[House Hearing, 118 Congress]
[From the U.S. Government Publishing Office]
OVERSIGHT OF THE
U.S. FOOD AND DRUG ADMINISTRATION
=======================================================================
HEARING
BEFORE THE
COMMITTEE ON
OVERSIGHT AND ACCOUNTABILITY
U.S. HOUSE OF REPRESENTATIVES
ONE HUNDRED EIGHTEENTH CONGRESS
SECOND SESSION
__________
APRIL 11, 2024
__________
Serial No. 118-99
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Printed for the use of the Committee on Oversight and Accountability
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Available on: govinfo.gov,
oversight.house.gov or
docs.house.gov
__________
U.S. GOVERNMENT PUBLISHING OFFICE
55-452 PDF WASHINGTON : 2024
COMMITTEE ON OVERSIGHT AND ACCOUNTABILITY
JAMES COMER, Kentucky, Chairman
Jim Jordan, Ohio Jamie Raskin, Maryland, Ranking
Mike Turner, Ohio Minority Member
Paul Gosar, Arizona Eleanor Holmes Norton, District of
Virginia Foxx, North Carolina Columbia
Glenn Grothman, Wisconsin Stephen F. Lynch, Massachusetts
Michael Cloud, Texas Gerald E. Connolly, Virginia
Gary Palmer, Alabama Raja Krishnamoorthi, Illinois
Clay Higgins, Louisiana Ro Khanna, California
Pete Sessions, Texas Kweisi Mfume, Maryland
Andy Biggs, Arizona Alexandria Ocasio-Cortez, New York
Nancy Mace, South Carolina Katie Porter, California
Jake LaTurner, Kansas Cori Bush, Missouri
Pat Fallon, Texas Shontel Brown, Ohio
Byron Donalds, Florida Melanie Stansbury, New Mexico
Scott Perry, Pennsylvania Robert Garcia, California
William Timmons, South Carolina Maxwell Frost, Florida
Tim Burchett, Tennessee Summer Lee, Pennsylvania
Marjorie Taylor Greene, Georgia Greg Casar, Texas
Lisa McClain, Michigan Jasmine Crockett, Texas
Lauren Boebert, Colorado Dan Goldman, New York
Russell Fry, South Carolina Jared Moskowitz, Florida
Anna Paulina Luna, Florida Rashida Tlaib, Michigan
Nick Langworthy, New York Ayanna Pressley, Massachusetts
Eric Burlison, Missouri
Mike Waltz, Florida
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Mark Marin, Staff Director
Jessica Donlon, Deputy Staff Director and General Counsel
Dan Ashworth, Deputy Chief Counsel for Oversight
Reagan Dye, Professional Staff Member
David Ehmen, Counsel
Ryan Giachetti, Counsel
Sarah Feeney, Professional Staff Member
Mallory Cogar, Deputy Director of Operations and Chief Clerk
Contact Number: 202-225-5074
Julie Tagen, Minority Staff Director
Contact Number: 202-225-5051
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C O N T E N T S
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Page
Hearing held on April 11, 2024................................... 1
WITNESSES
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Dr. Robert M. Califf, M.D., MACC, Commissioner of Food and Drugs,
U.S. Food and Drug Administration
Oral Statement............................................... 5
Opening statements and the prepared statements for the witness
are available in the U.S. House of Representatives Repository
at: docs.house.gov.
INDEX OF DOCUMENTS
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* Letter, April 10, 2024, from Judge Rotenberg Center;
submitted by Chairman Comer.
* Letter, April 9, 2024, from Taxpayers Protection Alliance;
submitted by Chairman Comer.
* Statement for the Record; submitted by Rep. Connolly.
* Editorial, The Reality of Radiation, by Reps. Donalds and
Brandon Williams (NY-22); submitted by Rep. Donalds.
* Article, Wall Street Journal, ``Truth About Puberty
Blockers''; submitted by Rep. Gosar.
* Article, ScienceDaily, ``Vitamin D Determines Severity in
COVID-19''; submitted by Rep. Gosar.
* Statement for the Record, from Doctors of America; submitted
by Rep. Norton.
* Article, Northwestern Now, ``Vitamin D Appears to Play Role
in COVID-19 Mortality''; submitted by Rep. Grothman.
* Article, UChicago News, ``Vitamin D Deficiency May Raise Risk
of COVID-19''; submitted by Rep. Grothman.
* Email, February 17, 2022, from FDA to the White House;
submitted by Rep. McClain.
* Email, February 20, 2022, from FDA to the White House;
submitted by Rep. McClain.
* Email, February 19, 2022, to FDA; submitted by Rep. McClain.
* Email, February 4, 2022, to FDA; submitted by Rep. McClain.
* Article, Politico, ``The FDA's Food Failure''; submitted by
Rep. Tlaib.
CONTINUED INDEX OF DOCUMENTS
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* Questions for the Record: to Dr. Califf; submitted by
Chairman Comer.
* Questions for the Record: to Dr. Califf; submitted by Rep.
Gosar.
* Questions for the Record: to Dr. Califf; submitted by Rep.
Foxx.
* Questions for the Record: to Dr. Califf; submitted by Rep.
Grothman.
* Questions for the Record: to Dr. Califf; submitted by Rep.
Cloud.
* Questions for the Record: to Dr. Califf; submitted by Rep.
Higgins.
* Questions for the Record: to Dr. Califf; submitted by Rep.
Sessions.
* Questions for the Record: to Dr. Califf; submitted by Rep.
Donalds.
* Questions for the Record: to Dr. Califf; submitted by Rep.
Burchett.
* Questions for the Record: to Dr. Califf; submitted by Rep.
McClain.
* Questions for the Record: to Dr. Califf; submitted by Rep.
Langworthy.
* Questions for the Record: to Dr. Califf; submitted by Rep.
Waltz.
* Questions for the Record: to Dr. Califf; submitted by Rep.
Crockett.
* Questions for the Record: to Dr. Califf; submitted by Rep.
Pressley.
The documents listed are available at: docs.house.gov.
OVERSIGHT OF THE
U.S. FOOD AND DRUG ADMINISTRATION
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Thursday, April 11, 2024
U.S. House of Representatives
Committee on Oversight and Accountability
Washington, D.C.
The Committee met, pursuant to notice, at 1:07 p.m., in
room 2154, Rayburn House Office Building, Hon. James Comer
(Chairman of the Committee) presiding.
Present: Representatives Comer, Gosar, Foxx, Grothman,
Cloud, Palmer, Higgins, Sessions, Biggs, Mace, LaTurner,
Fallon, Donalds, Perry, Timmons, Burchett, McClain, Fry, Luna,
Langworthy, Burlison, Waltz, Raskin, Norton, Lynch, Connolly,
Krishnamoorthi, Khanna, Mfume, Porter, Bush, Brown, Stansbury,
Garcia, Frost, Lee, Crockett, Moskowitz, Tlaib, and Pressley.
Chairman Comer. The Committee on Oversight and
Accountability will come to order. I want to welcome everyone
here today.
Without objection, the Chair may declare a recess at any
time.
Alright. I will recognize myself now for an opening
statement.
Again, welcome to the Committee on Oversight. We want to
thank Commissioner Califf for his participation in today's
oversight hearing of the U.S. Food and Drug Administration.
There might not be a Federal agency that is more integral to
Americans' day-to-day lives than the FDA. FDA is charged with
regulatory oversight of the food and drug industries,
industries that ensure Americans have food on the table by
innovating safer and more stable crops, industries that provide
Americans new medications to treat diseases, industries that
create cutting-edge medical devices that can keep your heart
pumping or replace a knee. These industries are vital to keep
Americans safe, healthy, and happy. These industries provide
millions of jobs and nearly $3 trillion in economic value.
Unfortunately, the FDA under President Biden is suffering
from dysfunction and is failing to do bare minimum to carry out
its core mission, which is to make certain our Nation's food
and drug products are safe and effective. Further, the FDA
appears consistently unprepared for certain crises. That is why
our Committee has conducted several investigations into areas
of concern at the FDA. These investigations have identified a
pattern of issues within the FDA.
At the beginning of Congress, Subcommittee Chairwoman
McClain launched an investigation into the infant formula
crisis. Her Subcommittee revealed how the FDA attempted to hide
behind the COVID-19 pandemic as an excuse for neglecting
facility inspections and justifying poor performance. The FDA's
telework policies and lax approach to oversight left it
unprepared to address the shortages when Abbott's facility in
Sturgis, Michigan was shut down. Additionally, the Biden White
House and the FDA took 3 months to act to increase production
of infant formula. The result of these failures? Barren
shelves, leaving millions of young families unable to access
the formula needed to feed their babies.
We have also investigated the FDA's failure to prepare for
and adequately respond to drug shortages for essential
medications used to treat infection, heart disease, and cancer,
just to name a few examples. FDA and Democratic policies, such
as the Inflation Reduction Act, have dramatically diminished
the profitability of manufacturing generic medications. This
has resulted in fewer manufacturers and a greater risk of
shortage. The FDA must improve coordination with manufacturers
and Federal agencies, including DEA, DOJ, and DOD, to increase
production. The FDA has failed to incentivize domestic
manufacturing of pharmaceuticals, resulting in significant
offshoring of these facilities. We conducted oversight of the
FDA's failure to return to pre-pandemic levels of inspections
of those manufacturing facilities for prescription drugs
abroad. Inspections of foreign manufacturing facilities were 79
percent lower in 2022 than 2019. Last year alone, this failure
resulted in two separate recalls of eye drops manufactured in
India that caused an outbreak of dangerous drug-resistant
bacteria, killing four people.
Through our investigation of tobacco products regulations,
we learned the FDA is failing to consistently and effectively
regulate tobacco products. According to the Reagan-Udall
Foundation, the FDA has been reactive and overwhelmed in its
tobacco products regulation. The FDA has delayed review of
applications for products that can reduce harm for many
Americans. Further, the FDA's failure to regulate has allowed
unsafe and illicit products to proliferate. In fact, the United
States Court of Appeals for the Fifth Circuit slammed the FDA
for sending manufacturers of flavored e-cigarette products on a
wild goose chase. Meanwhile, the FDA is also failing to prevent
illicit-flavored tobacco products from China entering the
country and harming Americans. The FDA is not implementing
enforcement actions to address illicit-flavored tobacco
products in stores across the country.
Additionally, the Committee examined the FDA's refusal to
regulate hemp-derived products, such as CBD. Instead of using
its existing authority, the FDA is requesting new authorities
and money that it does not need. This is the FDA putting its
own bureaucratic priorities over the American people who can
benefit from these products. The FDA's refusal to regulate hemp
products is creating a significant confusion in the market and
resulting in products with intoxicants that can be dangerous to
Americans who use these products. It has also halted businesses
trying, in good faith, to enter the market while bad actors
continue to thrive. Finally, we found that the FDA ignored
decades of research regarding the ineffectiveness of an over-
the-counter decongestant causing Americans to waste their hard-
earned money on a medication that is simply ineffective.
These examples are just scratching the surface of the
dysfunction and failures that are ongoing within the FDA.
Today, I am hopeful we can take a deep dive to better
understand how the FDA is responding and taking action to
ensure a safe food and drug supply. I now yield to Ranking
Member Raskin for his opening statement.
Mr. Raskin. Thank you very much, Mr. Chairman, and thank
you to Commissioner, Dr. Califf, for being with us here today.
The FDA regulates everything from bottled water to infant
formula, meat, poultry, and egg products, prescription and non-
prescription drugs, vaccines, medical devices, microwaves,
personal care products, and tobacco. During the Biden-Harris
administration, the FDA has made critical progress to ensure
that we have access to safer food and to effective drugs.
For example, last fall, FDA acted quickly to investigate
reports of lead appearing in children's cinnamon applesauce
packets for their school lunch. The cinnamon was adulterated
with lead, which was added by the manufacturer in order to
increase the weight of the product to make it more profitable
in the process. However, the applesauce contamination issue
could have been completely prevented if end-product inspections
for food were required. The FDA asked Congress to amend the
Food, Drug, and Cosmetic Act as part of the Fiscal Year 2024
budget request to require that industry conduct testing of
final products exactly for such contaminants and provide FDA
immediate access to those results. This would greatly help to
ensure the safety of all of our food products for kids and for
everyone else, but the FDA needs these additional authorities
to make that happen. And, Mr. Chairman, I was very pleased to
hear your opening comments, and I hope you would join me in
supporting giving the FDA additional regulatory authority,
precisely to address the kinds of problems that both you and I
have identified. The FDA itself has proposed multiple solutions
that would address the problems we are talking about today. The
Democrats support greater and more refined regulatory authority
to make our food and drugs safer and we hope our colleagues
will join us.
In the wake of infant formula and prescription drug
shortages, FDA also advanced legislative proposals earlier this
year to strengthen notification requirements and data sharing.
Right now, they do not have any authority to tell drug
manufacturers to produce more drugs. One proposal they have
offered would require manufacturers to notify the FDA--dealing
with this first problem of the applesauce--would require
manufacturers to notify FDA about pathogens that are discovered
in certain critical foods. In the case of infant formula, this
authority would help FDA prevent contaminated infant formula
from reaching any more consumers and babies. A second proposal
they have suggested would expand FDA's authority to gather data
from industry about potential drug shortages and supply chain
disruptions.
FDA has improved access to contraception and protections
for medication abortion access. In 2021, FDA advanced the
accessibility of medication abortion by removing the in-person
dispensing requirement for mifepristone and allowing it to be
distributed by mail through retail pharmacies. In July 2023,
FDA approved the first over-the-counter birth control pill,
Opill. As a result, consumers' access to contraception has
improved at a critical time when many states are enacting
increasingly draconian and oppressive abortion restrictions.
FDA has also made advancements to combat a range of life-
threatening diseases. In March of last year, FDA approved the
first OTC opioid overdose reversal medication, naloxone nasal
spray, a critical step toward reducing opioid overdose deaths
in our districts. FDA also recently approved new genome editing
technologies to treat sickle cell anemia, a disease that has
ravaged a lot of communities, primarily African-Americans. This
advancement is a crucial step toward treating sickle cell
anemia and represents a breakthrough in gene therapy. FDA also
secured additional supply chains in the wake of cancer drug
shortages.
It is crucial that FDA continue to carry out its mission
and create meaningful regulations based on sound science and
not conspiracy theories or ideological programs. Public attacks
on FDA without any corresponding legislative solutions simply
undermine its ability to effectively protect public health.
Anti-abortion activists brought a case against FDA over its
updated guidance on mifepristone, the first of a two-pill
medication abortion. The activists claim that FDA did not
properly collect data on drug risks and complications. However,
this claim is contrary to the FDA's review of ``extensive
research showing that mifepristone is safe, including to take
it home.'' FDA followed its standard procedure in reaching that
conclusion, and according to FDA, it must act reasonably based
on the information available rather than act based on perfect
data which seldom exists. If the objective of anti-abortion
activists is to undermine FDA's authority, the consequences
will be devastating to public health. An FDA that bases its
decisions on political science rather than actual science is
not in the best interest of consumers.
Congress must ensure that FDA is empowered to rely on the
facts rather than bend to the will of people pushing an
ideological agenda. Thank you, Mr. Chairman, and I yield back.
Chairman Comer. The gentleman yields back. Now pursuant to
Committee Rule 9(g), the witness will please stand and raise
his right hand.
Do you solemnly swear or affirm that the testimony you are
about to give is the truth, the whole truth, and nothing but
the truth, so help you God?
Dr. Califf. I do.
Chairman Comer. Let the record show the witness answered in
the affirmative.
We appreciate you being here today and look forward to your
testimony. Now, let me remind the witness, who I am pretty sure
you are an old pro at this by now, we have read your written
statement, and it will appear in full in the hearing record.
Please limit your oral statements to 5 minutes. As a reminder,
press the button on the microphone in front of you, so that it
is on and that members can hear you. When you begin to speak,
the light in front of you will turn green. After 4 minutes, the
light will turn yellow. When the red light comes on, your 5
minutes has expired, and we would ask that you please wrap up.
I now recognize Commissioner Califf to please begin his
opening statement. Dr. Califf?
STATEMENT OF DR. ROBERT CALIFF, M.D., MACC
COMMISSIONER OF FOOD AND DRUGS
U.S. FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Dr. Califf. Thank you, Chair Comer, Ranking Member Raskin,
and members of the Committee. Thanks for the opportunity to
testify about the Food and Drug Administration's work to
protect and promote public health.
In the United States, the safety of medical, food, and
cosmetic products depends on the actions of both industry and
the FDA. Industry bears the responsibility of creating a supply
of medical, food, and cosmetic products that are safe and
protect and promote public health. FDA guides an overseas
industry to help ensure that Americans can have a confidence
about the medical, food, and cosmetic products they are using
and that they are duly warned about the risks of tobacco
products. From that lens, I would like to focus on the Agency's
work in four main areas today: first, addressing
vulnerabilities in the supply chain; second, reversing the
decline in our national life expectancy; third, accelerating
effective treatment for thousands of rare genetic diseases; and
fourth, undertaking the most significant reorganization in FDA
history with a focus on human foods and improving oversight of
all of our regulated industries.
As we saw during the pandemic and continue to see, we have
a significant global supply chain vulnerability, including lack
of redundancy and resiliency and over-reliance on foreign
sources for critical products, particularly medicines and
devices. Preventing and mitigating supply chain issues in the
industries we regulate have been a primary focus. In 2023
alone, we worked with manufacturers to prevent over 230
threatened drug shortages. During the infant formula shortage,
FDA's use of temporary enforcement discretion enabled safe
products to enter the U.S. market, which increased supply and
doubled the number of firms producing infant formula for the
U.S. from 2021 to 2022.
FDA's continued oversight will be critical until supply
chains are more resilient, particularly for infant formula. We
will continue to promote competition in manufacturing quality
and implement modernized systems to respond to shortages
faster. It is why we have requested additional authorities that
would provide more visibility into the supply chain.
The trends in life expectancy and chronic disease in the
U.S. are concerning. And while we are leading the world in the
creation of new drugs and devices, our major causes of death
and disability are driven by fundamentals: tobacco use, poor
nutrition, and lack of adherence to inexpensive generic
medications. Given the burden of tobacco-related diseases, it
is encouraging that over the past year, we have seen a
reduction in cigarette smoking in the U.S. and a significant
decrease in overall tobacco product use among high school
students, primarily driven by a decline in e-cigarette use.
Despite these important wins, driven by a combination of
education and enforcement actions, our work is not finished. We
remain committed to reducing the health burden of tobacco
product use in the U.S.
