the pine beetle disaster in
Mississippi when we had that tremendous drought. It really
affected our timber in softwood in Mississippi. And as you
know, forest landowners and homeowners across the state have
just been devastated by this pine beetle infestation.
And due to the problem Mississippians are facing, just
enormous economic hardship and risk such as forest fires, and
trees falling on their homes, power lines falling on the roads.
I mean, it is really significant in our state, with this that I
don't remember happening in a very long time.
But yesterday the national FSA Office announced the
Emergency Forest Restoration Program (EFRP). The sign-up was
beginning, they announced yesterday for all 82 Mississippi
counties, and this was much quicker than we anticipated, and I
am grateful that you made it happen quickly following our
conversation at the last Senate AG Committee Hearing just a few
weeks ago. It has been very helpful. And I am relieved that the
forest owners will have some access to the funds for costs
associated with the commercial thinning, the fire breaks, and
the debris removal.
I think everybody in my church has had a tree down on their
house or close to it, from attending church and listening to
all the concerns. But even driving the interstates throughout
the state, it is really affecting us.
But however, there is still a long road ahead of getting
Mississippi forest landowners, homeowners, and municipalities
back on their feet. And I am continuing to explore multiple
angles to assist them. The Emergency Forest Restoration Program
Authorization is certainly a huge step forward for landowners,
and I want to make sure as many eligible Mississippians get
help as soon as possible. That they know they are supposed to
go sign up, where to go sign up, so I just want to ask you for
your commitment to continuing to help me with that, and help
ensure a smooth sign-up process for my constituents.
So many times they will go to the office and they will say,
it was so complicated, or I didn't get the right help. But I am
just asking for your commitment to continue to do that.
EMERGENCY FOREST RESTORATION PROGRAM
Secretary Vilsack. Senator, you have that commitment, and I
think you can take some credit for the early sign-up, and for
the fact that we extended the sign-up period, traditionally 60
days, in this case, it is 120 days.
Senator Hyde-Smith. Thank you so much. We have gotten a lot
of calls. Now, I am going to switch to the Veterinary Medicine
Loan Repayment Program, and last year's budget hearings we
discussed this program, an important program that provides
awards to help offset the educational loans of veterinarians
who agree to serve in USDA designated rural veterinary shortage
areas, which is very critical.
I also mentioned the significance withholding tax applied
to these awards, which diminishes the effectiveness of the
program. You know, we give out these great awards, and then
they have to turn around and give so much of it back to us in
those taxes, but the Explanatory Notes accompanying your 2025
budget request for the National Institute of Food and
Agriculture proposed legislation to end the withholding tax on
these awards. And I truly appreciate your drawing attention to
this issue.
Would you just, because it is in so many states, that this
is effective, would you share with the subcommittee how
burdensome this withholding tax is and how eliminating it would
free more resources for your Department to help address the
rural veterinarian shortage?
VETERINARY MEDICINE LOAN FORGIVENESS PROGRAM
Secretary Vilsack. Well, it costs roughly $200,000 to get
that veterinary degree, and most of the folks who are getting
it are not in a position to, basically, put that kind of cash
into their career, so they have to borrow it. So anything that
provides help and assistance or anything that diminishes that
help and assistance, obviously, is something we do need to be
concerned about.
Frankly, the Veterinary Loan Forgiveness Program, as good
as it is, probably could be better, and with tight budget
concerns and considerations, we did the best we could. And one
way to make it better is to make sure that it isn't reduced by
the tax, and we would hope that that we get some direction from
all of you that gives us the ability to go to our friends at
Internal Revenue Service (IRS) and essentially say that this
shouldn't be a taxable event.
Senator Hyde-Smith. Yeah. Well, I certainly appreciate your
approach to that because the shortage in rural areas is so
significant. And we are talking our food supply here.
Secretary Vilsack. Absolutely.
Senator Hyde-Smith. And we want healthy animals. So thank
you so much for that.
Senator Heinrich. I am going to go back to Senator Moran
for his second round.
Senator Moran. Thank you for your kind consideration this
time. Mr. Chairman, thank you.
Senator Heinrich. I am so tough on you, Jerry.
Senator Moran. Mr. Secretary, Final Rule on WIC Program, I
am concerned, and I am pleased and you have expanded the access
to fruits and vegetables, but you have diminished the
availability of dairy; not true?
WIC PROGRAM
Secretary Vilsack. No, sir.
Senator Moran. That is good to know because we specifically
directed, there was an agreement in increasing the--in the
Appropriation Bill, there was a direction in the lease report
language not to reduce that. So maybe just explain to me, what
the rule is on WIC?
Secretary Vilsack. We did reduce the commitment to fluid
milk, and the reason we did is this is a supplemental program.
We were basically providing 120 percent of the average daily
milk consumption under the previous WIC rule, so we reduced
that down to 78 percent, so consistent with the supplemental
nature of WIC. Having said that, we also made the packaging for
other dairy products, like yogurt, easier, so the expected
anticipation is that more dairy is going to be consumed as a
result.
In addition, we are seeing an increased number of
participants in WIC, so we expect and we project that roughly
130 million more quarts of milk will be sold in the program
than the previous year. So I think I can make the argument
that, in fact, dairy is being assisted notwithstanding the fact
that the percentage of milk may be down a bit.
I would also point out that there are a multitude of ways
in which this Department is assisting the dairy industry, and I
won't go into them, but I am happy to give you the infographic
that shows billions of dollars of assistance to the dairy
industry.
Senator Moran. Thank you for your answer. I will find out
what the response to your answer is, and may be back in touch
with you. I think it was last week that NASS, the National
Agricultural Statistics Service, announced that it was
canceling the July Cattle Report and discontinuing the Cotton
Objective Yield Survey. I think that creates some concern among
state departments and commodity groups. Is there more
information that USDA can make available so that this
information is there? Can you look into that, Mr. Secretary?
NASS REPORTS
Secretary Vilsack. I mean, the problem, Senator, is that
budgets have consequences, and when the NASS budget was reduced
there is a consequence, and more importantly, to this
particular topic, when it takes five or 6 months for the budget
to be passed then the ability and the options available for
dealing with a cut in the budget are limited, limited in this
case to the estimates that are--future estimates as opposed to
estimates that have occurred in the previous 5 months of the
fiscal year.
So I would encourage adequate funding, and encourage
earlier decisionmaking, with all due respect, because it makes
it easier. And in addition it is not just the NASS budget, it
is also the fact that none of the pay increases were
incorporated in the budget, so NASS and everyone else in USDA
had to find the resources to deal with pay increases as well.
So it is a complicated.
Senator Moran. It is a cost-saving measure, in part, but it
is also lack of information, timely information to create the
statistic that is needed.
Secretary Vilsack. Well, I understand but----
Senator Moran. No. I am just reiterating what you told me
to make sure I understand. Is that true?
Secretary Vilsack. That is correct. Yeah.
Senator Moran. Okay. Well, I certainly wouldn't defend the
timeliness of Congress.
Secretary Vilsack. That would be hard to do.
Senator Moran. It would be hard to do, and I wouldn't try.
I can assure you--the people that you have been visiting with
this morning in this room share that view, that we ought to get
our work done on time.
I think my last question, Mr. Chairman, this is a narrow
issue but has consequences. In my meeting with conservation
district leaders, the conversation turned to, they were
contracting for employees to do NRCS work, contract employees
who operate NRCS vehicles, and act within their scope of NRCS
contract duties, it has been determined that nonFederal partner
employees like those are not covered by the Federal Tort Claims
Act, and therefore it is hard to find the folks who are willing
to take the risk to drive the NRCS vehicles and not have
insurance coverage to do so. Is there a plan for fixing, or is
this is another one that you can put the responsibility? We
need to amend the Tort Claims Act?
NRCS CONTRACTOR FLEET INSURANCE
Secretary Vilsack. I would ask for the opportunity to ask
our General Counsel's office about that particular issue, so
that I give you an accurate response. We will get a response to
you in the next couple of days, if that is soon enough.
Senator Moran. I didn't necessarily expect, although it
wouldn't surprise me if you knew this topic, but I wanted to
raise it because the pace to--the challenges of finding
employees in NRCS, it has become----
Secretary Vilsack. It is a fair question, and we ought to
have an answer to it.
Senator Moran. Okay. Thank you, Mr. Secretary.
Senator Heinrich. Senator Manchin.
Senator Manchin. Thank you, Chairman.
Secretary, thank you for being here, I appreciate all your
hard work. Last year, I had the privilege, truly, and you and I
have had a relationship, and been friends for a long time, but
collaborating with you and watching how you and your team
worked, it is unbelievable.
Coming to the aid of apple growers throughout the Mountain
State, we had a heck of a problem, together we facilitated the
successful harvest of our apple crop after unprecedented
oversupply issues threatened the livelihoods of farms, bad
weather left a significant share of apples cosmetically
unsuitable for the fresh market in just a few short weeks.
Our teams working together hand-in-hand to establish a
brand new emergency apple buyback program, which worked
tremendously, saving tens of millions of apples from rotting in
the fields, the salvaged apples were then donated to charitable
organizations, and food banks, not only in West Virginia, but
nationwide.
So I want to express my gratitude for your staff, and most
importantly, yourself for taking the initiative and lead on
this. However, oversupply challenges in the apple industry are
widespread affecting growers nationwide. Maybe you can share
the USDA strategy for achieving a sustainable long-term
solution to this issue, and then some--it is going to go away.
APPLE OVER SUPPLY
Secretary Vilsack. Normally, we have sufficient resources
within Section 32, and perhaps the Commodity Credit Corporation
to address surpluses of commodities, which is the traditional
way. However, this year, for whatever reason, there seems to be
a lot of surpluses of a lot of commodities. In fact, we have
probably $2 billion of need compared to roughly a billion
dollars of resource. So to the extent that we could get, you
know, either additional resources within section 32 or maintain
the flexibility that we utilize to solve these problems from
time to time through the CCC, those two ways--those are the
most effective and efficient ways.
I think we are hopeful that with some of the other work
that we are doing with the school meal rule, with the WIC and
more and more consumption of fruits and vegetables that we will
see over time, a diminishment of those surpluses, but in the
meantime, we will continue to use the tools we have as long as
there is no interference with those tools.
Senator Manchin. All right. Also, Mr. Secretary, the COVID-
19 pandemic resulted in an unprecedented nationwide shutdown,
resulting in the prolonged office closures, and significant
disruptions in the labor market leading to millions of job
vacancies across the nation. In your written testimony, you
highlighted staffing challenges at the USDA, particularly
within the USDA Office of Rural Development (RD).
You have noted a concerning trend where the portfolio is
expanded by 85 percent, yet staffing levels have declined by 30
percent. As a Senator representing a predominately rural state,
that is going to be troubling for all of us, especially in our
states. So can the Department of Agriculture, can you believe
with the staffing you have, or the reduction you have, with the
demand you are having for services, can you meet the
challenges, and what can we do to help?
RURAL DEVELOPMENT STAFFING CHALLENGES
Secretary Vilsack. Well, Senator, we are going to meet the
challenge as best we can, because the people who work for USDA
are incredibly committed and are hard workers, and they are
people that actually risk their mental health to get the job
done. I can't tell you how many conversations I have had with
folks who work for USDA who basically talk about the stress and
strain of working not one job, but oftentimes two jobs, or two-
and-a-half jobs.
So to the extent that you can provide--that you can right-
size programs for people that would help, to the extent that
you can provide resources to adequately enable RD, to hire
additional people. There was a period of time where they were
under a freeze for a period of time that made it more
difficult. And also to recognize that we, like is the case in
many other areas of agriculture we have an aging workforce and
we have significant retirements, so giving us the tools to be
able to retain good people, or to attract new people with
recruitment tools.
Senator Manchin. How is the recruitment going as far as--in
rural areas especially?
Secretary Vilsack. Well, the problem is, this is a much
bigger problem, Senator. Your Federal pay scale used to be
the--it used to be the best job in a rural place, in West
Virginia, in Pennsylvania, in my home State, Iowa, where I now
live. But it is not necessarily the best job today. So there
needs to be a discussion here about--are we serious about
Federal employment? And if we are we need to take a look at the
pay structure, and system so that it is more competitive.
Senator Manchin. How many, and this is across the whole
spectrum, but as far as in USDA, how many are still working
from home, or remote, and how many are back in? What percentage
is back into the office?
TELEWORK AND REMOTE WORK
Secretary Vilsack. The best way I can describe this is
roughly 82 percent of our workforce is sort of on the job where
the job needs to be done. Now, that doesn't mean that they are
necessarily----
Senator Manchin. Is that the same as it was before the
pandemic? I mean, they are back to where they were working.
Secretary Vilsack. I would say for the most part, not in
every mission area, but for the most part, collaboratively, or
comprehensively, the work is getting--I can guarantee the work
is getting done, and I can give you chapter and verse of how
many loans we have done, and compare that to where it was
before the pandemic. We are cranking out the work. There is no
question about that.
Senator Manchin. Let me just say one thing. I get more
compliments working with your office, than I do with almost any
agencies in the Federal Government because it is a rural state,
we are so interacting with you all the time. So I just want to
thank you, and all your staff here, they have done a great job.
We are very appreciative.
Secretary Vilsack. That may be because you have my cell
number.
Senator Manchin. That may be because we both know, where we
both live.
[Laughter.]
Senator Manchin. Thank you, sir.
Senator Heinrich. Secretary, first off I want to recognize
the inherent challenges that exist to expanding tribal self-
determination within different parts of your Department, but I
would just ask that you commit to working closely with me and
my colleagues this year to determine what is needed for USDA to
expand tribal self-determination opportunities, including
through 638 Contracting Authority.
TRIBAL SELF DETERMINATION
Secretary Vilsack. Senator, we are more than happy to work
with you, and more importantly, or as importantly with the
tribes. I mentioned the consultations that are going to take
place. They are in nutrition, they are in forestry, they are in
food safety, in an effort to try to figure out how to structure
the self-determination that fits the mission of USDA. We are a
little different than the Department of Interior, because many
of the programs that the Interior Department have are expressly
in and confined to tribal areas and tribal nations.
Our programs bleed over into non-tribal areas, so it is
important for us to make sure that we are aligning it
appropriately, but we are very committed to this, as I think
expressed by the fact that we have over 160 stewardship
arrangements on the Forest Service, that is a good example, the
work that we have done in the food distribution program,
another example.
Senator Heinrich. Yeah. And you have been very good about
visiting New Mexico if you ever want to see a 638 contract that
is been very successful, the Pueblo Santa Clara's 638 contract
with USDA has been a real success.
I am going to turn things back over to the Ranking Member
for his final questions, and then I think we will probably wrap
up.
Senator Hoeven. Thanks Mr. Chair, the CCC, incredibly
important because it is a flexible tool that we use for a lot
of different purposes, as you know, and I believe it is
something that that needs to be there because we never know
what is going to happen in this--again this huge diverse world
of agriculture. And so I think how we use it really matters,
there is a number of things that we have used it for recently,
going back to the drought issue that 2021, for example, my
state was included, and there is about $5.5 billion right
there, right now, that we have designated for some of these
different uses, some you like better, some I like better. But
again a number of or a variety of things that I think are
really important.
So again, my first point is, that CCC is an important tool,
we need to be able to use it, we need to have flexibility, and
I think you and I both agree the AG Secretary needs some
ability, hopefully, working closely with us to utilize that
tool and have it for the future but also where are you in terms
of getting some of the current programs dispersed that we have
utilize CCC--funding for?
CCC UTILIZATION
Secretary Vilsack. Several of those areas. I will take the
fertilizer area, for example, there is an opportunity for us to
do significantly more projects, but we have to go through the
Environmental Review, oftentimes there is a process by which
before we can make an award, or finalize an award, we have to
go through the National Environmental Policy Act (NEPA)
process, that takes time, it takes staff, it takes resources,
which we have.
We have done 42 projects, but I anticipate that we would
probably see another 50 projects in that space, so that is
ongoing. There are ways in which we are working on the drought
issue, and specifically with our sister agencies to determine
whether or not there is a--an interesting collaborative that
could potentially be between the Department of Interior and
USDA, in terms of those resources, and then we are trying to
work through our--the OGCs of the two departments.
There are HPAI, those ongoing expenses continue to accrue,
and we continue to pay them out, the Climate-Smart Agriculture
Initiative was structured at the request of farmers, and
ranchers, in 80 different organizations to be a three- to five-
year commitment, so those resources will go out over a period
of time.
So it is a question of the structure of the storage request
that Senator McConnell requested. Well, it turned out that
there was quite a bit of demand for that, to the point that it
far exceeded the amount of money that we had allocated, so we
are taking a step back and trying to figure out how to
restructure that program to provide the assistance for the
folks who actually need it, immediately, and an additional
maybe modified approach for those who are confronted with a
slightly different risk.
I mean, so it depends on the specific item within CCC, but
it is not for lack of effort, it is not for--we are not sitting
on the resources, every single one of those is being advanced,
and if you look at the resources that have been invested, I
think you will find there is been significant activity in all
of those accounts.
Senator Hoeven. Well, and I think that is an example of
program where you and I both recognize that creates an
opportunity for us to work together to do some important things
between Farm Bills. And so I think we need to make sure that we
continue to work together to ensure we have, because there is
some that seem to want to take it away.
Secretary Vilsack. No. That is right.
Senator Hoeven. And it has got to be collaborative, right,
it has got to be a working relationship.
Secretary Vilsack. Absolutely, and I think, frankly, if we
could be a bit more creative about the structure of the Farm
Bill, that this is a vehicle as we did with, Agricultural Risk
Coverage (ARC), and Price Loss Coverage (PLC), and Conservation
Reserve Program (CRP) that essentially provides the resources
for funding of those programs.
And the commitment I would make to you, Senator, is that we
will never, ever, ever drain the account. We will never just
for one thing, as has happened in the past, drain the account
and force you to replenish it. We are very sensitive to the
importance of maintaining some set of responsibility, fiscal
responsibility in the utilization of those tools.
Senator Hoeven. That is good. There are two other questions
I want to try to get here. I know you addressed some of the
Avian flu stuff which is, obviously, very important but one is
on advancing some of these new initiatives on precision AG like
we have in our state. We have this great partnership between
North Dakota State University, Grant Farm, and ARS, and I think
that this is just a huge benefit for farmers, in terms of
precision AG which is such a big deal.
If you will address how we can do more there? And then I do
want to come back and ask you, we are getting budget pressure
from things like WIC where we saw a $1 billion increase this
past year, and then another $700 million increase this year. So
we don't want our AG research and some of these new initiatives
so vital to farmers, crowded out of this budget. So if you
could kind of address those two in the time we have remaining?
Secretary Vilsack. Well, the answer to the first question
is, continue to be supportive of, and increase the funding for
research, education, and extension. Every year we ask for
significant increases in those--Research, Education, and
Economics (REE) (ph.), and every year, we get a significant
amount, but often less than what we were asking for. So that is
the answer to that question.
The answer to your question is I think eventually you all
are going to have to confront the notion that this is a program
that is very difficult to--with specific accuracy--to define
precisely how many people will use it from day-to-day, week-to-
week, month-to-month, and it is very similar in that vein as
the SNAP Program. The SNAP Program is a mandatory program. WIC
should be a mandatory program.
Senator Hoeven. Thank you, Mr. Chair. Just by closing
comments, to hand it back to you then would be, again
appreciate your work on all of these things I kind of laid out
how important I think it is in terms of when we talk farm
policy, it affects everybody in the country. So again, thanks
for being here today.
Senator Heinrich. Thank you, Ranking Member Hoeven, and I
want to thank the Secretary and Mr. Nelson for being here
today. This has been a great hearing.
ADDITIONAL COMMITTEE QUESTIONS
Questions for the record are due by next Tuesday, April
23rd. And we would appreciate responses back within--from USDA
within 30 days if you can.
SUBCOMMITTEE RECESS
[Whereupon, at 11:08 a.m., Tuesday, April 16, the hearing
was adjourned, and the subcommittee was receessed, to reconvene
at a time subject to the call of the Chair.]
AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2025
----------
WEDNESDAY, MAY 8, 2024
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
The subcommittee met, pursuant to notice, at 10:00 a.m. in
Room SD-124, Dirksen Senate Office Building, Hon. Martin
Heinrich (chairman) presiding.
Present: Senators Heinrich, Murray, Baldwin, Manchin,
Peters, Hoeven, and Hyde-Smith.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
STATEMENT OF HON. ROBERT CALIFF, M.D., COMMISSIONER
OPENING STATEMENT OF SENATOR MARTIN HEINRICH
Senator Heinrich. This hearing of the Agriculture
Appropriation Subcommittee is now called to order.
And I would like to begin by welcoming FDA Commissioner,
Dr. Robert Califf, and thank you for being here today.
I look forward to discussing the fiscal year 2025 Budget
Request for the FDA. The responsibilities of the Food and Drug
Administration are vast, and impact the lives of nearly every
American. We need to ensure we have the resources to continue
your critical mission. And I am committed to working with you
during the Appropriations process to provide the funding that
you need.
That begins now with the fiscal year 2025 Budget Request
that is in front of us. The request includes a total of 3.695
billion in discretionary funding, a $168 million increase, a
relatively modest increase for this Agency. I am interested in
hearing about your priorities within this budget request, Dr.
Califf, and what role this committee can play in ensuring we
continue to have the world's safest food and drug supply.
I will say that I am frustrated with FDA's lack of urgency
in regulating the tobacco products and e-cigarettes that are
flooding the market. And I am also concerned with highly
pathogenic avian influenza and its potential impact to our food
supply.
I continue to be interested in investing resources in our
domestic infant formula supply as we continue to recover from
the 2022 formula crisis. All of these issues continue to be
public health threats to our nation, and the FDA should be
using all tools available to address them. I look forward to
hearing your thoughts on these issues, and what FDA is doing to
address them.
Dr. Califf, I want to reiterate my continued support for
FDA and the dedicated employees at your Agency. Last year we
had to make some pretty difficult budget decisions under grim
spending caps, and I am afraid that it is likely this year will
not be much better. That is why it is important for us to hear
your priorities, and the priorities of members of this
committee. And thanks again for being here.
And I will turn things over to my ranking member, Senator
Hoeven.
STATEMENT OF SENATOR JOHN HOEVEN
Senator Hoeven. Thank you, Mr. Chairman. And Dr. Califf,
thanks for being here, and for your service as the leader at
FDA, incredibly important position.
I know it has been a busy time since your return, as
Commissioner from the COVID-19 pandemic, to the infant formula
crisis, and the current highly pathogenic avian influenza
outbreak, which we will talk about a little bit, among dairy
cattle, as well as ongoing drug and device shortages.
So all of that on top of what you have to do every single
day, which is, of course, to keep the food and drug supply safe
for, you know, well more than 300 million Americans.
Your Agency has authority over 160 (sic) foreign
establishments and--excuse me--160,000 foreign establishments,
and 135,000 domestic establishments, which is really
incredible. And that ranges from food processing plants to
facilities that manufacture life-saving medications, also
countless individual products. So I appreciate that when it
comes to keeping food and drugs safe and effective. You have
got to get it right. And you really have got to get it right
every single time, which is an incredible task.
And that is, of course, why we provide the budgetary
increases, you know, that we have, which have been substantial
over the last 10 years. And Americans expect that. I mean, they
expect, you know, you have set a high standard, and they expect
that to be maintained in an ever more complex and
interconnected world.
So there are a lot of things we will talk about today,
obviously no shortage of food safety issues. I appreciate the
steps you are taking in terms of the reorg. I know that has
been a massive task, and we want to talk about how that is
going. Also, I am concerned in your budget plans for adequately
funding state food inspectors, which we want to touch on. And
then the drug shortage we are seeing across the country with
various drugs, and that is something that we will need to
discuss here as well; also, the rare diseases, lab-developed
testing regulations, and of course, artificial intelligence,
right.
So a lot of important topics in your job, it is kind of
like you touch on everything, and everybody, every day. Thanks
for being here. Appreciate it.
Senator Heinrich. Dr. Califf.
SUMMARY STATEMENT OF DR. ROBERT CALIFF
Dr. Califf. Thanks, your commenting about everything every
day. I just had my 55th high school reunion, and everyone there
had some opinion about what the FDA should or should not be
doing. I can assure you.
So Chairman Heinrich, and Ranking Member Hoeven, and
Members of the Subcommittee, thanks for the chance to be here
before you today. I do want to start by thanking the
subcommittee for your continued support of the FDA in a
difficult fiscal environment. The Agency greatly appreciates
the subcommittee's sustained commitment to our mission.
The budget I am pleased to present to you today requests a
total of $7.22 billion for the Agency, an increase of $341
million above the fiscal year 2024 enacted levels. Looking
ahead to fiscal year 2025, we intend to take significant new
steps in our approach to addressing our numerous challenges, in
particular through the largest reorganization in the history of
the FDA. Virtually every component of the Agency will be
impacted in some way by the changes, which will affect over
8,000 of our 18,000 employees. At the center of this
reorganization, we are building a newly Unified Human Foods
Program.
Following the independent evaluation by the Reagan-Udall
Foundation and an internal review, we are bringing together
human foods functions, resources, and personnel from across the
Agency, all under a single leader. Importantly, this new Human
Foods Program will create a clear line of authority. The new
Deputy Commissioner has full decisionmaking authority over the
entire program.
We are also, renaming the Office of Regulatory Affairs as
the Office of Inspections and Investigations, signaling a
refocusing of that office on its core function of inspections,
investigations, and import operations, eliminating duplication
and increasing efficiency in how we handle these activities.
As part of this effort, we are shifting the Office of
Regulatory Affairs Medical Products, Tobacco Products, and
Specialty Labs into the Office of the Chief Scientist to form a
highly integrated network of laboratories and laboratory
scientists that provide coordinated, cutting-edge regulatory
science research, and support for all of the FDA.
Additionally, we are making a number of other realignments
to further improve efficiency and communication across the
Agency, including moving cosmetics functions to the Office of
the Chief Scientist, which is best positioned to support
scientific expertise necessary to review cosmetic ingredients
and implement the new authorities provided under the
Modernization of the Cosmetics Regulation Act.
The fiscal year 2025 budget requests will provide a solid
foundation for these newly envisioned programmatic changes, as
well as strengthen the Agency's capacity to protect and promote
a safe and secure U.S. Food and Medical Product supply.