Food safety and improved nutrition are essential to combat
the epidemic of chronic disease and premature death. A
healthier food supply, coupled with improvements in key
nutrition information, will help consumers make informed health
choices. This includes proposed actions to display simplified,
at-a-glance, front-of-package nutrition information, to
establish voluntary sodium targets, update the definition of
the term ``healthy'' in advertising, and to create a nutrition
center of excellence.
Thanks to Congress' investment in the Human Genome Project
decades ago, many of the approximately 10,000 rare diseases
which impact at least 30 million Americans can now be treated
with new gene editing and gene therapy technologies. We are
preparing to navigate a large number of these exciting
therapies that will require new clinical trial methods, deep
scientific reviewer expertise, and development of reliable
long-term follow up systems involving electronic health records
for real-world evidence.
Last, the Agency has made significant progress in its
proposed reorganization. The proposal aims to unify human foods
functions into the new Human Foods Program under the direction
of the deputy commissioner for human foods, and to solidify the
Office of Regulatory Affairs' role as a front line of FDA's
field-based operations. This will enhance our outbreak response
and fully realize the preventive vision of the FDA Food Safety
Modernization Act. These proposed changes will strengthen the
Agency, making it more efficient, nimble, and ready for the
future with the ever-changing and complex industry we regulate.
In conclusion, the essential work of the Agency continues
in thousands of work streams that Americans and the world count
on every day, thanks to the dedication and perseverance of FDA
staff. We look forward to continuing to work with Congress on
the Agency's mission and thank you for the opportunity to
testify.
Chairman Comer. Thank you very much, Commissioner. We will
now begin the questioning phase. The Chair recognizes
Representative Gosar from Arizona for 5 minutes.
Mr. Gosar. I thank the Chairman. Now obviously, the FDA
made a mistake in granting the Emergency Use Authorization and
license of COVID-19 vaccines. It has been confirmed that the
vaccines do not stop transmission. Moreover, 1,635,048 injuries
due to COVID-19 vaccines have been reported to the Health and
Human Services through the Vaccine Adverse Event Reporting
System, including 37,382 deaths. Considering that under 10,300
deaths have been reported due to all other vaccines combined,
the harm due to COVID-19 vaccines is absolutely staggering, and
not to mention that there is no accountability.
Legally, it is impossible to sue COVID-19 vaccine
manufacturers for the injuries caused by their products. Just
last month, the Federal court forced the FDA to retract tweets
and statements for its years-long smear campaign against
ivermectin as an effective treatment for COVID-19. Now, let us
enter Ozempic. J.P. Morgan predicts the market of Ozempic and
similar drugs will exceed $100 billion by 2030. Concerningly,
there is a plethora of Federal lawsuits, 18 in all so far,
alleging serious side effects from this class of drugs, also
known as glucagon-like peptide-1 receptor agonists, or GLP-1
RAs. Gastroparesis, or simply stomach paralysis, and several
severe indigestion, obstruction, and vomiting have been cited
in the lawsuits. One woman claimed to have lost teeth from
excessive and frequent vomiting. One law firm is investigating
the claims of additional 10,000 people potentially harmed by
this class of drugs. The plaintiffs predict 20,000 total people
will be suing manufacturers of the GLP-1 RAs in the future. The
European Medicine Agency is investigating Ozempic for suicidal
ideation, according to Forbes. Also, according to Forbes,
studies indicate that Ozempic and other GLP-1 RAs, like
Rybelsus and Wegovy, may cause gallbladder disease.
Furthermore, a recent study linked Ozempic to thyroid
cancer. Ozempic is basically a synthetic hormone that tells
your brain that it is full, therefore deactivating digestion,
as well as causing the pancreas to increase insulin levels in
order to lower blood sugar. Many Ozempic patients face
blockages and obstructions. That makes sense as the body is
being fooled into stopping that digestive pathway. Does
purposely paralyzing the stomach strike you as a healing type
of a remedy? It does not to me.
It seems that the goal of Big Pharma is to get people
hooked for life on their products, whether it be an annual flu
or COVID-19 vaccines, perpetual statins to lower cholesterol,
beta blockers for high blood pressure, expensive never-ending
cancer treatments, yet all this intervention does not seem to
yield much fruit. Chronic disease is skyrocketing. Fifty
percent of American adults have a chronic disease. Forty
percent have two or more. Are Ozempic and related drugs the
next big thing Big Pharma is going to push on millions of
people no matter what the harms are or lack of effectiveness?
As the head of the FDA, you should like to take this
opportunity to express your regret. As head of the FDA, would
you like to take an opportunity to express your regret in
failing to curtail the chronic disease epidemic in America?
Dr. Califf. I would like to respond. You raised so many
issues and I have got a minute and 20 seconds, so I will just
start with the vaccine, which I think may be the most important
one to talk about. So, here is the progression as I see it.
First of all, I am pretty simple. I am from South Carolina, and
I am a cardiologist. I am used to looking at life and death and
seeing what the differences are. The question with any medical
intervention, knowing that all interventions have risks and
benefits, and the question is always do the benefits outweigh
the risk. I will remind you, the initial vaccine trial that led
to the EUA did show a dramatic reduction in the rate of
infection in the two groups. The virus then mutated, but the
good news is now we have a progression of overwhelming evidence
in every country, including the United States.
Mr. Gosar. So, would you----
Dr. Califf. If you are up-to-date on your vaccine----
Mr. Gosar. I understand this, but----
Dr. Califf [continuing]. You are less likely to be dead.
You are less likely to be admitted to the intensive care unit.
If you live in a county with a higher vaccine rate, the
mortality rate is lower. If you live in a country with a higher
vaccine rate, the mortality rate is lower. So, when you compare
the two, yes, vaccines have side effects. The risk of being
dead is lower if you are vaccinated.
Mr. Gosar. OK. This is my last question because I am
running out of time. Do you not agree that the vaccine should
have put into the fund or face liability issues because the
people were used as guinea pigs? Do you believe in peer-
reviewed science because there is another part that did not get
really reviewed very well?
Dr. Califf. Well, I will remind you again, we always have
to do studies or clinical trials to figure out the risks and
the benefits. That is a normal part. In most of my career, I
personally participate in clinical trials when I have the
chance, so that we can have the data and the knowledge to make
wise decisions, for example, and get vaccinated, so we are less
likely to be dead.
Mr. Gosar. I get that, but why did you have to retract
everything you said about ivermectin? Because your office came
out against ivermectin. Now, I agree that there are some
problems in the manufacturing of that dosage, but if in doubt,
leave it out.
Dr. Califf. Well, we didn't retract everything we had to
say about ivermectin, and, in fact, you know, possibly we had
an attack against ivermectin. Drugs are not----
Mr. Gosar. I hope the courts are watching this right now
because they ordered you to.
Dr. Califf. If you look at the randomized trials of
ivermectin, and there are many of them now, there is no benefit
of ivermectin in the treatment of COVID. That is a statement,
just a fact, and any drug for which there is no benefit in
their risk, people have to make their own decisions about what
to do. What we are not doing is telling doctors what they have
to do. Doctors have the right to prescribe off label.
Chairman Comer. The gentleman's time has expired. The Chair
now recognizes the Ranking Member for 5 minutes.
Mr. Raskin. Mr. Chairman, thank you. I am going to follow
up on this because this exchange to me was extremely
illuminating because what we have here is the commissioner, who
is the head of the Food and Drug Administration, and then we
get a drive-by spray of propaganda, disinformation, and
ideological attacks. So, let me try to sort some of this out,
and maybe it will help to illuminate why we have a Food and
Drug Administration rather than leaving it to politicians in
state legislatures or in Congress to make decisions based on
ideological whim.
But let us start with ivermectin, which I believe is an
animal deworming agent that some people were advocating for use
to treat COVID-19. Has this been approved as a form of
treatment or a cure for COVID-19?
Dr. Califf. No, it has not. If I may, I should also point
out it also has benefit for humans with worms, which is a huge
problem in Asia. So, it actually won a Nobel Prize because it
is an amazing drug both for animals and humans who have worms.
And there was a good reason to think it may work in the case of
COVID, and that is why, thankfully, the community, including
the NIH, did a number of randomized clinical trials. There is
just no benefit, and you know that is true of most things that
we try. There is nothing wrong with thinking it might work. It
just didn't.
Mr. Raskin. Well, what about hydroxychloroquine, which was
another thing that was advocated?
Dr. Califf. Basically, the same story. There was really
exciting preliminary work in the laboratory that said
hydroxychloroquine may have activity against COVID, so the
randomized trials were done. Unfortunately, no benefit. Again,
nothing wrong with thinking it may work and trying it out in a
randomized trial, but then we have the data now, so that leads
you to the conclusion. So, we have not been able to grant
occasion for those.
Mr. Raskin. Yes. I mean, I am aware of a lot of political
attacks and criticism against the FDA, but I can never figure
out the coherence of it. Sometimes, they seem to be saying get
out of the way and just let anybody advocate whatever they want
and use whatever they want without any testing and without the
various protocols you go through. And then other times they
attack you because you do not have enough authority to do the
things that we would want you to do in order to make kids'
cinnamon applesauce clean, for example. So, let us take that
one, which has caught my eye since we certainly ate a lot of
cinnamon applesauce in our house when our kids were little.
Let us see. Your FDA-regulated products are manufactured or
handled at something like 275,000 or 280,000 different
registered facilities across the land. So, what keeps you from
inspecting every private manufacturing facility that produces
things like cinnamon applesauce or peanut butter?
Dr. Califf. Well, if I may, I will try this very quickly. I
think the best way to think about FDA, in general, is that we
are referees. You all in Congress actually write the rulebook,
much like in any sport. It is the leadership that writes the
rulebook. We enact what is in the rulebook. And in the case of
food establishments, like most sports, the first line of
defense are the players in the game, which is the industry that
produces the products, and by and large they do a great job,
but sometimes they do not. And as referees, we have to be
really wise about where we step in because we do not have an
unlimited budget.
So, what keeps us from inspecting all 275,000? You do not
have to be a brilliant mathematician to know how many people
you would have to have. But what we can do, for example, in
food for children is to have the manufacturers be required to
do the testing, which is the way the drug system works. The
manufacturers of drugs have to test every batch. And in the
case of cinnamon applesauce, if there had been mandatory
testing when it got imported into the U.S. from Ecuador, the
stores that were selling it probably would have picked it up at
that point.
Mr. Raskin. And those kids ended up with lead poisoning,
right?
Dr. Califf. Right. Lead poisoning is a very serious
problem, as you know, and it causes chronic issues.
Mr. Raskin. So, you advocated mandatory testing. You would
like us to give you that regulatory authority?
Dr. Califf. Yes.
Mr. Raskin. And I do hope that is something that our
colleagues on the Republican side of the aisle would join us
in. In the case of infant formula shortages, last Congress, we
passed a bipartisan bill to help address those shortages, but
nearly 200 House Republicans voted against a second bill to
give FDA resources to strengthen its oversight and inspection
of facilities to prevent shortages like that from happening.
So, we cannot have it both ways. If we want an effective,
strong regulator, we have got to give them the authority and
the resources to get the job done. Thank you very much, Mr.
Chairman. I yield back.
Chairman Comer. The gentleman yields back. The Chair now
recognizes Mr. Grothman from Wisconsin for 5 minutes.
Mr. Grothman. Thank you much. I do not know if this is why
you came over here, but we are going to give you another
vitamin, another COVID-related topic. Throughout the COVID
epidemic, I spoke multiple times on the floor with regard to
the value of vitamin D. Now, the adequate level of vitamin D
varies depending upon how you talk to, you know, 20 nanograms,
30 nanograms, 50 nanograms, but whatever the study you look at,
the number of lives saved if everybody had adequate levels of
vitamin D is tremendous, OK? It is a relatively cheap vitamin,
but for whatever reason it was not pushed by the medical
establishment and resulted, in my opinion, in the deaths of
hundreds of thousands of people. I mean, even the most moderate
studies, I would say, would say that you were less than half as
likely to die of COVID if you had adequate levels of vitamin D,
and if you get up to around 50 nanograms, you have a very, very
small population dying.
Oh, by the way, another thing bothers me. If you went in
for a medical checkup during that time, they would not even
test you for vitamin D, which is not all that expensive because
you get blood tests for other things you are doing. Could you
comment on the lack of emphasis of the benefits of vitamin D,
given that the evidence appears overwhelmingly helpful and very
cheap, the lack of emphasis from the public health
establishment on having vitamin D?
Dr. Califf. Well, as I have already said, you know, as FDA,
this is really not in our domain. The vitamin D is available on
the market. We do not regulate the practice of medicine. That
is determined by the medical profession, and other agencies may
have more to say about that. But I would point out one key
thing about vitamin D, just very basic in my role as a person
who has done clinical trials all my life. There are many
diseases for which if you measure vitamin D levels, the higher
the vitamin D level, the lower the risk of the disease. But it
turns out when randomized trials have been done, where you take
equal people and give some vitamin D and others placebo, for
most diseases, it turns out there is no difference, and that is
because people with higher levels of vitamin D are different in
many other ways. They tend to be healthier and spend more time
in the sunshine and all sorts of other things that are
different. And the randomized trials so far, and COVID, to the
best of my knowledge have not been positive, but, again, I want
to make the point. This is not something FDA regulates. It is a
dietary supplement, basically a vitamin. It is on the market,
it is freely available in your local store, and that is between
the doctor and the patient.
Mr. Grothman. I would like to submit a couple of columns
here, and I will yield the remainder of my time to the
Chairman.
Chairman Comer. Without objection, so ordered.
Chairman Comer. He yields me time. So Commissioner, I want
to ask this question about tobacco. With tobacco and FDA's
Center for Tobacco Products, I think it is safe to say the
current regulatory process at the CTP is not at all what
Congress envisioned when it passed the Tobacco Control Act 15
years ago. From the Reagan-Udall Foundation report you
commissioned and recent court rulings, I have to conclude that
those seeking to play by the rules do not even know what the
rules are because FDA will not tell them or FDA will not put
information out, or they will put information out and then
change it.
So now, after 15 years, FDA has granted only 45
authorizations out of some 26 million applications and only
five authorizations for modified risk tobacco product. And
while FDA rejects applications based on science and data from
manufacturers who have spent untold millions to comply with
what they think the rules are, American store shelves are
overflowing with products from China, and your Agency does not
seem to be doing anything about it. So, Commissioner, given
what I just described, I have to wonder, do you even want a
functional regulatory process for these products, or is it the
objective to target the U.S. tobacco industry even if it means
allowing a flood of Chinese products containing God knows what
into this country?
Dr. Califf. Mr. Chairman, you know, you are from Kentucky.
I grew up in South Carolina, lived in North Carolina, and I was
a cardiologist at a major medical center. I saw many, many
people die from the ravages of tobacco. So, the basics here,
first of all, the major cause of remediable death in the United
States still today is tobacco-related illness. Four hundred and
sixty thousand people will die from tobacco-related illness
this year. So, we are very much intent on doing the very best
job we can, starting with combustible tobacco, and the good
news is, as I said in my opening statement, we have a decline
in that. Well, it was not even present when the initial law was
passed that you referred to, the presence of vaping or e-
cigarettes. No one anticipated there would be 26 million-plus
applications of vaping products. That is a bit overwhelming.
The good news here, we are 99 percent done, including almost
completely done now with the major manufacturers.
And so, the onus that Congress did give us is what is
called a public health standard. When it comes to vaping
products, does the benefit of helping adults reduce use of
combustible tobacco, the major killer, outweigh the risk of
teenagers and children getting addicted to nicotine, which is a
brutal, fierce addiction that is almost impossible to shake
once you have it. And so far, only 31 products, last I counted,
have produced the evidence to meet that public health standard.
All the others you refer to simply didn't produce the evidence.
Now, if I could say a word about enforcement. I know that
was the other issue. It bothers me as much it does you to see
what is on our shelves, but I do want you to know that we
really picked up our enforcement: over 600 warning letters to
manufacturers, hundreds of civil money penalties now, and we
have also now begun to do injunctions to stop. But every one of
these cases is in an environment where every step we make ends
up in court in complicated lawsuits and have to cause us to go
back and take that into account, so it is a battle every day.
We are engaged in it, and, yes, we do want to regulate it. The
closer we can get to zero combustible tobacco, the better. The
role of vaping is still something we are working on.
Chairman Comer. And we will get back to that. My time has
expired. I will have another round of questioning with that
specifically because these products on the shelves that are
getting the bad headlines are Chinese products that are not
even regulated by the FDA. FDA regulates the American
companies, but the Chinese companies are the ones that are the
bad actors, so we will get back.
My time has expired. I now recognize Ms. Norton from
Washington, DC. We will get back on that. Ms. Norton?
Ms. Norton. Thank you, Mr. Chairman. Dr. Califf, across the
Nation and right here in the District of Columbia that I
represent, drug shortages are negatively affecting patients and
their families. Drug shortages can lead to daily challenges for
patients, affecting every element of their lives as well as
health outcomes. For example, because of shortages of ADHD
medication, we have heard reports of previously capable
students barely able to pass grades. Adults are forced to
contact every local pharmacy to track down a medication that
may be the difference between being productive and focused in
the workplace or losing their livelihoods. Drug shortages have
occurred for decades. And in the wake of recent shortages, the
Department of Health and Human Services and the Food and Drug
Administration developed new proposals to prevent and mitigate
shortages. Earlier this month, HHS released a white paper with
potential policy solutions to address shortages. Mr. Califf,
what policies can the FDA execute to mitigate drug shortages?
Dr. Califf. Thank you so much for the question, and I will
try to go quickly here because we have spent so much time on
this. This has been going on for decades, and most of what the
FDA can do is to mitigate impending shortages when we know one
is about to happen. But the way we do that right now is we have
spotty pieces of information about what is going on out there
from the manufacturers, and we spend a lot of time on the phone
finding manufacturer B to make up for what manufacturer A
cannot do. So, we have given you a comprehensive list of the
information we need.
Remember that most of the starting material now for our
drugs is coming from China, the key petrochemicals that lead to
drugs. India is a major player in the generic drug industry,
and so the supply chains are complicated, and we only have bits
and pieces of information. We need more of it. But you referred
to several other kinds of drug shortages, and it may be worth
just quickly going through this. I do not want to take all your
time, but I think the most common shortages by orders of
magnitude are inexpensive generic drugs.