Outside of the reorganization, we are also looking to make
significant strides in other critical cross-cutting areas. For
example, the past 4 years have demonstrated the importance of
managing supply chains and mitigating shortages of critical
products. Our fiscal year 2025 budget requests $12.3 million
for supply chain work across nearly all product areas, as well
as establishing positions to coordinate these activities across
the Agency.
Finally, I also want to emphasize the importance of the
Agency's modernization of IT infrastructure and data processes
at the FDA. We are requesting an increase of $8.3 million to
further build on our centralized enterprise data modernization
capabilities, as well as $2 million to implement common
business processes and data optimization.
The rapidly changing world demands that our systems evolve
to meet future needs. This includes incorporation of computing
advances like artificial intelligence, and advanced
cybersecurity methods to protect our data and information. The
industries we regulate and our own workforce have focused on
the use of AI coupled with better data and sophisticated
computing infrastructure for innovative ways to benefit public
health, from efforts to detect contamination patterns and
screenings for imported food products, to helping to identify
potential cancer therapies for certain ultra-rare cancers.
Finally, we have contributed significantly to the joint
effort to deal with the highly pathogenic avian influenza
outbreak. And I am pleased that our supply of milk products is
safe. However, this virus, like all viruses, is mutating. We
need to continue to prepare for the possibility that it might
jump to humans.
Thank you for inviting me today. And I look forward to
answering your questions.
[The statement follows:]
Prepared Statement of Dr. Robert M. Califf, M.D.
Chairman Heinrich, Ranking Member Hoeven, and Members of the
subcommittee, thank you for the opportunity to appear before you today
to discuss the President's Fiscal Year 2025 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. In a
difficult fiscal environment, 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 ongoing and emerging challenges.
During my second tenure at FDA, I have spoken regularly about the
need for operational change to address the numerous emerging demands of
new technology and the rapid transformation in how the products we
regulate are manufactured, distributed, purchased, sold, and used.
Looking ahead to FY 2025, we intend to take significant new steps in
how we approach these challenges, including by implementing the largest
reorganization in FDA's history. Following the independent evaluation
by the Reagan-Udall Foundation and FDA's own review of how we addressed
the infant formula supply chain response, this reorganization will
establish a single, unified Human Foods Program by merging all human
foods functions, resources, and personnel from across the Agency. We
are also taking this opportunity to further improve other functions of
the Agency to create an organization that will break down siloes and
fragmentation, leading to enhanced efficiency and collaborative
operations to more effectively meet FDA's public health mandate.
The funding requested in the President's FY 2025 Budget builds upon
our existing work with additional resources crucial in helping the
Agency adapt to a changing landscape. Our FY 2025 program level request
totals $7.22 billion, which represents an overall increase of
approximately $341 million in annual funding above the FY 2024 Enacted
level. Of this total, $3.5 billion is for user fees, which is an
increase of approximately $168 million over FY 2024 Enacted levels. As
part of the total program level, the Budget also requests $3.7 billion
in budget authority, an increase of $173 million. This funding will
allow FDA to make significant progress on several important fronts,
including (1) food safety and nutrition; (2) medical products; (3)
crosscutting issues; (4) modernizing infrastructure, buildings, and
facilities; (5) tobacco issues; and (6) strengthening biodefense. Of
course, none of the crucial work done at FDA would be possible without
our talented and dedicated workforce, which is why we're also
requesting an increase of $114.8 million for public health employee pay
costs as part of the total request for budget authority.
human foods program
FDA has worked in concert with the broad ecosystem of States,
territories, local governments, Tribes, and the vast array of industry
entities to make the American food supply as safe as it's ever been. As
our knowledge base expands, we continue to identify areas where
improvement would further enhance the safety of our food.
FDA's Budget request includes key investments for the Agency's
Human Foods Program with $1.26 billion to support our continued efforts
and commitment to strengthening FDA's food safety and nutrition
capacity. FDA requests an increase of $15 million, in part to support
microbiological methods and sampling improvements, which will enable
more rapid and effective mitigation of produce-borne outbreaks in pre-
harvest produce production environments. This body of work will
strengthen root-cause investigations essential to FDA's outbreak
prevention strategy for produce. Such an increase would also help
support FDA's food chemical safety programs, including an increased
focus on post-market assessments of intentionally added ingredients and
authorized substances used in food, food packaging, or color additives
for food manufacturing to ensure they meet the safety standard in the
Federal Food, Drug, and Cosmetic Act. An increase would also support
our work to reduce exposure to contaminants that may enter food through
the environment, processing, or other means.
In addition, funding in our request will be used to grow the
Agency's nutrition program within the planned Center of Excellence in
Nutrition, as envisioned in the Agency's proposed transformation of the
Human Foods Program. With an emphasis on early childhood nutrition,
this request assists FDA in addressing the enormous public health
burden of diet-related chronic diseases. As a cardiologist, I've seen
firsthand the results of poor nutrition and diet, often stemming from
childhood, and the long-term impacts from diet-related chronic disease
that can occur. This is almost certainly one key cause of our recent
decline in life expectancy-more than a 5-year deficit in life
expectancy compared with other high income countries. This request will
also assist FDA with its nutrition and labeling work in alignment with
the White House's National Strategy for Hunger, Nutrition, and Health.
medical products
FDA is dedicated to ensuring that safe and effective drugs,
biological products, and devices are available to improve the health
and quality of life for people in the United States. Without a doubt,
responding to the rapid advancements made across regulated industries
is one of the most challenging aspects of FDA's work, but one that we
are excited about every day.
FDA is committed to ensuring that products it regulates meet the
requirements for marketing authorization while facilitating innovations
in their development. Through effective interactions with private
industry, Congress, and the public, we believe that FDA can help
harness these groundbreaking advancements, like gene editing and
artificial intelligence. Since 2016, FDA has been implementing the 21st
Century Cures Act (Cures Act), a law enacted to accelerate medical
product development and bring new innovations and advances to patients.
The Cures Act authorized $500 million over 9 years to help FDA cover
the cost of implementing the law.
Overall, the enactment of the Cures Act has been associated with a
dramatic surge in biomarker- based genetic therapies for rare diseases
as one example, but this may be just the front edge of a major surge in
highly effective, specific therapies for previously untreatable
diseases. FDA requests an increase of $5 million for 21st Century Cures
to reflect the last authorized level for Cures in FY 2025, for a total
of $55 million.
cosmetics
FDA appreciates the Committee's support for this vital area, and
requests $8 million in FY 2025 to support the continued implementation
of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). MoCRA
provided the most significant expansion of FDA authority to regulate
cosmetics since 1938. However, MoCRA did not include any new funding to
implement these new authorities. These new resources would allow us to
continue building on current efforts to better position the Agency to
tackle issues such as asbestos contamination of talc-containing
cosmetics, such as tattoo inks and permanent makeup. These requested
resources will help bolster our activities in the cosmetics space, such
as developing regulations and compliance policies; managing submission
platforms associated with MoCRA provisions; reviewing MoCRA-required
information submitted to FDA for industry compliance; and hiring
additional subject matter experts to manage critical projects, such as
the assessments of the use of perfluoroalkyl and polyfluoroalkyl
substances (PFAS) in cosmetic products.
shortages and supply chain
Shortages of drugs, devices, and foods that Americans rely on for
their everyday needs can occur for many reasons, including market
failures, manufacturing and product quality problems, manufacturing
delays, and discontinuations. FDA plans to continue to use a proactive
approach towards shortages--to the extent possible within its resources
and authorities--to make supply chains more resilient, increase
regulatory oversight, and when possible, help prevent or mitigate
shortages of critical medical and food products that Americans rely on.
The FY 2025 budget includes $12.3 million to advance FDA's capabilities
to help prepare for, build resilience to, and respond to shortages that
are supply- or demand-driven. For example, FDA will use this funding to
improve analytics to estimate risk of disruptions in drug manufacturing
and identify vulnerabilities so that we can be in a better position to
intervene sooner. Further, approximately $3 million of this increase is
dedicated to the recruitment of skilled investigators who will conduct
inspections. This investment aims to bolster the regulatory oversight
of the drugs, devices, and biologics industries, helping FDA to
effectively provide inspection coverage to the increasing number of
manufacturers within the medical products industry, and enhancing our
ability to promote high-level manufacturing quality and a reliable
supply chain.
enterprise transformation
To improve the efficiency of our operations, FDA has proposed
targeted investments to support our modernization activities. We
request $2 million to support centralization of planning,
implementation, and governance of high-priority business process
improvement efforts. This funding will also support the work to build a
unified data and operational platform to support our inspection work.
This comprehensive initiative aims to modernize operational approaches
and foster cohesion, with a specific focus to improve how we plan and
conduct inspections so that more inspections can be done in the context
of better supporting data and more efficient operations.
it stabilization and modernization
FDA requests an increase of $8.3 million to further build FDA's
centralized Agency- wide data modernization capabilities and strengthen
our common data infrastructure, data exchange, and IT tools. With these
additional resources, FDA will continue to improve data exchange and
underlying technology platforms in support of the Agency's programs and
mission-critical responsibilities to meet future challenges.
Specifically, a stronger digital infrastructure better allows us to
meet the challenges of emerging threats, support real-time evaluation,
and more efficiently analyze information for recalls, adverse events,
outbreaks, and biothreats. The rapidly changing capability of the
information technology ecosystem demands that our systems evolve to
support the rapid adoption of artificial intelligence in the products
we regulate, including ensuring the continued success with our
intensive cybersecurity program.
FDA is requesting 2-year budget authority (FY 2025--FY 2026) for
this funding to provide more flexibility and ensure the most effective
use of these resources.
foreign office expansion
In addition to assessing the current state of our domestic
enterprise, FDA continues to assess the state of our foreign offices
and international work including inspections, oversight, and
collaboration with foreign food and drug agencies. The dependence of
the industries we regulate on increasingly complex and interdigitated
global supply chains demands that we apply more resources to assuring
the quality and integrity of these dependencies.
To support these efforts, FDA is requesting an increase of $1
million for foreign office expansion. This funding will support the
expansion of the Agency's foreign office footprint by increasing our
resources to improve oversight of quality management systems and supply
chains, facilitate additional FDA foreign inspections, and increase our
ability to engage with counterpart regulatory authorities to strengthen
public health protections.
modernizing infrastructure, buildings & facilities
In addition to necessary investments in our core operations, the FY
2025 budget provides limited funding to support FDA's Infrastructure
and Buildings & Facilities. These programs directly support FDA's
priorities by providing office and laboratory space for FDA's workforce
to perform its critical health work.
tobacco regulation
Tobacco product regulation continues to be one of FDA's greatest
opportunities to save lives and prevent devastating impairment of
quality of life caused by cancer, strokes, and other consequences of
tobacco use. FDA regulates the manufacture, marketing, and distribution
of all tobacco products. Applications for more than 26 million tobacco
products have been submitted over the last 3 years. FDA has resolved
99% of those submissions, while ensuring decisions are scientifically
accurate, legally defensible, and aligned with the authorities granted
by Congress. In addition to premarket review, key areas of focus
include policy and rulemaking, compliance and enforcement, research
support, and public education campaigns. The Budget provides $798.6
million for the Tobacco program, which will further bolster resources
to invest in these critical regulatory activities.
Within this request, there is an additional $114.2 million in
proposed user fees to ensure that FDA has the resources to effectively
address all regulated tobacco products, including e- cigarettes and
other novel products, particularly those popular among youth. These
products represent an increasing share of FDA's tobacco regulatory
activities. The additional funding will bolster compliance and
enforcement efforts, enhance premarket application review, and expand
tobacco public education campaigns and science and research programs,
as we work to mitigate harms and to protect consumers from the dangers
of tobacco use. To ensure that resources keep up with the evolving
landscape, the proposal would also index future collections to
inflation.
The Agency remains vigilant in overseeing the market and continuing
to prioritize the use of our resources to maximize public health
impact, including compliance and enforcement efforts to curb the
unlawful marketing of all tobacco products, especially those used
prominently by youth.
strengthening biodefense
The COVID-19 pandemic also highlighted the need to proactively plan
for the next public health emergency and ensure we have the resources
and capacity in place to fully respond. The Agency has a unique and
central role in the whole-of-government response to protect public
health. The FY 2025 Budget's Strengthening Biodefense request for FDA
includes $670 million in new mandatory resources for spending over 5
years to advance activities to better prepare FDA for the next
pandemic. These resources will help ensure an adequate level of
regulatory capacity to respond rapidly and effectively to any future
pandemic or biological threat by supporting the Agency's biodefense
efforts, both domestic and globally, by bolstering FDA's capacity to
provide timely recommendations and scientific advice to manufacturers
designing and testing vaccines. Additionally, this funding will support
increased research and development of diagnostics, next-generation
personal protective equipment (PPE), and technology for biosurveillance
and early warning. And finally, these resources will further strengthen
data exchange and technology platforms to help ensure that FDA is in
the position to respond to a public health crisis quickly and
effectively.
conclusion
While we are in the midst of a challenging budget environment, FDA
continues to work with the resources at its disposal to serve the
Agency's critical public health mission. The additional resources
requested in this year's Budget represent the areas of greatest need as
we modernize to address evolving consumer and industry needs. 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 Heinrich. Dr. Califf, why don't you start right
there and just talk a little bit about what that preparation
looks like?
Dr. Califf. Sure, first of all, it is important. As you all
know, we have talked about One Health for a long time, the fact
that we all live in a world and a universe where animals and
humans are more and more connected because of international
transportation, the fact that more people are living closer to
farms and on farms. But this is a real example of One Health.
Just roughly speaking, it is always a little more
complicated than just the first take on it, but essentially,
the Agriculture Department regulates the cows, we regulate the
milk at the FDA, and the CDC has primary responsibility for the
health of the workers on the dairy farms. And so we all have to
work together across these organizations and agencies to take
care of things.
And there are so many aspects, I can't go through them all,
but primarily from the FDA perspective, today, we are
accountable for the milk. So when we heard about the problem,
we needed to launch a program of testing the milk to make sure
that it was safe, knowing that it was likely that there were
more infected herds than we initially knew.
And in fact, that is what we found. As you well know, when
we looked at just milk before pasteurization, that is the raw
milk coming into the bulk tanks, about 20 percent of a national
sample turned out to have fragments of virus in it. And then
the question was, is this infectious virus, or is it
essentially fragments of dead virus that had been taken care of
by pasteurization? We had a good reason to believe
pasteurization would work because of 100 years of pasteurized
milk. And in fact, it did. We found no evidence of live virus.
And I am pleased to say there are many NIH and Agriculture
Department researchers around the country, and universities,
who were also looking, and we all found the same thing. But
now, the other part that we are accountable for at HHS and
within FDA is the countermeasures in case this does jump to
humans. So we got to have testing, got to have antivirals, and
we need to have a vaccine ready to go. So we have been busy
getting prepared for--if the virus does mutate in a way that
jumps into humans on a larger level.
Throughout all of this, because there are so many agencies
involved, countless hours of phone calls, and Zoom conferences
to make sure that we are all coordinated, all in an environment
where, let us just say it is not easy to get access to the
farms because, you know, people are understandably protective
of the environments in which they work.
So a lot of work across the agencies here, and I feel like
it has been a good example of how One Health can come together.
Senator Heinrich. Great. Dr. Califf, how do you see the
infant formula being managed under the new Human Foods Program?
Dr. Califf. Well, I would really like to answer that
question in two parts. And I think you may remember the day I
was confirmed was the day of the Abbott recall, so it is not a
very warm welcome to the FDA to hear that this is going to
unfold. And so the first part is what we have already done,
because just a comment about the reorganization, I am sure we
will talk more about it with other questions, but we can't
enact the reorganization until we get through Congressional
notification process.
We are still waiting on one branch of the Four Corners to
give us the okay. Then we have to negotiate, or really reach
agreement with the unions, which I don't think it is going to
be a big problem, but the unions that represent 80 percent of
our employees have a right to have a say. And then we are ready
to go. We are amassed at the starting line to really get going.
We have hundreds of people across the FDA who have
volunteered to be champions of change in this massive
reorganization. But in the interim because of the urgency of
the infant formula issue, we have already done a lot of the
work that we had to do. We now have many more people working
within currently CFSAN, the food, part of the FDA on this sort
of basic science and regulation that needs to go on, and we
have beefed up the inspectorate, so they are called
investigators at the FDA. We have a dedicated corps; all of the
infant formula facilities are being inspected at least once a
year.
In the case of the Abbott Plant, there is a consent decree,
so we are essentially there every day talking with them, and as
issues come up, dealing with them jointly. But it is a whole
different world now that the scientific experts, the
investigators, and the leaders meet on a regular basis, plan
the inspections, and when things are found, they are dealt with
very quickly, as compared to a process which, in the routine
prior, you know, it took some time to institute the changes.
And we have, as you know, hired Jim Jones as the head of
the Human Foods Program, although it is not the Human Foods
Program yet until we--and this better decisionmaking structure,
there was nothing wrong with the people that were trying to
make decisions before, but it was not optimally organized to
lead to crisp decisions that would lead to action being taken.
Senator Heinrich. Great. Ranking Member Hoeven.
Senator Hoeven. Thanks, Mr. Chairman. Yeah, I feel like the
question just always, with these issues, leads to more
questions. On the avian flu, now that has jumped to humans in
some--I know there was a case in Texas, and has gone from
cattle to humans already, in some cases, correct?
Dr. Califf. So you might enjoy just a quick note about the
biology here, not that I am--I mean I am a doctor, not a
clinician, not a biological scientist, but the attachment of
this virus is through receptors, that deal with something
called sialic acid that are ubiquitous in all animals,
including people. And it turns out the human conjunctiva,
apparently, is the one part of the human that right now is
susceptible.
And so the one case that we have was conjunctivitis, not a
serious illness, but conjunctivitis. And that case has been
worked up by the CDC as best they could. But like all viruses,
it comes and goes. So you have got to really catch it while the
person is actively infected to do all the things that you would
like to do. The real worry is that it will jump to the human
lungs, where, when that has happened in other parts of the
world for brief outbreaks, the mortality rates been 25 percent,
so one in four, that is about 10 times worse than COVID.
And so it is really, you know, we don't control how the
virus mutates, and it is just a mathematical--viruses are
always mutating; it is a mathematical probabilistic thing where
the mutation will make it able to attach to these receptors in
the human lining of the lung, that would make it perhaps
transmissible through the airways, which would be really bad.
So we have to be ready, and we have to do everything we can
to limit the spread of the virus, which has gone around the
world multiple times now, in many different species, but there
is this debate, but there is a concern that when it invades
cattle for the first time, which are closer to the human being
than a bird, say, and the cattle are often intermingling with
pigs on farms, and with farm workers, you know, a lot of the
experts have told us they are particularly worried right now.
So the public need not be worried. The risk is still low
that that will happen, but it is sort of like I have -- this
may be a bad analogy--but I think of it, having had relatives
go through this, I would rather have the low deductible
insurance than the high deductible insurance. That is if we
institute the countermeasures now and reduce the spread of the
virus now, then we are much less likely to see a mutation that
jumps the humans for which we are ill-prepared.
So the investment now, and the careful attention to
management of the herds on the farms is really--and part of our
job at FDA, we will have an active surveillance system on the
milk so the public can be reassured that this, you know,
critical part of the food supply is staying safe.
Senator Hoeven. So I mean, it has moved from birds to
cattle, and that process, you have got to be very careful,
cattle, possibly hogs, or ultimately to people. How do you
create a barrier there, that both, you know, the actual animal
and then the byproducts? I mean, how do you create a very good
barrier there so people are comfortable you got this thing, you
know, contained or stopped from further migration?
Dr. Califf. Unfortunately, there is no absolute barrier
that can be created. But there are elements of protection that
are important, like farm workers, if they are on a farm with
infected cattle, and one good thing here, the cattle don't die.
The mortality rate of cows with this virus is less than 1
percent from what we are told.
So the cattle will recover, but the workers need to be
protected with PPE, just like we all went through with hospital
workers with COVID when you are around animals that are
infected. In the poultry industry, as you may know, they have
already been through this.
Senator Hoeven. Right.
Dr. Califf. And the use of PPE is just routine in the
poultry industry, but this is new for the cattle industry, and
so there is a lot of work to be done to get to the right place
there.
Senator Hoeven. Is this our future with viruses, where we
are just going to have to be with--across the board having that
kind--you know the equipment, and the garb and everything, to
stop it?
Dr. Califf. You know, there is such a hard balance here for
people like me because it is 25 years, if you look at all the
literature, and the establishment in the government, of
elements of protecting against future pandemics. This has been
predicted. It is just a matter of time. I mean it happened in
1918, that was probably a very similar incident of bird to
human, or something like that, and so we are going to see these
things cycle through, and what we want is to be better and
better at dealing with it when it happens.
And as we learn measures to prevent it from happening, and
try to do it, but like I say there is no absolute barrier that
we know of now, so it is, when there is an outbreak containing
it which we--you know that would mean, for example, what is
happening now is not shipping--and I am not an expert on cattle
ranching, but cows get sold all the time and move across state
lines.
So containing it means if you got an infected herd, not
doing that. And that is happening now, and I think it has been
successful, but it also means having those countermeasures
ready to go, so you got the antivirals, the vaccines, the
monoclonal antibodies ready to go just in case it happens. So
it is not new. It is going to be part of our lives, it probably
happened a lot more historically in ways that we didn't even
know because we didn't have ways of measuring it.
Senator Hoeven. Thank you.
Senator Heinrich. Senator Baldwin.
Senator Baldwin. Thank you. You mentioned your high school
reunion. I am heading to a big reunion in a couple weekends,
and I am sure I am going to hear everyone will have an opinion
on what should be happening in Congress. You are hearing from
your old classmates.
Anyways, thank you for joining us today, Commissioner; and
I am going to continue on the same uh theme that previous
senators have asked, because I represent America's dairy land.
And the outbreak of avian flu in dairy herds in the United
States is a significant issue. Wisconsin is home to over 5,000
dairy farms--dairy herds, and roughly 22 percent of the
nation's total herd count. So this is a big deal for us.
As you can imagine Wisconsin farmers and dairy producers
are concerned about its potential to spread to their own
operations. Two weeks ago I sent you a letter requesting robust
coordination and communication on highly pathogenic avian
influenza, in order to protect our nation's farmers, workers,
and dairy supply chain.
So I am really interested in--you know, you outlined
already the different agencies that have a role in this, human
health, health of the herd, health of the food supply; please
talk about that coordination and communication, and how it is
happening?
Dr. Califf. Well, I would point to multiple levels of
coordination. At the highest level, the OPPR, which you all
helped create, through legislation and the White House,
coordinates across agencies. I mean, as you all know, the
Agriculture Department is a separate department. FDA is within
Health and Human Services
Senator Baldwin. Right.
Dr. Califf. And so there is an office there which has a
call every single day, where leaders, in fact, I am missing the
call today, but the leaders of each of the relevant agencies
review what has happened the previous day, what the plan is,
and what the long-term plan is. And then within HHS, because we
have CDC, ASPR, and FDA, in particular, who have to be
involved.
We have a separate call every day just for the HHS part of
it, to make sure that we have our act together as it relates to
human health. And of course, at FDA, we have a cross thing,
because we also have the Center for Veterinary Medicine in the
animal involvement.
So there is a lot of coordination. I think it is going
well, and it is very strategic, but we do have some hurdles.
And I just say, well beyond that, you also know that the states
play a huge role in the management of the safety of the food
and farms, in particular.
And so we are constantly in touch with all the regulators
in the states, and every state system is different in terms of
how it is configured. So access to the farms, for example, is
something that really has to be negotiated through the states,
the farmers, and the owners of dairy farms are more comfortable
with people that they know that are in their state. So all this
has to be coordinated. I feel like we are doing a good job of
that.
Senator Baldwin. Let me just ask a little bit. You talked
about the difficulty in getting access to the farms, but you
mentioned earlier the ability to test unpasteurized, and then
test pasteurized milk, are you having any difficulty at the
processing stage of getting that access?
Dr. Califf. The pasteurized milk is absolutely no problem
to test, because we just have, we have people that go to stores
and buy milk off the shelves anyway for all sorts of other
testing. As I am sure you know, from the state that you are in,
you have all these cows, the milk goes into bulk tanks which is
a mixture of a number of cows, and that is a very sensitive
area because it does point, if there are infected cows, as to
where the infections are. And technically, it is no problem but
we want to make sure that we have trust. And so there is
negotiation that needs to go on to make sure that there is a
safe way to handle the data, and that people are not going to
be castigated if they happen to have an infected herd. So we
are working through all that state by state.
Senator Baldwin. Yeah. Okay. And can you share if you need
any resources in order to increase your testing and treatment
capacity?
Dr. Califf. Well as you might imagine, we have expended a
lot of resources in the absence of any additional funding, and
we are keeping track of that, and looking at potential sources
within in our case within HHS, for example. I think it is
predictable that we are going to be in a new environment for
milk, in particular, because of this virus, the way it has
affected other species as it sort of cycles around. And one
thing about cattle they are always new cattle coming up, so
they are always going to be cattle that are susceptible to
getting infected.
So it is predictable there will be a need for resources. We
are keeping track of things, and as we get a handle on what we
need to do going forward, we will keep you completely informed
about where we stand, including the reserve opportunities
within HHS.
Senator Baldwin. Thank you Dr. Califf.
Senator Heinrich. Senator Hyde-Smith.
Senator Hyde-Smith. Thank you, Mr. Chairman.
And thank you for being here today, Dr. Califf. I want to
talk about medical gases. I hate to drive this nail into the
wall but I have not seen any movement on this issue so we are
going to continue to pursue this because I have constituents in
Mississippi that this really affects. I have repeatedly brought
up the issue of medical gas whether in previous hearings and
several letters, and my colleagues and I continue to push on
this issue.
Congress required the FDA to update its regulations for
medical gases in July of 2016, and almost 8 years later the FDA
has still failed to fulfill its obligation to the millions of
American patients who rely on medical gas daily.
My colleagues and I have consistently encouraged the FDA to
meet its statutory requirement and promulgate rules for medical
gases. But instead the FDA continues to regulate medical gases
under regulations written for traditional pharmaceuticals that
do not share the unique characteristics of this category of
drug products.
While I appreciate the fact that the FDA finally issued its
long overdue proposed rule for medical gases in 2022, this
month will mark 2 years since the rule was even published. The
FDA only received four, 1 2 3 4, public comments, and yet your
Agency still has not published the final rule making. And there
is just really no excuse for the delay. It is time to finalize
the rule. So what is your plan for publishing a final rule
making in the 2024 calendar year?
Dr. Califf. Yeah. I am not going to beat around the bush
about this. I distinctly remember you are bringing this up last
year, and I also told you that time, it was a long time ago,
but I was actually a co-founder of a medical gas company. So
you know, that company no longer exists, so I don't have any
conflict related to this, but I feel like I have a good
understanding of it.
What I would say is just a couple of quick things. This
rule involves every single part of FDA, and there has been a
lot of negotiation that need to go on to make sure that we get
it right as it affects things like veterinary health, and
biologics, and devices, and drugs all relevant here. I also say
we have a published date to have this concluded by October of
2024.
Senator Hyde-Smith. So October of 2024 is when we can
expect the final rule?
Dr. Califf. I would say before then.
Senator Hyde-Smith. Wonderful, wonderful news, because I
don't want to have to ask it again next year.
Dr. Califf. No, you don't. And I don't want to have to take
the question again. I would love to see this thing out. And I
can't give you the exact date but I think it will be----
Senator Hyde-Smith. Okay. That is good enough. And I still
have some time left, and I want to talk about the illegal
advance prescribing. I have repeatedly brought to your
attention to the dangers the women face when allowed dangerous
life-ending chemical abortion drugs which can be ordered by
consumers through the mail, are purchased in retail pharmacies
without ever seeing a doctor in person.
My husband has a doctor's appointment Friday morning for a
sinus medication that he can't get refilled until he sees the
doctor. So it blows me away that you can get this with no
doctor oversight, and it is a drug that will literally cause
you, intentionally, to have an abortion and end your pregnancy,
and the life of that child.
The FDA is supposed to protect Americans from taking
medications that could be harmful, however, you continue to
look the other way and claim that mifepristone is safe, in
part, based on the lack of reports of nonfatal adverse events,
due to the FDA's own relaxed reporting requirements, and
continue to allow the women to put their lives at risk in the
name of the pro-abortion agenda.
And it has been reported on more than one instance, that
American women are stockpiling the abortion pills through
advanced prescribing from abortion companies and providers. And
according to another article in Politico, an FDA spokesperson
stated that the FDA is concerned about the advanced prescribing
of mifepristone, and that mifepristone is not approved for
advanced provision of a medical abortion, it is not even
approved for that, and they can get it without even seeing a
doctor.
So what concerns the does the FDA have with the advanced
prescribing of this mifepristone? And is it true that the FDA
has not approved mifepristone for advanced provisions of an
abortion. And I have two follow-up questions with that?
Dr. Califf. Well, I know you are aware that I am limited in
what I can say because the issues around this are currently
under consideration by the Supreme Court.
Senator Hyde-Smith. But what is FDA doing?
Dr. Califf. Well, remember that, first of all, just one
technical point to make is that there has to be a prescription.
The companies can't write prescriptions so it is doctors that
writes prescriptions.
Senator Hyde-Smith. Without seeing a doctor though, without
physically seeing the doctor, they can just write the
prescription with no visit.
Dr. Califf. All right, so----
Senator Hyde-Smith. Like for sinus medication that he has
to go in to see the doctor.
Dr. Califf. But remember we don't regulate the practice of
medicine, so there has to be a doctor that writes the
prescription the conditions under which that is done are----
Senator Hyde-Smith. But when they are violated the law by
allowing them to stockpile, what is your responsibility then?
Dr. Califf. We don't advocate stockpiling as a method but
we don't--again we don't regulate the practice of medicine.
Senator Hyde-Smith. So you have no role whatsoever in
preventing the stockpiling of this.
Dr. Califf. I don't know how we would.
Senator Heinrich. Senator, your time has expired.
Senator Hyde-Smith. Thank you.
Senator Heinrich. Senator Peters.
Senator Peters. Thank you, Mr. Chairman.
Dr. Califf, good to see you again here. In 2021 the FDA
found that some infant formula products had been released to
the public while contaminated with Cronobacter, this didn't
just cause widespread panic, and a nationwide formula shortage,
it also revealed I think the effects of a glaring problem, that
the FDA does not currently have the authority to inspect infant
formula until after the product has left the manufacturer's
control.
The FDA's two past budgets have requested additional
authority to require industry to conduct testing of final
infant formula products, and I have been working on legislation
to provide this authority that is so essential for you to
protect infant formula. The bill would require infant formula
manufacturers to test for key contaminants before releasing
their product out to the public, and give positive test results
to the FDA.
So my question for you, sir, is if the FDA had the
authority to test infant formula products before they went out
to the market how would that prevent future recalls, and
potential supply chain difficulties like we saw during 2021
infant formula crisis?
Dr. Califf. I really do appreciate the question, and the
background there. And you are correct that there is no
requirement of reporting to the FDA the results of testing the
companies, so even if they find bacteria they are accountable
for getting rid of those lots and not putting them into
circulation. But it would really help us a lot if there were a
requirement for testing, and if the tests are positive that we
be notified.
So in the case of the recall that we had there were just a
lot of bad conditions in that one plant, we would have known
about that a lot earlier had we know about the results of
testing the companies.
And I might add, in most of our regulatory paradigms that
the first line of defense is the industry that we regulate,
like in the production of medications. We don't test every lot
of medications but the company that manufactures the drug is
required to do it, and they have the records available for us
to look at.
And we would like to see the same thing happen, not only
with INF formula, but also with regard to all critical foods,
particularly for children. You are aware that we recently had
the contaminated apple sauce with lead. And so we are asking
Congress to give us the authority to require that that be done.
Senator Peters. Great. Thank you. Last year one of my
constituents, Shandra Eisenga, lost her life after being
treated for a tuberculosis infection with a contaminated bone
graft from Aziyo Biologics. Her case, I think, just shows how
dangerous it is when TB is spread through the transplantation
of human cells tissue as well as cellular-based products.
Inspected lots were not just sent to Michigan, but also to
California, Louisiana, New York, Oregon, and Texas, and this
was the second outbreak from this company, which was also
responsible for a 2021 outbreak that infected 80, and killed
eight people.
I remain concerned that we are not doing enough to stop the
spread of TB through transplantation of human cell tissues, and
cellular-based products. And that is why I have introduced
legislation that would conduct an educational campaign about
the risk associated with human cell and tissue transplants, and
would allow for civil monetary penalties for companies that
violate compliance standards, similar to that of traditional
medical devices, or tobacco products.
So my question for you, sir, does the FDA have the
resources it needs to ensure that all registered human cell and
tissue establishments are being properly inspected?
Dr. Califf. Again, I really appreciate the work you are
putting into this. And I will just say the issue of cell and
tissue therapy is one of the most promising things that we have
in our armamentarium of developing treatments to prevent and
treat human disease. But it also has a downside, and it gets
very complicated because it intersects with the practice of
medicine issues, and very complicated interpretation of
regulations about the type of tissue used, and how much it
falls into a category more like a drug, or a device in terms of
the way it is regulated.
So your efforts to clarify this are much appreciated. It is
a focus of ours. The Civil Monetary penalties will be a big
help to us because it is murky, it gives bad actors a chance to
do bad things in a way that is hard for us to stop, when we
have so many good actors who are doing so much good with this
type of treatment.
I also applaud your efforts at education. It is a
complicated area when you hear about stem cells, and cell
therapy, and such, it is very exciting, but the details are
important, and if there are, like I say, some people not acting
above board in this regard.
I don't want that to detract from the majority of people
who are really breaking new ground in ways that are going to be
very good for human health.
Senator Peters. Right, absolutely, but we do have to have
the oversight. So I appreciate. Thank you for your comments.
Thank you, Mr. Chairman.
Senator Heinrich. Senator Manchin.
Senator Manchin. Thank you, Mr. Chairman.
Dr. Califf, last year, during your previous testimony
before the Committee and FDA held an Advisory Committee Meeting
on opiates, which you know is extremely devastating to this
entire country, especially to my State of West Virginia. In
particular, the questionable clinical trial practice known as
Enriched Enrollment. The Enriched Enrollment process has made
it significantly easier for FDA to approve opiates and allow
for broad marketing to the public. The process removes the
patients with pre-existing opiate sensitivities from clinical
trials instead of sticking with traditional double-blind
studies.
This has skewed results and seriously underestimates risks
associated with a proposed drug involved in the clinical trial.
The Advisory Committee last year expressed concerns during the
meeting about the Enriched Enrollment is able to really address
whether an opiate is better than a non-opiate.
In September I sent a letter, sent you a letter asking for
an update on what FDA is doing in response to these concerns.
We haven't heard a thing. So what have you done, in response to
concerns raised regarding the Enriched Enrollment?
Dr. Califf. Well, Senator, thanks for the question. As we
have discussed before, I am a clinical trialist by profession,
it has been my whole career, so I certainly understand the
issue that you are raising. And you know that we had the
Advisory Committee meeting, the advice is publicly available,
and we take it seriously. I don't think you will see Enriched
Enrollment as a practice in the routine management of the
affairs of opioids. There are other circumstances in medicine
and health care where it is a very important constituent of the
armamentarium of clinical trial methods that are important to
have available.
Senator Manchin. Let me go. Well, let me go into this then.
And one of the recommendations in external review of the FDA
regulations of opioids report that you ordered was to ensure
the FDA be as transparent as possible regarding decisionmaking,
which I appreciate. The Advisory Committee has presented
complex scientific reviews of safety and efficacy of medicines.
And most patients and the general public really don't have a
background to fully understand the scientific studies, which
you are explaining.
But the FDA announced that it will be holding a listening
session on June 13th to discuss the role of the advisory
committees, specifically, to improve the public understanding.
One element that you have stated is to reduce voting. How can
you reduce voting with these scientists, and like yourself,
being in that position before if you can't vote to where you
think something is effective or not?
And that leads into another question. I could never believe
this happened, okay, with Zohydro. When Zohydro, I don't think
you were there at this time, 11 to 2, the Advisory Committee
voted against putting this product on the market, and at that
time, I think she was the Head, Woodcock, was the Head of it,
did it anyway. And I could not believe it, could not believe
it. So if you take voting out of the process.
Dr. Califf. I don't know. Senator, I don't know if anyone
who has--first of all, as a clinical scientist, the epitome,
the peak of my academic career was being on the Cardiorenal
Advisory Committee where everything comes together.
Senator Manchin. Yeah.
Dr. Califf. I don't know if anyone is advocating the taking
of voting completely away.
Senator Manchin. As to reduce the voting, how would that--
Dr. Califf. But let us remember, advisory committees are to
give advice to the FDA, often not about a particular product,
but about a field, how to think about a field, where the vote
doesn't particularly have a purpose. In addition to that, what
the FDA is most interested is what the Advisory Committee is
thinking, what is behind the reasoning for the way they feel
the way they do. That is much more important than the sort of
excitement of having a vote from people that have convened for
one day without all of the background that the FDA has, that
has been meeting, and looking at the data for months.
So the Advisory Committees are very important. I am a big
proponent of having them. We just need to make sure that they
are meeting the purpose for which they exist. And with regard
to votes that go the other way, if we always took the advice of
advisory committees, we wouldn't need the FDA, just convene an
advisory committee, so----
Senator Manchin. These are scientists giving you a
different opinion. The only thing, when I look at an advisory
committee, these are people that are not beholding to the
company that is asking you to approve a new patent, or whatever
it may be.
Dr. Califf. Well, they are----
Senator Manchin. Let me just say this, because my time is
very limited and the thing that opiate is just a scourge on our
society, and it has been for quite some time. It has devastated
my state in ways that you can't even believe, and what it has
done around the country. We killed more people with overdoses
than we have in any wars we have ever fought in, starting back
from the Civil War.
But I can't ever figure out why do we allow, I mean, and
evaluate, if a new product is coming on the market, your job is
to make sure it is an improved product that will reduce the
suffering of humans, it is better for a society, and these
products keep coming at you all and they not taking anything
off. If something is going to improve and be better, then don't
you think something should be removed from the market? They are
just flooding the market with the things they have had forever,
killing Americans, and killing West Virginians, and bringing
more things to do more damage.
Dr. Califf. Well, let me just say I, you know, my staff is
available to yours, and I think they are talking.
Senator Manchin. Sure.
Dr. Califf. And as frequently as possible. In my view, we
need a legal construct if we are going to pull things off the
market.
Senator Manchin. We will work with you on that. If you are
telling me we have to do something, you need legislation here
to pull things off the market once they have been approved, and
even though something is replacing, it is better.
Dr. Califf. I really, you know, Senator, as I have aged in
this job, I really believe----
Senator Manchin. We are all aging right now.
Dr. Califf. [continued] we at the FDA are referees,
primarily. The Rule Book is written by Congress, so when you
write a law, we follow the law.
Senator Manchin. Okay. Fair enough.
Dr. Califf. Let me mention one other, just, you may be
prepared to ask about this.
Senator Manchin. Okay.
Dr. Califf. The issue of--you know, personally, I am very
much in favor of something you have advocated for, which is for
a new opioid to come on the market, as opposed to all other
drugs and the classes of drugs, it ought to have an advantage
over what is--we don't need more opioids on the market, I think
we agree on that.
Senator Manchin. Yeah. Yes, we do.
Dr. Califf. Unless there is something that is really a
significant advantage. But right now the rule book that we
referee upon, says if the drug is better for the indication
than nothing, then it is allowed on the market, and so----
Senator Manchin. You need language basically saying, if it
is an improved drug that will perform better than the existing
drug is, so we will remove the existing drug.
Dr. Califf. That is right.
Senator Manchin. Okay. Got it.
Senator Heinrich. Thank you, Senator. We are going to do a
quick second round, so if you want to stick around we can have
some more conversation about this.
Doctor, I don't want to put you in a situation with regard
to the Supreme Court decision, but I do want to ask you just
patently, is mifepristone safe?
Dr. Califf. You know, I am on the record multiple times
about this. We stand by the decisions of the FDA over the
years, and the constant looking at the surveillance data and
clinical trials as they come in, mifepristone is safe and
effective for its indication, and we stand by that.
Senator Heinrich. Thank you. Talk to me about vaccine
development and HPAI, and I know your role is to approve
vaccines, but where are we in that process, and if we do have a
zoonotic transmission to humans; you know, what is our posture
and are we ready for that?
Dr. Califf. I would say we are ready, you will notice that
part of the budget has--sort of separate from the rest of the
budget, has a pandemic preparedness part of the budget. The way
I look at it, we are in an enviable position compared to any
time in the history of the world, Senator Hoeven made--
rhetorically, I think, made the point that pandemics have
always been around. It is just that now because they used to be
limited by the fact people didn't travel, now we are on
airplanes, and as we saw with COVID, it moves quickly from one
place to another.
The enviable position we are in now, is we have mRNA
templates that are platforms that we have confidence in
already, where what used to be a mystery, how do you make a
vaccine, by the old method that would take many months, now we
can do it in just a few weeks to a couple of months, but we
have got to have the funding to keep the source warm, so that
we can start up right away.
Senator Heinrich. That mRNA platform is applicable in this
case?
Dr. Califf. Yes, sir.
Senator Heinrich. Great.
Dr. Califf. And you know, it is a great thing for many of
the--viruses are relatively simple compared to other kinds of
organisms. So coming up with a matching vaccine for the exact
genetic makeup of the virus is entirely possible in a very
short period of time. So it is another place, I didn't mention
NIH before, is a critical player here. The NIH is doing a lot
of the background work to characterize the virus with its
excellent virologists, so that we can be ready, working with
the industry that makes the vaccines.
Senator Heinrich. Talk to me a little bit about vaping. Why
are we not making faster progress on the incredible number of
unapproved vaping products there are on the market?
Dr. Califf. If you will bear with me for just a minute, I
would like to sort of go through my thinking on this, because
it is--I am as frustrated as you are with it, I have to live
with it every day, and I have relatives that are addicted to
nicotine. I am from South Carolina, and practice medicine, and
maybe the seat of the tobacco industry in the past, in Durham.
So first of all, I do want to point out that we are making
progress in combustible tobacco, although we are still going to
lose almost 500,000 Americans this year to tobacco-related
illness. That and hypertension are the two biggest remediable
causes of death that we are dealing with, but just as we are
making that kind of progress with combustible tobacco, along
came vaping.
It was 2016, during my first term, that we deemed vaping,
but we had no idea it was going to result in 26 million
applications for vaping products. That happened while I was
away at Alphabet, and I came back to find a Center for Tobacco
Products full of good, hardworking people, but an overwhelming
number of applications from an industry.
I was in Silicon Valley, I must say, the combination of an
addictive substance called nicotine, with marketing done
through Silicon Valley techniques, was overwhelming. We had a
Reagan-Udall Report, we have a new Head of the Center for
Tobacco Products, Brian King, and we have made tremendous
progress in this regard. But just as we are getting a handle on
the basics of vaping, and by the way, at least by the surveys,
the number of teenagers vaping did decline last year, but it is
nowhere where it needs to be.
Just as we are making that progress, along comes the
Chinese manufacturing of vaping products, and the overwhelming
vaping products now used by American youth and getting addicted
is made in China. So can I go one more minute on this?
Senator Heinrich. Please.
Dr. Califf. Here, we have products that are not legal to
sell to Chinese people in China, made in China, and imported
into the United States in large numbers. Now, the old regime of
dealing with this, one of you had mention several hundred
thousand establishments, it is actually a million, because we
have 300,000 retail stores selling vaping products in the
United States. If we take our 1,400 investigators, i.e.
inspectors, and try to have them manage 300,000 vaping
establishments, that math doesn't work.
So we have got to stop this at the point of import. So we
are actively working now with the, you talk about multiple
agencies, the Justice Department, remember, we can't enforce
without the Justice Department agreement if we have to go to
court on these issues. And CBP, the Border Force is very
important here. So I want to work with you all to come up with
a way--and you would be amazed if you saw what we have to go
through to take action with one product coming into the
international mail facility.
It is a very complicated legal proceeding because every
company has a right to defend itself in court from actions that
we take. I think the circumstance here, where we have a product
that China won't sell to its own people, being imported into
the United States to addict youth. We ought to be able to come
up with a way to say it is pretty simple: When it comes in,
destroy it.
And CBP, by the way, can recover the money from the
importer for an illegal product that is an authority that we
don't have at the FDA. So we are actively working on that mix.
I don't blame----
Senator Heinrich. If you need additional authorities from
Congress, or additional direction to make sure that we are
addressing this in a more efficient way, I think you would find
a very receptive audience.
Dr. Califf. I wish I could tell you exactly what it is now,
but we will have a composite view from the Justice Department,
the FDA, and Border Patrol about what would be most effective.
Senator Heinrich. The CBP. Yeah.
Dr. Califf. I want to just cut it off, just not even let it
in, then we can deal with the vaping industry in the United
States which has many additional issues, but at least we could
deal with that.
Senator Heinrich. Okay. Senator Murray.
Senator Murray. Mr. Chairman, thank you very much. And
thank you, Commissioner Califf, good to see you again.
As I always say every time families head out to the grocery
store, or sit down for a meal, they are putting their trust in
the FDA. The health and safety of our Nation depend on the
world-class experts at FDA who work diligently to protect our
food supply, address threats like shortages or contaminants,
and a lot more. The stakes are always high as we saw during the
infant formula crisis, something I want to see FDA to do more
to learn from, because no parent should ever worry about
whether the formula that they feed their baby is safe. So I am
glad we have this opportunity to talk about the resources your
Agency needs to fulfill its really important mission.
Before I start my questions, I also want to say one thing I
think we both agree on, agree your Agency does not need, and
that is political interference in FDA's science-driven
decisionmaking processes. We have seen a number of baseless
claims and disinformation from anti-abortion activists, and
some Republican lawmakers which are really threatening to
undermine FDA's credibility and its authority.
So let me set the record straight, and Dr. Califf, I hope
you will continue to as well. Mifepristone is safe, it is
effective, and that is just not me saying that, it is
scientists, experts, and decades, decades of data.
Republican politicians should not be overruling experts on
science or overruling women about their own health care
decisions. And at a time when women across the country are
facing rampant attacks on abortion access, this dangerous
disinformation is an attack we all can and all should be
fighting loudly and clearly.
I just wanted that on the record so thank you, Mrs.
Chairman.
Dr. Califf, you, before I got here talked a little bit
about H5N1 avian flu. This is something that Senator Burr and I
put together, the Office of Pandemic Preparedness and Response
Policy, and we got funding for it in the last bill; can you
talk a little bit about how your Agency is coordinating with
OPPR and other Federal agencies?
Dr. Califf. Yes, as we discussed just a few minutes ago,
OPPR has been a central coordinator of the effort across
agencies that, you know, have boundaries that have to be
overcome to work together. So the Agriculture Department is in
an entirely different sphere than FDA and CDC, which are within
HHS.
So there is a daily call, I am actually missing it today
for this hearing, of the leaders of the--and the top leaders in
addition to the key people who carry out the operations, where
what happened the day before is reviewed, what needs to be done
that day is reviewed, and the long-term plans are made.
So I am glad that you put together the plan. I just hope
that the funding is adequate in the future, because as Senator
Hoeven pointed out, we are going to continue to have outbreaks
and pandemics for the foreseeable future.
Senator Murray. Thank you. On cosmetics reform, I was
really glad that we provided $7 million for the implementation
of the modernization of Cosmetics Regulation Act of 2022, that
I negotiated and got signed into law. That bill, for the first
time, provided much-needed new authority to FDA to make sure
that families know the products we put on our bodies every day
are safe. I want to ask you today what steps the Agency has
taken over the last year to implement those new authorities and
what resources are requested in your budget for this year?
Dr. Califf. Well, first of all, thanks for doing that. I
think it was decades of trying before, this finally happening.
People tend to think of cosmetics as just something you put on
your skin for looks, but the skin, you know the quiz of the
day, the skin is the largest organ in the human body and it
absorbs what is put on it. And so there is good reason to at
least know what is in the cosmetics that you are using.
You know, I am pleased to say we made a decision to put
cosmetics in the Office of the Chief Scientist under the
purview of Dr. Namandje Bumpus, who is our Chief Scientist who,
by the way, I just was pleased to elevate to Principal Deputy.
She has done such a great job.
The progress we have made really exceeded what we have
planned, that is for the first year, which is that we now have
the listing. So there is a place for the cosmetics companies to
list that they are on the market, and what is in them, and
there is also an adverse event reporting system for the first
time. We were able to capitalize on CDER's Drug Adverse
Reporting System to put one in quickly.
We have definitely--this is done on a shoe string and we
have in the budget we have an $8 million ask to really
instantiate this office and get to the next level. As you also
know, there are several Cosmetics that are very worrisome in
terms of health, where we have to do a lot of work in order to
take the kind of actions that are needed to protect health, and
we need a budget to make sure those things can be done.
Senator Murray. Thank you. And this is something really
important to me, so I appreciate the work that this committee
did on that. I understand that the proposed Unified Human Foods
Program continues to make its way through the administrative
process. It has been well documented that these reforms are
overdue, FDA's regulation and enforcement of Food Safety
Standards on issues ranging from bacteria in vegetables, to
arsenic in baby food are really critical. What is your Agency
requesting in fiscal year 25, for implementation of the
reorganization?
Dr. Califf. Well, in this budget we are asking for an
additional $15 million, and I honestly regard that as a hope
for a down payment. I think you will--if you go to the Reagan-
Udall Report you will see beautiful graphs, although they are
somewhat depressing, of the funding of the drug and the medical
product side of the FDA.
Thanks to the user fees it is, you know, meeting the mark.
It could always be better, but the food side of the FDA has
been increased but well below the even the cost of living
inflationary increase at a time when the food's industry is
increasingly complex, global, interdigitated with many issues.
So part of what we are doing in the reorg is to create a
budget where you can really see exactly what is the money being
spent on. I recognized when I came in, when I asked for the
budget on the medical product side, it was really clear because
the user fees institute a businesslike process, whereas on the
food side, there was a lot of intermixing in ways that were
harder to depict.
I think when you all see the places where it is needed, and
I will just point to two examples that I think are really
critical. We all know that, you know, we are in a global
environment where more and more things are getting into the
food in the way of chemicals. We chose Jim Jones to be our
leader of the Human Foods Program. He has a history in the EPA
of dealing with chemical contamination.
We had, basically, a tiny little crew of people working on
that, on the food side of the FDA. So as you see what is at
stake and what needs to be done, I hope that will make clear,
you know, what funding is needed, and also give you a way to
make sure when you invest money that you can actually see what
is being done.
The other one that is enormous is nutrition. We talk about
three pillars of risk, obviously microbial which everyone
understands, chemicals which are of great concern, but our
biggest cause of death and disability from food is actually bad
nutrition, and we have got this tremendous epidemic of obesity,
diabetes, cardiovascular disease, and cancer emanating from all
that in a setting in which our tools on the nutrition side are
very limited.
So we are going to have a Center of Excellence in
Nutrition, nested in that is going to be the Critical Foods
Group that was mandated in FDORA that will deal with infant
formula and medical foods. So hopefully this will all clarify
where the money is actually going to be useful, as opposed to
just asking for money based on a broad concept.
Senator Murray. Okay. Thank you. Thank you very much. And
Mr. Chairman, thank you for the extra time.
Senator Heinrich. Ranking Member Hoeven.
Senator Hoeven. Thanks Mr. Chairman. So Senator Peters and
I are working on some legislation in regard to infant formula.
He is really coming at it from the safety, and I am coming at
it from adequacy, so we want to make sure it is helpful to you,
doesn't impose costs and restrictions, and it would be
counterproductive. Do you have any specific thoughts in regard
to that?
Dr. Califf. The safety side is pretty straightforward, as
you know, and there is just some things that we need. And again
just to reemphasize, as I learned at my high school reunion,
people think the FDA has magical powers to just march in and
force people to----
Senator Hoeven. And at the reunion you told them in fact
you did.
[Laughter.]
Dr. Califf. No. I was asking for sympathy.
Senator Hoeven. Okay.
Dr. Califf. So the safety side is--well, you know, we just
need a few more things that would require that first line of
defense that we always depend on, which is the industry doing
what it should do, and our checking to make sure they are doing
what they should do. On the adequacy part it is really
complicated, and I would just say, I look forward to working
with you. I have ideas, it is very complicated by the WIC
Program, and the way the states purchased the formula.
Many of us believe that the industry is too concentrated in
a few companies.
Senator Hoeven. Yeah, right.
Dr. Califf. But it also turns out if you look globally, in
every country, they are just a couple of companies that
dominate in each company, and we have programs now to entice
people into the market, but if half the market in every state
is WIC, it is very hard for new entrance to actually get a
foothold and have enough sales.