Well, believe it or not, the price is not supporting the
cost of manufacturing and distribution and quality, and the
white paper you referred to has a lot of detail about this in
it that I would refer you to. Our supply chain pricing has hit
a point where the price is below what keeps the manufacturers
in the game. So, when we do an inspection and find a problem
and a supply line shuts down, that company may very well go out
of business. Now, that is very different than the shortage of
Ozempic that you referred to and has been discussed. There, the
manufacturer is making a huge amount of money with every dose.
It is just that the demand is so much higher than they
anticipated. That will take care of itself over time.
We also referred to Adderall, which is the stimulants for
ADHD, very important because these drugs are highly effective
for this problem, and it is bad for students that have ADHD to
not be treated. Unfortunately, the very same chemicals are
showing up increasingly in overdose deaths. The over 100,000
overdose deaths we have are typically a mixture of fentanyl
plus something else, often a stimulant. The supply of these
drugs is determined by the DEA, not by the FDA because it is a
scheduled addictive substance, so it is a much more complicated
issue.
The generic one is the one that we hope that we have now
solutions in this white paper that have to do with fixing the
economics of that industry. Remember that it is not just
Americans. The 8 billion people in the world need a reliable
source of generic drugs. For the world, these drugs are really
important to treat the chronic diseases that were referred to.
And right now, in most low-income countries, we just heard from
a foundation that 80 percent of antibiotics in one country were
actually fake drugs. So, we have to have an industry that
produces high quality at a low cost with a supply chain which
is completely known, and we need the data, so that we can
actually help intervene when there is an impending shortage
like a supply line goes down or a company goes out of business.
So, we have asked for that, and I hope we can get it.
Ms. Norton. My time has expired.
Chairman Comer. Thank you. The Chair now recognizes Ms.
Mace from South Carolina for 5 minutes.
Ms. Mace. Thank you, Mr. Chairman. Commissioner Califf,
thank you for being here today, and thank you for your work on
scheduling reform and your recommendation that cannabis should
be moved to Schedule III. Well, I and many cannabis advocates
believe this does not go far enough. This is a long-overdue
start. So, my first question today, I understand this issue now
rests with the DEA, and I am curious if you have an update on
the timing of their decision.
Dr. Califf. Now, we are both from South Carolina, we know,
you know I cannot. I do not even know. But if I did, I could
not tell you anyway. So, that timing of a regulatory decision
is something that would be up to the DEA, not up to me.
Ms. Mace. We think it will happen this year or have any
idea?
Dr. Califf. I know that there is no reason for DEA to
delay. I think they just have to take into account all the
regulations that are in play.
Ms. Mace. OK. Thank you. If the DEA concurs with the FDA's
recommendation, can you help me understand if the FDA will take
on additional responsibilities or if your role will change as
it relates to cannabis?
Dr. Califf. This is a very complicated topic, but I will
just say that cannabis, you know, remember, there are over 30
different forms of cannabis now, different chemicals that are
made, and it falls in this area where state regulation has been
dominant. This is an area where I believe we would be better
off if we had guidance from Congress about how to proceed.
Medical marijuana is one thing where there is a medical
purpose, and it is proven through traditional medical pathways,
but when it is used for recreational purposes, there is no
medical benefit in that case, so it does not fall under our
typical regulation.
But what is in play with this and several other things that
I think we will probably talk with the Chairman about here
shortly, like CBD, the question is how do we reduce harm that
is done when it is used inappropriately or at a dose which is
dangerous, or when it is packaged in a way to market it
specifically to children. We are seeing some of this stuff
packaged in gummy bears that is easily mistaken for children's
candy, but we are going to need help and a regulatory pathway,
remembering that almost everything we do, there is a health
benefit. Like, you create a new drug or a new device or a food
for a health benefit. This is an area of harm reduction when it
is used recreationally.
Ms. Mace. Right. Well, and also, I mean, it reduces the
morbidity and the addiction to opioids prescribed by doctors,
too. I mean, there is just a huge amount of benefit. I have
seen it benefit in my own life, and welcome to my world. I am a
mom of teenage kids. I have seen packaging of things. I see
what kids are bringing to school. Even in a state that
prohibits cannabis, kids are doing it all over the place, and I
have a bill called the States Reform Act. There is a balance
between Federal regulation and also regulation amongst the
states. One of the things you mentioned was about packaging.
Myself, like my colleagues, we are concerned about the
safeguards for our youth. And one of the things in the States
Reform Act is it addresses the packaging that should not be
marketed like it is candy, or candy bar, or chips, or whatever
kind of candy is your favorite.
In South Carolina, I understand these products, so I am
concerned about safeguards for youths in intoxicating hemp-
derived products. So, in South Carolina, these products are not
age-gated or appropriately tested, and many of the packages do
resemble candy or snacks, and that sort of thing. For my
family, it is an ongoing conversation about what looks cool and
looks like it might be fun and exciting really is not,
especially on a young brain.
Dr. Califf. Without revealing too much about my age, I am a
child of the 1960's. So, it would be nice if in my lifetime, we
came up with a regulatory scheme where I think America, you
know, whatever your belief is about use of the product, where
the safety issues that you have referred to are written into
law, so that we have a scheme whereby we can regulate it. As I
said, we are referees. You write the rules. We need the right
rulebook in order to play the referee role.
Ms. Mace. I would encourage you and I would love for you to
review the States Reform Act, a bill that I wrote last session,
that takes into account, you know, the regulatory side and the
Federal side, but also states being in the driver's seat.
Again, one of the impositions in the bill is addressing and
ensuring that we do not market to kids, things are not packaged
to children, and that sort of thing.
And then I only have 20 seconds left. While I firmly
support the right of Americans to make choices about what to
put in their body, we can all agree it is a desirable outcome
for less people to smoke cigarettes, the negative health
effects of which are well-known. Any comment on alternative
non-nicotine products today while you are here, in 5 seconds or
less?
Dr. Califf. So, yes, there are several categories.
Medications is one category where I hope we will see more in
the pipeline. It is not robust. When it comes to chemicals that
are synthesized that also activate nicotine receptors, they
also cause addiction to nicotine, and the inventiveness of
entrepreneurs in this area is profound right now because
chemistry has gotten so much better. So, there are some things
I am very concerned about in non-tobacco nicotine and even
compounds that are one component removed from nicotine, which
may even be more potent in terms of addiction.
Ms. Mace. Thank you, and I yield back, Mr. Chairman.
Chairman Comer. The gentlelady yields back. The Chair now
recognizes Mr. Lynch from Massachusetts.
Mr. Lynch. Thank you, Mr. Chairman. Dr. Califf, welcome.
Thank you for your good work.
Dr. Califf, in March 2024, the FDA issued a proposed rule
regarding electrical stimulation devices that are intended to
reduce or stop self-injurious or aggressive behavior in some
patients. The proposed rule, if finalized, would remove ESDs,
these electric stimulation devices, from the market, and the
devices will no longer be considered legally marketed. I have
tried to read as much as I can on these. As an attorney, I try
to refrain from making medical decisions on my own, especially
for my constituents. I do know that the Geneva Convention
regards these devices as torture. But I also have a group of
families in my district, who have children and loved ones who
are undergoing these treatments, and they claim that those
treatments help.
Now, as a result of this rule, these treatments will go
away, and my constituents have asked me to ask you and the FDA
to meet with them to talk about the consequences of the FDA's
rule. And so, as a Member of Congress, on behalf of my
constituents, I am asking you and all your staff to provide an
opportunity for those families to meet with you and to discuss
their concerns.
Dr. Califf. Well, thank you for bringing this up. I know it
is part of your duty to do so. This is a very tough issue. And
I have worked in psychiatric wards during my career, and I
think most people cannot appreciate the anguish of families who
have loved ones who are in a situation that might call for this
or other serious mental health problems, but anyone who has
been through it, I think, has a special feeling about it. As I
think you know, there is a proposed rule that we have now put
out there. There is a docket, and we do encourage everyone to
submit their comments and views to that docket. I will
definitely take this back to our staff. I know that our staff
has met with these families before, but this has been going on
for a while, so we will go back and reconsider.
Mr. Lynch. It has. It has. It has, and it is heartbreaking.
Let me ask you. So, shifting to something completely different.
Last year, the FDA made nearly 200 additions to its public list
of AI-and machine-learning-enabled medical devices currently
marketed in the United States, and there has been some
wonderful success. You know, Dana-Farber Cancer Center is near
and dear to my heart, Mass General Brigham, that cancer center
as well. Wonderful, wonderful progress in diagnosing breast
cancer from mammograms. Clearly there are enormous potential
benefits here, but there is also some concern around privacy
and also the lack of explainability of some of these algorithms
that are being used on the diagnosis or the predictive end.
What are we doing to mitigate the negative aspects of the
use of AI? And I know it is coming at us hot and heavy in so
many areas, but I would like to hear what the FDA is doing
about guarding against the dangers that might be present by
this widespread adoption of AI.
Dr. Califf. Thanks for the question. I will have to contain
myself here because you may know that I worked at Alphabet, or
Google, during the 5 years between my two FDA stints, and very
heavily into this. And I think it is going to be a huge benefit
but also with a huge risk on the other side if it is not
regulated. And also, we have many mutual friends. I will be at
Mass General next week as visiting professor and learning from
the people in the Harvard system, you know, a lot about this
stuff. Well, this is one of the topics.
The thing I would emphasize is that I do not think it is
explainability that is really the issue. And I think an easy
way to think about this, think about yourself before you had a
map in your car that you could talk to when you used to drive
the car, and you get into an argument about which way to go and
then you would have to pull out the map and look at it. Well,
now you just talk to your car, and what is going on with the
car is AI continuously, in real time, taking into account
everything that is happening on the roads. The template of what
is there and your personal preference is that it learns as you
go along. And I think if AI works, we will take it for granted
because there are many things we do in medicine. If you ask me
how does aspirin work, we know a lot about aspirin, but exactly
how it works for each disease, we are not so sure, but we know
it does work for particular things.
So, what we are really focused on is creating a community
in our health systems and the industry that, like I have
already said, we are referees. The first line is self-
regulation by the industries. And what is really important
here, I think where AI is going, generative AI, it learns as it
goes. The more information it has, either the better it gets or
the worse it gets. You do not know which one, and if you just
put it in place and do not tend to it and monitor it, it can go
wrong in really bad ways. I saw that at Alphabet. It was
something we were really worried about.
And so, we have got to reformat our health system so that,
as time goes on, you are constantly looking at what the
algorithm is doing. Are its predictions accurate? That is
really the key thing that we have to do, and right now, we are
not configured to do that. So, we are working very much with a
community of health systems and the industry to come up with a
scheme of what is called assurance labs, and this would be you
sell your AI thing to somebody, it goes out there, there has
got to be a monitoring that says it is either working or it is
not, in practice. And it also looks for this bias that we are
all concerned about, that if you put the wrong information in,
you end up with a prediction which is preferential to one type
of person compared to another. That has got to be looked at.
So, I will stop there, and I can go on a while on this.
Mr. Lynch. Yes. Yes. Well, thank you for your answer,
Doctor. Mr. Chairman, thanks for your indulgence. I yield back.
Chairman Comer. The Chair recognizes Mr. Sessions from
Texas for 5 minutes.
Mr. Sessions. Mr. Chairman, thank you very much.
Commissioner, thank you for taking time with us. As you have
noted, a cardiologist also spending time in mental health
stress units, I think that part of what I am going to talk with
you about would come directly to observations that you may
strongly identify with.
In August of last year Assistant Secretary for Health
Levine sent Drug Enforcement Agency director, Anne Milgram, a
recommendation from the FDA to downgrade marijuana, also THC,
from Schedule I, to Schedule III under the Controlled
Substances Act. This recommendation made the claim that
marijuana meets the criteria for control under Section III. In
reviewing the FDA's recommendation, I believe that the FDA did
not base its assessment in scientific fact or realities of how
marijuana has been abused and used in our country today. The
FDA's assessment relied on, I think, cherry-picked data, for
example, concluding in the report that since the potential for
abuse of marijuana is less than heroin, marijuana should be
downgraded.
This completely ignores the realities of a drug that is
causing enormous consequences of children and adults in our
country, high schools, middle schools, and communities. Just
last week, Bloomberg editorial board published an article
emphasizing the sharp rise in marijuana THC related traffic
fatalities. One analysis, which is consistent with the HITDA
report out of Colorado, a 10-percent increase in vehicular
deaths, in California, the increase was 14 percent, in Oregon
22 percent. During 50 percent of the deaths on a highway, the
driver had THC in their blood, and those are only the
marijuana-related traffic deaths that we know about. We know
that there are other problems.
In your Agency's analysis, you scrap the long-held five-
factor test for determining a drug's medical necessity to
simply two factors. Two factors that relied on the fact that
marijuana, as was reported, currently is accepted for medical
use because it is prescribed by healthcare practitioners
through medical marijuana programs. So, what I would ask you
is, why did the FDA create a new, less rigorous two-factor test
to determine this when you know the reams of data and evidence
suggests it is not only addictive, but it is a contributory to
not only death, but long-term stress of people who use this and
confirmed by the medical community?
Dr. Califf. Well, sir, I appreciate the question. I think
you have already demonstrated, between you and the other
representative, that there is not agreement in Congress about
what should be done with this. And again, we would very much
appreciate if Congress did come to a conclusion for the
country. It would make our job better.
Mr. Sessions. Well, I think Congress has not spoken----
Dr. Califf. Right.
Mr. Sessions--because we believe it is a dangerous product.
We receive calls from thousands of parents every year about
their children. We see drug-related not only instances in
schools, but principals, teachers, people report the real
problem, and the problem gets even worse as gummies are
introduced into the system.
Dr. Califf. I certainly appreciate those concerns.
Mr. Sessions. So, I think Congress has spoken.
Dr. Califf. Let me remind you that a Schedule III does not
put marijuana on the market in the United States. It is still
highly controlled.
Mr. Sessions. No, it does not, but you do know exactly what
it does do, and you have, through the FDA, suggested that it is
not a dangerous product like heroin. Well, neither were
cigarettes like heroin.
Dr. Califf. Well, with all due respect, I think it is
differentiable from heroin and cigarettes.
Mr. Sessions. I think it is, too, that it is a dangerous
product.
Dr. Califf. Cigarettes directly cause death. I appreciate
that you feel that way, and your colleague just gave exactly
the opposite point of view.
Mr. Sessions. No, she talked about the public opinion, not
the medical opinion. You are a medical doctor----
Dr. Califf. Yes----
Mr. Sessions [continuing]. A cardiologist, and you are here
to answer. And I thought you did do a fair job to answer that
you do see where, when not used properly, it is a dangerous
product, and it is a dangerous product. And I thank you very
much, and I appreciate you being here today.
Dr. Califf. All right. Thank you.
Mr. Sessions. Mr. Chairman. I yield back my time.
Chairman Comer. The gentleman yields back. The Chair
recognizes Mr. Krishnamoorthi from Illinois for 5 minutes.
Mr. Krishnamoorthi. Thank you, Mr. Chair. Dr. Califf, in
February 2021 I was Chair of this House Oversight's
Subcommittee, Economic and Consumer Policy Subcommittee. We
studied the presence of toxic heavy metals in baby food at that
time. And in March 2021, we issued a report with regard to the
presence of lead, arsenic, cadmium, and mercury in astonishing
levels in baby food products. For example, we found that baby
food had, on average, 177 times the permissible amount of lead
in drinking water. In response to public pressure coming off
that report, FDA issued an action plan called Closer to Zero.
This was the first time FDA would be regulating toxic heavy
metals in baby food, which is obviously a good thing.
When my Subcommittee issued its report in March 2021, FDA
said that it would issue its initial draft guidance regarding
permissible lead limits and baby food within 1 year, so roughly
April 2022. Instead, it missed that deadline and issued its
draft guidance in 2023. But let me talk to you about some of
the other toxic heavy metals in baby food that are covered by
the Closer to Zero Program. I want to throw up here a
screenshot of your website from today.
[Chart]
Mr. Krishnamoorthi. And specifically, I want to talk about
when you say final guidance will be issued with regard to
permissible limit of other toxic heavy metals. So, in terms of
when, for instance, arsenic in baby food would be examined and
you would be issuing final guidance on permissible levels, your
website says, and this is my red circle, ``no update.'' That is
what it says, right?
Dr. Califf. I cannot see it, but I will take your word for
it. I cannot see it from this distance.
Mr. Krishnamoorthi. Let me talk to you about cadmium
levels. Again, screenshot from your website today. You say that
we should expect final cadmium levels at some undetermined
point, and, again, your website says, ``no update.'' You do not
disagree with that, right?
Dr. Califf. I am not up to date on the exact, but I will
assume that you are telling the truth here.
Mr. Krishnamoorthi. Thank you. Mercury, a dangerous toxic
heavy metal in baby food, again, we go to your website, and
with regard to when we should expect to hear from you with
regard to permissible levels of mercury in baby food, you say
``no update,'' right?
Dr. Califf. You say it, it must be so.
Mr. Krishnamoorthi. Dr. Califf, this is unacceptable,
completely unacceptable. It has been 3 years since we issued
that report. The public, the parents are outraged about the
amount of toxic heavy metals that are present in baby food. And
quite frankly, sir, I respectfully say that your Closer to Zero
Program at this point is closer to zero update, and that is
very, very disturbing.
[Chart]
Mr. Krishnamoorthi. I want to turn my attention to another
topic, which is the youth vaping epidemic, and you and I have
spoken about this before as well. Your own 2023 survey
indicates that 10 percent of middle and high schoolers are
vaping today, 90 percent of them prefer flavored vapes, and the
vast majority, sir, the vast majority of those flavored vapes
are illicit vapes coming from China. Here is one of those
illicit vapes right here. It is a Strawberry Mango EBCREATE
vape, and it is illegal, but you can buy it today because you
folks have not cleared the shelves of these illicit products.
On December 7, 2023, a dozen of us wrote to you asking for a
comprehensive approach to dealing with these illicit Chinese
vapes, and you didn't respond to me at that time, did you?
Dr. Califf. I would have to go back and look, but we have
had much correspondence about this issue, so I am not sure of
that particular one.
Mr. Krishnamoorthi. I know you are too busy to respond to
us. Of course, it has been 5 months, sir. After that, we wrote
you February 1, 2024, again, same issue. We want to know how
you are going to deal with these illicit vapes coming from
China. You didn't respond to that one either, right?
Dr. Califf. I would have to go back and look.
Mr. Krishnamoorthi. Sir, what bothers me about your
answers, is this. The reason why you did not respond to us with
your approach to clearing the shelves of these illicit vapes
from China is perhaps because you do not have an answer. It is
because you do not have an approach. And mark my words, the
illicit vapes coming from China flooding our market, these kid-
friendly flavors such as the ones here or the ones I hold in my
hand, is the next chapter in this youth vaping epidemic, and it
is time you take this seriously. Thank you. I yield back.