So these are daunting problems, and we would love to work
with you. It is not our primary responsibility, but we
obviously have opinions, and it affects us when it is not
working.
Senator Hoeven. Yeah. Right, that is what we want to do.
Drug shortages in your opinion what is the greatest challenges
you face in this space, and you know, how can we improve that?
Dr. Califf. The answer is kind of similar. But let me break
it in half. We have a set of things that I regard as a hole
plugging activities, that is our primary issue there, when we
know of an impending shortage, and there are over 200 per year
happening now, we have a set of maneuvers we can do that are
much like you would do if you were in a town and the grocery
store was going out of business, you need to find another
grocery store.
We get on the phone. We go to all resources to find
alternatives either to produce the same product or a drug that
is equivalent. And we need some help there from you all in
filling in the holes in our knowledge base that would enable us
to put together what we need to plug the holes much more
efficiently. And we have asked for an additional $12 million in
the budget for analysts and people to, basically, anticipate
when shortages may occur, so we can preempt. We are successful
in preempting about 80 to 90 percent of the shortages, but we
still have too many that are occurring.
But part two is actually the big deal, and it is very much
like what I said about the formula. We have a market failure,
and it is very hard to--just to quickly go through this--it is
really important to understand that we have two industries
essentially with some overlap, but two industries in the
pharmaceutical arena. The innovator industries make patented
drugs which have protection from patents from competition.
Senator Hoeven. Right.
Dr. Califf. I believe the price is too high there. I know
there are different opinions about that, but let us just say
that the profits are good, and there is every incentive for the
companies to make every drug they can sell because they make
money.
Ninety-five percent of our prescriptions now are generic
drugs, and they are essentially copies of the innovator drug
after the patent is over. It is simple way to think about it.
The prices there are too low, our generic prices are actually
lower than Canada and Europe, and so the shortages we are
seeing, the probability of a shortage is directly related to
how low the price is.
Now, I am a capitalist American, just put yourself in the
shoes of a CEO and say, you can either make a drug that is
going to make a big profit for your company, or you can make a
drug where you are guaranteed to lose money because the price
is too low, which one are you going to do?
So the companies, even in India, where the cost of labor is
so low, they are telling us they can't make and distribute the
product at the price they are getting. And in the middle of all
this, in America of course, is the middleman, the GPOs and
PBMs, which I know you all have been talking about, they are
not regulated by anybody right now, basically, and this is an
area where work needs to be done.
It is not my job to say exactly what should be done. Of
course I have ideas, like I do about infant formula, but unless
we fix the market failure, we at FDA are going to be expending
more and more energy just plugging holes in the system that we
could have predicted were going to happen in the first place.
But we can't tell anyone to make a drug, we can't--we don't
make the drugs ourselves, so we are just trying to line up the
people that do make them, in a way that can be successful.
Senator Hoeven. I want to follow up with you on that
disparity, in terms of the pricing between, you know, the new
name brand patent-protected drug and the generic. I have not
heard that point on the generic before, so that is interesting.
I think it is something we will try to follow up with you and
understand better. But I think the drug shortage is important,
we want to find ways to address it that are actually effective
for consumers, and don't create you know market distortions or
burdens.
Dr. Califf. If I may, I would refer you to an HHS Report
that came out just a few weeks ago, that goes through this in
great detail, and I think if your staff reads it, that they
probably already have, but get a briefing on it because I think
it will give you a lot of insight into what is happening here.
I mean, I am personally traveling over to India to--because we
are very dependent now on foreign manufacturing of these
products because there is not enough American----
Senator Hoeven. Which is a concern as well?
Dr. Califf. Yeah. It should be.
Senator Hoeven. Thank you.
Senator Heinrich. Senator Manchin.
Senator Manchin. Very carefully--very quickly on that. Do
we produce any antibiotics here in America? Someone told me a
strep throat could take us down.
Dr. Califf. Not many.
Senator Manchin. Has the alarm been raised why we should
have some manufacturing producing the necessities for us just
off the basic?
Dr. Califf. I feel like from the day I came into this job,
this time, I have been screaming and shouting from the
rooftops. But I mean, as you know, Senator, you have had family
in the generic drug business.
Senator Manchin. Right. Well, they were told--well, they
had to close down the plant because they had too many drugs
they were producing.
Dr. Califf. Right. I mean, your cost of labor in West
Virginia is competitive. I will just say.
Senator Manchin. Yeah.
Dr. Califf. And yet still, couldn't keep that going.
Senator Manchin. And they were taken down because of FDA,
they were--back then it just made it impossible because they
have so many drugs they were producing. They are producing
those by the billions now, but we don't do any of that anymore.
I just think it is a horrible situation. And I have talked to
Secretary Becerra about this, and basically getting--we have
manufacturers who want to get back in business in making that
and stockpiling it so we do have it here in America made.
The other thing I want to mention to you. On December 22nd,
2022, which was basically the fiscal year 2023 Omnibus Bill
that we passed, it included my FREED of Opioids Act, which
requires FDA to review how they approve new opioid drugs. So
that is in the law. Okay.
Now, also May 26th of that same time, and right now it is
the SUPPORT Act it passed the HELP Committee. And the SUPPORT
Act, I think does what you wanted, it was myself and Senator
Braun, it is ensuring the FDA fully examines Clinical Trial
Impact and Vitalness Before Endorsement Act, which is the
EFFECTIVE Act, which would allow the Food and Drug
Administration to deny a new drug application for an opioid
analgesic drug, on the basis of the drugs not being clinically
superior to other commercially available drugs. Would that
help?
Dr. Califf. That bill we have----
Senator Manchin. And that bill has gone through the gambit,
we have just got to attach it to something right now.
Dr. Califf. Yeah. We will have to get with your staff--
there are always details in these things.
Senator Manchin. Well, Audrey will be happy to reach out to
you.
Dr. Califf. The basic concept is one--you know, this is an
exception to the rule for opiates, but I think the destruction
of and deaths that you have talked about merit it in this case.
Senator Manchin. Sir, what is happening? Is this, I mean, I
understand the lobbying force up here, you know, and Big
Pharma, and all that, but the bottom line is, there is a lot of
drugs we depend on, and I support them a thousand percent. This
is one I never grew up with it, I never had, and these things
weren't on the market when I was a kid. I got taken care of
pretty good. When I was in the hospital, if I ever went to the
hospital they took care of me, what I needed.
When I got out of the hospital I couldn't get--if I still
liked what they gave me in the hospital, I couldn't get
anywhere else; so all of a sudden. And we know the history on
that one. But we have a couple of things here we would like to
work with you on. And I think you might have some powers
already, and we are trying to give you more let us make sure
this other one is done the right way. Okay. Thank you, sir.
Senator Heinrich. Senator Hyde-Smith.
Senator Hyde-Smith. Thank you, Mr. Chairman.
The gulf shrimp industry is very important to Mississippi,
Dr Califf, and right now because of bad actors in other
countries Mississippi shrimpers and processors don't know if
they are going to survive another season, and this is a real
situation. I was on the coast night before last in Mississippi,
and the primary reason for this is that many foreign countries
unfairly subsidize shrimp production and dump shrimp on to the
market at prices that domestic producers can't compete with
because we do not subsidize.
Ecuador is one of the primary bad actors, and shrimp
imports from Ecuador are growing faster than imports from any
other country. It is also important for inspection of imported
shrimp to be robust, especially during times like these when
gulf shrimpers are struggling so much with unfair trade
practices.
I was happy to see that in August 2023 FDA signed a
regulatory partnership agreement with Ecuador to strengthen
food safety and shrimp intended for the U.S. market. This is
important both for public health and for the future of our
domestic shrimp industry. Domestic shrimpers should not have to
compete with unfair trade practices, but they should especially
not have to compete with shrimp riddled with illegal or
dangerous chemicals and drugs.
What percentage of imports from Ecuador has FDA inspected
since this arrangement was signed and have any imports been
refused to your knowledge?
Dr. Califf. Sorry. I would have to get back with you on the
exact numbers, but I sure agree with you that first of all, you
all gave us additional funding to implement programs like this.
We have to keep foreign imports to the same standards that we
have in the U.S., and the more we can get these countries to do
a good job on their own, the better off we are going to be in
terms of using our resources to double-check and make sure
things are okay.
So the agreement with Ecuador is the first of three that we
hope to have. The other two big importers are India and
Indonesia, very similar issues there. You are right, over 90
percent of our shrimp that we eat now is imported. Personally
when I eat shrimp and grits, as we discussed last year, it is
South Carolina or North Carolina shrimp are my preference, but
I put Louisiana and Mississippi right up there too.
And I agree with everything you said about needing to
fortify the industry here. As you all know we don't--our remit
is not within the economics of the industry, we have to
regulate whatever the economics are dictating, but we do have
this obligation that you are refer to keep the chemicals out.
But we will get back to you with the details of the number of
inspections, and what has been done in the way of detecting
things, and preventing them from getting into the country, if
they are not up to snuff.
Senator Hyde-Smith. Thank you. That would be very much
appreciated.
Thank you, Mr. Chairman.
Senator Heinrich. I want to thank you, Commissioner Califf,
for being here today. And I look forward to working with you,
and the members of this committee, as we work through this
year's Appropriations process.
ADDITIONAL SUBCOMMITTEE QUESTIONS
For members questions for the record are due by next
Wednesday, the 15th of May. And we would appreciate responses
back from FDA within 30 days.
Questions Submitted by Senator Martin Heinrich
cessation products
Question. Last year, on June 1, 2023, at a Cancer Moonshot event at
The White House, Commissioner Califf acknowledged some of the
challenges those seeking to bring forward new cessation products may
encounter and said that there are things that FDA is trying to do to
reduce the ``friction'' related to bringing forward medical products in
this space.
Answer. Please see response to next question.
Question. What actions, if any, has CDER taken since Dr. Califf
made these comments last year with respect to helping to bring forward
new, innovative smoking cessation medicines for patients and their
doctors and/or reducing the ``friction'' he referenced? What new
actions does CDER plan to take, if any, in addition to the guidance
previously issued?
Answer. As smoking results in many serious or life-threatening
conditions (e.g., heart and lung disease and cancer), FDA recognizes
there is an unmet need for novel therapies particularly for individuals
who have not been able to quit despite available therapies.
Because we consider nicotine dependence to be a serious or life-
threatening condition with an unmet medical need, we are encouraging
development of novel smoking cessation drug therapies that show benefit
over existing products by outlining 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.\1\
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\1\ https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/smoking-cessation-and-related- indications-developing-
nicotine-replacement-therapy-drug-products
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The NRT Guidance outlines strategies for applicants to make NRT
development easier, efficient, and streamlined:
--Clarifying the appropriate pathways 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 abbreviated pathways 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 are 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 will hold a joint public meeting with NIH this
fall to discuss innovations in development of smoking cessation
products, and we anticipate the Federal Register notice for that
meeting to be announced in the near future.
Question. Smoking cessation products have been approved for
decades. Why does FDA believe patients seeking to quit with available
smoking cessation medicines are not more successful in their quit
attempts?
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. 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.
FDA's 2023 Nicotine Replacement Therapy (NRT) Guidance contemplates
the need to get novel therapies directly in the hands of consumers in
the nonprescription setting, without going through development as a
prescription product first. As such, we outline pathways to get
approval direct to over-the-counter (OTC), which reduces potential
hurdles for access, and work with manufacturers to get novel products
over the goal line for approval. It also outlines abbreviated pathways
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 details
on how to qualify for this review.
Question. Does the agency agree new smoking cessation therapies are
needed to help patients be more successful in their quit attempts? If
so, what new actions will CDER take to expand and improve treatment
options for smokers seeking to be more successful in their quit
attempts.
Answer. Please see response to previous question.
Question. Does CDER see an opportunity to modernize the regulatory
framework for nicotine replacement therapies to better balance public
health benefits with real-world experience akin to FDA's approach to
the development of therapies to treat simulant use disorders?
Answer. Nicotine use disorder and other substance use disorders
(e.g., opioid use disorder) are very different, even though they fall
into the same general category of addictive disorders.
In the case of smoking cigarettes, we are concerned primarily with
long-term health effects. There are limited and mixed data on whether
reduction in smoking short of cessation leads to net positive clinical
outcomes, while smoking cessation is associated with demonstrated
positive clinical outcomes. However, we are eager to work with sponsors
and other stakeholders to advance scientific understanding of novel
endpoints demonstrating meaningful reductions in harms associated with
smoking. These differences make shorter-term endpoints regarding
reduction in use more clinically meaningful in the case of, for
example, opioid use disorder than in the case of nicotine use disorder.
In general, different substance use disorders have different
mechanisms of action and clinical effects that may lead to differences
in clinical presentation and responses to treatment. As a result, study
designs, patient populations, and endpoints may differ across
therapeutic areas targeting different forms of addiction.
Question. Does FDA see a path for additional endpoints that reflect
a more realistic experience with the challenges individuals, and their
clinical teams, are experiencing in quitting nicotine and which
reflects the real-world realities of the staggering public health toll
smoking continues to take in our country? If so, what steps is FDA
taking to encourage discussion with developers on such endpoints?
Answer. FDA's 2023 Nicotine Replacement Therapy (NRT) Guidance
provides recommendations to sponsors in the clinical development of NRT
drug products intended to help cigarette smokers stop smoking
cigarettes or maintain abstinence from smoking. While the guidance
reflects FDA's current thinking on the topics it covers, it does not
bind sponsors or the FDA. FDA encourages sponsors that wish to discuss
their drug development program to request a meeting with the
appropriate review division. Each year, FDA review staff participate in
many meetings with requesters who seek advice relating to the
development and review of investigational new drugs and biologics, and
drug or biological product marketing applications. FDA reviews New Drug
Applications (NDAs) based on the best available science as applied to
the data submitted in the NDA.
Question. What steps is the Commissioner taking to make sure that
CDER's approach to the regulation of cessation medicines is keeping
pace with the ongoing unmet clinical needs and public health urgency in
helping patients be more successful in their quit attempts? Please
specify the timeline for such action underway and or planned for the
future. Please also specify the metrics the agency is using to track
progress against these actions.
Answer. As referenced our prior responses, we are encouraging
development of novel smoking cessation drug therapies that show benefit
over existing products by outlining how to qualify expedited
development pathways such as fast track, breakthrough, and priority
review.
Additionally, it is important to note that FDA does not develop
drugs. Historically, FDA has seen limited interest from sponsors in
developing NRT products and we have not seen a recent change. All New
Drug Applications (NDAs) are subject to the performance goals and
procedures for the Prescription Drug User Fee Act (PDUFA VII) 2023-
2027. Please see the PDUFA VII commitment letter for more
information.\2\ The goals letter represents the product of FDA's
discussions with the regulated industry and public stakeholders, as
mandated by Congress.
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\2\ https://www.fda.gov/media/151712/download?attachment
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Question. What metrics does FDA believe Congress should use to
measure the agency's progress in advancing smoking cessation
therapeutic innovations and, ultimately, helping smokers be more
successful in their quit attempts?
Answer. Please see response to previous question.
foreign manufacturer tobacco registration
Question. In 2009, Congress required under the Tobacco Control Act
that the FDA publish a rule requiring foreign manufacturers to register
with the FDA if they wanted to sell tobacco products in the U.S.
It has been more than a decade--since the 2012 Unified Agenda to be
exact--since FDA first told us it would issue the foreign manufacturer
registration rule--so companies like those in China--could not import
products unless they were registered. Earlier this year--in the latest
Unified Agenda, FDA again pushed the date for a proposed rule.
When will FDA publish this rule?
Answer. The Center continues to weigh competing priorities given
available resources and updates the policy agenda annually. In the
meantime, FDA receives information about foreign manufacturers as part
of the premarket tobacco product application (PMTA) process. A PMTA
must include information including a full statement of the components,
ingredients, additives, and properties, and of the principle or
principles of operation and a full description of the methods used in,
and the facilities and controls used for, the manufacture, processing,
and when relevant, packing and installation. This is true for
applications from both domestic and foreign manufacturers.
tobacco product expos
Question. In February of this year, the Total Product Expo took
place in Las Vegas, NV. The Expo's purpose was to showcase vapor
products to independent retailers.
I understand you were made aware of the potential for illicit
manufacturers attending and participating in this expo ahead. I also
understand that, even though FDA was present at the expo, they did not
seem to take any actions regarding these illegal products.
Why did you refuse to act after FDA was present and witnessed this
illegal activity? Do you plan to take action against any of the
manufacturers who were selling illegal product at the Las Vegas expo?
Answer. Tobacco industry trade events and industry conferences are
one way for CTP to engage with stakeholders and monitor the
marketplace. This engagement with industry provides an opportunity to
gather information on shifts in the tobacco product market, marketing
techniques, and novel products. As has been the case in the past few
years, CTP staff attended the Total Product Expo in 2024. However, CTP
did not attend a similar expo in Miami in 2024.
Following the May 8th hearing, CTP attended the Houston expo in
June. CTP makes decisions about which events to attend on a case-by-
case basis depending on a consideration of factors, including available
resources.
We collect information during these types of events; we take action
based on the specifics of an investigation. The information gathered at
this type of event, along with other information received through
monitoring the marketplace, including inspecting manufacturers,
distributors, or importers; compliance checks of tobacco product
retailers; monitoring and surveillance of a tobacco product
manufacturer's or retailer's website; and reports submitted by the
public or other interested stakeholders, help to inform compliance and
enforcement efforts, which could include potential actions. FDA does
not publicly disclose enforcement strategy or discuss potential future
enforcement activities.
Question. There was a similar E-vapor product expo in Miami, FL on
March 14-16, 2024. Was FDA aware of this expo? Did FDA send enforcement
agents or any other FDA personnel? Were there any enforcement actions
taken at the Miami expo?
Answer. Please see response to previous question.
Question. There is an Alternative Product Expo show coming up in
Houston in June. Will FDA be present at this show. Can you commit to
taking action against any manufacturers who are present and are
exhibiting illegal products?
Answer. Please see response to previous question.
dora class drugs
Question. We understand that FDA is waiting for DEA to ask them to
conduct their 8 Factor Analysis for the DORA Class. Is there anything
FDA can do in the meantime to prepare?
Answer. The Drug Enforcement Administration (DEA) is the lead
agency for scheduling under the Controlled Substances Act (CSA). With
the exception of some general information provided in the responses to
Questions 14, 16, and 17, any questions regarding the process for CSA
scheduling (including the removal of a drug or other substance from the
schedules), or the current status of a particular drug scheduling
evaluation, should be directed to the DEA.
Question. How does FDA's 8 Factor Analysis overlap with DEA's own 8
Factor Analysis? If there are differences, how are they reconciled?
Answer. While DEA is the lead Federal Agency responsible for
regulating controlled substances and enforcing the Controlled
Substances Act (CSA), HHS has a number of responsibilities under the
CSA, several of which are performed by FDA on behalf of HHS.
As a part of this work, FDA provides scientific and medical
recommendations to HHS about the appropriate controls for controlled
substances. To make this recommendation, FDA's Center for Drug
Evaluation and Research, including the Controlled Substance Staff
(CSS), is responsible for preparing the ``eight-factor analysis'' (or
8FA), in consultation with the National Institute on Drug Abuse (NIDA),
that serves as the basis for the scheduling recommendation to HHS and
DEA.
When requested by DEA pursuant to 21 U.S.C. 811(b), the CSA
requires HHS to conduct a ``scientific and medical evaluation,'' under
which the following eight factors set forth 21 U.S.C. 811(c) must be
considered with respect to the drug or other substance proposed to be
controlled or removed from the schedules:
--Actual or relative potential for abuse
--Scientific evidence of pharmacological effect
--Current scientific knowledge regarding the substance (including
whether the substance has a currently accepted medical use in
the U.S.)
--History and current patterns of abuse
--Scope, duration, and significance of abuse
--Risk to public health
--Psychic or physiological dependence liability
--Whether the substance is an immediate precursor of a substance
already controlled
The circumstances and relevant data sources may differ for the
particular substance under evaluation for drug scheduling
considerations, e.g., for drugs proposed under a new drug application.
Such circumstances include where such drug may warrant scheduling under
the CSA, or drugs or other substances emergent in patterns of
nonmedical use and drug abuse, or drugs that are subject of a petition
submitted to DEA that requests a particular drug scheduling action. At
the time of a DEA request for FDA to conduct an 8FA for an emergent
substance of concern, DEA typically will provide FDA with law
enforcement and drug seizure data, and sometimes also with basic
pharmacological data from studies they have conducted (e.g., under
agreements or contracts). For petitions submitted to DEA, DEA may
provide supplementary law enforcement and seizure data in referring a
petition to FDA with an 8FA request. For drugs that are subject of a
petition to DEA or a drug application submitted to FDA, the petitioner
or applicant will have responsibility to provide some of the data
relevant under the Eight Factors.
Some of the data gathering from these various sources can occur
concurrently, but the totality of data must be considered by FDA during
our process of conducting an 8FA.
The drafted 8FA and the recommendation on scheduling are
transmitted from FDA's Office of the Commissioner to the HHS Office of
the Assistant Secretary for Health, and then from HHS to DEA. It is DEA
that, after reviewing the HHS documents and recommendation, makes the
final determination of whether to initiate rulemaking proceedings to
control a drug or other substance or remove it entirely from the
schedules in accordance with 21 U.S.C. 811(a)-(c).
Question. Can DEA and FDA do their 8 Factor Analysis concurrently?
Answer. Please refer to the response to previous question.
Question. What is the typical process FDA goes through to conduct
an 8 Factor Analysis? How long will it take; Is there a way to speed it
up; What happens once it's complete; What if DEA has a reason to
disagree with it; Then what?
Answer. Please refer to the response to previous question. Based on
differing circumstances and data availability for the drugs or other
substances under evaluation, there is considerable variability in the
time it may take to proceed through the administrative review process.
Scientific and medical findings made by HHS are binding on DEA. The
agencies also may communicate as necessary under our Memorandum of
Understanding to discuss data, viewpoints, or process matters for
pending drug evaluations.
Question. Does FDA consider any other agencies' interest, such as
NIH, when completing the 8 Factor Analysis?
Answer. Please refer to the response to previous question. Also,
please note that FDA always shares a drafted 8FA with colleagues at the
National Institute on Drug Abuse (NIDA), and seeks their concurrence on
our scientific and medical findings before transmitting documents to
the HHS Office of the Assistant Secretary for Health (OASH). When the
8FA and scheduling recommendation are transmitted from FDA to OASH,
NIDA is also welcome to share any additional input with OASH at that
time if they so choose.
artificial intelligence
Question. Commissioner Califf, artificial intelligence (AI) is
dramatically impacting every aspect of our lives, including the field
of drug development, and it is critical that the FDA is prepared to
address AI-related issues in a systematic way. I note that in May of
2023, the Drug and Device Centers at FDA published a discussion paper,
``Using Artificial Intelligence & Machine Learning in the Development
of Drug & Biological Products,'' that aimed to foster dialogue on the
use of AI and machine learning in drug and biological product
development.
Is the FDA planning to establish an FDA-wide team to serve as a
centralized point of entry for early-stage drug developers? By doing
so, this would allow developers to receive specific agency guidance on
the utilization of artificial intelligence modes and techniques that
fall within the scope of the agency's regulatory authorities, as well
as provide clarity on whether proposed uses do not require any agency
oversight or review.
Answer. FDA has taken significant steps to coordinate a cross-
center approach to regulating AI in drug development, as recently
outlined Artificial Intelligence & Medical Products: How CBER, CDER,
CDRH, and OCP are Working Together. FDA is in the process of forming a
team of internal experts focused on AI in drug development. However, a
centralized, FDA-wide AI team might not be the optimal entry point for
drug developers, as working with the appropriate review team with
relevant experience on the particular type of product would likely be
more efficient.
Such a team might coordinate with staff possessing AI expertise
that is relevant to the AI model being proposed.
FDA maintains open channels for engagement with industry on using
emerging technologies in drug development. There are various mechanisms
to engage with the Agency depending on how the sponsor intends to use
the AI model; for example, a sponsor could request a formal meeting,
attend an FDA program, or utilize a specific Agency pathway.
______
Questions Submitted by Senator Jeff Merkley
tobacco products
Question. Under a Federal court order, the FDA had from September
9, 2020, to September 9, 2021, to review premarket tobacco product
applications (PMTAs) for e-cigarettes.
However, after more than 2.5 years, the FDA has not met the
deadline to complete its review of these products. FDA also failed to
meet its own deadline to finalize the review of e-cigarettes with a
large market share by the end of last year.
In the FDA's most recent filing with the court, the FDA indicates
that it will not complete its review of large market share products
until June of this year.
In 2023, 7.7% of students or more than 2.1 million youth reported
the use of e-cigarettes and more than 25% of youth e-cigarette users
use an e-cigarette product every day.
Studies have also found that young people who use e-cigarettes are
more likely to become smokers, and many are low-risk youth who would
not have otherwise smoked cigarettes.
Why is the FDA taking so long to complete its review of product
premarket tobacco applications (PMTAs) for e-cigarettes and why has it
been unable to meet its own deadlines?
Answer. To date, FDA has received PMTAs for nearly 27 million e-
cigarette products, and has resolved over 26 million. The PMTAs that
FDA has received have included applications for nearly one million non-
tobacco nicotine products from more than 200 applicants. These
determinations also include agency action on applications for 99.5
percent of the larger market-share products, the applications for which
are generally the most voluminous and complex.
Due to the unprecedented number of applications submitted for
premarket review as well as the large number of applications moving
through review at the same time, the finite nature of our review
resources, and the necessarily rate-limiting effects of ensuring
consistency across reviews, among other things, this process takes
time.
FDA must also ensure review decisions are legally defensible and
consider all submitted information. Amendments submitted by applicants
during the review process and outcomes in litigation that impacts our
approach are two examples of the many internal and external factors
that can significantly impact review timelines. These issues can
lengthen the review timeline and impact review resources. Despite these
factors, FDA remains committed to working as expeditiously as possible
to resolve pending applications.
Since youth use of e-cigarettes peaked in 2019 at 5.3 million kids,
youth use of these products has declined substantially. The 2023
National Youth Tobacco Survey (NYTS) shows further progress, with an
estimated 2.1 million kids who were using e-cigarettes in 2023, which
includes 580,000 fewer U.S. high school students using e-cigarettes
since 2022. More recent 2024 NYTS data \27\ shows that another half a
million fewer U.S. youth reported current use of e-cigarettes in 2024
compared to 2023. This decline is a good public health outcome, as well
as a positive reinforcement of the work that has been done and that the
Agency will continue to do as it strives for additional progress on
this issue.