Chairman Comer. The gentleman yields back. The Chair now
recognizes Dr. Foxx from North Carolina for 5 minutes.
Ms. Foxx. Thank you, Mr. Chairman. Commissioner Califf, the
Center for Tobacco Product, or CTP, must make timely decisions
on whether products, especially tobacco harm reduction
products, can be allowed for sale or not. However, stakeholder
groups with pending premarket tobacco product applications, or
PMTAs, have been waiting for several years for a decision,
which far exceeds the 180-day review period written into law.
Can you tell me in 25 words or less why has the CTP failed to
comply with the statutory review period, despite the fact that
the CTP staff has more than doubled in the last decade?
Dr. Califf. You said less than 25 words. It has 26-plus
million applications. We are now 99 percent done, and soon we
will be within that timeframe.
Ms. Foxx. But you know among those applications are very
frivolous applications, and there are, like, a couple of dozen
in there that are coming from legitimate places, and you all
should have focused your attention on those. It is hard to
believe that an Agency that has doubled its staff over a decade
to over 1,200, receives over $700 million per year in funding,
is still not meeting the deadline for these PMTAs, the serious
ones, again, it is my understanding relatively few serious from
legitimate companies. What steps are needed to bring more
accountability to the CTP?
Dr. Califf. I would remind you that the vaping industry
right now pays no user fees, so all the money and people that
are hired are hired off of the combustible product industry.
There we have tremendous gains. So, in terms of the
transparency, now the applications, people can track it. The
information is published, and you are seeing continuous
improvement in our efficiency.
Ms. Foxx. So, what performance metrics does the CTP have to
ensure they are being good stewards of the tobacco user fees?
Dr. Califf. It is the numbers of applications, the time it
takes to review them. The outcomes of the reviews are discussed
by numerous watchdog groups that are looking at everything that
we do.
Ms. Foxx. Had the CTP done its job over the last decade,
there should have been tobacco harm reduction products approved
through the appropriate process. There is clearly a demand for
these products. It is being filled by illicit-flavored
disposable e-cigarettes, now make up more than 70 percent of
the e-cigarettes or ends market, as my colleague is talking
about, most of which are from China. What is the FDA doing to
rectify this problem of illicit products in the market?
Dr. Califf. If I may, ``tobacco harm reduction product'' is
an industry term. I would say we are all in favor of reducing
harm from tobacco, and as I went over with an earlier question,
we have an increasing number of warning letters, civil money
penalties and injunctions now, and seizures now at places of
import. It is a very large number of products. There is no
question about it, it is a big job, and we have a lot more work
to do.
Ms. Foxx. Commissioner, you have recognized the critical
need for the public to have access to accurate medical and
scientific information to help inform the decisions they make
about their health. How does the FDA justify the decision to
spend millions on ad campaigns and scare tactics, such as brain
worms or metal dragons that are not based on verifiable facts?
And when will the FDA focus on the facts about what can make
cigarettes deadly as Congress intended in the Tobacco Control
Act instead of relying on misunderstandings and outdated
narratives?
Dr. Califf. I am not sure I follow that question. I would
just say we have seen dramatic progress and reduction in
combustible pack tobacco use, significant reduction in the
number of people dying, although it is still 460,000. I will
just note that in my time at Alphabet, I learned a lot about
advertising. I think our statements are based in fact, and they
include a component to reach into the culture of people that
need to receive the information. Simply stating a fact, when
you are talking to a teenager, it is not necessarily the best
way to reach that teenager. You need to have the mind prepared
to absorb the information.
Mr. Foxx. So, brain worms and metal dragons----
Dr. Califf. I do not know about brain worm and metal
dragons, but I will take your word that something alluding to
that must exist somewhere in there.
Ms. Foxx. Thank you, Mr. Chairman. I yield back.
Chairman Comer. The gentlelady yields back. The Chair
recognizes Mr. Khanna from California for 5 minutes.
Mr. Khanna. Thank you, Mr. Chairman. Commissioner Califf,
thank you for your service. So many Americans are frustrated
that even with insurance, they are having to pay thousands of
dollars for drugs for cancer, for multiple sclerosis, for
getting inhalers, hundreds of dollars. I want you to help
explain to the American people why this is happening and to
start by giving two sentences on what the FDA's ``Orange Book''
is.
Dr. Califf. Well, the ``Orange Book'' is a listing of
patents that are relevant to drugs that are marketed.
Mr. Khanna. Correct. And if something is listed on the
``Orange Book,'' is it correct that for 30 months, a generic
manufacturer cannot produce that?
Dr. Califf. With some caveats, but, essentially, that is a
fair statement.
Mr. Khanna. So, let us take a couple of examples. You have
a multiple sclerosis drug, Copaxone, produced by Teva. It costs
patients between $3,000 and $50,000, and it is currently listed
on this ``Orange Book.'' Now Teva, the company producing it, is
going to come again to have it listed with no real changes to
the drug, cosmetic changes. If they list it again, then no
generic-manufactured drugs can be produced, correct, for 30
months?
Dr. Califf. It is a little more complicated than that. I
mean, you left out one step before that, which is that you have
to have a patent, which says it is a significant new thing.
Mr. Khanna. Sure, but----
Dr. Califf. Our role in the ``Orange Book'' is ministerial;
that is, we list----
Mr. Khanna. But you have discretion on whether to list it
or not, correct?
Dr. Califf. Not much discretion.
Mr. Khanna. But technically, you have that discretion?
Dr. Califf. Not really. We have to list them, and----
Mr. Khanna. What would happen if you did not list them?
Dr. Califf. We would get sued.
Mr. Khanna. But what is happening is you have these
companies that are getting you to list this and not have
generic competition. And so then, as a result of it, the
American people are paying $50,000 for drugs on multiple
sclerosis, or in the case some--revumenib for leukemia
--they are paying $17,000 because you are listing something
in the FDA that is not allowing generic competition. Now, you
can say the blame is with the Patent Office, but if those were
not listed at the FDA, you would have generic alternatives. Is
that not correct?
Dr. Califf. You know, my grandfather was a Baptist
minister, we are all sinners, so we will take our share of
blame here. It is a point of emphasis between us and the Patent
Office now to try to get rid of frivolous patents, which is
what you are referring to, frivolous patents just to extend the
time period in which a company----
Mr. Khanna. Would you say that in the case of Copaxone
where Teva is asking for more patents and multiple sclerosis
patients are paying $3,000 to $50,000, that that could be
frivolous, or with revumenib, which is where they have 27
patents to treat leukemia, there could be some of those being
frivolous?
Dr. Califf. As FDA commissioner, that decision really is an
FTC decision. I have personal opinions about parts of this----
Mr. Khanna. What is your personal opinion on those two?
Dr. Califf. There are too many efforts made to extend
patents, but I will not comment on this specific one.
Mr. Khanna. But what about for AstraZeneca and the inhalers
with Symbicort?
Dr. Califf. I cannot refer to a specific one. I will note
that my mom got some extra life expectancy due to revumenib,
so, and I am very familiar with what happened with the cost.
Mr. Khanna. And so, my question I guess is, what can we do
in Congress because this is what is frustrating people. And I
am not blaming you, sir, but I am saying that you have got a
system where you are listing these drugs--maybe you are saying
your hands are tied--it is not bringing those costs down. From
the American people's perspective, how do we solve this? And if
you could give me 10 seconds because I have one more question,
but do you have a 10-second recommendation?
Dr. Califf. Maybe the analogy is worn out. Again, we are
the referees, so it may be something where our staff will meet
together with yours and the Patent Office and see if there is
anything that can be done to tighten up the laws here.
Mr. Khanna. The last question I want to ask, and it is not
a ``gotcha'' or anything because I know when you were in the
FDA, then afterwards, you got consulting fees from Merck,
AstraZeneca, Biogen. I take you at your word that there were
ethics reviews, and then you said that there were no ethical
conflicts, but one of the things I proposed is Members of
Congress should not become lobbyists. Would you commit today,
that after your service as FDA chair, you will not take any
money as consulting fees from Big Pharma going forward?
Dr. Califf. I have a written record on this for 2 years.
Beyond that point, you know, we will have to see. I will be----
Mr. Khanna. But why not just make that commitment, so that
the American people have confidence that you will not take? You
can make plenty of money at Google or somewhere else. Why not
just say I am not going to take Big Pharma money?
Dr. Califf. I am not looking to make money. I am looking to
contribute to the development of effective----
Mr. Khanna. And why not say you will not take it after
regulating it? Just make that commitment today.
Dr. Califf. I certainly have made a commitment for a period
of time, but I cannot speak for the rest of my life.
Mr. Khanna. I think you should.
Dr. Califf. I appreciate your opinion.
Chairman Comer. The gentleman's time has expired. The Chair
recognizes Mr. Fallon from Texas for 5 minutes.
Mr. Fallon. Thank you, Mr. Chairman. I think we have some
bipartisan agreement. Representative Khanna, I would love to
co-author any bills you have for preventing Members of Congress
from becoming lobbyists. I think it is good government, so
thank you for that.
Thank you, Mr. Chairman, and I am here today, Commissioner,
not so much as a Member of Congress, but as a parent, and I
just wanted to visit with you on a few things. Particularly,
you know, I have two teenage boys, 17 and 14, and I see the
teenage vaping, you know, skyrocketing, and I think that is an
entry to some really nefarious habits moving forward. And I am
particularly concerned about the use of illegal and unregulated
Chinese vapes. I know it was touched on before and the FDA's
role in contributing to this, I think, you know, proliferation
that we see across the country.
So, the Tobacco Control Act of 2009 created pre-market
review process allowing for new tobacco products to enter the
market. Yet, as myself and nearly 60 of my colleagues pointed
out in a letter we sent to the President last month, a letter
led by my good friend, Congressman Richard Hudson, despite the
FDA's receiving over 26 million smoke-free applications since
this law, the FDA has authorized fewer than 50 product
applications, with less than 10 being commercially available.
During this time, however, they have authorized thousands of
combustible cigarette product applications, but as of January
2024, there were only 23 authorized e-cigarette products and
all by three manufacturers.
The FDA's inability to produce, or to process rather, the
PMTAs in a timely manner has resulted in the proliferation of
illegal Chinese vapes flooding the market all over the country
to meet the consumer demand, often in flavors that, I am sure
you hopefully agree, are horrific insomuch as they appeal to
kids. Peach, mango, watermelon, which is a flavor currently
offered by EBCREATE, a wildly popular brand formerly known as
Elf Bar, this is a Chinese company whose vapes are illegally
here yet easily purchased at local stores. In fact, a local
smoke shop over in Virginia, this picture was taken 2 days ago.
[Chart.]
Mr. Fallon. And you can see in the yellow up there, those
are all displayed. They are illegal Chinese vapes along the
wall, and we are not speaking about hypotheticals or back-alley
deals. This is flagrant noncompliance, and this was just
randomly discovered. By the inaction of the FDA, what we
essentially see is almost a prohibition on legal products with
unregulated and illegal products rushing in to meet the demand.
Then by further weak action on enforcement, U.S. stores have
seemingly no concerns about openly selling the products all
over the place. So, Commissioner, by law, how long does the FDA
have to review PMTAs and take action on?
Dr. Califf. I believe it is 180 days as legal.
Mr. Fallon. You are correct, and how long on average is it
actually taking?
Dr. Califf. It is hard to calculate an actual number. There
are 26-point-something million applications, so, and some still
outstanding. So, you know, we are obviously not meeting 180-day
timeline, although it is getting better as we are plowing
through, and 99 percent complete, which still leaves hundreds
of thousands to go.
Mr. Fallon. The industry stakeholders have told us that
they are claiming it is 3 years. Is that feasible?
Dr. Califf. You know, remember the history, and when I was
commissioner in 2016 was right when vaping was starting and
then went immediately to millions of products. There were some
laws in between. And it is the case that there was such a flood
of products, it could be if you went back, you know, 3 or 4
years ago, you would say OK, 3 years until now, but you look at
applications coming in now, it is much shorter than that.
Mr. Fallon. Because the FDA's website shows that they
approved PMTs for 2023 took roughly 2-and-a-half to 3 years for
each one.
Dr. Califf. There was a bolus effect that had to be dealt
with. As one of your representatives already pointed out,
millions were taken care of by getting rid of the ones that did
not have useful data in them.
Mr. Fallon. I think that it would behoove you all to have a
regulatory framework in place, and warning letters are one
thing. How many seizures have we had at retail shops across
country?
Dr. Califf. We have only had a few seizures. We have had
32,100 civil money penalties, and those are ramping up
considerably as we go. As I think you know, seizures require a
whole different order of magnitude of legal work both before
and----
Mr. Fallon. So, we only have a few seconds left. These are
all over the place. So, what do you think that the FDA can do
to, you know, mitigate this?
Dr. Califf. Well, given the fact that there is a vape shop
in almost every neighborhood, it would take a lot more people
to do what you are saying of clearing the shelves. So, we have
an action plan. It is going to get better and better. As I have
already said, if user fees were paid by the vaping industry--
that will be about $100 million--we could hire a lot of people
and spend a lot more time out there in the shops.
Mr. Fallon. And I am not trying to suggest that every
illegal Chinese vape is going to be taken from the shelves, but
you know as well as I that you can set examples and make
examples, and then word gets out that if you have these
products, you are going to heavily fine and they are going to
seize them as well. Thank you, Mr. Chair. I yield back.
Chairman Comer. The gentleman yields back. The Chair now
recognizes Mr. Mfume from Maryland.
Mr. Mfume. Thank you very much. Mr. Chairman, I want to
thank you and Ranking Member Raskin for convening this hearing.
And before I go into my observations, Dr. Califf, let me go
back to something that the Ranking Member said earlier that I
do not want to get lost in all of this. And that is that maybe
what we ought to be doing in addition to this is trying to find
a way to create more regulatory pathways, giving the FDA the
ability to do many of the things that you said you could not do
here today.
Dr. Califf, I am deeply concerned about the over-
prescribing of ADH medications, particularly Ritalin and
Concerta, as it relates to kids in poor neighborhoods as a
means of dealing with their ``hyperactivity in school,'' and
that so many studies have shown that whether they are poor
Black, poor White, poor Latino, this over-prescription seems to
take place. And I am not a conspiracy theorist. I just do not
think Humpty Dumpty fell. I think he was pushed. And so, moving
under that premise, I think that unless we do have greater
regulations over the over-prescribing of these medications, it
will continue.
Now, let me just flip that around to the other side. I am
also deeply concerned about children who are unable to focus on
things and are given these medications and where all the
protocols have been followed, and I am concerned about that
because, in many instances, those drugs, unfortunately, have
been part of the shortages. I am concerned about cancer
patients who are forced to delay treatment, as you know because
many of the required medications are out of stock.
So, those are just a couple of things that I am hearing
from my constituents in Baltimore on a regular basis. I know
that supply chains were disrupted during COVID, and that there
had been intermittent and sometimes not intermittent drug
shortages occurring throughout the U.S., but I would be less
than honest if I did not just tell you from my perch some of
the things that I hear. And I recognize you do not carry your
magic wand in your back pocket. The only thing you can do is to
help guide us, listen to us, and suggest to us ways that we can
help you.
The FDA serves as an important regulator, to say the least,
and it is well-positioned to assess potential supply chain
disruptions. Can you tell us and this Committee and the people
around the country who may be watching these proceedings, how
is FDA working now currently with manufacturers to mitigate the
ongoing drug shortages? And have those manufacturers, in your
opinion, been transparent with the FDA about potential
shortages and the real root causes of those shortages?
Dr. Califf. Thank you for that. First of all, just a
comment you made about the under-prescribing and the over-
prescribing. I think it exemplifies a major problem that we
have in the intersection of the responsibilities of the FDA and
the practice of medicine. There is no doubt that people that
need these drugs are not getting them and people that do not
need them are getting them, and that equilibrium, of course, is
not set by the FDA. I am also a physician. It is a clinical
quality issue that we need to work on, and we are trying to
help as best we can with that.
But your main question about the manufacturers, we work
every day with the manufacturers. They are required to give us
certain information, but, frankly, they have resisted giving us
some of the crucial information that we really need. When there
is an impending shortage, we are finding that they are very
cooperative to work together to try to fix it. But it would be
better if we had all the data we needed to put together
predictive algorithms that would allow us to intervene
preemptively much, much earlier and prevent the shortage. So,
we have a list that you all have a copy of that list the areas
where the correct information would make a difference.
But, I also want to point out that while there is a
shortage of the stimulants for ADHD, the biggest shortages are
occurring in inexpensive generic drugs where the less expensive
the drug, the more likelihood of shortage because of the way
the market is not succeeding in rewarding high-quality
manufacturing. And that is a point I think we really need to
address over the next few years.
Mr. Mfume. And any guess on your part as to what factors
affect non-generic drug shortages?
Dr. Califf. For non-generic drug shortages, there are
really only two major types. Because a non-generic drug, as we
have already discussed, in general, the manufacturer is making
a handsome profit once the product is on the market.
Mr. Mfume. That is my point.
Dr. Califf. So, they are pretty good at figuring out how to
make it.
Mr. Mfume. Yes.
Dr. Califf. The exception, as I said, is Ozempic or the
weight loss drugs where the demand is just so high they have
not been able to keep up.
Mr. Mfume. Yes. Thank you very much. Mr. Chairman, I yield
back.
Chairman Comer. The Chair now recognizes Mr. Biggs from
Arizona for 5 minutes.
Mr. Biggs. Thank you, Mr. Chairman, and thank you,
Commissioner Califf for being here today.
The University of Arizona has been engaged in research that
would advance pain and addiction research to help combat the
opioid crisis. They are looking for ways to expedite known drug
candidates through the Phase 2 and Phase 3 trials to take non-
addictive pain relief medications to the market. U of A has
informed me that they have found if they can repurpose
clinically available medications that are proven to be non-
addictive and have also shown to be effective for treating
different types of chronic pain. They think they are ready to
go forward in these trials. But they also report that there is
a need to repurpose some of the medications specific to sex
differences because pain is differentiated based on sex, and
that would have an impact on how they develop this drug.
So, the question is, during the COVID era, FDA was able to
expedite clinical trials. U of A tells me that they are
struggling to obtain approval for Phase 2 and Phase 3 clinical
trials on something that could alleviate chronic pain and help
reduce the risk of opioid addiction that we see so rampant in
the society today. So, I guess my question is, could this be a
statutory problem, a regulatory problem, a resource problem?