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\27\ https://www.fda.gov/news-events/press-announcements/youth-e-
cigarette-use-drops-lowest-level-decade
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Question. Will the FDA commit to finalizing all reviews for pending
large market share products by the agency's current June deadline?
Answer. At this time, FDA has taken action on 99.5 percent of the
Covered Applications. FDA remains committed to making determinations on
all remaining applications, including the Covered Applications, as
expeditiously as possible, while ensuring the decisions are
scientifically accurate, legally defensible, and aligned with the
authorities granted by Congress.
Question. On June 23, 2022, FDA issued a marketing denial order for
several of JUUL's e-cigarette products, after it found that JUUL's
premarket tobacco product applications (PMTAs) lacked sufficient
evidence to demonstrate that marketing of the products would be
appropriate for the protection of public health.
However, on July 5, 2022, the FDA issued an administrative stay of
its marketing denial order, saying there were scientific issues that
warranted further review of JUUL's application.
FDA's re-review of JUUL's application has been going on for almost
2 years, and during this time, JUUL has been allowed to keep its
products on the market.
Recently, FDA indicated that it would complete the review of all
large market share e-cigarette products by June 2024.
JUUL is the brand most responsible for fueling the youth e-
cigarette epidemic, and, according to FDA and CDC data, JUUL was the
fourth most popular brand with youth in 2023.
All JUUL e-cigarettes also have a high level of nicotine. According
to the manufacturer, a single JUUL pod contains as much nicotine as a
pack of 20 regular cigarettes.
Will FDA complete an additional review of JUUL products by June,
which is its deadline to complete the review of all large market share
e-cigarette products?
Answer. Following the May 8th hearing, in June 2024, FDA rescinded
the marketing denial orders (MDOs) issued in June 2022 to JUUL Labs,
Inc. This action was taken, in part, as a result of new case law, as
well as FDA's review of information provided by the applicant.
Rescission of the MDOs is not an authorization or a denial and does not
indicate whether the applications are likely to be authorized or
denied. Rescission of the MDOs returns the applications to pending
status, under substantive review by FDA. The Agency's regulations
significantly limit what FDA can disclose regarding the content of
pending applications.
______
Questions Submitted by Senator Joe Manchin
eerw clinical trials
Question. Last year, on April 19, 2023, the FDA held an Advisory
Committee meeting on opioids, in particular the questionable clinical
trial practice known as ``enriched enrollment''.
The enriched enrollment or EERW process has made it significantly
easier for the FDA to approve opioids and allow for broad marketing to
the public. The process removes patients with pre-existing opioid
sensitives from clinical trials, instead of sticking with traditional
double-blind studies. This has skewed results and seriously
underestimates risks associated with the proposed drug involved in the
clinical trial.
The Advisory Committee last year expressed concerns during the
meeting about if EERW is able to really address whether an opioid is
better than a non-opioid.
What has FDA done in response to concerns raised regarding the use
of EERW clinical trials?
Answer. As you note, on April 19, 2023, FDA held a meeting of the
Anesthetic and Analgesic Drug Products Advisory Committee to discuss
how to evaluate long-term efficacy of opioid analgesics and the risk of
opioid-induced hyperalgesia with a focus on proposed clinical trial
designs to research these issues, including EERW trial designs. There
were detailed presentations on, and discussions of, the advantages and
limitations of EERW trial designs in this context. FDA is currently
considering the experts' recommendations and other available evidence
and data, and the Agency agrees that it is important to continue
reviewing the value of EERW and other trial design methodologies.
advisory committees
Question. One of the recommendations in the External Review of FDA
Regulations of Opioids Report--that you ordered--was to ensure that the
FDA ``be as transparent as possible regarding decision- making''.
Advisory Committees present complex scientific reviews of safety and
efficacy of medicines. Most patients and the general public don't have
a background to fully understand the scientific studies discussed in
these settings.
The FDA announced that it will be holding a listening session on
June 13th to discuss the role of Advisory Committees, specifically ``to
improve the public understanding of advisory committees''. One element
of this you have stated is to reduce voting.
Voting has helped with conveying complex analysis to the public.
Even FDA's Director of Oncology Center of Excellence, Dr. Richard
Pazdur, has said voting is necessary because ``[FDA] needs that
clarity--[FDA] has to make a decision''.
Can you clarify when you believe an Advisory Committee should or
should not vote?
Answer. Whether FDA will include voting questions at an Advisory
Committee (AC) meeting depends on the subject of the meeting and the
advice FDA is seeking from the AC. Voting is not a mandatory part of AC
meetings, and votes are typically not taken at meetings discussing
general issues, such as clinical trial design or the development of
guidance documents. At other AC meetings, members may cast formal votes
on particular issues, such as whether benefits outweigh risks in a
product submission.\3\
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\3\ Voting Procedures for Advisory Committee Meetings FDA
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The feedback FDA obtains from votes on discrete questions can help
the Agency gauge a committee's collective view on complex issues.
However, many of the issues considered by ACs are nuanced, and FDA
staff may be primarily interested in the discussions and interpretation
of particular aspects of the data rather than a summative conclusion
regarding risks and benefits of a product.
Question. I introduced the bipartisan FDA Accountability for Public
Safety Act to help provide greater transparency to FDA's approval
process. Specifically, if an Advisory Committee votes against approval
and the FDA decides to go against this vote, like in the case of the
11-2 vote against Zohydro, the FDA must submit a report to Congress
that includes the medical and scientific evidence to justify its
approval.
This commonsense bill helps with providing the greater transparency
needed. Dr. Califf, you cited concerns with the public misunderstanding
that votes are non-binding, however it is important that the FDA
provide an explanation as to why they rejected the Advisory Committee's
recommendations.
My bill does not make votes binding, but it does require that the
FDA provides this explanation. Advisory Committees are outside experts
whose recommendations are made based on scientific evidence.
Dr. Califf, how will you ensure Advisory Committee discussions are
clear and transparent?
Answer. FDA continues to explore ways to optimize its advisory
committees (ACs). Following the May 8th hearing, the Agency held a
public listening session on June 13, 2024, where we received public
comments about FDA's use of and processes for AC meetings. FDA also
established a docket that was open for public comment until August 13,
2024. FDA will consider public feedback as we move forward with our
optimization initiatives.
We note that ACs do not vote to approve products-that is a
regulatory decision for FDA alone. Rather, ACs provide valuable input
on issues that would be helpful to FDA in considering the information
and data submitted to support a marketing application. FDA carefully
considers AC input in its decision-making.
drug supply chains
Question. The FDA has previously reported that nearly 40 percent of
finished drugs and roughly 80 percent of active pharmaceutical
ingredients are manufactured abroad. During the COVID pandemic we saw
disrupted drug-supply chains lead to increased drug shortages.
In particular, Americans' access to essential medicines--as defined
by FDA's report--are reliant on international supply chains putting
them at risk of shortage.
Has the FDA provided an updated report on current domestic
manufacturing capacity and our reliance on international supply chains?
Answer. We note that the figures you cite in your question come
from a 2017 Government Accountability Office (GAO) report.\4\ We want
to clarify a misconception that the data in that report reflect the
volume of drug product produced by foreign manufacturers. In the report
it is noted that ``FDA estimates that nearly 40 percent of finished
drugs and approximately 80 percent of active pharmaceutical ingredients
(API) are manufactured in registered establishments in more than 150
countries . . .'' (emphasis added). This is referring to the number of
finished product and the number of APIs that are manufactured in
foreign registered establishments, not the volume of finished drugs and
API manufactured at foreign registered establishments. The Agency does
not currently have a full picture of the actual volume of foreign drug
reliance.
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\4\ https://www.gao.gov/assets/gao-17-143.pdf
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In February 2024 we published our final guidance, ``Reporting
Amount of Listed Drugs and Biological Products Under Section 510(j)(3)
of the FD&C Act" \5\, on reporting to the Agency under this FD&C Act
provision (as added by the CARES Act ). This final guidance recommends
that for calendar year 2023, the annual reports required by section
510(j)(3) should be submitted no later than July 31, 2024; reports for
subsequent calendar years should be submitted by March 31st of the
following calendar year (e.g., CY 2024 reports should be submitted by
March 31, 2025). Now that the guidance is final, we expect more firms
to fulfill their obligation to submit this data.
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\5\ https://www.fda.gov/media/175933/download
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Following the May 8th hearing, CDER published its FY 2023 Report on
the State of Pharmaceutical Quality. This report, like its five annual
predecessors \6\ shares multiple presentations of data on site and
product demographics that help to characterize the source and quality
of drugs marketed in the U.S. However, the full picture of the volume
of drugs manufactured in each country is not currently feasible.
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\6\ https://www.fda.gov/about-fda/center-drug-evaluation-and-
research-cder/report-state-pharmaceutical-quality
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Question. Will the FDA work with the Administration for Strategic
Preparedness and Response to identify areas of concern and potential
opportunities to support production of essential medicines in the
United States?
Answer. Reliance on foreign manufacturing is not a new concern for
FDA. There are some things we can do to make it easier for
manufacturing to be done in the United States, however there are
significant economic issues that are out of our purview that have
contributed to increased foreign manufacturing, specifically, pricing
pressures, labor, and regulatory costs. We have been working closely
with colleagues across HHS to identify authorities and capabilities
available to address those other market forces. The Administration for
Strategic Preparedness and Response is a critical partner in this, via
the Supply Chain Control Tower and other capabilities, all as part of
the HHS Supply Chain Working Group.
Within FDA, one of the most important things we can do to help
reduce our reliance on foreign manufacturing is to encourage and
facilitate the adoption of advanced manufacturing. Ensuring that both
innovator product and generic drug manufacturers will have access to
information regarding advanced manufacturing technologies is vitally
important because advanced manufacturing requires a skilled workforce
and can help domestic companies operate in smaller facilities with
lower costs and fewer potential quality issues, improving the global
competitiveness of U.S. manufacturing.
______
Questions Submitted by Senator Kyrsten Sinema
ethylene oxide
Question. As I've expressed to you and Administrator Regan in the
past, I have serious concerns with how the rulemaking around Ethylene
Oxide (EtO) was handled. The potential impact of this rule on the
safety and availability of sterilized medical devices is one that I
still don't believe EPA has taken with full seriousness, including
comments made by your Agency about the risks to medical device supply
chains.
Can you explain how the EPA worked with you and your Agency to
address concerns about medical device supply chains requiring EtO for
sterilization in the final rulemaking? Are there currently alternative
modalities that don't use EtO that would be able to handle the volume
and kinds of medical device sterilization should this rule be
implemented? Are you and your staff satisfied with the final rulemaking
with confidence that it will not endanger public health by impeding the
sterilization of necessary medical devices?
Answer. FDA shares the same goals of protecting the public health
by lowering ethylene oxide (EtO) exposure to workers and community
members, while also maintaining the availability of supplies of sterile
medical devices for patients in the U.S. The Environment Protection
Agency final rule reflects key changes to help achieve both goals after
engagement with FDA.
More than 20 billion devices sold in the U.S. every year are
sterilized with EtO, accounting for approximately 50% of devices that
require sterilization. These include critical devices, such as wound
dressings, stents, and kits used in routine hospital procedures or
surgeries. In many cases, EtO may be the only method that effectively
sterilizes and does not damage the device during the sterilization
process. Even for devices that may be able to use an alternative,
sponsors likely will need to undertake testing and new validation, and
in some cases, redesign of the device may be necessary-a process that
can take several years, depending on the device and material. While
some innovations appear promising, other methods of sterilization
cannot replace the use of EtO for many devices.
Understanding the fixed nature of EtO sterilization capacity in the
U.S., FDA has implemented programs and initiatives to support
innovation in medical device sterilization, and we remain committed to
this effort. This work includes developing Sterilization Master File
Pilot programs to support certain changes for sterilization processes,
launching innovation challenges to encourage new strategies to reduce
EtO emissions and the development of new sterilization methods or
technologies, proactive engagement with industry to help advance
innovative alternatives to EtO, and our medical device town hall
series.\28\
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\28\ https://www.fda.gov/medical-devices/workshops-conferences-
medical-devices-unpublished/medical-device- sterilization-town-hall-
fda-activities-and-challenges-reducing-reliance-ethylene
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drug clinical trials
Question. The FDA is currently implementing guidance to improve the
diversity of patient populations represented in clinical trials,
including new requirements that study sponsors provide diversity action
plans for phase 3 trials of new drugs and medical devices to ensure
medical products are safe and effective for all intended populations.
I've been proud to support the work of Arizona universities,
researchers, and patients who are participating in the National
Institutes of Health (NIH) All of Us program and other efforts to
diversify health research and ensure health innovations work for all
Arizonans, including our Tribal communities.
However, clinical trials used for U.S. drug approval can occur
outside the United States and may not appropriately reflect the unique
demographics, health care systems, and lifestyles represented in
Arizona and in the U.S. nationally. There may also be challenges in the
U.S. to overcome common barriers to participation for rare and rare
pediatric diseases, given smaller populations, especially in our rural
and underserved areas.
What is the FDA doing to improve the proportion of patients from
the U.S. represented in overseas clinical trials and how does the FDA
assess the representativeness of populations outside of the U.S.
relative to the U.S. population? How is the FDA working with study
sponsors to address the challenges in rural and rare disease
communities?
Answer. Participants in clinical trials should be representative of
the patients who will use the medical products. FDA has a longstanding
commitment to promote the inclusion of underrepresented populations in
clinical trials and to help reduce barriers that may prevent the
enrollment and retention of a diverse trial population. For global
medical product development, the Agency supports the use of well-
designed and conducted multi-regional clinical studies; however,
foreign clinical data must be relevant to the patient population in the
United States and our practice of medicine.
FDA has also published a number of guidances with recommendations
on enhancing diversity in clinical trials to help ensure that results
are generalizable to the intended use population, including
recommendations that can help increase enrollment of populations with
rare diseases, and those in rural locations. Some of these actions
include:
--The November 2020 final guidance Enhancing the Diversity of
Clinical Trial Populations--Eligibility Criteria, Enrollment
Practices, and Trial Designs \29\, to provide sponsors
recommendations to help increase clinical trial diversity and
better reflect the population most likely to use the future
medical product.
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\29\ https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/enhancing-diversity-clinical-trial- populations-
eligibility-criteria-enrollment-practices-and-trial
--The 2023 published guidance Digital Health Technologies for Remote
Data Acquisition in Clinical Investigations \30\ and draft
guidance Decentralized Clinical Trials for Drugs, Biological
Products, and Devices \31\ to help sponsors design more
patient-centric trials with flexible locations.
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\30\ https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/digital-health-technologies- remote-data-
acquisition-clinical-investigations
\31\ https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/decentralized-clinical-trials- drugs-biological-
products-and-devices
first cycle drug approvals
Question. Given the stated goals in the Prescription Drug User Fee
Act to promote the efficiency and effectiveness of the first cycle
review process, how is the FDA working with sponsors to better identify
and resolve potential issues during the first cycle review to ensure
faster patient access to safe and effective novel prescription drugs
and generics? How have first cycle approval rates changed in the past 7
years for generics and for novel approvals, and what factors have
impacted the most recent increases or decreases in first cycle
approvals?
Answer. FDA understands the importance of efficient review cycles
to ensure access to safe and effective prescription drugs. For new
drugs covered by PDUFA, FDA provides timely advice and feedback to
sponsors at various points during the drug development process,
potentially addressing new issues quickly before the application review
process.
FDA's first-cycle approval rates for ``novel'' drugs (NME NDAs and
original 351(a) BLAs) are generally high, although there has been year-
to-year variability over the past 7 years with lows in FY 2021 that
have started to increase. Since FDA reviews each drug application on a
case-by-case basis, it is challenging to retrospectively categorize the
issues identified into distinct themes or trends; general percentages
are presented below.
FY 17
--NME NDA/Original 351(a) BLA--priority review 100%
--NME NDA/Original 351(a) BLA--standard review 75%
FY 18
--NME NDA/Original 351(a) BLA--priority review 87%
--NME NDA/Original 351(a) BLA--standard review 67%
FY 19
--NME NDA/Original 351(a) BLA--priority review 91%
--NME NDA/Original 351(a) BLA--standard review 86%
FY 20
--NME NDA/Original 351(a) BLA--priority review 85%
--NME NDA/Original 351(a) BLA--standard review 48%
FY 21
--NME NDA/Original 351(a) BLA--priority review 60%
--NME NDA/Original 351(a) BLA--standard review 42%
FY 22
--NME NDA/Original 351(a) BLA--priority review 78%
--NME NDA/Original 351(a) BLA--standard review 56%
FY 23
--NME NDA/Original 351(a) BLA--priority review 80%
--NME NDA/Original 351(a) BLA--standard review 59%
With respect to generic drugs covered by the Generic Drug User Fee
Amendments (GDUFA), one of FDA's goals is to maximize the efficiency
and utility of each assessment cycle, so that we can reduce the number
of assessment cycles for abbreviated new drug applications (ANDAs) and
facilitate timely access to quality, affordable, safe and effective
generic medicines. To achieve this, FDA communicates frequently with
industry, similar to PDUFA, and funds research under the GDUFA Science
and Research Program to better understand drug products and develop new
tools to evaluate generic drug equivalence. FDA also develops Product-
Specific Guidances to assist generic drug developers and established
the Drug Competition Action Plan (DCAP) in 2017 to further encourage
robust and timely market competition for generic products.
As a result of these and other efforts, FDA's times to approval for
ANDAs have decreased under the GDUFA program, and we have also made
progress in minimizing the number of review cycles for applications to
obtain approval. While there is some year-to-year variability, in more
recent years (FY 2018-FY 2023), the rate of first cycle approvals has
generally increased, as noted below:
--FY 18 17.1%
--FY 19 15.1%
--FY 20 15.2%
--FY 21 16.7%
--FY 22 15.9%
--FY 23 17.6%
FDA works with all sponsors to resolve issues and help speed
development of new and generic drug products, while maintaining high,
scientifically-based assessment standards.
real-world data
Question. More and more of our health care system is now digitized
and there are more potential sources to pull data and information from
to help clinicians and researchers. Data is fragmented across multiple,
complex systems however and there must be the strongest protections to
preserve and protect patient data and personally identifiable
information. Does FDA guidance currently allow for or is the FDA
working with organizations who can help connect researchers and
clinicians to de-identified health care data across real-world data
sources like electronic health records, payor claims, and mortality
data? What specifications or guidance does the FDA currently provide
regarding use of encryption tools and privacy-preserving record
locators to optimize the collection of comprehensive real-world data?
Answer. FDA guidance provides sponsors, researchers, and other
interested parties with recommendations related to the use of real-
world data-such as from electronic health records (EHRs), claims, and
registries-to support a regulatory decision. As FDA seeks to improve
the comprehensiveness and validity of studies using de-identified data
while protecting privacy, the Agency supports research projects with
external organizations that use methods of encryption to link data in
commercial EHR systems with claims and mortality data.
With regard to the use of encryption tools and privacy-preserving
record locators, such standardizing specifications are not generally
within the purview of the Agency. Nonetheless, FDA guidance addresses
considerations to ensure that linkages of de-identified data lead to
datasets that are complete and fit-for-use in regulatory decision-
making.
______
Questions Submitted by Senator John Hoeven
human foods program
Question. As touched upon during our hearing, we appreciate the
work FDA is undertaking to establish the unified Human Foods Program
and the reworking of the Office of Regulatory Affairs. It's been said
this is the largest reorganization in FDA's history. At the end of the
day, Americans want to be assured that the food they eat it is safe.
What are the specific objectives of the reorganization, and what
metrics will you use to determine whether or not the new programs are
achieving said objectives while increasing the safety of our food
supply system?
Answer. Among other things, the changes in the Human Foods Program
(HFP) reorganization will allow the Agency to more effectively realize
the preventive vision laid out in the FDA Food Safety Modernization
Act; elevate the importance of nutrition to help reduce diet-related
diseases; and strengthen state partnerships and embrace innovative food
and agricultural technologies that will position the Agency to more
effectively regulate and uphold the safety of the Nation's food supply.
As the reorganization is implemented, communicating these strategic
goals and priorities of the newly established HFP, for both
transparency and accountability, will be important. We are developing
strategic management processes for the new organization and are working
on communicating HFP priorities and accomplishments in FY 2025. In the
longer-term, a key component of the HFP is the Office of Strategic
Programs, which will facilitate strategic planning and performance
management across the program and evaluate progress toward annual and
multi-year priorities.
laboratory developed tests
Question. FDA recently finalized its Laboratory Developed Tests
(LDT) regulation, which as I understand it, is an attempt to improve
the safety of lab tests, pathology results, diagnosis, and treatment.
While well-intentioned, we should make sure to avoid one-size-fits-
all rules that may result in unintended consequences or lead to the
stifling of innovation.
Can you describe the feedback FDA received during the rulemaking
process, and how the comments received are addressed in the final rule?
Answer. FDA received more than 6,500 comments on the notice of
proposed rulemaking from a variety of entities including medical device
associations, members of the medical device and pharmaceutical
industries, medical and healthcare professional associations, hospitals
and academic medical centers, accreditation organizations, other
advocacy organizations, government agencies, and individuals.
Comments supporting FDA's proposal pointed to problems with
laboratory developed tests (LDTs), concerns about the significant
impact of problematic LDTs on patients and the treatment decisions of
healthcare providers, and the need for increased oversight of LDTs by
FDA. Some comments also emphasized the importance of creating a ``level
playing field'' between laboratory and non-laboratory manufacturers of
in vitro diagnostics (IVDs), and described how phasing out the general
enforcement discretion approach for LDTs would incentivize innovation
by non- laboratory IVD manufacturers.
Some comments also raised concerns or requested clarification
regarding the evidence related to the safety or effectiveness of IVDs
offered as LDTs; the sufficiency of regulation by the Centers for
Medicare & Medicaid Services and other non-FDA entities; FDA's legal
authority to regulate LDTs; the impact of the phaseout policy on access
to and the pricing of IVDs offered as LDTs; the impact of the phaseout
policy on test innovation; the impact of the phaseout policy on small
laboratories; the impact of the phaseout policy on specific patient
populations; the details of the phaseout policy; the types of IVDs
offered as LDTs for which the FDA intends to continue the general
enforcement discretion approach and generally not enforce some or all
applicable requirements; and FDA's implementation of the phaseout
policy and the resources needed for such implementation. FDA responded
to comments in the preamble to the final rule.
In part based on comments received on the notice of proposed
rulemaking, FDA's final phaseout policy described in the preamble to
the final rule includes several targeted enforcement discretion
policies for specific categories of IVDs manufactured by a laboratory,
which were not included in the proposed phaseout policy described in
the preamble to the proposed rule.
Specifically, FDA intends to:
--Exercise enforcement discretion and generally not enforce
requirements for LDTs manufactured and performed within the
Veterans Health Administration or the Department of Defense.
--Exercise enforcement discretion and generally not enforce premarket
review requirements for LDTs approved by, conditionally
approved by, or within an approved exemption from full
technical documentation under the New York State Department of
Health Clinical Laboratory Evaluation Program, as described in
the preamble to the final rule.
--Exercise enforcement discretion and generally not enforce premarket
review requirements and most quality system (QS) requirements
for LDTs manufactured and performed by a laboratory integrated
within a healthcare system to meet an unmet need of patients
receiving care within the same healthcare system.
--Exercise enforcement discretion and generally not enforce premarket
review and most QS requirements for currently marketed IVDs
offered as LDTs that were first marketed prior to the date of
issuance of the rule and that are not modified, or that are
modified in certain limited ways as described in the preamble.
--Exercise enforcement discretion and generally not enforce premarket
review and most QS requirements for non-molecular antisera LDTs
for rare red blood cell antigens where such tests are
manufactured and performed in blood establishments, including
transfusion services and immunohematology laboratories, and
where there is no alternative available to meet the patient's
need for a compatible blood transfusion. These serological
tests are used for typing red blood cell units for non-ABO/
Rh(D) antigens to ensure the patient receives a compatible
blood transfusion.
Question. How will FDA work to ensure this is not a regulatory
barrier that contributes to paperwork burdens on physicians and
hospitals, or negatively impacts the development of new, innovative
tests?
Answer. Increased FDA oversight is important to realize the
potential of innovative laboratory developed tests (LDTs) by, for
example, motivating the development of robust scientific data on safety
and effectiveness. FDA believes the final phaseout policy will also
incentivize innovation by non- laboratory manufacturers and help ensure
that innovation from laboratory manufacturers yields in vitro
diagnostics (IVDs) for which there is a reasonable assurance of safety
and effectiveness. FDA's previous enforcement discretion approach for
LDTs may have disincentivized innovation by non-laboratory
manufacturers who compete with laboratory manufacturers that offered
their tests without complying with FDA requirements. Addressing the
current imbalance in oversight may foster innovation by manufacturers
who can make safe and effective novel tests available to many labs.
Moreover, by applying the same general oversight approach to
laboratories and non- laboratories that manufacture IVDs, FDA will give
stakeholders greater clarity regarding compliance expectations.
The final phaseout policy includes several enforcement discretion
policies that the Agency anticipates will reduce burdens for physicians
and hospitals. For example, FDA intends to exercise enforcement
discretion and generally not enforce premarket review and quality
system requirements for certain LDTs manufactured and performed by a
laboratory integrated within a healthcare system to meet an unmet need
of patients receiving care within the same healthcare system.
fda staffing and telework issues
Question. Like many organizations, FDA utilized telework during the
height of the Public Health Emergency. At FDA, there are certain
activities during drug development that still require in- person
collaboration, including meeting management, inspections, and first
cycle approvals for products.
Can you summarize FDA's current telework policy?
Does FDA's current telework policy allow for critical in-person
meetings, i.e. meetings with drug developers on drug reviews?
Answer. FDA understands the value of in-person interactions to
foster deeper connections, creativity, and seamless teamwork. The
Agency remains steadfast in our commitment to facilitating in-person
meetings while accommodating the diverse needs of our workforce and
stakeholders.
FDA's current telework policy prioritizes meaningful in-person
engagement while providing eligible employees with flexibility for
remote work, telework, or on-site work arrangements according to job
roles and organizational goals. Business needs may require certain
positions to work on-site more frequently and vary between the various
components of FDA. Positions may therefore be required to regularly
attend in-person meetings with internal team members, industry
sponsors, or other interested parties.