What might we be looking at? And I realize I am giving you a
very specific example but hoping that you can give us some
information.
Dr. Califf. Well, you know, the way it works at FDA on the
drug side is there are user fees that are paid, and we have
statutory or agreed-upon, passed by Congress every 5 years, for
the user fees timelines. We are meeting those timelines which
are agreed to between the industry, the FDA, and then put into
law by your passing the law.
I am not aware of the particular circumstance you are
giving. There is a thing that we say at FDA: ``In God we trust.
All others must bring data.'' So, I would have to know the
specific data coming from University of Arizona to know if
there may be some issue that is causing a back and forth that
would not fall within the usual timeline, but when that
happens, it is very much noted that that is the case, so.
Mr. Biggs. We would love the opportunity to present you
with additional information, whatever we need to----
Dr. Califf. Sure.
Mr. Biggs [continuing]. Find out what may be the hitch in
the get-along, if we could.
Dr. Califf. That will be fine.
Mr. Biggs. With that, I will yield to the Chairman.
Chairman Comer. Thank you for yielding. Commissioner, it is
FDA's responsibility to ensure the safety and efficacy of all
drugs marketed and sold in United States regardless of where
the drugs are manufactured. Yet the number of inspections
conducted annually has been declining since 2013. At the same
time, Chinese and Indian manufacturers have received the most
FDA warning letters by far. These violations include
contaminated medicines, non-sterile manufacturing, and
falsified data. So, how is the FDA working to keep foreign
manufacturers accountable?
Dr. Califf. I really appreciate that question. As I have
already established, we are doing a major reorganization
because I agree with you that we need to pick up the pace of
the inspections that we are doing, but, again, as I have
already said, the first line of defense is the manufacturers
themselves. And so, here is where modernization of our data
systems is important because the more we can keep up with what
is going on, not just in U.S. facilities, but all around the
world, the better we are able to target our inspections and to
have the frequency that is needed to keep the manufacturer in
shape.
One of the big areas that we are working on now is India,
where we have completely redone our inspectional system, and I
have personally gone to India to meet with the Indian
Government to work on the relationship, so that the inspections
can proceed, and I believe they are acting in good faith in
India right now, as one example. So, think of it as a layer of
data and information that should be constantly coming in now
that all manufacturing is digitized. And on the human side
where the inspector actually shows up, the investigator in the
facility, those are being increased, and it has been a major
point of emphasis in our reorganization.
Chairman Comer. There are not a lot of bipartisan agreement
on controversial issues in this Congress, but one thing I think
there is overwhelming bipartisan agreement on is the fact that
we need to have more domestic manufacturing of our
pharmaceuticals. In your medical opinion as commissioner of
FDA, what can we do in Congress to encourage an environment
where all of our essential, or much more at the very least, of
our essential pharmaceutical production is manufactured in the
United States?
Dr. Califf. As one of your colleagues pointed out through
the Socratic method of asking the question, I do not think it
is a big issue for innovator drugs because that industry does
not experience much in the way of shortage. But for this
generic area, it is an area where we do need to reshore
significant----
Chairman Comer. But, it is a national security issue as
well.
Dr. Califf. Absolutely.
Chairman Comer. Right.
Dr. Califf. And when the raw material is coming from China,
it is an issue that we need to take seriously. So, as you know,
FDA does not deal with the prices and the market per se. I
would refer you to the HHS white paper that just came out with
a large input from us. And basically, we need to create an
economic market situation where the price is fair, so that the
manufacturer can produce a product, but also invest in the
technology of manufacturing and can be done using American
labor, which is more expensive than labor in other countries. I
would also say, I am not talking about 100 percent reshoring. I
do not think we need that, but we need enough of a footprint in
the U.S. and in nearby countries that we are assured that if
something goes wrong anywhere in the world, we keep this up.
Ninety-five percent of our prescriptions are now generic.
Chairman Comer. And we will touch on that later. My time
has expired. The Chair now recognizes Ms. Bush from Missouri
for 5 minutes.
Ms. Bush. Thank you, Mr. Chairman. St. Louis and I are here
today, Dr. Califf, to first thank you for the work that the FDA
has done to eliminate cumbersome restrictions on mifepristone,
one of two drugs used for medication abortion. As Ranking
Member Raskin mentioned at the top of the hearing, mifepristone
is subject to a risk evaluation and mitigation strategy, also
known as REMS. During the peak of COVID-19, the FDA suspended
enforcement of a REMS requirement that mifepristone be
dispensed in person. Due to the success of this trial run, we
know that in January 2023, the FDA permanently updated the
strategy to remove the in-person dispensing requirement. This
has proven that the in-person dispensing requirement was never
actually medically necessary.
I have a bill called the Protecting Access to Medication
Abortion Act, which would assure that mifepristone, one, does
not have an in-person dispensing requirement; two, allows
patients to access prescriptions for mifepristone via
telehealth; and three, authorizes all pharmacies certified to
dispense mifepristone to patients to do so via mail. So, thank
you to the FDA for your commitment to your evidence-based care
that serves patients and not politicians.
Next, I want to turn to sickle cell, a disease that affects
approximately 100,000 people across our country, the majority
of whom are Black people, and about 2,000 people across my
district. In fact, according to the CDC, 1 out of every 365
Black children in the United States are born with sickle cell
disease. It cuts at least 20 years from life expectancy. And
so, as a nurse, I have treated people with sickle cell disease.
Patients experience totalizing pain, and it is debilitating.
This illness completely takes over your life and it is heart
wrenching, and we do not speak enough about it.
So last year, the FDA issued a groundbreaking approval of
the first gene therapy to treat sickle cell disease, and so
this new technology is the first-time genetic editing has been
used to treat any disease. As a result, patients who face
excruciating pain and even death from sickle cell disease will
now be able to better manage this life-threatening condition
for many who may have been unable to hold steady employment,
spend time with friends and family, or otherwise participate in
everyday life because of this illness. This is truly life
altering and is life sustaining. This technology would be
impossible without the diligent and the science-driven work of
the FDA.
So, Dr. Califf, what did the FDA consider when determining
the new sickle cell treatment, determining that it is safe and
effective?
Dr. Califf. As I believe you probably know, there are
actually two treatments approved, one using gene editing per se
and another using a viral vector, and in both cases, human
clinical trials were done. Taking sickle cell patients, as you
well know being a nurse, people with sickle cell disease, even
though the genetic issue is essentially the same area of the
human genome, the manifestation of the disease is quite
different.
So, what was done in these trials were to take people who
are having the worst outcomes--that is, many attacks, painful
crises--and then doing the gene effort, and then following them
after and showing that those crises abated almost completely.
It was quite a remarkable result but in a small group of
patients. And so, there is a lot yet to learn, but it was
important to give access to that treatment to those who would
benefit.
Ms. Bush. OK. OK. Is there potential for this new treatment
to be used to treat other genetic diseases?
Dr. Califf. It is very exciting, and I alluded to it in my
opening comments. You know, I was around for the Human Genome
Project, and people for decades said, ``where is the beef'',
you know. We put all this money into $3.2 billion base pairs
and knowing what they are. Now we are here because thanks to
the science, we can go in with molecular scissors and snip out
the gene that is causing the problem and put in a new one, or
snip out the gene that is causing the problem if we do not need
to put in a new one. There are 10,000 rare diseases with no
treatment right now.
You are talking about parents of children who have terrible
outcomes. And so, this is such a revolution in terms of
therapeutics, that we are making major changes within the FDA,
but it has got to go further than that because you are aware
that the cost of these treatments is quite high. So, I think
there is going to be a lot for you in Congress to work with the
administration on here to figure out, you know, if you are a
parent of a child with a rare disease, now there is hope that
within a few years, we could have an effective treatment. But
if we have hundreds to thousands of effective treatments, the
environment in which this is done has got to look different
than it does right now. I hope that was helpful.
Ms. Bush. Yes. Yes. And, Chairman, can I? OK. Thank you.
One last question. How can we ensure that people who require
these genetic therapies are not priced out because like you
started to allude to?
Dr. Califf. Well, I can take these out and say, you know,
as FDA commissioner on a hearing about FDA, it is definitely
not in our remit. But I can assure you there are many
discussions going on across HHS where, as you know, for
example, in sickle cell disease, the majority of patients are
on Medicaid----
Ms. Bush. Right.
Dr. Califf [continuing]. Because their medical costs are so
high and the difficulty with jobs in a case where you are sick
a lot, that we got to come up with new pricing schemes. And I
am an academic, a health policy person, but I should not opine
on that here at this hearing, but I would be glad to talk with
you separately.
Ms. Bush. OK. I will reach out. Thank you. Thank you, Mr.
Chairman. I yield back.
Chairman Comer. The Chair now recognizes Mr. Higgins for
Louisiana for 5 minutes.
Mr. Higgins. Thank you, Mr. Chairman. Mr. Califf, thank you
for being here. Your authority is vast and your responsibility
is great, and you are a gentleman of distinguished stature, so
I appreciate you being here today. You have to give serious
answers to hard questions, and I do indeed have some hard
questions to submit to you, and, Bob, we are submitting the
more interesting questions in writing for the record after the
hearing.
Mr. Higgins. For legislative purpose, I have a specific
line of questioning regarding imported seafood, so it is what I
am going to be discussing with you. Just as a matter of
background, according to my research and investigations, about
60 to 65 percent of seafood consumed in America is imported.
And generally speaking, given the limited resources that you
have at your avail, you are able to supervise the inspection of
about one-tenth of 1 percent of imported seafood. Is that
generally correct, sir?
Dr. Califf. Well, we settle it all differently. First, and
by our account, it is more than 65 percent of seafood, if you
are asking me.
Mr. Higgins. This is the Republican side, so I am being
conservative.
Dr. Califf. OK. But much as I described on the drug side
just a few minutes ago, it starts with a digital inspection.
That is, we have information about these facilities from----
Mr. Higgins. And then the shipper and the owner and the
input.
Dr. Califf. And as it comes in, we use artificial
intelligence now to look at the characteristics of the shipment
to pick out, so it is not just the small number you referred to
out of overall. It is the high-risk part of the import that we
are also looking at.
Mr. Higgins. Yes, and I appreciate that level of expertise
and, of course, the dynamics of illegal imports or would
include inspections beyond the biological and chemical realm.
But according to a September 2017 GAO report titled, ``Imported
Seafood Safety: The FDA and USDA Could Strengthen the Efforts
to Prevent Unsafe Drug Residues in Imported Seafood,'' a
whistleblower has come forward indicating that a company called
Choice Canning, an Indian shrimp exporter, has knowingly
shipped antibiotic contaminated shrimp to the United States.
Despite this, FDA data shows that only 21 shrimp samples from
this company have been tested since 2003.
Just to put this in perspective, again, respectfully, sir,
you have a massive job to do and limited resources. I respect
that and I want to help. This company that I am referencing,
the Choice Canning Company, which is a known violator, imported
24 million pounds of shrimp to the United States last year
alone. So basically, imported seafood is coming into our
country, and the billions and billions of pounds, very little
of it is being actually inspected at the laboratory level for
biological and chemical contaminants. And the reason we are not
getting sick is because we cook the seafood, basically. That is
the reality. So, I would like to ask you, if you had
legislation from this body that gave you teeth in your
enforcement, like the authority and mechanisms to destroy
shipments that had been found to be contaminated, would that
power be helpful for FDA enforcement of imported seafood that
violates American standards for biological and chemical
contaminants?
Dr. Califf. You ask the question in a specific way that I
am reluctant to say just yes.
Mr. Higgins. Yes, you can say just yes.
Dr. Califf. What I would say is in the general direction
you are going, I would say, in general, including this arena,
the industries have, by and large, followed our ability to do
what you described. It is not just true in the area that you
mentioned, but, in general, I believe we would exercise our
authorities responsibly and could more quickly take care. I
mean, there is stuff which sits there for a long time given all
the things we have to do in order to stop while it is coming
in.
Mr. Higgins. Roger that. Thank you, sir. I am going to
close by saying that my intention is to legislatively empower
the FDA to have very aggressive responses to shipments of
contaminated seafood that enter our country. Mr. Chairman, I
yield.
Dr. Califf. Let me thank you for that. And I am a South
Carolinian, and I think our shrimp is better than yours, but in
any case, there is nothing I would like better than to see a
resurgence of the seafood industry in the United States.
Mr. Higgins. Well, I have learned from a young man not to
argue with a gentleman in a bow tie, so I will let you have
that, sir.
Chairman Comer. The Chair now recognizes Ms. Stansbury from
New Mexico for 5 minutes.
Ms. Stansbury. Thank you, Mr. Chairman, and thank you, Dr.
Califf, for being here today. It is wonderful to have you. I
want to thank your staff for being here today as well, and I am
grateful for the opportunity to highlight the importance of
science and science-based decisionmaking in this hearing and
all that you are doing to protect the American people to ensure
that we have access to medicines that work, that we have food
that does not harm us; and to ensure that every American can
get lifesaving care, and also for your work and the
Administration's support of our work this last Congress to pass
once-in-a-generation legislation to expand access to
healthcare, to invest in science and innovation, and, of
course, to expand access to prescription drugs for our seniors.
The FDA is truly on the front lines of that battle every
single day, and we are really grateful for the work that you
do. And I will say on a personal note, I have a family member
who was formerly an FDA employee, and you represent the best of
the best that our country has to offer. And nowhere is this
more important than in the realm of reproductive care where we
have to continue to follow the science and ensure reproductive
freedom, especially in the face of unprecedented attacks.
You know, as we have seen, Republicans in this body, in
fact, in this room and across the country, have been working to
ban abortion, first through Donald Trump's Supreme Court, which
overturned Roe vs. Wade last summer, and then chipping away
state by state to implement abortion bans, including where in
Arizona, just this week, the Court has upheld a Civil War-era
abortion ban. That is right. For folks that do not know this,
this ban was put in place in 1864 before an end to slavery had
been ratified by this body, before women could vote, and before
Arizona was even a state. Let us be clear. No judge, no
politician, no person should be able to tell any woman in
America or anywhere in the world what she can do with her own
body. And nowhere is this more important right now than in the
U.S. Supreme Court, which we are all watching very carefully in
the wake of their hearing of oral arguments in a case in which
the FDA has been involved since the last couple of years over
Mifepristone.
So, Dr. Califf, I want to ask you a question, if you could
talk to us a little bit, not only about the implications of the
decision by the Supreme Court, which we are expecting this
summer, for women to access reproductive care through medicated
abortion, but also what are the wider implications for FDA's
ability to use science to approve medicines?
Dr. Califf. Well, thank you for the question. I have to
note that since this case is under consideration by the Supreme
Court, I am very limited in what I can say. I will say that we
stand by our decisions. They are still in play today, and I
will add that, you know, we do have concerns if judges start
second guessing FDA decisions, about what that means for the
broader area of having a rational system of availability of
medications and devices for the American public.
Ms. Stansbury. Right. So, the FDA approved Mifepristone to
be used as a totally appropriate medicated way of addressing
issues around reproductive care, and the broader implications
are that if judges start legislating from the bench on this
kind of medicine, it could be anything. It could be cancer
treatments. It could be any kind of medication or intervention
in your health, and I think the American people need to
understand the implications of this case, the potential impacts
for public health and the ability for it to impact every
American's opportunity to access life-saving care.
So, we appreciate your work. And I am personally thankful
to be from a state, from New Mexico, that has worked to protect
reproductive care. But, if the Supreme Court does overturn
FDA's decision to approve that medication this summer, we could
see a ban on medicated abortion across the United States,
including in places like New Mexico, where it is protected. So
that is why this body has to urgently take action, it is why we
have to defend the science, it is why we have to sit here and
defend our agencies who are making sure that American women and
all people have access to the care that they need. And it is
why we have to do everything we can to defend our institutions
because the lives of our communities literally depend on it.
Thank you.
Dr. Califf. Just a quick comment, if I may. Everywhere I go
in the world, our system of drug development and decisionmaking
is the envy of the rest of the world. They all want to be like
us in that regard. As I have already commented, our use of
generic drugs in public health is falling a little short now
with our drop in life expectancy. But the system that you
described is one that it is very important that we preserve in
general, in addition to the topic you are specifically talking
about.
Chairman Comer. The Chair now recognizes Mr. Perry from
Pennsylvania.
Mr. Perry. Thank you, Mr. Chairman. Thank you, Dr. Califf.
I want to talk to you about the World Health Organization. And
the----
Dr. Califf. I am sorry. My name is called all kinds of
things. It is Califf.
Mr. Perry. Califf, sorry. I am sorry. Sorry.
Dr. Califf. I have gotten a lot of different pronunciations
here, but I am used to that.
Mr. Perry. That wasn't an incorrect pronunciation. That was
just plain damn wrong.
Dr. Califf. OK.
Mr. Perry. I want to talk to you about this treaty, I think
185, maybe, plus nations, including places like Yemen, Iran,
Iraq, Afghanistan, Cuba, Haiti, and some terms in that, we have
not seen it. We have not seen the 30-plus amendments, so we are
kind of shooting in the dark here. And I do not know that you
know any more than any of the rest of it about it, you know,
than we do, but there was another draft just last month that
created a multilateral system for sharing pathogens with
pandemic potential. I already listed some of the countries
involved. It also commits each party, which would include us if
we were signatories, to promote timely access to credible and
evidence-based information on pandemics, and the aim there, I
guess, is to combat misinformation and disinformation, I guess,
as you see it or as they see it.
So, my question is, with the potential threat to U.S.
sovereignty for decisionmaking on whether a pandemic even
exists and the prescribed remedies, including lockdowns and
maybe even medicating, would you commit before the Committee
today to pledge not to adopt policies included or pursuant to
the treaty until such time and if such time as that treaty
would be ratified by the U.S. Senate?
Dr. Califf. I am not sure how to answer that question given
the complexity of what you said, but it is hard for me to
imagine that we would do something at FDA that is not a
government policy. Now, you refer to the Senate in particular.
I am just not familiar enough.
Mr. Perry. Well, if the Senate does not ratify it, it would
not be a treaty that we would be signatories to, or at least
not legally. And I just want some or to know if there is any
intention on the FDA's part to institute any of the provisions
within the treaty without the proper ratification from the U.S.
Senate.
Dr. Califf. I do not think that particular issue would fall
within our purview, so, and I do not know enough about it to
make a commitment. But I will comment that----
Mr. Perry. Sure.
Dr. Califf [continuing]. You know, if we just look at the
avian flu situation we are in now, the knowledge of the
molecular structure of whatever the pathogen is turns out to be
really, really critical to come up with countermeasures to
treat it, and so I hope we can work out a way. And then also,
even for food safety, we talked about the imported food that we
get the genetic composition of the pathogen turns out to be
really important. So, I sure get what you are saying. We got to
do this carefully, whatever we do, but I hope there will be a
way that, for example, we do not get exposed to a new pandemic
where we know nothing about the organism until it is too late.
Mr. Perry. I think most people in America want to maintain
their medical sovereignty, the individual medical sovereignty
that we all enjoy. Regarding censorship, the CDC was involved
in media companies taking down social media posts regarding
misinformation and disinformation, again, terms that I think
are loosely defined. But the FDA has been involved in this
process in the past, having awarded several grants in the range
of hundreds of thousands of dollars to places like the
University of Maryland College Park, Texas Woman's University,
regarding, again, misinformation and disinformation.
Commissioner Califf, has the FDA coerced social media companies
to take down users' social media posts regarding the pandemic
or any other topic due to what they describe as myths or
disinformation?
Dr. Califf. Not to my knowledge.
Mr. Perry. Not at all to your----
Dr. Califf. Not to my knowledge.
Mr. Perry. So, would you consider you are paying--If the
FDA is granting-organizations, like the University of Maryland
or Texas Women's University, to mitigate the spread of
misinformation or disinformation, that is, essentially,
subcontracting out that duty. You are saying the FDA has not
done it, particularly, but have they done it indirectly through
their surrogates or their subcontractors via the grant program?
Dr. Califf. I am not aware of the particular contract you
are talking about, but let us remember that throughout the
entire history of the FDA, the FDA considers data and
information, makes a decision about a product, puts together
the risks and benefits into a judgment as to whether it should
go on the market. It is put in the label. The label is then
transmitted to clinicians all over the country, who then work
with their patients to make decisions about what to do. The
sovereignty that you refer to is typically a patient-doctor
relationship based on that information. Places like University
of Maryland has a major, first-rate medical center. They are
intermediaries in this process of relaying useful information.
Now, if someone is saying something that is flat out wrong, you
know, how that is dealt with by University of Maryland, that is
their business.
Mr. Perry. But, it also has the imprimatur of your
approval, and when they are found out to have been wrong in the
past for coercing social media companies to take down so-called
posts that then were later found to be incorrectly done, where
is the remedy, and is there an apology from the FDA? Is there
an admonishment from the FDA to these universities that have
been fast on the trigger and coerced and changed the narrative
or changed behavior based on things that are not true?
Dr. Califf. Far be it from me to apologize for a
university. I am a longtime university person before coming to
FDA, but I think what the university does is the university's
business.
Mr. Perry. Well, understand it also is a reflection on the
FDA. Mr. Chairman, I yield.
Chairman Comer. The gentleman yields back. The Chair now
recognizes Representative Brown from Ohio.
Ms. Brown. Thank you, Chairman, and thank you, Commissioner
Califf, for coming before us today.
On March 15, 2023, Congresswoman Pressley and I wrote to
you urging an investigation into the link between chemical hair
straighteners and uterine cancer. I would personally like to
express my gratitude to the Food and Drug Administration for
your rapid response and dedication to addressing this matter. I
am pleased the FDA has already taken immediate steps with the
proposed rule to limit the use of harmful chemicals found in
many hair straightening products. As you know, Black women
experience scrutiny and discrimination regarding our hair,
which has led to widespread use of these products. Black hair
should not restrict our ability to learn in school or advance
in the workplace, nor should our haircare products come with
health risk. As the FDA finalizes this rule, I look forward to
working together to ensure our consumer products remain safe
for everyone.
Furthermore, I know you are hard at work to protect
Americans in other ways, too. The Biden-Harris Administration
and Democrats continue to fight to protect and preserve women's
reproductive rights. The FDA's recent landmark approval of
over-the-counter birth control moves us one step closer to
reproductive freedom, even amid brutal, backward, and barbaric
abortion bans like Arizona's and other attacks in reproductive
health, including my own state of Ohio. Women must have the
right to control when, if, and how to start a family. Increased
access to safe and reliable contraception provides space for
that decision to be made while putting control back in the
hands of women. So, Commissioner Califf, what have been the
impacts so far of over-the-counter birth control hitting
shelves across America?
Dr. Califf. Well, we are in the early phase of it,
obviously, and there is always a lot to work out when something
goes commercially because of pricing and all. But the
availability, I think, as more manufacturers come on the
market, given the precedent, we should see much more widescale
availability so that people can use the products as indicated.
Ms. Brown. OK. Thank you. And finally, one last issue I
would like to touch on concerns a disease impacting far too
many in the Black and Brown community. Roughly one in 8--1 in
8--Black Americans live with diabetes, while in my district of
Cuyahoga County, the Black diabetes rate is over 25 percent,
over 1 in 4. Certain FDA-approved weight loss drugs aid in
obesity management for adults with weight-related conditions,
like type 2 diabetes. For many, these drugs are lifechanging
and lifesaving. Unfortunately though, these medications are
often too unaffordable and inaccessible for those who need them
most, especially uninsured individuals. So, Commissioner
Califf, how is the FDA working to ensure these new, highly
effective treatments are reaching populations who need them
most?
Dr. Califf. Well, first of all, I appreciate your
description of the problem, and there are special populations
at much higher risk. You have referred to one. I would say
rural people, in general, are also suffering greatly, and it is
one of the main reasons that we are seeing this very
troublesome decline in life expectancy. Right now, despite the
fact that we are producing the majority of the innovations in
medical products, we are almost in last place among high-income
countries in terms of life expectancy and the disability and
multiple chronic diseases that go along with it.
Unfortunately, our tools at FDA specifically are very
limited for what you described because we are limited by law in
dealing with price or of products when they come to market.
This is a policy issue, though, for all of the administration
and for Congress to consider. The one thing that we do that
when we have a product, like a set of products like this, that
looks so effective, so far, is working with the manufacturers
to get more products on the market because the competition does
bring the price down, but what you are referring to is most
unfortunate in many ways. There is a saying that I love. It
makes you feel bad in a way, but it was in the Atlantic during
the pandemic, and technological solutions drift into societies,
penthouses. Diseases seep into societies' cracks, and the
problem is, here we have a highly effective treatment. Who is
getting most of it? The wealthy and highly educated people. Who
needs it the most? It is the people that you described who may
have lower income and are in the need. So, this is a major
policy problem. I am sorry, the FDA is limited in what it can
specifically do, but I can assure you that, for example, CMS is
thinking hard about what am I to do about this.
Ms. Brown. Well, I thank you for your thoughtfulness, and I
thank you for this work that you are doing, and I look forward
to continuing and staying in a good contact with you. And with
that, I yield the balance of my time.
Chairman Comer. The Chair now recognizes Mr. Palmer from
Alabama for 5 minutes.
Mr. Palmer. Thank you, Mr. Chairman. Commissioner Califf,
in your testimony, you said the use of CBD raises safety
concerns, especially with long-term use. And you mentioned a
couple of things that were problematic, including harmful male
reproductive system exposure, particularly concerning for
children during pregnancy. The FDA is engaged in monitoring the
use of CBD. Is that correct?
Dr. Califf. It is a little complicated because CBD does not
fall directly under any particular regulatory scheme that we
have.
Mr. Palmer. Should it?
Dr. Califf. So, when people do report things to us, we note
it, and we have had funding from Congress to study the problem
from independent studies that have been----
Mr. Palmer. I appreciate that, but my question is, should
the FDA be more involved in monitoring CBD because it is
becoming extremely popular throughout the country.
Dr. Califf. We would very much like Congress to establish a
regulatory pathway for CBD.
Mr. Palmer. Well, I have an article from the National
Institute on Drug Abuse, and it talks about vaping. We also
talked about vaping. I am not going to get into that, but I do
have major concerns about the products coming in from China,
but also have concerns about the lethality of vaping, whether
it is tobacco or marijuana. And is that something that the FDA
is actively engaged in monitoring?
Dr. Califf. To the extent that we can. Again, as we
discussed earlier today, the regulation of marijuana is another
area where we would benefit greatly from Congress reaching
agreement on a regulatory pathway that enables the prevention
of harm from being done.
Mr. Palmer. I am glad you brought that up because I agree
with you. This body in the 1990's recognized that the tobacco
industry had worked to increase the amount of nicotine in
tobacco. Nicotine is not the carcinogenic that causes people to
get lung cancer. It is the smoke, the tar, and the other things
from inhaling the smoke. You have some of the same issues with
marijuana, that there is tar and other things that are ingested
into the lungs.
But the thing that concerns me about this as well is, and
this Congress acted, I think, effectively in dealing with the
tobacco industry in the 1990's. But what concerns me right now
is that we are not doing anything, to my knowledge, to regulate
what is going on in the marijuana industry and, particularly,
the genetically modified products. In the 1960's, 1970's,
1980's, as I reminded my colleagues, THC content was about 2
percent. Now it is anywhere from 17 percent to 28 percent, and
that is the addictive part of marijuana that affects the
frontal lobe that impacts judgment. And what we are starting to
see now, again, it comes in different forms. You do not just
smoke it. You could take it as a gummy. You could get it as an
oil.
And what is happening is more and more children are coming
in contact with it. And there is a report from the National
Center for Biotechnology Information that are found in one of
the medical publications that says that in terms of addiction,
9 percent of those people who just experiment with it become
addicted, 17 percent of those who start as teenagers become
addicted and anywhere from 25 percent to 50 percent of daily
users. Is that another area where the FDA needs to engage
because we see more and more states legalizing this? So, it is
not a DEA problem. It is a consumer problem.
Dr. Califf. I believe that this is a similar area where
harm reduction through a regulatory strategy is probably our
best approach, and we need more research on exactly what the
facts are. Remember that the tobacco industry was engaging in
genetic manipulation, basically, going way back just through
the old-fashioned Mendelian radiation of the plant, and then
development of mutations that will lead to more and more
nicotine in the product. And now we have chemical synthesis,
which can imitate almost any of these in a highly efficient
way, to produce the kind of effects that you described.
Mr. Palmer. Increase addiction.
Dr. Califf. So we are concerned and we would like see a
regulatory pathway. We talked earlier about the fact for the
most part, the FDA is a referee, and we need a rulebook and you
guys write the rulebook, so we would really like to see a
rulebook in this area.
Mr. Palmer. Commissioner Califf, I appreciate your answers.
I yield back.
Chairman Comer. And I have to comment on that. We write a
lot of rule books, that we have trouble with this
administration complying with the rules like they sing to their
own drummer there, but anyway, march to their own drummer.
Anyway, the Chair now recognizes Mr. Frost from Florida for 5
minutes.
Mr. Frost. Thank you, Mr. Chairman, and good afternoon,
Commissioner. Like many of my constituents, I am deeply
concerned with the H5N1 avian flu outbreak. It has impacted
birds, livestock. At least one person in Orlando lost several
of our Lake Eola swans, which is in the center of my district.
It is a symbol of our city. While it does seem clear that the
avian flu is not currently able to spread easily among people,
folks are still wondering about how safe they are. It is
brought up a lot in my district. Commissioner, how is the FDA,
in coordination with the Department of Agriculture and the CDC,
ensuring that Americans have access to reliable and up-to-date
information about this?
Dr. Califf. Well, thanks for bringing this up. It is a very
important issue today. As you have noted, avian flu has been
around for a while, but it is only recently that it has now
infected cattle and now cattle and multiple cows in multiple
states, and so this is really an all-of-government effort.
There are Zoom conferences multiple times a day now involving
FDA, CDC, Agriculture, as you said, but also many other areas
of government that have a stake in the game of interstate
commerce and Department of Justice and issues that are related.
So, we are all working together, and you should see frequent
communications as we work through this, remembering that the
most recent episodes with the cows is a relatively new thing,
so we are starting with a lot of uncertainty and working our
way through it.
Mr. Frost. And since 2006, the Federal Government
stockpiled antivirals designed to prevent severe illness and
death from the flu. Will this medication be effective against
avian?
Dr. Califf. Well, this relates to the discussion that we
just had. It is very useful to know the molecular or genetic
composition of the virus and in this case, if you look at the
composition of this virus, there is nothing in it that should
confer resistance to the current antivirals that we have
stockpiled, so we feel good about that. I should note it is
always the case when you have an actual illness, you have to
empirically prove that it works, and so fortunately, right now,
there is really only one infected human that we know of. So, it
is not something that we can test, but it looks good at this
point.
Mr. Frost. Thank you. I appreciate it, Commissioner.
Another subject that is really important to me and it is
personal to me are allergies. I am a survivor of anaphylactic
shock just a few years ago that almost killed me. I also want
to make sure that the other 20 million Americans with food
allergies know that what they are taking or what they are
eating is safe. A recent study found that 93 percent of all
medicines contain an allergen, and many popular over-the-
counter allergy drugs contain lactose. Do you believe that the
FDA has the power to require labeling of prescription and over-
the-counter medicines for food allergens and gluten?
Dr. Califf. We definitely have the power to require
labeling when it is indicated.
Mr. Frost. Three years ago, President Biden signed into law
the FASTER Act requiring labeling of sesame as a food allergy,
and also requiring HHS to submit a comprehensive government
report on food allergies within 18 months. That report has not
yet been submitted, and it is very frustrating to Americans
with food allergies and their families. Does this report fall
under the responsibility of the FDA, and, if so, would you be
able to provide an update on the status of it?
Dr. Califf. I will have to get back with you on that
because I am not familiar with that particular report. But we
are very familiar with the fact that allergies in the U.S. are
apparently growing and that there is a great need to make sure
we get this right.
Mr. Frost. OK. Yes, we would love to follow up on that. I
think we even gave a heads up about that question so you could
be prepared, but it is all right. We will follow up about it.
Mr. Frost. Thank you. I yield back.
Mr. Palmer. [Presiding.] The gentleman yields. The Chair
now recognizes the gentlelady from Michigan Representative
McClain for her 5 minutes of questions.
Mrs. McClain. Thank you, and thank you for being here
today. Commissioner Califf, you assumed the Office of the
Commissioner of the FDA in February 2022, correct?
Dr. Califf. That is correct.
Mrs. McClain. Thank you. When you assumed office, were you
aware that a manufacturer who made more than 40 percent of the
country's infant formula was voluntarily recalling all the baby
formula it made at its Sturgis plant?
Dr. Califf. I was very familiar because it happened on the
day I was confirmed, so I did not know before----
Mrs. McClain. So yes, thank you. So, I will take that as a
``yes.'' In the days and weeks that came after you assumed
office, were you aware that there was a shortage of infant
formula across the country?
Dr. Califf. Well, in the first days and weeks, there was
not a shortage, but as the shortage evolved, I was very much
aware of it.
Mrs. McClain. So yes, thank you. Were you aware that 10
states reached rates of over 90 percent of out-of-stock and
nationwide, 74 percent of stores had no infant baby formula?
Dr. Califf. Those numbers do not sound right to me, but
there was a lot of out-of-stock and absence of formula.
Mrs. McClain. Directionally, what do you think they were?
Could you say we were reaching crisis mode, or we were just
like short one or two cans?
Dr. Califf. It is closer to crisis and sure wanted to----
Mrs. McClain. OK. Thank you. Mr. Chairman, I would like to
enter into the record two internal email exchanges within the
FDA, the first dated February 4, 2022, in which the FDA
officials are discussing the potential for infant formula
supply issues and asking for media support from the White House
to educate the public; the second on February 19, 2022, in
which the FDA officials were discussing the supply issue that
were already happening.
Mrs. McClain. Now, despite these discussions within the
FDA, media reports, the President was not aware of the problem,
even though it was headlining in nearly every news channel and
every paper across the country for 3 months. So, my question
is, did the FDA not raise concerns about the potential shortage
even before the recall?
Dr. Califf. As you know, there is a record that says there
was a supply disruption task force that was put up during the
COVID crisis. It was also used for this purpose, working to----
Mrs. McClain. So, it was elevated?
Dr. Califf [continuing]. To the task force which has----
Mrs. McClain. Did the FDA raise concerns about a potential
shortage even before the recall? Yes or no.
Dr. Califf. I cannot speak for before the recall, but at
about the time of the recall.
Mrs. McClain. OK. Well, let me help you because I can tell
you the FDA did, in fact, raise the issues to at least nine
different White House officials, and President Biden took no
action. So, I would like to enter into the record an email
between the FDA and the nine White House staff, including
members of the National Security Council, Domestic Policy
Council, and the Special Assistant to the President for Public
Health.
Chairman Comer. [Presiding.] Without objection, so ordered.
Mrs. McClain. Thank you. This email dated February 17, of
2022, which was the day of the voluntary recall, shows the
White House in communication with the FDA about the recall. So,
I am just helping you out there.
Mr. Chairman, I would like to enter another email into the
record, an email dated February 20, 2022, just 3 days after the
voluntary recall, which shows the FDA Chief of Staff already
raising concerns about infant formula shortages and
communicating this concern with the White House.
Chairman Comer. Without objection, so ordered.
Mrs. McClain. Commissioner, here is my question. Why did it
take 3 months for President Biden to invoke the Defense
Protection Act?
Dr. Califf. I cannot speak for President Biden and that
particular decision. I will note, as I have already said, you
know, I do not have the emails that you are referring to, but--
--
Mrs. McClain. I will get them to your office, and I will
promise you I will get them to you in a timely fashion. I
guess, my question is----
Dr. Califf. But this evolved over time, so the exact timing
of when the DPA should have been brought in is something that
is a matter of discussion.
Mrs. McClain. ``A matter of discussion.'' That is your
answer. I mean, so your office has been in communication with
nine White House staffers. Either the FDA did not tell him or
he did not act. Which is it?
Dr. Califf. Yes. I think you have the emails, and I cannot
really comment beyond that.
Mrs. McClain. Well, you know, what baffles me is you make
about $200 grand. You are supposed to be in charge, but when
the you-know-what hits the fan, everybody runs for the hills. I
am going to switch topic.
Dr. Califf. Well, just hold on a minute. I----
Mrs. McClain. It is my time, sir, when asking about its
handling of this is unbelievable. I mean, you do not have an
answer. I would love to have an answer, but I am going to
switch gears.
Dr. Califf. Well, you overestimated my salary, which is----
Mrs. McClain. It is about $191,000, so that is pretty
close. But, Commissioner Califf, it costs millions of dollars
to prepare premarket tobacco product applications, ``PMTAs.''