One example are formal meetings with industry, as agreed to in the
Prescription Drug User Fee Act (PDUFA) VII \7\ and Biosimilar User Fee
Amendments (BsUFA) III.\8\ As of January 22, 2024,\9\ FDA's Center for
Drug Evaluation and Research and Center for Biologics Evaluation and
Research expanded in-person face-to-face industry meetings with a
hybrid component to allow maximum participation to include all PDUFA,
BsUFA, and Over-The-Counter Monograph Drug User Fee Program (OMUFA)
meeting types. All meetings have a hybrid component to enable attendees
who may not be able to attend in-person to participate. However, anyone
who is invited may attend in-person if they prefer. Thus far, FDA has
received positive feedback from industry regarding the flexibility that
virtual, hybrid, and in-person meetings provide. FDA will continue to
work with industry to fully meet our user fee commitments and to ensure
FDA's workforce operates at the highest level as we work to further our
public health mission.
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\7\ PDUFA Reauthorization Performance Goals and Procedures Fiscal
Years 2023 Through 2027
\8\ Biosimilar Biological Product Reauthorization Performance Goals
and Procedures Fiscal Years 2023 Through 2027
\9\ Beginning February 13, 2023, prior to expiration of the COVID-
19 Public Health Emergency, CDER and CBER started a phased return to
in-person meetings. From Feb. 13, 2023 until Jan. 21, 2024, industry
requested 83 in- person meetings. 90% of those meetings were granted as
in-person. No meetings were delayed or denied due to conference room
availability.
---------------------------------------------------------------------------
facility inspections
Question. There continues to be high demand for drug and biologic
facility inspections.
What other tools, beyond on-site inspections, does the Agency have
to help assess compliance of drug manufacturing facilities?
Answer. The Agency has a set of alternate tools it can use, as
applicable and appropriate, as standalone or in conjunction with an
FDA-conducted on-site inspection to provide oversight for FDA-
regulated products, including mandatory requests for records under
section 704(a)(4) of the FD&C Act and voluntary remote interactive
evaluations. FDA used remote records requests to obtain information on
the compliance of manufacturers when inspections were curtailed due to
risk to agency and industry personnel during the COVID-19 public health
emergency. These records requests help the Agency to maintain oversight
over regulated establishments, determine best use of limited Agency
inspectional resources, and when appropriate, help FDA make decisions
on new drug applications and abbreviated new drug applications.
Additionally, these records help the Agency determine whether
sufficient corrective actions have been taken by previously compliant
manufacturers to address identified objectionable conditions, allowing
more efficient use of Agency resources.
For foreign inspections, records requests under section 704(a)(4)
and other remote regulatory assessments continue to serve as a valuable
tool for the Agency when inspections cannot be conducted in certain
countries or regions due to factors such as security issues. FDA also
has Mutual Recognition Agreements (MRAs) in place with several foreign
regulatory authorities (e.g., European Medicines Agency (EMA),
Medicines and Healthcare products Regulatory Agency (MHRA), and
SwissMedic) allowing the Agency to rely in part on inspections
conducted by foreign regulatory authorities meeting U.S. requirements.
These MRAs can help avoid duplication of inspections by multiple
regulatory authorities for manufacturers and also enables the Agency to
reallocate resources to other drug manufacturing facilities with higher
risk profiles.
Question. The Agency has issued a number of draft guidances on the
use of alternative tools, including remote regulatory assessments and
remote interactive evaluations.
Has FDA begun using these tools to optimize their resources and
capabilities in gathering data? If so, what has the Agency's experience
been?
Answer. The Agency frequently used the authority for records
requests under section 704(a)(4) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) during the COVID-19 public health emergency to
collect information on the compliance of drug manufacturers, when
facility inspections were curtailed due to risk to Agency and industry
personnel. The Agency continues to use authority for section 704(a)(4)
records requests-which were expanded by Congress in 2022 to device
establishments and facilities subject to bioresearch monitoring
inspections-when an on-site inspection is not feasible. These records
requests, under which FDA can require the provision of records in
advance or in lieu of an inspection, allow the Agency to help maintain
oversight over regulated establishments and have also been used, as
appropriate, to help make decisions on new drug applications and
abbreviated new drug applications. Lastly, records requests and other
types of remote regulatory assessments (RRAs) continue to serve as a
valuable tool for the Agency when inspections cannot be conducted in
certain countries or regions due to security issues. They have also
been beneficial in providing FDA with information to help show
corrective actions have been taken based on previous inspection
findings, allowing more efficient use of Agency resources.
In FY 2023, FDA Office of Regulatory Affairs, Office of Import
Operations (OIO), conducted 1,155 remote foreign supplier verification
program (FSVP) inspections, with respect to human and animal foods;
currently in FY 2024, OIO has conducted approximately 523 remote FSVP
inspections. While such remote activities are a good tool, more time is
needed to enable improved efficiencies in the process and to address
challenges seen by industry. FDA has also seen some challenges
regarding document sharing and communications, particularly with
foreign facilities. Additionally, the collection of information via
section 704(a)(4) records requests were sometimes more time- and
resource-intensive than expected and at times, does not necessarily
result in time and human resource savings. Although they are useful and
viable tools, RRAs including section 704(a)(4) records requests and
remote interactive evaluations, they are not a replacement for an
onsite inspection.
biopharmaceutical production
Question. There has been an increased focus on enhancing the
availability and production of drugs and biologics domestically to
improve supply chain capabilities and avoid disruptions and shortages
of critical medical products.
What is FDA doing to incentivize domestic biopharmaceutical
production and capacity?
Answer. Reliance on foreign manufacturing is not a new concern for
FDA. There are some things we can do to make it easier for
manufacturing to be done in the United States, however there are
significant economic issues that are out of our purview that have
contributed to increased foreign manufacturing, specifically, pricing
pressures, labor, and regulatory costs. We have been working closely
with colleagues across HHS to identify authorities and capabilities
available to address those other market forces. The Administration for
Strategic Preparedness and Response is a critical partner in this, via
the Supply Chain Control Tower and other capabilities, all as part of
the HHS Supply Chain Working Group.
Within FDA, one of the most important things we can do to help
reduce our reliance on foreign manufacturing is to encourage and
facilitate the adoption of advanced manufacturing. Ensuring that both
innovator product and generic drug manufacturers will have access to
information regarding advanced manufacturing technologies is vitally
important because advanced manufacturing requires a skilled workforce
and can help domestic companies operate in smaller facilities with
lower costs and fewer potential quality issues, improving the global
competitiveness of U.S. manufacturing.
counterfeit products
Question. How is FDA addressing concerns over counterfeit and
substandard products potentially making their way into the country?
Answer. FDA's Office of Criminal Investigations (OCI) plays a
crucial role in investigating and helping prosecute individuals
involved in the shipment of illegal FDA-regulated products into the
United States. OCI created the International Operations Program (IOP)
to help address this issue, and special agents assigned to IOP work
closely with Customs and Border Protection at the international mail
facilities, express parcel carriers, and air cargo facilities to detect
shipments involving illegal FDA-regulated products and to investigate
those involved in these illegal activities, as appropriate. OCI also
collaborates with international counterparts, including United Kingdom
agencies, Interpol, and Europol, to seize violative shipments and stop
the flow of illegal FDA-regulated products destined for the United
States; degrade (if not eliminate) the capabilities of those trading in
these illegal products; and prosecute those engaging in these illegal
practices.
FDA also accomplishes this important work through the refusal of
imported FDA-regulated products that appear to be adulterated,
misbranded, or unapproved new drugs. In 2012, FDA was granted the
authority to administratively destroy adulterated, misbranded, or
counterfeit drugs valued at $2,500 or less. In 2018, FDA was also
granted the authority to detain, refuse, and administratively destroy
imported articles containing certain active pharmaceutical ingredients
even if the article has little to no explicit evidence of intended drug
use. These authorities are intended to protect the integrity of the
United States drug supply chain and the public by preventing
distribution or use of violative drugs that potentially pose a threat
to consumer's health. FDA investigators also examine allegations of
counterfeit and substandard products that have been introduced into the
country. These actions can form the basis for initiating the types of
criminal investigations or interdiction activities as described above,
as well as domestic enforcement actions that would stop further
distribution of such products.
pdufa performance goals
Question. Patients have come to rely on the FDA as the gold
standard for ensuring the safety and efficacy of new medications. PDUFA
was put in place over 30 years ago to address unacceptable delays, with
program funds used to help ensure that the agency has the necessary
resources to keep pace with innovation. Under PDUFA, FDA commits to
certain performance goals for the timely conduct of sponsor meetings
where alignment can be reached on data and study design expectations
that would support future product approvals. In the most recent PDUFA
performance report (FY 2022), FDA met 6 out of the 20 procedural
meeting goals. This results in sponsors either delaying study starts or
proceeding at risk without FDA alignment, either of which may result in
delayed access for patients.
What efforts are being taken to ensure the review capabilities and
workforce capacity exists to meet PDUFA's performance goals?
Answer. FDA plays a vital role during drug development by providing
advice and feedback to sponsors at various points during the process.
Timely interactive communication with sponsors during drug development
is a core Agency activity and helps ensure that new and innovative
products are developed and available to the American public as soon as
possible.
After FDA receives an application, the Agency'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. FDA staff are expected to adhere to internal review timelines,
established in part through user fee agreements. 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.
FDA works with all sponsors to resolve issues and help speed
development of new products, while maintaining high, scientifically-
based safety and efficacy standards.
To efficiently conduct reviews of human drug applications and meet
PDUFA commitments, FDA must be able to hire and retain sufficient
numbers and types of technical and scientific experts.
To strengthen this core capability, FDA has established a
modernized position management system, more efficient recruiting
practices, a dedicated scientific recruiting function, and metric goals
for human drug review staff hiring. The vital hiring authorities in the
CURES Act have also greatly improved FDA's ability to hire and retain
scientific experts in more complex and specialized areas and meet our
growing responsibilities. The Agency continues to put every effort into
meeting our hiring goals.
From FY23-25, 333 newly funded FTE positions were provided with the
passage of PDUFA VII as shown on Page 59 of the PDUFA VII commitment
letter available online.\10\
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\10\ https://www.fda.gov/media/151712/download?attachment
---------------------------------------------------------------------------
A current update on our hiring efforts can be found on our website
and is updated quarterly.\11\
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\11\ https://www.fda.gov/industry/prescription-drug-user-fee-
amendments/pdufa-and-bsufa- quarterly-hiring-updates.
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biosimilars
Question. Biosimilars offer a market-based approach to providing
more affordable biologic products after the patent and exclusivity
protections expire. These products, like generic drugs, can be an
effective option for patients in the marketplace.
How is FDA ensuring the timely availability of safe and effective
biosimilar products?
Answer. Just recently, the Agency approved our 50th biosimilar in
April 2024. FDA has many activities in the biosimilar space and many of
them are reflected in the overarching goals outlined in the Agency's
Biosimilar Action Plan:
--Enhancing the efficiency of the biosimilar product development and
approval process.
--Maximizing scientific and regulatory clarity for the biosimilar
product development community.
--Developing effective communications to improve understanding of
biosimilars.
--Supporting market competition by reducing attempts to unfairly
delay competition.
We also included a legislative proposal in the President's FY 2025
Budget request to eliminate the statutory distinction between
biosimilar and interchangeable biosimilar products. This proposal would
deem all approved biosimilars to be interchangeable with their
respective reference products. This proposal would also help eliminate
any confusion caused by the statutory distinction between biosimilars
and interchangeable biosimilars and could save patients and the Federal
Government money.
FDA has developed a variety of educational resources for both
health care providers and patients to provide unbiased, accurate
information about biosimilars. We are continuing that work by
developing additional materials and using innovative dissemination
methods to reach intended audiences.
sunscreen
Question. In accordance with the President's Cancer Moonshot goals
to continue reducing cancer death rates, the Committee is interested in
understanding what progress is being made in the approval of next
general sunscreen products. The FDA last approved a new over-the-
counter monograph sunscreen active ingredient, or UV filter, in the
1990s. Since that time, other countries around the world have moved
ahead of the United States in the development of new products, and
eight new products submitted to the FDA under the sunscreen monograph
Time and Extent Application process have been stalled in the approval
process. In 2014, Congress enacted the Sunscreen Innovation Act, which
authorized the issuance of guidance for the criteria for a generally
recognized as safe and effective (``GRASE'') determination for
nonprescription sunscreen products, and required the agency to finalize
the sunscreen monograph within 5 years of enactment. Despite these
efforts, no new sunscreen active ingredients have been approved. In
2022, CDER Director of the Office of Nonprescription Drugs Theresa
Michele noted that research studies were ongoing on the eight products
noted above that were submitted to the FDA. No new updates have been
provided since that time.
Will you provide the latest status regarding an update to the
sunscreen monograph, including the status of research studies and a
timeline of when FDA expects to be ready to approve new sunscreen
products?
Answer. At the outset, we note that the question cites to a webpage
published in 2022 with comments from Dr. Theresa Michele.\12\ The scope
of ingredients addressed in the 2022 webpage is limited to ingredients
that are currently permitted to be lawfully marketed in the U.S.
However, the question seems to be addressing a different subset of
ingredients-specifically, those that are not currently permitted to be
lawfully marketed in the U.S. as active ingredients in sunscreen
products. While there are data gaps relevant to both sets of
ingredients, the regulatory status of these two groups of ingredients
is not identical. Given the emphasis of the question on ``new''
ingredients, we assume the intent of the question is to inquire as to
the status of ingredients that are not currently permitted to be
marketed in the United States. Accordingly, our response addresses that
group of ingredients.
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\12\ https://www.fda.gov/drugs/cder-conversations/update-sunscreen-
requirements-deemed-final-order-and- proposed-order
---------------------------------------------------------------------------
Many Americans rely on sunscreens as part of their skin cancer
prevention strategy, which makes satisfactory evidence of both safety
and effectiveness of these products critical for public health. To help
reduce the risk of skin cancer, sunscreen products are often used on a
near-daily basis over a whole lifetime, starting at age 6 months, and
are applied over much of the body surface--thus frequently involving
extensive, repeated, cumulative exposure to their active ingredients.
Since sunscreens were originally evaluated, newer data emerged
showing that a number of sunscreen active ingredients are absorbed
through the skin and into the body. Consequently, safety questions
about sunscreens--particularly questions related to long-term use of
absorbed ingredients-remain a priority. FDA's safety testing framework
for sunscreens was strongly supported by an independent advisory
committee.
As such, FDA encourages sunscreen manufacturers to submit data
showing that sunscreens containing active ingredients that are not yet
available in the United States are generally recognized as safe and
effective. To that end, we have directed industry to helpful guidance
documents FDA has published on the safety and effectiveness data needed
to determine whether a nonprescription sunscreen active ingredient is
GRASE \13\ and on conducting Maximal Usage Trials (MUsT) \14\ needed to
assess how much of a sunscreen ingredient is absorbed through the skin
into the body. In addition, FDA conducted and published two pilot
trials \15 16\, evaluating the absorption of various sunscreen
ingredients. Wherever possible, FDA has also taken steps to offer
industry tailored study recommendations that take into consideration
the specific pharmacological properties of sunscreens and that could
reduce testing burdens.
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\13\ https://www.fda.gov/media/94513/download
\14\ https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/maximal-usage-trials-topically- applied-active-
ingredients-being-considered-inclusion-over-counter
\15\ https://jamanetwork.com/journals/jama/fullarticle/2733085
\16\ https://jamanetwork.com/journals/jama/fullarticle/2759002
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Question. Regarding timeline, if and when FDA receives a needed
data for sunscreen active ingredients that are not currently permitted
to be marketed in the U.S., FDA will review it in a timely manner and
in accordance with the timeframes set forth in user fee letters
negotiated with industry.
FDA also notes that while having additional sunscreen choices may
be desirable to consumers, new sunscreen active ingredients are not
necessarily safer or more effective than the ones already available in
the U.S. by virtue of being available in markets other than the U.S.
Many currently marketed and widely available sunscreen products provide
broad-spectrum protection with an SPF of 15 or more and are effective
not only in helping to prevent sunburn, but also in reducing the risk
of skin cancer and early skin aging caused by the sun, when used as
directed in their labeling.
FDA is committed to working with industry and public health
stakeholders to help ensure that the sunscreens consumers use to
protect themselves and their families are safe and effective for their
intended use.
foreign manufacturer tobacco registration
Question. In 2009, Congress required under the Tobacco Control Act
that the FDA publish a rule requiring foreign manufacturers to register
with the FDA if they wanted to sell tobacco products in the
U.S. Like many, I am concerned with the influx of illicit vapor
products manufactured in China that are being illegally imported into
the United States.
Can you share what FDA is doing in terms of enforcement on this
issue, and when we can expect the rule required by the Tobacco Control
Act?
Answer. FDA continues to work on the Establishment Registration and
Product Listing for Tobacco Products proposed rule, which appeared in
the most recent Unified Agenda.\17\ CTP also included the rule on its
recently published policy agenda which outlines rules and guidance
documents that are in development or planned for development.\18\ The
proposed regulation would prescribe the format, content, and procedures
for establishment registration and tobacco product listings for both
domestic and foreign manufacturers of tobacco products.
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\17\ https://www.reginfo.gov/public/do/eAgendaMain
\18\ https://www.fda.gov/tobacco-products/rules-regulations-and-
guidance/center-tobacco-products-regulation- and-guidance-policy-agenda
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The Center continues to weigh competing priorities given available
resources and updates the policy agenda annually. In the meantime, FDA
receives information about foreign manufacturers as part of the
premarket tobacco product application (PMTA) process. A PMTA must
include information including a full statement of the components,
ingredients, additives, and properties, and of the principle or
principles of operation and a full description of the methods used in,
and the facilities and controls used for, the manufacture, processing,
and when relevant, packing and installation. This is true for
applications from both domestic and foreign manufacturers.
unapproved drugs
Question. I'm told there are reports of numerous unapproved
phenobarbital drugs containing prohibited excipients that are currently
marketed for use in neonates with seizures, which would present a
serious safety threat for vulnerable infants.
Has the FDA utilized its enforcement authority to remove unapproved
phenobarbital drugs from the market and if not, does the Agency plan to
do so this year?
Answer. FDA approved Sezaby (phenobarbital sodium) in November 2022
for the treatment of neonatal seizures in term and pre-term infants.
Sezaby is an 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.
FDA is aware that there are a number of unapproved phenobarbital
sodium injection products currently on the market. According to the
labeling for some of these unapproved phenobarbital sodium products,
these products are intended 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.
In general, as with FDA's compliance activities across the Agency,
we follow a risk-based enforcement approach that involves
prioritization in light of the facts of a given circumstance. This
includes prioritizing enforcement for drug products that pose the
highest risk to public health. This risk-based enforcement approach
best supports FDA's public health priorities. The Agency is currently
reviewing a Citizen Petition regarding the marketing status of
phenobarbital drugs and will respond to the Petition as soon as
possible and post the response to the public petition docket.
food regulation
Question. As I have stated before, FDA is the gold standard for
safety and efficacy. However, I am concerned that some States are going
beyond FDA in banning certain chemicals, ingredients, and additives in
food.
Is FDA concerned that these actions have the potential to leave us
with a patchwork of food regulations, while at the same time,
relinquishing FDA's authorities to the States?
Answer. Yes, a strong national food safety system is not built
state by State. Clearly, having States issue these types of bans, while
they may be within their rights under our current regulatory system, is
not ideal. States play a crucial role as our partners in regulating the
food supply and coordinating our efforts is integral to our success.
FDA must lead the way on food chemical safety. Not only because it is
confusing for consumers for there to be different standards and
impractical for industry, but because the determination of safety
should be based entirely on science, and not on where you live in the
U.S.
FDA maintains active, and widely used, regulatory programs to
assist industry in meeting its pre- market requirement to ensure all
substances (including food chemicals) are safe under their intended
conditions of use. All assessments of these ingredients are conducted
by the Office of Food Additive Safety in FDA's Center for Food Safety
and Applied Nutrition (CFSAN).
Regardless of the regulatory program used (food additive or color
additive petition process, food contact notification, or the Generally
Recognized as Safe (GRAS) Notification Process), the safety standard
must be met for all substances used by industry for use in food or food
packaging that there is a reasonable certainty of no harm under the
intended use conditions.
Chemical safety is one of the three fundamental risk management
pillars of the new FDA Human Foods Program, which is a recognition of
the importance of our food chemical safety work. As the reorganization
is finalized, we are continuing to implement our enhanced approach to
food chemical safety designed to ensure we keep pace with innovation
while maintaining as our first priority the safety of foods available
to consumers.
food traceability rule
Question. Will you commit to engage with the food industry to
address the most challenging aspects of the Food Traceability Rule,
including working with industry stakeholders to determine any changes
that may be necessary to allow for successful compliance with the Rule?
Answer. FDA remains committed to serious engagement with the food
industry regarding the Food Traceability Rule. We continue to work
closely with industry to help them prepare for implementation of the
rule, including by providing technical assistance. We also are engaging
in ongoing discussions with industry, organized by the Reagan-Udall
Foundation, regarding challenges, opportunities, and potential
solutions for implementation.
Together, we can attain the Food Traceability Rule's public health
goals of faster identification and rapid removal of potentially
contaminated food from the market, resulting in fewer foodborne
illnesses and deaths.
smoking cessation
Question. HHS recently released an updated Framework to Support and
Accelerate Smoking Cessation (the Framework). The Framework
acknowledges that despite the progress made in the last 60 years to
reduce the rates of cigarette smoking among U.S. adults cigarette
smoking and secondhand smoke exposure still claim nearly half a million
lives in the United States each year.
Last year, on June 1, 2023, at a Cancer Moonshot event at The White
House, you acknowledged some of the challenges those seeking to bring
forward new smoking cessation products may encounter.
What actions, if any, has CDER taken to help bring forward new,
innovative smoking cessation medicines for patients?
Answer. As smoking results in many serious or life-threatening
conditions (e.g., heart and lung disease and cancer), FDA recognizes
there is an unmet need for novel therapies particularly for individuals
who have not been able to quit despite available therapies.
Because we consider nicotine dependence to be a serious or life-
threatening condition with an unmet medical need, we are encouraging
development of novel smoking cessation drug therapies that show benefit
over existing products by outlining 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.\19\ The NRT Guidance outlines strategies for applicants
to make NRT development easier, efficient, and streamlined:
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\19\ https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/smoking-cessation-and-related- indications-
developing-nicotine-replacement-therapy-drug-products
--Clarifying the appropriate pathways 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
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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 abbreviated pathways 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 are 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 will hold a joint public meeting with NIH this
Fall to discuss innovations in development of smoking cessation
products, and we anticipate the Federal Register notice for that
meeting to be announced in the near future.
Question. What new actions does CDER plan to take, if any, in
addition to the guidance previously issued?
Answer. Please see response to previous question.
Question. Does the agency believe additional, new smoking cessation
therapies are needed to help patients be more successful in their quit
attempts? If so, what new actions will CDER take to expand and improve
treatment options for smokers seeking to be more successful in their
quit attempts.
Answer. Please see response to previous question.
Question. What steps is FDA taking to make sure that the regulation
of cessation medicines is keeping pace with the ongoing unmet clinical
needs and public health urgency in helping patients be more successful
in their quit attempts? Please specify the timeline for such action
underway and or planned for the future. Please also specify the metrics
the agency is using to track progress on these actions.
Answer. Please see response to previous question.
Additionally, 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. All New Drug Applications are subject to the performance
goals and procedures for the Prescription Drug User Fee Act (PDUFA VII)
2023-2027. Please see the PDUFA VII commitment letter for more
information.\20\ The goals letter represents the product of FDA's
discussions with the regulated industry and public stakeholders, as
mandated by Congress.
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\20\ https://www.fda.gov/media/151712/download?attachment
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draft report and plan on best practices for guidance
Question. Earlier this year, FDA published a ``Draft Report and
Plan on Best Practices for Guidance'' which proposes eliminating the
notice and comment period for Level 1 guidance documents. FDA currently
has the authority to issue Level 1 guidance documents without prior
public participation when responding to urgent issues, and did so
during the COVID-19 pandemic.
What policy objective is FDA seeking to achieve by seemingly
expanding this policy?
Has FDA examined the costs and any potential unintended
consequences associated with this policy, and if so, what has the
agency found?
How does publication of a draft version of significant guidance
documents allow patient groups, health care professionals, and other
stakeholders the opportunity to prepare prior to implementation? Is FDA
concerned this policy change could impact productive stakeholder
engagement with FDA?
Answer. Following FDA's rapid issuance of over 80 guidance
documents (not including revisions) related to the COVID-19 public
health emergency, including many that were issued without prior public
comment, section 2505(a) of the Consolidated Appropriations Act, 2023
was enacted. In that provision, Congress directed FDA to examine our
practices for the efficient prioritization, development, review,
clearance, issuance, and use of FDA guidance documents.
FDA guidance documents are prepared for regulated industry, FDA
staff, and the public to describe the Agency's interpretation of, or
policy on, a regulatory issue.\21\ Unlike statutes and regulations,
guidance documents do not establish legally enforceable rights or
responsibilities and are thus exempt from notice and comment
requirements applicable to most rulemaking under the Administrative
Procedure Act.\22\ However, the Federal Food, Drug, and Cosmetic Act
(FD&C Act) and FDA's Good Guidance Practices regulation require FDA to
provide an opportunity for public comment prior to publication for all
Level 1 guidance documents (i.e., guidance documents that include
initial interpretations of a statute or regulation, changes in
interpretation or policy that are of more than a minor nature, complex
scientific issues, or highly controversial issues), unless FDA
determines that prior public participation is not feasible or
appropriate.\23\ If FDA determines that public participation is not
feasible or appropriate prior to publication of a guidance document,
FDA must invite public comment upon publication and take such comment
into consideration.\24\ For Level 2 guidance documents (i.e., guidance
documents that set forth existing practices or minor changes in
interpretation or policy), FDA invites public comment upon
publication.\25\
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\21\ See 21 CFR 10.115(b)
\22\ See 21 CFR 10.115(d); 5 U.S.C. 553(b)(A); (d)(2)
\23\ See 21 U.S.C. 371(h)(1)(C)(i); 21 CFR 10.115(g)
\24\ See 21 U.S.C. 371(h)(1)(C)(i); 21 CFR 10.115(g)(3)
\25\ See 21 U.S.C. 371(h)(1)(D); 21 CFR 10.115(g)(4)
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In accordance with the directive in section 2505(a) of the
Consolidated Appropriations Act, 2023, FDA issued a ``Draft Report and
Plan on Best Practices for Guidance'' (2023 Draft Report and Plan)
identifying proposed best practices for the efficient prioritization,
development, review, clearance, issuance, and use of guidance
documents. This included considering whether, consistent with the FD&C
Act, there are additional categories of Level 1 documents for which, or
circumstances under which, FDA could use our authority to issue Level 1
guidance documents ``for immediate implementation,'' meaning without
prior public comment. This proposal is consistent with recommendations
FDA made in its 2011 report ``Food and Drug Administration Report on
Good Guidance Practices Improving Efficiency and Transparency'' and is
based upon over 20 years of FDA experience in implementing its Good
Guidance Practices and experience gained during the COVID-19 Public
Health Emergency.