Manufacturers have had products pending at your facilities for
years. I know we have talked about this, and you know the
concern of all the illicit and illegal products coming over
from China. When do you anticipate getting some results from
these American companies that have actually been waiting for
over 4 years on their tobacco products?
Dr. Califf. As we have already discussed, we are 99 percent
done with almost 27 million applications. We have, you know, 1
percent left to go. These are big decisions, and they are going
to be rolling out. We expect to be caught up, for example, with
the ones that are largest from the American Pediatric Group
that follows us by the end of this year.
Mrs. McClain. Wonderful. Thank you, sir. I yield time.
Chairman Comer. The Chair now recognizes Representative Lee
from Pennsylvania.
Ms. Lee. Thank you, Mr. Chair. As we have discussed today,
the FDA has a critical responsibility to ensure that our food
supply, medications, and medical products are safe and
effective, but the FDA does not hold this responsibility alone.
The Agency does not have the resources to singlehandedly ensure
the integrity of every product produced by every food, drug,
and device manufacturer. The private sector also has a critical
role in ensuring that their products are safe, a responsibility
that they need to take seriously.
Recent reporting has uncovered how Philips Respironics, a
Pittsburgh-based company and one of the largest medical device
manufacturers in the world, received hundreds of complaints
about its CPAP machines and ventilators prior to issuing a
recall in 2021, a recall that ended up being one of the largest
in history. Not only did the company receive hundreds of
complaints from hospitals, providers, and patients as far back
as 2010, but its own internal evaluations indicated their
machines were toxic, yet the company withheld this information
from the FDA and the public for more than a decade. They
continued to sell these hazardous machines enabling their stock
prices to soar to the highest levels in decades while the most
medically vulnerable in our communities--our infants, our
seniors, our veterans--suffered. In Pennsylvania, there are now
more than 700 personal injury lawsuits and class actions
against the company due to irreparable harm its devices caused
patients. Philips is one of the most egregious examples of what
can occur when corporations do not take their responsibility to
public health seriously.
From COVID-19 vaccine manufacturing failures to dangerous
levels in children's applesauce products, we have seen the
private sector repeatedly fall short. Dr. Califf, what is the
private sectors' responsibility in ensuring that medical
devices that are brought to the market are safe and effective?
Dr. Califf. As we have discussed multiple times today, the
primary first line responsibility is with a regulated industry.
This is a situation in which we oversee the industry, but the
industry has that primary responsibility to produce safe and
effective products, whether it is a device, a drug, or a food.
Ms. Lee. So, what investigative action or enforcement
actions does the FDA have, or does the Agency need to hold
companies like Philips accountable for regulatory noncompliance
and to deter future wrongdoings?
Dr. Califf. This has come up with regard to almost every
commodity now, that it would be better for public health, I
believe, if we had direct recall capabilities across the
spectrum of products that we regulate when we find problems,
such as you are referring to. I would also like to see a
bulking up of our post-market surveillance capabilities. After
all, every American has an electronic health record now, and
there is a lot that we can do so that we find out about these
problems earlier than we currently are. And we need to make
sure the manufacturers actually report in a timely fashion when
they do get problems that they are aware of.
Ms. Lee. So, over the years, the FDA has promised to
overhaul the way that it detects dangerous medical devices by
allowing more real-time data and medical registries. What
progress has the FDA made toward those goals?
Dr. Califf. Well, you know, this is actually work that I
have been involved in, in my academic life, for 30 years. So,
if you just think about it, everyone has an electronic health
record. Every important medical transaction essentially is
digitally captured now. We have multiple blocks in the system
that keep us from putting the data as best we can, so we are
very dependent on voluntary registries where either companies
pay for it or health systems pitch in, and then the FDA buys
the data.
I am pleased to say there is a lot of discussion with NIH
and other parts of HHS now about having better data pooling
capabilities, so that we know about these things in real time.
And we now have a model globally where it is happening in
Israel, where 100 percent of the population has real-time
electronic health record accessibility to detect problems but
also, importantly, to find advantages. Sometimes there are
surprises where something works better than expected, but right
now we do not know about it in real time.
Ms. Lee. OK. Looking at the time, I already know that I am
not going to get through this next question, so I want to
respect yours and my colleagues' time and yield back.
Chairman Comer. The Chair now recognizes Mr. Burchett from
Tennessee for 5 minutes.
Mr. Burchett. Thank you, Mr. Chairman. Thank you,
Commissioner. I appreciate you doing all of this without a
bathroom break, so it is great admiration for you there. I have
a question about the 2018 Farm Bill. It is about the
cultivation, sale, and transportation of hemp-derived products.
Since 2018, what regulations has the FDA put in place regarding
hemp-derived products?
Dr. Califf. Well, I mean, we have a law from you all
defining hemp as less than 0.3 percent THC, and you have given
us money to study the problem, and our conclusion, as it
relates to human health, is they are not safe enough to be
called a dietary supplement or a food. And so, we have asked
Congress to put together a regulatory pathway that will be
appropriate so these products are available, but they are
labeled, they are identified. And in cases, for example, gummy
bears packaged for children, there is a way for us to take
action quickly in those situations.
Mr. Burchett. Have any outside groups requested that the
Food and Drug Administration regulate hemp-derived products?
Dr. Califf. Yes, we have had multiple citizens petitions,
but as I have said, the requests have been to regulate these as
dietary supplements, and they do not meet the definition of a
dietary supplement because of elevated liver enzymes and other
health problems that we believe make them unsafe as
supplements. But they could be regulated in other ways and made
available if Congress thinks that is the right thing to do.
Mr. Burchett. Are you an M.D.? It is not in my notes, but
you were saying some medical things there, and I am curious.
Dr. Califf. I am a board-certified cardiologist, 35 years
of intensive care unit and outpatient practice, sadly, not
practicing right now.
Mr. Burchett. Yes, sir. So, you would question whether we
have a heart then if you are a cardiologist. Is that correct?
Dr. Califf. Let us just say the heart and the brain are two
different things.
Mr. Burchett. Let the record reflect that our commissioner
is punch-drunk from being up here so long, but thank you,
brother.
I am concerned about hemp, and I will tell you why. It is
not in my notes, and it always makes my people nervous when I
do this, go off the thing. My daddy fought in the Second World
War, and I can remember and I have seen videos of, you know,
``help us grow hemp to save the world.'' You know, they have
made rope out of it, and then, of course, it is a cousin of
marijuana, but it does not have the THC level. And they come
down here and we passed this thing in the Farm Bill, and all of
these folks that want to grow hemp, they all say, ``Oh, we have
got the greatest thing in the world.'' But dadgummit, I am a
United States Congressman, and I have got a little farm, and I
checked into growing hemp. It is not going to make you a
fortune, but I have to get a dadgum fingerprint to do it.
It just seems to me that the big boys in the cotton
industry, and I am sure they will be rushing up to my office
right after I say this, but they wrote these dadgum
regulations. You and I both know it. They do not want the
competition. They do not want hemp in there. You can watch the
videos. You know, these people say it is not the miracle that
they claim it is because there is a huge labor factor involved
in it, and it really ticks me off that these folks have been
fed this bill of goods, and, you know, it is just not
happening. It is not happening like it should. And I am
wondering, have you, anyone, you and your office had any
meetings with the cotton industry officials in which hemp-
derived products were mentioned?
Dr. Califf. I am not aware of any meetings for the cotton
industry. That would be an unusual industry for us to meet
with, but----
Mr. Burchett. Due to the fact that you are not ingesting
it, correct? OK. Well, you see that is another problem with the
product. It goes to two different, separate groups, and so I
think that is by design actually, the way, so that it keeps it
more complicated. Are you aware in the first 2 years of the
Biden administration that the value of hemp production in the
U.S. decreased by 71 percent? No?
Dr. Califf. Not aware.
Mr. Burchett. OK. I will get away from the hemp thing, and
I have only got 30 seconds. The Center for Tobacco Products, I
feel like they have continued to not tell the truth in some
cases to the American people. They tell us that vaping is
harmful or more harmful than cigarettes, yet--let us see--Dr.
Nancy Rigotti of Harvard concluded U.S. health agencies and
professional medical societies should reconsider their
cautioned position on e-cigarettes for quitting smoking. The
burden of tobacco-related disease is too big for potential
solutions such as e-cigarettes to be ignored. Would you say
that that is--I am out of time, but you get where I am going
at--is it more harmful than cigarettes if is not over-used, if
it is not abused?
Dr. Califf. Here is what I would say. Combustible tobacco
kills people. I was just over in the U.K. because we are having
a regulator. I went to Oxford, where Sir Richard Doll did the
British doctor study, the doctors who smoke died 10 years
earlier than the ones who did not. Vaping--if combustible
tobacco didn't exist, you would be horrified by what is in the
residue from vaping. When you think about that going into your
lungs----
Mr. Burchett. Sure.
Dr. Califf [continuing]. Over the course of decades, it is
pretty horrifying, but it is much less toxic in terms of all
the things that cause cancer and heart disease, the vaping,
then the combustible tobacco. So, that is why the term has been
used, ``harm reduction,'' to say if you have got someone using
combustible tobacco, they are a lot better off if they are
vaping, at least by those criteria, but compared to using
neither, there is no question that there is no benefit of
vaping other than if it helps you get off of combustible
tobacco.
Mr. Burchett. Tobacco is the one product, if you use as
directed, will kill you. So, I apologize, Mr. Chairman. I went
way over. Mr. Raskin, I apologize to you, too, brother. Thank
you, guys. Thank you, sir.
Chairman Comer. The Chair now recognizes Mr. Garcia for 5
minutes.
Ms. Garcia. Thank you, Mr. Chairman. Well, thank you, Dr.
Califf. I appreciate you being here and all your work and the
work of the FDA. I was going to talk a little bit about a
different topic, but I just want to clarify some of the truly
insane attacks on vaccines and just what happened during the
pandemic that we heard a little bit earlier today, which I
found to be really wild. I just want to reiterate that during
the pandemic, we lost 1.3 million American lives. In my city
alone, we lost almost 1,300 lives back home in California in
the city of Long Beach, and we know that many of the folks that
we lost would have lived if they had had access to the vaccine
or had been vaccinated. We know that for a fact. We know the
success of vaccines, and certainly, today, with more data, we
know how effective they have been.
What is concerning now, as we know, is early childhood
vaccinations are reaching new lows. We are having other
diseases come forward, like measles and other diseases, that we
are now not addressing because all of this vaccine denial that
is happening, unfortunately, not just across this country, but
also here in Congress and in this chamber. Vaccine hesitancy
outside of what happened to COVID-19 is going to cause this
country great harm. And instead of doing the responsible thing,
earlier today, we had folks on the other side attack vaccines
with, in my opinion, conspiracy theories and with treatments
that we know are ineffective and have shown not to work.
We also know this is not just a matter of personal choice.
Across the country, there are millions of people who do not
have the choice, who cannot get vaccinated because it might be
too young, they might be immunocompromised or have other
underlying health conditions. And so, America's high
vaccination rates is something that has helped our country for
so long that the FDA has been so involved with, and it is very
concerning that our vaccination rates and our vaccine process
is being attacked. I also want to note that there have been
comments made over and over again about vaccines, about somehow
vaccines causing turbo cancers or vaccines causing miscarriages
or that the COVID vaccine somehow has no effect on healthy
people, that are all false. And I know that you know this, your
team knows this, and I just want to reiterate that for the
public.
What I did want to say, and I have less time to do so, but
I want to just to transition and just thank you and your team
for what you are doing as it relates to listening to the LGBTQ+
community, myself as an openly gay person. I really appreciate
the FDA's move and decisions allowing particularly gay men to
be a part of the solution. When it comes to health, when it
comes to blood donations, when it comes to other forms of
surrogacy, the FDA has really stepped forward and especially on
the recent change in guidelines as it relates to the LGBTQ+
Americans and gay men being able to donate blood. I think that
as a gay person, it is comforting to know that if there was an
emergency where my blood or other blood was needed, that we
would have that same right, and thanks to all of you.
Dr. Califf, in the time I have remaining, could you
describe the FDA's draft proposal and how this helps advance
equality while also expanding the donor pool as relates to the
recent changes you are all making?
Dr. Califf. All right. Simply, first of all, let me just
say I appreciate your comments. Just back on the vaccines, just
one point I want to make, all medical interventions have risks
as well as benefits. In the earlier discussion, if you want to
be alive and not be in an intensive care unit, you are better
off getting vaccinated. There are some people that have side
effects, I just want to note that because it is important to
take care of those people also, but the benefits far outweigh
the risks.
Simply put, the question that you asked, people had raised
this issue about donation for many years, and we did a study
which showed that a questionnaire about behavior can do much
better than just the time-based thing related to the LGBTQ
community. So, we are well along in that now, and it looks like
it is really going to work, and we will be consistent with what
other countries are doing. So, we are really glad we were able
to come to this conclusion.
Mr. Garcia. Great. Well, thank you very much for your work
and for your team's work. I yield back.
Chairman Comer. The Chair now recognizes Mr. Fry from South
Carolina.
Mr. Fry. Thank you, Mr. Chairman. Commissioner, thank you
for being here. Congress enshrined harm reduction as a kind of
a pillar in the 2009 Tobacco Control Act. The FDA's 2017
strategic plan embraced that harm reduction with the former FDA
commissioner, noting that successfully implementing harm
reduction could dwarf the introduction of any new medical
technology and its positive impact on our public health.
Unfortunately, the Center for Tobacco Products' current
leadership under the Biden administration seems to have
abandoned harm reduction as a foundational principle of its
tobacco policy by refusing to authorize other tobacco products
that have been pending before your Agency for years. Your
Agency is failing to acknowledge the need for real change to
provide better options for 28 million American smokers.
A recent study from Yale University found that for every
0.7 milliliters of e-cigarette, e-liquid that goes unsold due
to flavor restrictions, 15 additional cigarettes are sold. It
was also found that e-cigarette flavor restrictions in place
for at least a year yielded 20-percent increases in sales of
cigarette brands disproportionately used by underage smokers.
Can you explain why the FDA and the CTP have authorized 900 new
cigarettes in the time that it has authorized only a handful of
vapor products?
Dr. Califf. First of all, we have not abandoned the
principle that you described, but it is a little more
complicated than that. It is the responsibility of the company
to produce a data set that shows that the benefits of
combustible tobacco reduction exceed the risks due to getting
teenagers addicted. Vaping products get people addicted to
nicotine if it is a new user, so we have always got to balance
that risk of getting millions of teenagers addicted to the
benefit to adults with combustible tobacco. So, there are 23
products now in the market that have met that standard, and
other companies are welcome to submit their data and produce
the data showing that they meet that public health standard.
Mr. Fry. Does CTP still believe in the continuum of risk of
nicotine products, and does the FDA think it is helpful for
adult smokers who would otherwise continue smoking cigarettes
to switch from combustible cigarettes to smoke-free
alternatives? Yes or no.
Dr. Califf. There is not a ``yes'' or ``no'' answer to that
because for adults, the best thing to do is to stop using
tobacco products altogether. The second best would be to switch
to a vape, but the very best would be, as we already discussed,
if you look at the residue from vaping relative to no use of
any tobacco product, it raises a number of issues over the long
term.
Mr. Fry. I think the concern that I have, sir, and I think
the concern that many people share is that there seems to be an
abandonment of a congressional, not only a directive, that we
are going to pursue harm reduction as an actual strategy in the
country. And if you have 900 cigarettes that have been approved
and only a handful of vape or other products, that seems to be
divergent to what Congress has outlined for your Agency. Would
you not agree with that?
Dr. Califf. I am not familiar with the 900 term, so I would
have to go back and look at that, but we have not abandoned the
idea that the company should show that it can successfully
transition people from combustible tobacco to vaping in a way
which does not increase the risk to teenagers of getting
addicted to nicotine and, therefore, being susceptible to
switching to tobacco.
Mr. Fry. So, in addition to vaping, you have other products
like Zyn or something similar to that. Would you consider that
to be a harm reduction product?
Dr. Califf. You know, we discussed this earlier. The term,
``harm reduction,'' tends to be used by industry to cover a lot
of different areas, but if there is a product that can cause
someone to stop using combustible tobacco and not get teenagers
addicted to nicotine, that is a benefit.
Mr. Fry. Commissioner, you know, reading about the FDA,
there seems to be some pretty heavy backlog within the Agency.
How are you utilizing your workforce to innovate the FDA, and
what type of metrics are you using to make sure that you are
being productive not only for companies that have products that
go before you, but for the American people?
Dr. Califf. As we discussed earlier today, I think everyone
was surprised by the over 26 million applications that came in,
and there was a big backlog, and we have now cleared 99 percent
of that backlog. But just like all other parts of FDA, when
applications come in, we keep track of where we are, and as we
are employing better technology and we are just going through
some organizational changes, you are welcome to read the
Reagan-Udall report that we commissioned to guide us there. So,
we are hard at work. We want to meet the timelines like we do
in all the other product areas, and we are going to do that as
fast as we possibly can. You make a good point there.
Mr. Fry. Thank you, Commissioner, and thank you, Mr.
Chairman. I yield back.
Chairman Comer. The Chair now recognizes Ms. Pressley from
Massachusetts for 5 minutes.
Ms. Pressley. Thank you, Commissioner, for joining us
today. First, let me just also acknowledge and thank you for
your responsiveness and your swift action on my outreach to you
regarding formaldehyde in chemical hair relaxers, also the
shortage of children's Tylenol and Motrin. Personally, as
someone living with alopecia totalis, I also appreciate your
efforts in that regard, and finally, for the purposes of my
question line today, reproductive justice.
Dr. Califf, last year the FDA took pivotal steps to protect
medication abortion access, including by allowing abortion
pills to be prescribed by telehealth and distributed by retail
pharmacies. Medication abortions accounted for 63 percent of
all abortions performed in the United States last year. If
mifepristone is pulled from the market, access to routine
medical care would be jeopardized for people across the
country. As part of their draconian, unpopular goal for a
national abortion ban--let us call it what that is--forced
birth, which for many will result in forced death, Republicans
continue to try to block access to medications, like
mifepristone, by spreading baseless conspiracy theories. The
fake news is rampant.
I have a teenage daughter, and we like to play a game
called ``Two Truths and a Lie''. So, if you will indulge me, we
are going to do some variation of that right now. I want to use
my platform to clarify some of this disinformation by playing a
game called ``Fact or Fiction''. Dr. Califf, I will say a
statement and you will reply with just one word stating if it
is fact or fiction. Let us start with this. Fact or fiction:
the FDA conducted a rigorous review of extensive research on
mifepristone.