Consistent with section 2505(c) of the Consolidated Appropriations
Act, 2023, in a Federal Register notice announcing the availability of
the 2023 Draft Report and Plan, FDA sought public comment from a broad
range of commenters, including regulated industry; researchers;
academic organizations; pharmaceutical, biotechnology, and medical
device developers; clinical research organizations; clinical
laboratories; health care providers; food manufacturers; and consumer
and patient groups. FDA is carefully considering comments as it
prepares its final report and plan.
grain reconditioning
Question. The FDA's grain reconditioning process plays a critical
role in the exporting of U.S. bulk commodities, which gets high-quality
crops from American farmers to their customers around the world.
Recently, I have heard concerns regarding the timing of reconditioning
plan approvals.
Is the FDA reviewing the reconditioning process to identify ways to
minimize delays? If so, please provide details and a timeline for
implementation.
Answer. FDA is aware of the concerns from industry regarding
reconditioning proposals and is collaborating with our Federal partners
at the USDA Federal Grain Inspection Service (FGIS) to address them.
For background, the reconditioning process can occur when adulterated
grain is identified at a point of export. In order to address food
safety concerns, a firm can propose a reconditioning plan, which FDA
may accept. FDA and FGIS work under a Memorandum of Understanding (MOU
225-80-2000)\26\ to facilitate interagency coordination on the
inspection and standardization of grain, rice, pulses, and other food
products assigned to FGIS by the Secretary of Agriculture. FDA and FGIS
have worked to identify procedures involved in the grain reconditioning
process that can be streamlined to help address these timeliness
concerns and are working to finalize these modified procedures in FY
2025.
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\26\ https://www.fda.gov/about-fda/domestic-mous/mou-225-80-2000
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______
Questions Submitted by Senator Mitch McConnell
tobacco 21
Question. In 2019, to address growing youth tobacco use, Congress
passed legislation raising the minimum age to purchase tobacco from 18
to 21. 180 days after enactment of that legislation, FDA was required
to promogulate a rule to update all references to persons younger than
18 years of age in subpart B of part 1140 of title 21, Code of Federal
Regulations, and to update the relevant age verification requirements
under part 1140 to require age verification for individuals under the
age of 30. However, nearly 4 years after the congressionally mandated
deadline, FDA has not produced a final rule. In response to questions
from letters in 2022 and 2023, FDA indicate that regulations would be
forthcoming. A final rule has been repeatedly delayed without
explanation, and in response to previous letters, FDA indicated it
cannot provide an update on specific timing of the rulemaking process.
Please provide an update on the status of the final rule, including
an explanation for the continuous delays.
Please explain the impact of the delayed rulemaking on
implementation of the Tobacco 21 legislation. What negative effects on
public health are occurring because of the lack of updated regulation?
In the absence of the congressionally mandated final rule, how does
FDA plan to measure retailer compliance of ID checks and communicate
these requirements to States and retailers?
Answer. Soon after the enactment of the Tobacco 21 legislation in
December 2019, FDA began implementing and enforcing the law's increased
Federal minimum age of sale by incorporating the increased age into
FDA's tobacco retail inspections and other surveillance activities.
Importantly, the Agency has continued to enforce the statutory
requirement that retailers not sell tobacco products to anyone under
the age of 21.
Following the May 8th hearing, on August 30, 2024, FDA published
the Prohibition of Sale of Tobacco Products to Persons Younger than 21
Years of Age final rule. Until the final rule goes into effect on
September 30, 2024, the current requirement of verifying identification
by means of photo identification for those under 27 years of age
remains. Once the final rule goes into effect on September 30, 2024,
verifying identification will be required for those under 30 years of
age. In the interim, FDA has provided educational materials to
retailers, such as updated webinars, describing how brick-and-mortar
and online retailers must comply with FDA's tobacco sale regulations,
and we continue to use our compliance and enforcement tools to ensure
retailers comply with requirements.
As noted above, FDA implemented and began enforcing the Tobacco 21
law by incorporating changes into FDA's tobacco retail inspection
program. From January 1, 2020, to April 30, 2024, FDA conducted over
330,000 inspections and issued over 43,200 warning letters (over 12,200
pertained to sales of electronic nicotine delivery system (ENDS)
products to individuals under the age of 21), and filed over 8,900
complaints for civil money penalties (2,500 pertained to sales of ENDS
products to individuals under the age of 21), and 33 complaints for no-
tobacco-sale orders to retail establishments where violations were
found during compliance check inspections.
______
Questions Submitted by Senator Susan M. Collins
neurology drug program
Question. I have led efforts in Congress to provide funding for the
Neurology Drug Program to help streamline the delivery of innovative
treatments to individuals with brain diseases, mental health
conditions, and brain injuries. Congress provided $2 million for the
Neurology Drug Program in FY23 and FY24. My understanding is that FDA
has hired 2 FTEs to carry out this work so far. Can you share more
about the responsibilities of these individuals, including tangible
examples of the work they are leading with the support of NDP funding?
Do you plan to hire additional staff to support these efforts? How
could you use additional funding to advance treatments for brain
diseases and disorders? Please speak directly to patient engagement
efforts that the agency could expand or begin.
Answer. While this is a non-exhaustive list, please find several
examples below of how FDA has utilized this critical funding, and how
the Agency would propose to utilize additional funding.
cder
In FY 2023, FDA's Center for Drug Evaluation and Research (CDER)
utilized the appropriated funding for the NDP to hire 2 FTEs to support
the program. In FY 2024, a third FTE, with training in
neurodevelopmental disorders, has been hired to support drug
development for rare pediatric neurogenetic disorders. These staff
members have provided critical support to develop new policy and
guidance in this area, as well in supporting product review.
Specifically, these CDER staff were instrumental to the approvals of
four new therapies for neurological disease in 2023: Skyclarys
(omaveloxolone) for the treatment of Friedreich's ataxia approved on
February 28, 2023; Qalsody (tofersen) for the treatment of amyotrophic
lateral sclerosis (ALS) in patients who have a mutation in the
superoxide dismutase 1 (SOD1) gene approved on April 25, 2023; Leqembi
(lecanemab) on January 6, 2023 and July 6, 2023 for the treatment of
Alzheimer's disease; and Agamree (vamorolone) for the treatment of
Duchenne muscular dystrophy. For 2024, these staff have contributed to
the approval of two new therapies for neurologic disease: Duuvyzat
(givinostat) for the treatment of Duchenne muscular dystrophy approved
on March 21, 2024, and Kisunla (donanemab) for the treatment of
Alzheimer's disease approved on July 2, 2024, among other activities.
CDER staff have also directed a multi-year grant to address challenges
in neurological disease drug development through the development of
innovative model-informed drug development to inform clinical trial
design.
cber
Within the Center for Biologics Evaluation and Research (CBER),
funding has been utilized to initiate a research project focused on the
identification of neural stem cell (NSC) quality attributes that can be
used to evaluate cellular therapy products and to improve
manufacturing. Results from this research may be useful in defining
methods and standards for the evaluation of the quality of NSC
products. CBER has also used the NDP funds to implement FDA's Action
Plan for Rare Neurodegenerative Diseases. This included participating
in a Pelizaeus Merzbacher Disease patient listening session held on
August 22, 2023. Additionally, CBER is in the process of hiring two
staff. One of the planned FTE is for a neurology specialist to support
additional guidance to industry, building on the final guidance CBER
published last year on Human Gene Therapy for Neurodegenerative
Diseases. The new staff will also contribute to CBER's engagement in
the activities outlined in FDA's Action Plan for Rare Neurodegenerative
Diseases, including the development of disease-specific science
strategies and engagement in the Public-Private Partnership for Rare
Neurodegenerative Diseases.
cdrh
The Center for Devices and Radiological Health (CDRH) has utilized
NDP funds to hire a medical officer with expertise in neurology and
device development. This individual has taken clinical lead on novel
brain neurostimulation device submissions focused on Movement Disorders
such as Parkinson's Disease. This includes several files as part of
CDRH's Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot
which focuses on including external stakeholder voices, such as patient
advocacy organizations and clinical professional societies, in the
device development process. Increased staff through the NDP program
enables continued outreach to community partners.
proposed uses of additional ndp dollars
Additional funding would help support NDP efforts in three ways.
First, the Agency currently receives a large number of requests for
external engagement activities in the neuroscience space, and many of
these requests must be declined due to inadequate resources. Additional
funding would allow for the recruitment of additional FTEs to be hired
and trained to assist with these activities. Second, additional funding
would allow for the NDP to fund more research efforts in the
neuroscience space to address and advance drug development. And
finally, additional funding would allow for continued expansion of
patient engagement and educational activities specific to neurologic
and psychiatric diseases. The NDP staff recognize the need for patient
engagement and the critical information that both FDA and patients
learn from one another.
With the growing innovation in clinical trial design and the uptake
of innovation in neurology and psychiatry trials, the NDP will need to
actively engage with key stakeholders to better understand, develop and
implement these innovations into clinical trials.
______
Questions Submitted by Senator Jerry Moran
food traceability rule
Question. Dr. Califf, your agency, issued the final Food
Traceability Rule with a compliance date of January 2026. Based on the
information I am receiving from the food industry, from growers to
point-of-sale, this Rule intends to regulate tens of thousands of
products, costing tens of billions of dollars for the food industry to
implement, and ultimately, consumers will pay the price at the grocery
store.
Food industry stakeholders have serious concerns about meeting the
compliance standards with the Food Traceability Rule by the current
implementation date.
I do want to be clear: I agree we should have a sense of food
traceability, but this Rule, according to the industry, is overly broad
and complex, which will create a huge burden that is, at this time,
unworkable for the industry and I think it would be in the interest of
your agency to work with the industry more effectively.
Given the importance of the States in assisting FDA to achieve its
public health goals, what alternatives are you considering to support
an integrated food safety system and ensure an over one hundred year
relationship between the States and FDA continues and flourishes from
this cooperation between Federal and State governments?
Answer. FDA's Food Traceability Rule establishes traceability
recordkeeping requirements to allow for faster identification and rapid
removal of potentially contaminated food from the market, so as to
reduce foodborne illnesses and deaths.
The Agency continues to work closely with industry to help them
prepare for implementation of the rule, including by providing
technical assistance. We also are engaging in ongoing discussions with
industry, organized by the Reagan-Udall Foundation, regarding
challenges, opportunities, and potential solutions for implementation.
Working together on implementation is expected to offer industry
benefits by helping narrow the scope of necessary recall actions, which
reduces expenditures by avoiding overly broad market withdrawals and
mitigates potential loss of consumer confidence in their brands.
Industry benefits from the rule may also include increased food supply
system efficiencies, such as improvements in supply chain management
and inventory control.
FDA values its longstanding partnerships with the States, and we
have enhanced our collaborative activities over the past decade by
building an Integrated Food Safety System (IFSS), which provides a
coordinated approach to food safety. FDA recognizes the importance of
engaging our State and local regulatory partners who will play a key
role in successful implementation of the Food Traceability Rule. Their
input is particularly important given their role in primarily
regulating retail food establishments and restaurants. FDA is currently
in the process of soliciting feedback from state/local partners on a
proposed Food Traceability Rule inspectional framework as well as
engaging state partners in development of a compliance strategy for the
rule.
We are committed to working with industry and IFSS partners towards
our shared public health goal of reducing foodborne illness. In a
complex and global food system, it is critical to protect consumers
from contaminated products by being able to rapidly identify the source
of these products and removing them from the marketplace as quickly as
possible.
Question. Can you commit that the FDA will begin serious engagement
with the food industry to address the most problematic provisions of
the Rule while extending the compliance deadline to allow both FDA and
industry to work collaboratively to refine the Rule?
Answer. FDA remains committed to serious engagement with the food
industry regarding the Food Traceability Rule. We continue to work
closely with industry to help them prepare for implementation of the
rule, including by providing technical assistance. We also are engaging
in ongoing discussions, organized by the Reagan-Udall Foundation,
regarding challenges, opportunities, and potential solutions for
implementation.
To give industry additional time, we extended the compliance date
when we finalized the Food Traceability Rule from 2 years to 3 years
from the effective date. We have also communicated that routine
inspections under the Food Traceability Rule will not begin until 2027
to give covered entities additional time to work together and ensure
that traceability information is being maintained and shared.
Together, we can attain the Food Traceability Rule's public health
goals of faster identification and rapid removal of potentially
contaminated food from the market, resulting in fewer foodborne
illnesses and deaths.
animal food additives
Question. Thank you for your agency's acknowledgment of our work in
the Senate and the House to address animal feed ingredients in your
budget request.
Dairy farmers in Kansas and across the United States are eager for
proactive tools to help them build on their environmental stewardship
work. One opportunity lies with FDA approval of animal feed ingredients
with a proven track record in other countries. That last point is
important because everyday products aren't approved here, and our
farmers lose a competitive edge over their global counterparts.
Are you able to update us on your agency's efforts to authorize
these products?
Answer. 1In the EU and Canada, the regulatory structures for animal
food ingredients allow many products that are currently classified as
drugs in the U.S. to be classified as animal food additives in those
countries. This is not the case under FDA's statutory authority, which
is why the Agency's fiscal year 2025 budget request included a
legislative proposal that would establish a new legal framework for the
approval and marketing of ingredients that would be defined as
``zootechnical animal food substances'' (ZAFS). This new regulatory
authority would deem to be animal food additives certain substances for
use in animal food or drinking water that function solely in the gut of
an animal to: affect the byproducts of the digestive process of an
animal, affect the gastrointestinal microbiome of the animal, or reduce
pathogens in food products made from the animal. We believe the
proposal to regulate these substances as animal food additives is
responsive to the interests of stakeholders in developing and marketing
such innovative products while still providing the appropriate safety
review. We look forward to working with Congress to continue to advance
this proposal.
More broadly, thanks to additional funding provided by Congress in
recent years, timelines for animal food ingredient reviews have moved
from 44% of reviews on time to 90% of reviews on time. Continued
support would assist in improving our timelines and preparing FDA to
receive additional product submissions if the ZAFs legislation is
enacted. Our goal is to achieve faster market access and availability
of safe animal food additive products for farmers.
Question. We have been working with stakeholders to find a way to
create a pathway for your agency to approve innovative feed ingredients
through the standard feed ingredient review process instead of the
cumbersome, inappropriate, and unnecessary drug approval process.
Towards this end, I introduced the Innovative FEED Act with several
of my colleagues, including Senator Baldwin, and we have the support of
the full committee Vice Chair Senator Collins.
Dr. Califf, can you talk a little about how the passage of this
bill would change or improve the process that is used today? Would the
legislation provide the Center for Veterinary Medicine (CVM) with
greater regulatory certainty or help streamline workstreams and
regulation approaches at FDA?
Answer. FDA cannot comment on pending legislation. However, FDA
does share the goal of the legislation, which is consistent with a
legislative proposal included in FDA's FY 2025 Budget request to create
a new category of animal food additives called zootechnical animal food
substances (ZAFS). Specifically, certain substances would meet the
definition of ZAFS if they are intended to be added to animal food or
drinking water, act solely in the animal's GI tract, and have no
nutritive value or technical effect on the animal food but have other
important benefits, such as affecting the byproducts of digestion,
reducing foodborne pathogens in food animals, or altering the animal's
GI microbiome. This legislative change would give FDA increased
flexibility to provide risk-based oversight and facilitate more timely
availability of innovative animal food additives. Under this proposal,
ZAFSs would be deemed to be food additives, and would not be animal
drugs, despite having intended uses that could otherwise make them
animal drugs under the FD&C Act.
sodium
Question. Dr. Califf, given your background as a cardiologist, I
want to discuss sodium and the complex nature of food supply chains and
dietary habits.
How does the FDA intend to assess the effectiveness of sodium
reduction efforts on population- wide sodium intake and associated
health outcomes? Are there specific metrics or studies planned to
evaluate the impact of these initiatives?
Answer. A key part of the FDA's sodium reduction plan is to monitor
progress toward our goals on a regular basis to understand changes that
are occurring. Following the May 8th hearing, in August 2024, the
Agency issued a draft guidance \32\ for new 3-year voluntary sodium
reduction targets in foods as part of Phase II of the Agency's ongoing
work building on the Phase I reduction efforts \33\ issued in October
2021 using food label, restaurant, and sales data.
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\32\ Voluntary Sodium Reduction Goals: Target Mean and Upper Bound
Concentrations for Sodium in Commercially Processed, Packaged, and
Prepared Foods (Edition 2)
\33\ https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/guidance-industry-voluntary- sodium-reduction-goals
---------------------------------------------------------------------------
Preliminary data \34\ from the first phase has shown that about 40%
of food categories had already reached the targets set in the 2021
guidance, or were close. The new voluntary targets, when finalized,
would support reducing sodium intake to about 2,750 milligrams/day (mg/
day), approximately 20% lower than intake prior to the Phase 1 targets
outlined in the FDA's 2021 final guidance.
---------------------------------------------------------------------------
\34\ https://www.fda.gov/food/food-labeling-nutrition/sodium-
reduction-us-food-supply-2010-2022-preliminary- assessment-progress
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These new targets for industry are also intended to help address
the excess intake of sodium in the U.S., which is currently almost 50
percent more on average than the recommended limit. Going forward, the
Agency intends to conduct an assessment of progress on sodium reduction
to the targets about every 3 years. As more data becomes available, FDA
will also continue to work with other government agencies, such as the
U.S. Department of Agriculture and the Centers for Disease Control and
Prevention on these monitoring efforts.
Question. Are there plans to establish further sodium reduction
targets beyond the current voluntary initiatives? If so, what factors
will be considered in setting these targets, and how will stakeholders,
including industry representatives and public health experts, be
involved in the process?
Answer. FDA is currently evaluating progress towards the 2.5 year
targets in the voluntary sodium reduction guidance that the FDA issued
in October 2021 \35\ using food label, restaurant, and sales data, and
has engaged extensively with stakeholders on sodium reduction efforts
and the targets. Preliminary data has shown that about 40% of food
categories had already reached the targets set in the 2021 guidance, or
were very close. Additionally, FDA intends to conduct an assessment of
progress on sodium reduction relative to the targets about every 3
years.
---------------------------------------------------------------------------
\35\ https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/guidance-industry-voluntary- sodium-reduction-goals
---------------------------------------------------------------------------
Additionally, following the May 8th hearing, on August 15, 2024,
FDA issued a draft guidance \36\ to establish Phase 2 of the voluntary
sodium reduction targets to continue facilitating a gradual, iterative
process to reduce sodium intake. The new targets focus on commercially
processed, packaged and prepared foods in the marketplace, because more
than 70 percent of sodium intake in the U.S. population is from sodium
added during food manufacturing and commercial food preparation. While
the new targets are still higher than the recommended 2,300 mg/day for
those 14 years and older, the new targets are part of an iterative
approach that balances the public health objective with the
practicality of shifting industry practices and consumer preferences to
advance public health. The draft guidance is also available for public
comment.
---------------------------------------------------------------------------
\36\ https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/draft-guidance-industry-voluntary- sodium-reduction-
goals-edition-2
---------------------------------------------------------------------------
______
Questions Submitted by Senator Cindy Hyde-Smith
tobacco products
Question. The FDA writes regulatory rules all the time. Yet, in two
House hearings in April, you described the FDA as ``the referee'' that
``doesn't write the rules, Congress does.'' There are at least two FDA
rules that would go a long way toward dealing with the illicit e-vapor
market that FDA has been sitting on for some time. First, you stated
you were unaware of the pending Foreign Manufacturer Rule, which has
been on FDA's Unified Agenda in some form since 2012. It is currently
listed in the ``Long Term Actions'' stage of rulemaking and the Notice
of Proposed Rulemaking date was pushed back again--from May 2024 to
November 2024. Why hasn't the FDA issued the rule requiring foreign
tobacco product manufacturers to register with the Center for Tobacco
Products (a loophole that is being exploited by the Chinese
manufacturers now making illegal e-vapor products)? Why can't the FDA
issue an Interim Final Rule given the level of urgency we are facing?
Answer. To issue an interim final rule, FDA must for good cause
find that the notice and public comment procedures for such rulemaking
are impracticable, unnecessary, or contrary to the public interest. At
this time, FDA has not identified a strong basis to make such
conclusions for purposes of issuing the tobacco manufacturer
registration rule. FDA will continue to work on the Establishment
Registration and Product Listing for Tobacco Products proposed rule,
which appeared in the most recent Unified Agenda.\37\ CTP also included
the rule on its recently published policy agenda which outlines rules
and guidance documents that are in development or planned for
development.\38\
---------------------------------------------------------------------------
\37\ https://www.reginfo.gov/public/do/eAgendaMain
\38\ https://www.fda.gov/tobacco-products/rules-regulations-and-
guidance/center-tobacco-products-regulation- and-guidance-policy-agenda
---------------------------------------------------------------------------
The Center has gained valuable experience in implementing
registration and listing for domestic establishments that is informing
development of the rule. The proposed regulation would prescribe the
format, content, and procedures for establishment registration and
tobacco product listings for both domestic and foreign manufacturers of
tobacco products. Although the requirement for domestic manufacturers
to register and list is in the statute, the proposed rule would
describe the types of data required for submission and help ensure the
data submitted by industry can best be used by FDA.
The Center continues to weigh competing priorities given available
resources and updates the policy agenda annually. In the meantime, FDA
receives information about foreign manufacturers as part of the
premarket tobacco product application (PMTA) process. A PMTA must
include information including a full statement of the components,
ingredients, additives, and properties, and of the principle or
principles of operation and a full description of the methods used in,
and the facilities and controls used for, the manufacture, processing,
and when relevant, packing and installation. This is true for
applications from both domestic and foreign manufacturers.
Question. Second, an FDA rule to require an importer of e-vapor
products to submit the product's FDA PMTA number at the time of entry
in U.S. Customs and Border Protection's (CBP) Automated Commercial
Environment (ACE) system has been on FDA's Unified Agenda since
publication in the Fall 2021 Agenda. This rule could potentially help
CBP and FDA prevent illicit products from ever entering the country.
The Notice of Proposed Rulemaking is currently listed as January 2024.
When FDA has continually stated that the importation of illicit, non-
compliant e- cigarettes from China is a major problem, why has this
rule been pushed back? Why can't the FDA issue an Interim Final Rule
given the level of urgency we are facing?
Answer. Following the May 8th hearing, the Agency, with the
Department of Treasury's concurrence, issued a proposed rule to require
that the submission tracking number for electronic nicotine delivery
system tobacco products that are being imported or offered for import
be submitted in the Automated Commercial Environment or any other
electronic data interchange system authorized by U.S. Customs and
Border Protection, at the time of entry. The proposed rule was issued
on August 16, 2024, and the Agency is accepting public comment on the
rulemaking through October 15, 2024.\39\
---------------------------------------------------------------------------
\39\ https://www.federalregister.gov/documents/2024/08/16/2024-
18343/submission-of-food-and-drug- administration-import-data-in-the-
automated-commercial-environment-for
---------------------------------------------------------------------------
Question. We know that FDA has issued import alerts for some e-
vapor products, but that not all e-vapor products that are the subject
of warning letters are covered in the current import alerts. Can you
issue a product-wide import alert for all e-vapor products, with the
products that have been FDA- authorized or that have pending
applications being the exception? If not, why not? If yes, will you
commit to issue that blanket import alert as soon as possible?
Answer. Taking action against illegal tobacco products across the
supply chain--including importation--is a top priority for FDA in
coordination with Federal partners. FDA works with Customs and Border
Protection (CBP) to prevent illegal tobacco products, including e-
cigarettes, from entering the country. Additionally, CBP and FDA, as
well as the U.S. Postal Service at the International Mail Facilities,
work collaboratively to screen products at entry for compliance with
applicable requirements.
FDA uses import alerts to help flag for its staff products that can
be detained without physical examination, including many unauthorized
e-cigarettes from China. However, import alerts only help when products
are accurately declared at the time of import, and bad actors are not
typically inclined to do that. CBP and other Federal partners are best
suited to identify and interdict against fraudulently declared products
and we continue to coordinate with them. For example, CBP is able to
identify and can seize a mis-declared product under their authority--
such as the 1.4 million units of unauthorized e-cigarettes products
seized at LAX airport last year.
Given that multiple agencies serve an important role in preventing
entry of unauthorized e- cigarettes into the United States, an ``All of
Government'' approach is critical. Accordingly, following the May 8th
hearing, on June 10, 2024, FDA and the Department of Justice announced
the establishment of a Task Force to bring together and coordinate
relevant expertise, operational abilities, and enforcement authority to
strengthen our efforts related to unauthorized e-cigarettes. FDA and
DOJ co-lead the Task Force, which includes CBP, the Bureau of Alcohol,
Tobacco, Firearms, and Explosives, the Federal Trade Commission, the
U.S. Marshals Service, and the
U.S. Postal Inspection Service. The Task Force will provide more
opportunities for communications and collaborations in this ``All of
Government'' approach. We are committed to engaging in more joint
operations with our Federal partners, and prioritizing this work, while
maintaining our comprehensive approach along the entire supply chain to
address unauthorized products from being imported, manufactured,
distributed, and sold domestically.
Question. During your testimony in the House, you described how
there are many tricks that importers use to evade proper inspection and
denial or seizure of their goods--such as mislabeling e-vapor products
as ``lanterns.'' You testified that ``there is a timeframe by which if
we [FDA] don't do something, the product goes on through.'' Please
expand on that testimony--what is that timeframe? Is it administrative
or statutory law? What other rules govern the authorities to hold
product for inspection or seize product for destruction at
international mail ports that Congress should consider amending to
extend the FDA timeframe to respond?
Answer. An FDA entry decision must be made prior to the end of the
conditional release period (within 30 calendar days after CBP has
conditionally released the product), unless otherwise extended. FDA is
evaluating our enforcement authorities, including where there may be
challenges or barriers to using these tools effectively.
Additionally, FDA uses import alerts to help flag for its staff
products that can be detained without physical examination, including
many unauthorized e-cigarettes from China. There are multiple import
alerts in place; one is for detention without examination of e-
cigarettes that do not have premarket authorization. If an imported
product is not on the list of authorized products, then FDA and CBP
consult on detainment. However, import alerts only help when products
are accurately declared at the time of import, and bad actors are not
typically inclined to do that. CBP and other Federal partners are best
suited to identify and interdict against fraudulently declared products
and we continue to coordinate with them.
It is important to note that CBP and FDA have different
authorities. CBP can seize a product under their authority for mis-
declared products. CBP can also seize unauthorized tobacco products
that are in violation of the Federal Food, Drug, and Cosmetic Act. FDA
can refuse admission of unauthorized tobacco products. If FDA were to
seize a product, we must work with the Department of Justice (DOJ) to
obtain a court order and engage with U.S. Marshals to seize the
product. Seizures must be coordinated and filed through the U.S.
Attorney's Office for the district where the goods are physically
located. Therefore, we rely on other Federal agencies to assist with
such enforcement actions and we must prioritize our requests.
We also work with CBP to conduct targeted operations and seize
products. For example, in December 2023, FDA, in collaboration with
CBP, announced the seizure of approximately 1.4 million units of
unauthorized e-cigarette products, including brands such as Elf Bar.
These actions were part of a three-day joint operation which resulted
in the seizure of 41 shipments containing illegal e-cigarettes with a
total value of more than $18 million. This mis-declared product
investigation took 3 months. Enforcement against mis-declared products
is resource- and time- intensive. FDA continues to explore additional
authorities or tools that would help us better execute our public
health mission.
Question. In the House, you testified that FDA ``can't be in
300,000 stores'' and that you need more user fee money to ``put many
more people on the ground.'' FDA already has inspection contracts in
place in all 50 States with entities whose specific task is to perform
on-site inspections of retailers at those 300,000 stores. FDA has spent
more than $480 million on this critically important and comprehensive
enforcement and monitoring system. That is how you were able to issue
thousands of citations for underage sales last year. It seems the same
inspectors can be used for illicit e-vapor enforcement, just like they
are used for underage sales enforcement. What direction have you given
to your state inspection contractors to look for the presence of
illicit e- vapor products, including Chinese disposable vapor products,
and to take enforcement action?
Answer. FDA has a comprehensive compliance and enforcement program
that spans the entire supply chain, including targeting manufacturers,
importers, distributors, and retailers.
FDA has an inventory of over 300,000 tobacco retailers that it
inspects, which includes those selling e-cigarette products. FDA's
tobacco retailer inspections cover the marketing, sale, and
distribution of tobacco products at retail locations and is currently
set up to identify unauthorized tobacco products along with underage
sales. FDA-commissioned inspectors conduct two types of compliance
check inspections for the Agency. During Undercover Buy Inspections,
the retailer is unaware an inspection is taking place and a trained
underage person, working with an FDA-commissioned inspector, attempts
to purchase regulated tobacco products to determine compliance with
identification check and minimum age of sale requirements. Currently,
underage inspectors are not used to identify other violations, such as
unauthorized products.
Expanding Underage Buy Inspections to other violations is a complex
process that FDA is currently looking in to. During an Advertising and
Labeling Inspection, FDA-commissioned inspectors present the retailer
with a Notice of Inspection and announce their presence. The inspectors
determine compliance with other retail provisions in effect, including
for example, premarket authorization requirements.
As a result of concentrated efforts to identify retailers that
violated the premarket authorization requirements, FDA has issued over
600 warning letters and 140 civil money penalties (CMPs) to brick-and-
mortar and online retailers for selling unauthorized e-cigarette
products.
We continue to do this work with limited resources. Currently, the
Family Smoking Prevention and Tobacco Control Act does not provide FDA
the authority to collect user fees from e- cigarettes, despite the very
significant resources that CTP expends to regulate these products.
More resources are needed to increase inspections and enhanced
enforcement actions.
Question. This question is perhaps the most important of them all.
During the April House hearings you described how the FDA ``needs to
work with Congress to come up with a way to deal with this specific
problem that cuts all of the red tape'' your agency has to go through.
You testified that there are ``things that are bogging [the FDA] down''
and explained that ``by law, we have to treat offshore and internal
people with the same rights in terms of their products'' and ``we're
going to need a more efficient system.'' Now that you and your staff
have had time to reflect since the hearing, please list for us the law
changes or additional authorities you--or your partners at Customs--
need to efficiently and effectively keep these products out of the
United States.
Please do not hold back; we would like all ideas to be on the
table.
Answer. We are working on an approach to enhance our ability to
stop unauthorized products from entering the country--both products
that are properly declared and mis-declared. We are working both
internally and with our Federal partners to enhance communication,
engage in more joint operations, and prioritize work to address imports
of illegal tobacco products. This includes streamlining processes,
where possible, and cutting red tape to make it easier to stop products
at the border.
FDA is actively taking a very close look at existing statutes to
identify opportunities for updates that could help address illegal e-
cigarettes, such as potentially extending authorities FDA has been
granted related to other product categories we regulate, such as food
and drugs. In general, we are looking to:
--Better identify and hold accountable the responsible party in the
U.S;
--Increase consequences for activities related to offering illegal
products for import; and
--Strengthen our ability to refuse importation.
In addition to efforts to examine our existing statutes and
authorities, FDA is also continuing to enforce against illicit products
in partnership with other agencies. Following the May 8th hearing, on
June 10, 2024, FDA and the U.S. Department of Justice (DOJ) announced
the creation of a Federal multi-agency task force to combat the illegal
distribution and sale of e- cigarettes. Along with FDA and DOJ, the
task force will bring together multiple law enforcement partners,
including the Bureau of Alcohol, Tobacco, Firearms and Explosives;
Customs and Border Protection; the U.S. Marshals Service (USMS); the
U.S. Postal Inspection Service; and the Federal Trade Commission, to
coordinate and streamline efforts to bring all available criminal and
civil tools to bear against the illegal distribution and sale of e-
cigarettes responsible for nicotine addiction among American youth.
The task force will focus on several topics, including
investigating and prosecuting new criminal, civil, seizure, and
forfeiture actions under the PACT Act; the Federal Food, Drug, and
Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco
Control Act; and other authorities. Violations of these statutes can
result in felony convictions and significant criminal fines and civil
monetary penalties. They can also result in seizures of unauthorized
products, which can help to make illegal e-cigarettes less accessible,
including to young people. Through their participation in the task
force, USMS will help FDA and DOJ effectuate seizures of unauthorized
e-cigarettes within the United States.
In order to clear shelves, it would require bringing thousands of
individual seizure actions across the country against the products on
the shelves today. We are working strategically to address the issue in
three ways. First, we are developing a strategy to focus our actions
across and up the supply chain at the importer, distributer, and
manufacturer levels to have impact. Second, DOJ is FDA's counsel on
these types of enforcement actions, and we work collaboratively to
bring the best cases forward. Third, the task force can bring to bear
the resources across the Federal Government to take a variety of
compliance and enforcement actions.
We will keep the Committee informed of this work and would be happy
to work with the Committee on legislative efforts to further address
this problem. Importantly, this is a whole supply chain issue and an
``All Government'' approach is needed. With more resources and
continued and collective engagement across agencies, FDA can increase
compliance and enforcement actions both at the border and elsewhere in
the supply chain.
unapproved drugs
Question. I was pleased to see the FDA approve the first product
specifically indicated in the United States for the treatment of
neonatal seizures in term and preterm infants. It is my understanding
that this product is the only approved product that does not contain
preservatives, such as benzyl alcohol, ethyl alcohol or propylene
glycol, all of which have been strictly prohibited by FDA guidance
since 2022 for products intended for neonates. Yet, there are reports
that numerous unapproved phenobarbital drugs containing these
prohibited excipients are currently marketed for use in neonates with
seizures, which presents a serious safety threat for vulnerable
infants.
Why has the FDA not utilized its enforcement authority to remove
unapproved phenobarbital drugs from the market, and does the Agency
plan to do so this year?
Answer. Sezaby (phenobarbital sodium), an FDA-approved
phenobarbital sodium injection product, is approved for the short-term
treatment of neonatal seizures in term and pre-term infants.
However, there are a number of unapproved phenobarbital sodium
injection products currently on the market which, according to the
unapproved labeling, are for the adult population as a sedative,
hypnotic, preanesthetic, or long-term anticonvulsant and for use in
pediatric patients as an anticonvulsant and sedative.
In general, as with FDA's compliance activities across the Agency,
we follow a risk-based enforcement approach that involves
prioritization in light of the facts of a given circumstance. This
includes prioritizing enforcement for drug products that pose the
highest risk to public health. This risk-based enforcement approach
best supports FDA's public health priorities. The Agency is currently
reviewing a Citizen Petition regarding the specific marketing status of
phenobarbital drugs and will respond to the Petition as soon as
possible and post the response to the public petition docket.
Question. The FDA Commissioner commented on the Agency's unapproved
drug guidance at a July 2017 hearing before the House Judiciary
subcommittee on Regulatory Reform, Commercial and Antitrust Law. The
then-Commissioner explained that ``if you want these unapproved drugs
to come through a regulatory process and develop the data to
demonstrate safety and effectiveness and go through the manufacturing
requirements, you have to provide an incentive"- the incentive being
that ``if [manufacturers] go through that process and spend the money
to do it, they're going to get a short period of exclusivity, and the
FDA is going to make an attempt to clear the market of potential
competitors.'' Why is the FDA not following through on its guidance to
industry by granting a period of exclusivity to companies that invest
in the regulatory process to prove safety and efficacy?
Answer. New drugs that lack required FDA approval can pose
significant risks to patients because they have not been evaluated by
FDA for safety, effectiveness, or quality before they are marketed. FDA
works diligently to protect patients by both encouraging FDA approval
for unapproved new drugs, and removing illegally marketed unapproved
new drugs from the U.S. market.
First, the Agency encourages manufacturers of unapproved new drugs
that are subject to approval to voluntarily come into compliance by
obtaining approval for their drugs to be legally marketed in the U.S.
Upon approval, certain drugs may qualify for exclusivity, such as 3-
year or 5-year exclusivities under section 505 of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) and 7-year orphan drug exclusivity
under the Orphan Drug Act if they meet eligibility requirements.
Determinations regarding periods of exclusivity are made upon approval
and necessitate a review of the data and information submitted to FDA
in the New Drug Application.
Second, FDA may take regulatory action against firms that illegally
market unapproved new drugs. FDA plans to issue guidance consistent
with FDA's good guidance practices regarding its enforcement priorities
for marketed unapproved new drugs. In general, as with FDA's compliance
activities across the Agency, we follow a risk-based enforcement
approach that involves prioritization in light of the facts of a given
circumstance. This includes prioritizing enforcement for drug products
that pose the highest risk to public health. This risk-based
enforcement approach best supports FDA's public health priorities.
cell and gene therapies
Question. Dr. Califf, I am concerned about the growing backlog and
seeming delays for cell and gene therapies, including disproportionate
and increasing clinical holds issued by the FDA for therapies under
development. I am glad FDA has approved nine additional cell and gene
therapies over the last year, including two sickle cell treatments and
the first cancer cell therapy. However, these faced multiple clinical
holds while under development and continue to see large numbers of
holds on other breakthrough treatments, including for other forms of
cancer and curative treatment for type 1 diabetes. I am concerned this
leads to delayed access to life- changing therapies for serious
conditions. Please provide more information about efforts at HHS to
accelerate the advancement and access of cell and gene therapies.
Answer. Clinical holds for Investigational New Drug applications
(INDs) investigating cell and gene therapy (C>) products have
markedly decreased in the past few years. Clinical holds for new INDs
investigating C> products declined from 24% in 2021 to 9% in 2024 to
date. Clinical holds for all active INDs investigating C> products
declined from 6% in 2021 to 1% in 2024.
The decline results from various 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. C> products
are complex and often novel biologics manufactured with new
technologies which can present regulatory challenges.
FDA works with all sponsors to resolve issues and help speed
development of new products, while maintaining high, scientifically
based safety and efficacy standards. FDA remains committed to advancing
the development of safe and effective C> products that have the
potential to treat serious or life-threatening conditions, including
various rare diseases, forms of cancer, and type 1 Diabetes.
sunscreen
Question. No new sunscreen active ingredients have been approved in
the United States since the 1990s. Since then, the rest of the world
has moved one or two generations of sunscreen ahead of the United
States. In 2014, Congress unanimously passed the Sunscreen Innovation
Act (SIA) to address administrative burdens identified by FDA as
barriers to timely evaluation. Officials suggested that new sunscreens
would be made available in the United States within 6 months of SIA's
enactment--nearly a decade ago.
The SIA resulted in the establishment of timelines for
consideration of both TEA and new sunscreen active ingredients,
authorized the issuance of guidance for the criteria for a generally
recognized as safe and effective (``GRASE'') determination for
nonprescription sunscreen products, and required the agency to finalize
the sunscreen monograph within 5 years of enactment, or November 26,
2019. At the time, FDA indicated SIA would streamline the agency's
review process without weakening safety requirements. Despite the SIA,
FDA approved no new sunscreen active ingredients.
Moreover, in anticipation of the November 2019 deadline, the FDA
published a proposed order that would, if finalized, lead to the market
withdrawal of two sunscreen active ingredients and removal of an
additional 12 sunscreen active ingredients, which would leave only two
UV filters as generally recognized as safe and effective, unless
sunscreen manufacturers conducted additional scientific studies. The
proposed order not only failed to achieve Congress' intended goal of
approving new sunscreen active ingredients-it could result in the
United States having only two sunscreen active ingredients available to
consumers while the rest of the world continues to invest in new, broad
spectrum sunscreen innovation. Skin cancer is the most prevalent cancer
in the United States, and it is also the most preventable. Use of broad
spectrum sunscreen is a proven and effective prevention tool against
skin cancer. What is the FDA doing to ensure that Americans have access
to the latest sunscreen technology?
Answer. FDA is strongly committed to supporting the availability of
new sunscreen active ingredients to the U.S. market. To that end, we
have directed industry to helpful guidance documents FDA has published
on the safety and effectiveness data needed to determine whether a
nonprescription sunscreen active ingredient is generally recognized as
safe and effective (GRASE)\40\ and on conducting Maximal Usage Trials
(MUsT)\41\ needed to assess how much of a sunscreen ingredient is
absorbed through the skin into the body. In addition, FDA conducted and
published two pilot trials,\42 43\ evaluating the absorption of various
sunscreen ingredients. Regarding the TEA active ingredients in
particular, when the Agency reviewed eight applications to market new
sunscreen ingredients several years ago, reviewers found that the
applications lacked the necessary data to support finding the
ingredients GRASE. Nine years ago, FDA described this informational gap
and the data that would enable the Agency to complete its review to the
public. To bring new active ingredients to market, manufacturers need
to show they are safe and effective for their intended use in sunscreen
products. If and when FDA receives the data needed to determine whether
an active ingredient that may not be currently marketed as an active
ingredient in sunscreen products in the U.S., whether or not it was
previously the subject of a TEA proposed order, the Agency will review
the data and make a determination in accordance with section 505G of
the FDCA. Until then, there is no new data that has been provided to
the Agency for it to review and to determine whether a new active
ingredient intended for use in a sunscreen product is GRASE.
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\40\ https://www.fda.gov/media/94513/download
\41\ https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/maximal-usage-trials-topically- applied-active-
ingredients-being-considered-inclusion-over-counter
\42\ https://jamanetwork.com/journals/jama/fullarticle/2733085
\43\ https://jamanetwork.com/journals/jama/fullarticle/2759002
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FDA also notes that while having additional sunscreen choices may
be desirable to consumers, new sunscreen active ingredients are not
necessarily safer or more effective than the ones already available in
the U.S. by virtue of being available in markets other than the U.S.
Many currently marketed and widely available sunscreen products provide
broad-spectrum protection with an SPF of 15 or more and are effective
not only in helping to prevent sunburn, but also in in reducing the
risk of skin cancer and early skin aging caused by the sun, when used
as directed in their labeling.
Question. The United States is falling behind the rest of the world
in terms of access to sunscreen active ingredients. For instance, the
United States has only 16 sunscreen active ingredients available--
potentially less upon the finalization of the sunscreen final
administrative order. In contrast, the European Union has 34 approved
sunscreen active ingredients. How can FDA's regulatory framework be
streamlined for ingredients currently on the market globally?
Answer. As noted above, important work has been done to streamline
bringing new sunscreen ingredients to market--including through the
CARES Act and other efforts. However, without data to review, FDA is
unable to make use of the new, more streamlined processes set forth by
the CARES Act. In order to accelerate its review of sunscreen
ingredients, FDA needs data demonstrating that these ingredients are
generally recognized as safe and effective for their intended use in
sunscreen products. The requested data is consistent with the data
routinely requested for drug products that are absorbed through the
skin and into the body, and the need for this data was strongly
supported by an independent expert advisory committee. That expert
committee noted that the requested data was the minimum that would be
needed to establish the safety of new sunscreen ingredients. FDA is
committed to initiating our review of this data as soon as we receive
it.
Question. The FDA's final administrative order could significantly
hinder Americans' access to the vast majority of sunscreens on the
market today. How is FDA engaging with experts and public health groups
to ensure it is utilizing appropriate sunscreen ingredient testing
requirements?
Answer. When considering appropriate testing for sunscreen
products, FDA has updated the advice to sunscreen manufacturers to
follow the most recent international standards for determining the
safety of drug products, including sunscreens. For example, FDA worked
with the International Conference on Harmonization (ICH) to update the
guidance on carcinogenicity testing in 2022 to improve safety
assessments and reduce animal testing, where it makes sense, without
sacrificing the safety of consumers using these products.
Wherever possible, FDA has also taken steps to offer industry
tailored study recommendations that account for sunscreens' specific
pharmacological properties and potentially reduce testing burdens. FDA
is committed to working with industry and public health stakeholders to
ensure that the sunscreens are safe and effective for daily, life-long
use.
Question. The FDA's public statements, after the proposed
rulemaking issuance, suggested that existing sunscreens might not be
safe. Although FDA subsequently modified its statements, this led to
public confusion about the safety and efficacy of sunscreen. As it
prepared to issue the final administrative order, is the FDA being
careful to ensure its rhetoric does not lead to inaccurate conclusions
that currently marketed sunscreens are unsafe?
Answer. FDA continues to regularly emphasize the importance of
sunscreen use in its public messaging. The Agency conducts several
educational efforts to promote sunscreen use, raise awareness about the
importance of sun protection, and ensure consumers have accurate
information.
Additionally, FDA produces a variety of educational materials,
including online news, videos, and social media content, concerning
sunscreen use and the importance of reapplication. Our educational and
outreach efforts are designed to enhance public understanding of the
risk associated with sun exposure and the role of sunscreen in reducing
these risks, consistent with our mission to protect public health.
grain reconditioning
Question. The FDA's reconditioning process for Distinct Low Quality
grain is a critical part of the official grain inspection process for
the export of U.S. bulk commodities. One area of concern I am hearing
about is the timing of approval for reconditioning grain, particularly
as the reconditioning process takes additional time to complete if an
incident occurs at night or on the weekends and results in delays and
increased costs for grain export facilities. Is the FDA reviewing the
reconditioning process to identify ways to minimize delays in the
process? If so, please describe in detail and when a new process will
be implemented.
Answer. FDA is aware of the concerns from industry regarding
reconditioning proposals and is taking steps to address them. There is
an existing Memorandum of Understanding (MOU 225-80- 2000)\44\ between
USDA's Federal Grain Inspection Service (FGIS) and FDA to facilitate
interagency coordination on the inspection and standardization of
grain, rice, pulses, and other food products assigned to FGIS by the
Secretary of Agriculture. There is a crosscutting FDA work group
consisting of members from the Center for Food Safety and Applied
Nutrition, Center for Veterinary Medicine, and Office of Regulatory
Affairs working with FGIS to revise the FGIS DirectiveA\45\ on
implementation of the MOU, to help expedite and enhance interagency
coordination of the processes currently in place. An FDA Standard
Operating Procedure (SOP) is also in development to detail procedures
and processes for grain reconditioning, which will help streamline and
standardize the process when FGIS notifies FDA of actionable lots. FDA
and FGIS are continuing to work through the specifics and are targeting
updates to the directive and SOP in FY 2025.
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\44\ https://www.fda.gov/about-fda/domestic-mous/mou-225-80-2000
\45\ https://www.ams.usda.gov/sites/default/files/media/
FGIS9060_2.pdf
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SUBCOMMITTEE RECESS
Senator Heinrich. And with that, this hearing is adjourned.
[Whereupon, at 11:22 a.m., Wednesday, May 8, the
subcommittee was recessed, to reconvene subject to the call of
the Chair.]
LIST OF WITNESSES, COMMUNICATIONS, AND PREPARED STATEMENTS
----------
Page
Califf, Hon. Dr. Robert, M.D., Commissioner, Food and Drug
Administration:
Prepared Statement of Dr. Robert M. Califf, M.D..............
34.........................................................
Statement of.................................................
31.........................................................
Summary Statement of Dr. Robert Califf.......................
33.........................................................
Collins, Senator Susan M., U.S. Senator From Maine, Questions
Submitted by...................................................
80.............................................................
Heinrich, Senator Martin, U.S. Senator From Mexico:
Opening Statement of
Questions Submitted by.......................................
57.........................................................
Hoeven, Senator John, U.S. Senator From North Dakota:
Questions Submitted by.......................................
69.........................................................
Statement of
Hyde-Smith, Senator Cindy, U.S. Senator From Mississippi,
Questions Submitted by.........................................
84.............................................................
Manchin, Senator Joe, U.S. Senator From West Virginia, Questions
Submitted by...................................................
64.............................................................
McConnell, Senator Mitch, U.S. Senator From Kentucky, Questions
Submitted by...................................................
79.............................................................
Merkley, Senator Jeff, U.S. Senator From Oregon, Questions
Submitted by...................................................
62.............................................................
Moran, Senator Jerry, U.S. Senator From Kansas, Questions
Submitted by...................................................
81.............................................................
Nelson, Mr. Chris, Associate Budget Director, Accompanied By.....
1..............................................................
Sinema, Senator Kyrsten, U.S. Senator From Arizona, Questions
Submitted by...................................................
66.............................................................
Vilsack, Hon. Thomas J., Secretary, Department of Agriculture:
Prepared Statement of........................................
6..........................................................
Statement of.................................................
1..........................................................
Summary Statement of.........................................
4..........................................................
SUBJECT INDEX
----------
DEPARTMENT OF AGRICULTURE
Page
Additional Committee Questions...................................
29.............................................................
Agricultural Trade...............................................
16.............................................................
Apple Over Supply................................................
24.............................................................
Bison Production.................................................
13.............................................................
Broadband Access.................................................
20.............................................................
CCC Utilization..................................................
27.............................................................
Creating More, New, and Better Markets...........................
9..............................................................
Crop Insurance...................................................
15.............................................................
Emergency Forest Restoration Program.............................
21.............................................................
H5N1.............................................................
18.............................................................
Loss of Farmland.................................................
15.............................................................
Meat Animal Research Center......................................
19.............................................................
NASS Reports.....................................................
23.............................................................
National AGRO-Bioscience Research Facility.......................
17.............................................................
NRCS Contractor Fleet Insurance..................................
24.............................................................
Ready to Use Therapuic Food......................................
13.............................................................
Rebuilding:
Rural America................................................
7..........................................................
USDA through Diversity, Equity, and Inclusion................
12.........................................................
Rental Assistance................................................
14.............................................................
Research and Innovation..........................................
11.............................................................
Rural Development Staffing Challenges............................
25.............................................................
Supporting Nutrition for the Nation..............................
9..............................................................
Tackling the Climate Crisis......................................
11.............................................................
Telework and Remote Work.........................................
26.............................................................
Tribal Self Determination........................................
26.............................................................
Western Drought Resilence........................................
14.............................................................
WIC Program......................................................
22.............................................................
Veterinary Medicine Loan Forgiveness Program.....................
22.............................................................
__________
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
Additional Subcommittee Questions................................
57.............................................................
Advisory Committees..............................................
64.............................................................
Animal Food Additives............................................
82.............................................................
Artificial Intelligence..........................................
62.............................................................
Biopharmaceutical Production.....................................
72.............................................................
Biosimilars......................................................
73.............................................................
CDER.............................................................
80.............................................................
CDRH.............................................................
80.............................................................
CBER.............................................................
80.............................................................
Cell and Gene Therapies..........................................
88.............................................................
Cessation Products...............................................
57.............................................................
Cosmetics........................................................
35.............................................................
Counterfeit Products.............................................
72.............................................................
Dora Class Drugs.................................................
61.............................................................
Draft Report and Plan on Best Practices for Guidance.............
78.............................................................
Drug:
Clinical Trials..............................................
66.........................................................
Supply Chains................................................
65.........................................................
EERW Clinical Trials.............................................
64.............................................................
Enterprise Transformation........................................
36.............................................................
Ethylene Oxide...................................................
66.............................................................
Facility Inspections.............................................
71.............................................................
FDA Staffing and Telework Issues.................................
70.............................................................
First Cycle Drug Approvals.......................................
67.............................................................
Food:
Regulation...................................................
76.........................................................
Traceability Rule
Foreign:
Manufacturer Tobacco Registration
Office Expansion.............................................
36.........................................................
Grain Reconditioning
Human Foods Program
IT Stabilization and Modernization...............................
36.............................................................
Laboratory Developed Tests.......................................
69.............................................................
Medical Products.................................................
35.............................................................
Modernizing Infrastructure, Buildings & Facilities...............
37.............................................................
Neurology Drug Program...........................................
80.............................................................
PDUFA Performance Goals..........................................
73.............................................................
Proposed Uses of Additional NDP Dollars..........................
81.............................................................
Real-World Data..................................................
68.............................................................
Shortages and Supply Chain.......................................
36.............................................................
Smoking Cessation................................................
76.............................................................
Sodium...........................................................
83.............................................................
Strengthening Biodefense.........................................
37.............................................................
Sunscreen
Tobacco 21.......................................................
79.............................................................
Products
Expos....................................................
60.....................................................
Regulation...................................................
37.........................................................
Unapproved Drugs
-