Dr. Califf. Fact.
Ms. Pressley. Correct. That is a fact. Mifepristone has
been on the market for almost 24 years, and more than 100
studies have affirmed its safety since. Fact or fiction: judges
know better than public health experts if medication abortion
is safe.
Dr. Califf. I cannot comment directly on that because the
Supreme Court is currently adjudicating a case that involves
it. But I am on record, and so are all of us, that it would be
bad for the entire system of drug development and availability
of medications in the United States if judges begin overruling
the FDA as a matter of routine.
Ms. Pressley. Thank you. So that is fiction. The FDA, not
the courts, determines the safety of drugs. Fact or fiction:
mifepristone as a form of medication abortion is safe and
effective.
Dr. Califf. Fact.
Ms. Pressley. Correct. That is fact . Research shows that
less than 1 percent of patients experience serious side
effects, posing fewer risks even than Advil or Tylenol. The
facts are adding up. Mifepristone is a safe, effective, and
routine form of healthcare that remains necessary and legal
across the Nation. Now, this may be a game for today's hearing,
but unlike Republicans, I have no interest in playing games
with people's lives, and this is gravely serious. For many,
especially black women, pregnancy and childbirth can be life
threatening.
Now, I know this is a shock to the far-right extremist old
white men making these decisions, but there are hundreds of
reasons why someone might want or need to terminate a pregnancy
with medication abortion, and policymakers and judges should
not be the ones making decisions for them. If Republicans and
anti-abortion extremists have their way, access to mifepristone
will be cut in every state, blue or red, even in my district,
the Massachusetts 7th, where abortion care is legally
protected. Since I have been elected to Congress, I have been
proud to lead the Abortion Rights and Access Task Force under
our Pro-Choice Caucus, fighting alongside my colleagues for
mifepristone access. I will continue to fight to affirm
abortion care as the fundamental human right that it is, and I
urge my colleagues to do the same. Thank you, and I yield.
Chairman Comer. The Chair now recognizes Mr. Burlison from
Missouri for 5 minutes.
Mr. Burlison. Dr. Califf, in May 2022, you made an
appearance on CNN and claimed that the leading cause of death
in the United States is ``misinformation.'' Do you recall being
on that interview? Do you recall making that statement?
Dr. Califf. Yes.
Mr. Burlison. OK. You are right because the claim that you
went on to say that in COVID, that you need to get vaccinated,
saying, ``Somehow the reliable, truthful messages are not
getting across, and it is being washed out by a lot of
misinformation, which is leading people to make bad choices.''
Now I would like to draw your attention to a tweet that I know
that you are familiar with. On the post forward, it says, ``You
are not a horse. You are not a cow. Seriously, you all, stop
it.'' Another sarcastic tweet from the FDA read, ``Hold your
horses, you all. Ivermectin may be trending, but it is not
authorized or approved to treat COVID-19.'' The FDA put out
these messages in 2021 and made similar posts on the other
platforms to discourage people from using ivermectin to prevent
or treat COVID. In January 2022, the FDA was sued by a number
of doctors who claimed that you are practicing medicine as an
organization. As part of that settlement, you were forced to
delete these. Is that correct?
Dr. Califf. That is correct.
Mr. Burlison. So, in fact, the U.S. Court of Appeals said
the FDA is not a physician, and even tweet-sized doses of
personalized medical advice are beyond your statutory
authority. Is that correct?
Dr. Califf. That is what the court said.
Mr. Burlison. Pretending that ivermectin is dangerous or
claiming that it is horse medicine, would you not agree that
that is the exact definition of misinformation?
Dr. Califf. I would not agree with that. There are very
well-done randomized trials showing no benefit of ivermectin.
Mr. Burlison. And you knew that in 2021?
Dr. Califf. I was not at the FDA.
Mr. Burlison. No, you did not know that in 2021.
Dr. Califf. I mean, I was not at the FDA in 2021.
Mr. Burlison. Dr. Califf, I will ask the questions. Even to
this day, you have to correct misinformation about ivermectin.
Let me ask this. Ivermectin won the Nobel Prize, did it not?
Dr. Califf. It won the Nobel Prize for the treatment of
worms.
Mr. Burlison. In humans. In humans, right? And next to
penicillin and aspirin, it is considered one of the wonder
drugs for use and its effectiveness in humans, correct?
Dr. Califf. For treating a variety of infections that would
commonly be known as worms, not for COVID, and it is a medicine
for animals also. Both are valid uses.
Mr. Burlison. Yes. At the end of the day, you created, in
my opinion, and I think that it is obvious because you are
still to this day having to correct people who think that a
form of treatment that has been used how many times would you
say, historically, has ivermectin been successfully used in
medical treatments?
Dr. Califf. Successfully used for worms, but no effective
treatment for ivermectin----
Mr. Burlison. It has been administered in humans billions
of times over the last, what, 30 years, correct?
Dr. Califf. Again, for the treatment of worms.
Mr. Burlison. Dr. Califf, let me ask this. Do you think
that tweets like this garner credibility to an organization
like the FDA? Do you think that snarky tweets that I would
think that my teenage daughters might write, do you think that
that garners credibility with the FDA and the American people?
Dr. Califf. I cannot really comment on that, and, again, I
wasn't at the FDA when that tweet was put out.
Mr. Burlison. Well, I am glad that the courts told you to
remove these tweets because it is snarky. I think it is
demeaning to the American people and certainly demeaning to
people, I believe, in my district. Thank you, Mr. Chairman. I
yield the rest of my time.
Chairman Comer. I am going to try to get a quick question
in here, Commissioner. You had mentioned in a previous
question, talking about hemp-derived CBD oil, that is non-THC
or 0.3 or less. You mentioned that you didn't think the FDA
could ever approve that as a nutraceutical. Is that the FDA's
position or not because there are a lot of people in the
industry, in the hemp-derived CBD industry, that believe that
CBD should be treated as a nutraceutical just like supplements
and vitamins at GNC and Vitamin World and places like that.
Dr. Califf. You are correct, and we have had a number of
citizens' petitions from people that have had that belief. But
the research shows, for example, elevation of liver enzymes,
which are very concerning, that if people take this over time,
that there is going to be damage to the liver, which could lead
to things like liver transplants.
Chairman Comer. And I have to say this, and I have seen
this in Kentucky with many different CBD manufacturers, there
is a big difference. They are CBD entities. Because it is the
wild west because the FDA will not regulate this product, there
are companies with labs that would be as good as anything that
Merck or Johnson & Johnson would have, and then there are
people operating out of the garage of their house. So, the
reputable CBD manufacturers in America, I believe, strongly
hope that the FDA will come in and not just take samples
because these companies are not all the same. You agree with
that, right?
Dr. Califf. I would say that is a characteristic of every
industry that we regulate, and often the good players are
penalized because of things that the bad players do. I come
back to the referee analogy. That is where a good referee can
be very helpful, but the referee needs a rule book that says
here are the rules, and you guys write the rules, so we would
really like it if we had a set of rules.
Chairman Comer. I am trying to play a small role in that
moving forward, but thank you. Now, the Chair recognizes Ms.
Crockett from Texas for 5 minutes.
Ms. Crockett. Thank you, Mr. Chair, and Dr. Califf, thank
you so much for being here. You are a brave man. I do not know
who would want to sign up for your job, especially in a time in
which it seems like we do not believe in science or we do not
know what data is or we are just going to ignore it. I am not
really sure. I do not know how long you were asked about
ivermectin. And let me tell you something. I do not know if you
have ever testified in court, but you will be a great witness
because you refused to answer the way that he wanted you to,
which would have been, again, putting out misinformation
because I do want to do a quick level set on something, and I
do not know how we continue to come back to this, but let me
just ask you a few questions. Was COVID-19 real?
Dr. Califf. Yes. I had it myself twice. I think twice, once
or twice.
Ms. Crockett. Did people die?
Dr. Califf. Just in the U.S. alone, over a million people.
It was in the top three causes of death for many months. You
know, I was an intensive care unit doctor. When I came to FDA,
I stopped practicing, but my friends in ICUs were overwhelmed.
Hospitals had to have trucks backing up to the hospital because
there wasn't enough room for all the dead people.
Ms. Crockett. And did vaccines save lives?
Dr. Califf. Yes. Thank you for asking that again. People
that are up to date on their vaccines have a significantly
lower risk of being dead or admitted to an intensive care unit
compared to those who are not up-to-date on the vaccine, and
worst of all are people not vaccinated at all. That is true on
the individual level. If you look at counties in the U.S., the
counties with a higher vaccination rate have lower death rates
from COVID. If you look at countries, you see the same general
relationship. So, the vaccines have been highly effective.
Ms. Crockett. Thank you so much.
Dr. Califf. Not perfect, but highly effective.
Ms. Crockett. I understand. I do not know that there is any
perfection. I know that there is none in this chamber.
Nevertheless, as a result of an administration that believes in
science and data, we now have ARPA-H, which ARPA stands for
Advanced Research Projects Agency for Health, and my district,
luckily, was the recipient of an ARPA-H customer experience
centers. And I am so excited because this means that as we are
looking at trials, as we are looking at diversifying them, we
will have a great opportunity right there in Texas 30. It is a
huge investment in science to make sure that we can save lives
and when the next pandemic arrives, we will actually be
prepared and have science so that we can stay on top of this
because the last time I checked, and, Doctor, correct me if I
am wrong, having a leader suggest that we should inject bleach,
are you aware of anyone being cured of COVID-19 because they
injected bleach into their body?
Dr. Califf. I am unaware of any such thing. If I might
comment in general, and this relates back to the discussion
about ivermectin, I came along when no one knew what caused a
heart attack. That was what I focused on. We tried 100
different things for the treatment of heart attack. Only a
couple of them worked. The others did not. And the only reason
we knew what worked is we went from the idea to doing a well-
conducted study, a randomized trial, and then if it worked,
then all the practitioners began to adopt it and use it. So, we
now treat heart attacks by going to the cath lab, opening the
artery, and some medicines that work.
Ivermectin has been studied multiple times in randomized
trials. No benefit, but it is highly effective for the
treatment. I use the word ``worms'' as a generic term for the
kinds of infections that typically occur in places like Asia
that can be devastating. It got a Nobel Prize because it is
effective for those, and it has been a lifesaver, but it has
been ineffective in COVID.
Ms. Crockett. I completely understand. The last area that I
am going to touch on in my last 45 seconds, because I am a
woman out of the state of Texas, there is no way that I am
going to have a conversation and not talk about reproductive
access. So out of curiosity, would you consider the medical
management of a miscarriage to be potentially a lifesaving
usage. Yes or no.
Dr. Califf. I have to decline to answer that because it is
currently under adjudication by the Supreme Court.
Ms. Crockett. That is perfectly fine. That is perfectly
fine. I am going to tell you yes, but I am going to give you
another question that you can answer. Would you consider
erectile dysfunction as a lifesaving usage for Viagra?
Dr. Califf. Not lifesaving.
Ms. Crockett. Not lifesaving. OK. Well, I am going to tell
you that based on my research, that mifepristone actually has
lifesaving characteristics, yet Viagra does not, and for those
that do not know, Viagra, from my understanding, is actually
nearly 10 times greater as it relates to risk of death, yet for
some reason, it is not sitting in the court right now. And I do
appreciate the fact that you laid out that when it comes down
to getting drugs approved, they actually go through trials. It
is not just randomness.
You take the randomness, you then say maybe there is some
evidence here, and then you put it through the wringer. After
putting it through the wringer for decades, women's lives have
been saved, and as a representative from the area that Roe v.
Wade actually initiated, I am appalled because for whatever
reason, some people want us to go back to horse and buggy in
this country. And I think, since now maybe we have the
internet, maybe we should take advantage of it, and we should
not say that we should remain in the times of horse and buggy.
And so, with that, thank you for the work that the FDA
does. I respect your research. I recognize that the courts do
not do research. I also recognize that this chamber seemingly
does not care about research, but because of the work that you
do, there are lives that are being saved, and I need you to be
funded to the fullest extent to make sure that we can continue
to save American lives. Thank you.
Chairman Comer. The Chair recognizes Mr. LaTurner from
Kansas.
Mr. LaTurner. Thank you, Mr. Chairman. Commissioner, thank
you for being here today. FDA holds the responsibility of
ensuring the safety and integrity of our Nation's food, drugs,
and consumer products, a responsibility that not only impacts
our economy, but also the health and well-being of every
American citizen. However, this FDA has failed to meet its
mission statement and is defined by crisis from persistent drug
shortages to the most significant disruption to the infant
formula market in history. We cannot afford to overlook these
critical failures. The well-being of all Americans depends on
it. Commissioner, I look forward to hearing from you today on
how to address these pressing issues.
Despite the backdrop of food and product safety issues
plaguing your organization, FDA continues to chase nutrition-
related policies like front-of-pack labeling, which are
arguably outside of FDA's purview. Can you explain to the
Committee what authority you feel FDA has to pursue nutrition-
labeling policy while heavy metals exist on our food supply,
illicit Chinese tobacco products remain accessible, and 263
drugs remain in shortage?
Dr. Califf. We actually have a law that instructs us about
food labeling that we are adhering to in this case, and I would
remind you, we have a shortened life expectancy in this
country, particularly in rural areas that is largely driven by
diet and poor nutrition. I am just from South Carolina. It
seems to me that putting the information on the front of the
package is probably more likely to get the useful information
so people can make wise choices. That does not seem to me like
something that should be that hard to get to. If you put it on
the back, if you are like me, when you go to the store, you are
unlikely to look at it. If it is on the front, you are going to
see it.
Mr. LaTurner. Can you tell me where you derive the
authority to do it, though, specifically?
Dr. Califf. Yes. We are glad to get with your staff and go
through the details of that, but we believe we do have that
authority.
Mr. LaTurner. I look forward to seeing that.
Mr. LaTurner. Do you feel it is a best use of taxpayer
dollars to shape American eating patterns in lieu of addressing
these other critical issues? I listed a few issues that seem
like a pretty big deal.
Dr. Califf. Certainly, tobacco is a huge one, but I would
have to say if we look at the fact that we have the lowest life
expectancy of any high-income country, it is being driven by
chronic diseases, which are being driven by diet, and so to say
that we should pay no attention to diet is a mistake. Now,
shaping what we are doing is proposing to give people the
information they need so that they can make healthy choices and
reduce these alarming rates of obesity, diabetes. I am a
cardiologist, vascular disease. I tell my cardiology colleagues
we have got no problem with business in the future in
cardiology.
Mr. LaTurner. I would only have a limited amount of time. I
pointed to front-of-pack labeling as an example, but it appears
the Agency has a number of outstanding rulemakings and goals
that are not related to food safety: the definition of
``healthy,'' a symbol for healthy, the dietary guidelines for
Americans, dietary guidance statements. The list goes on. Can
you please tell the Committee and consumers how all of these
pieces fit together? My concern is that not only are you
pursuing actions that you do not have the authority for, but
you are also painting a terribly confusing landscape of rules
and advice about what to eat.
Dr. Califf. Well, I would be happy to work with your staff
on going through this in more detail. But in short, what we now
know about diet, it is a pattern of eating over time that is
important in how long people live and whether they are burdened
by chronic diseases. It is not one specific thing. It is
multiple constituents of the diet when eating regularly in a
pattern create the kinds of health problems that are really
ravaging our country right now. If you look at rural areas in
particular, we are seeing alarming premature death rates that
are going in the wrong direction, actually, for the first time
in 50 years.
Mr. LaTurner. You said that earlier. My question is
specifically all of these different initiatives, how they work
together, and I look forward to getting an answer on that to my
actual question. It has been brought to my attention that
illicit flavored disposable e-cigarettes now make up a majority
of the entire e-cigarette market, which most of these products
are coming from China. Can you speak to the factors that have
allowed this issue to materialize and what your Agency plans to
do to rectify the situation?
Dr. Califf. Yes. Thanks. I mean, we have been over this
several times already this afternoon, but in brief, no one
anticipated 27 million applications for vaping products when
the door was open for applications. It has been a problem that
is quite large and that we are gradually making progress in.
Mr. LaTurner. What are you doing about it?
Dr. Califf. Warning letters, civil money penalties,
injunctions, and seizures, all of the above, and I hope that we
will continue to be able to increase our presence out there in
the field. Right now, we get no user fees from the vaping
industry, and that money would enable us to put a lot more
people in the field to take down these operations that you are
talking about.
Mr. LaTurner. It sure feels like warning letters are not
getting the job done. Can you walk us through whether and how
you personally have communicated these concerns to DOJ and
Customs?
Dr. Califf. We have had direct meetings, and I have
personally gone to several places of import to meet with the
Border Patrol and Customs people who are there when the stuff
comes in. By the way, if you want to get an education on this,
go to the International Mail Facility.
Mr. LaTurner. What about the DOJ?
Dr. Califf. Direct person-to-person meetings with DOJ. I
have the key person's cellphone number to call in off hours.
Mr. LaTurner. I am over time. I yield back, Mr. Chairman.
Thank you.
Chairman Comer. The gentleman yields back. The Chair now
recognizes Ms. Tlaib from Michigan.
Ms. Tlaib. Thank you, Mr. Chair. Thank you, Commissioner.
We are almost done. I am really pleased that you are here. I
had, in the last 2 weeks, a handful of community events, and
FDA issues did come up. I want to start with this. You know,
how much of what FDA is doing covering specifically food
safety? I mean, how much of your resources right now is
dedicated to food safety?
Dr. Califf. For detail, I would refer you to the Reagan-
Udall report that we commissioned last year that has the
detailed information.
Ms. Tlaib. Is it like 50 percent or?
Dr. Califf. Nowhere near 50 percent.
Ms. Tlaib. OK.
Dr. Califf. Although the ``F'' in ``FDA'' stands for food.
Ms. Tlaib. Yes.
Dr. Califf. On the medical product side, we have had very
good funding because of the user fees, but not on the food
side.
Ms. Tlaib. Mr. Chair, I do want to submit for the record an
article, ``The FDA's Food Failure.''
Chairman Comer. Without objection, so ordered.
Ms. Tlaib. I need to talk about this because it comes up a
lot. FDA right now has the authorization to regulate water to
keep deadly toxin out of produce, right?
Dr. Califf. The water is actually mixed. We regulate
bottled water. The water supply itself is regulated by EPA, as
just noted. Water on farms as it goes from where cattle may be,
for example, the plants, that is an area----
Ms. Tlaib. Yes, Commissioner. So, I am going to read from
the article--I think this is important--just as background, and
I know it was, like, a couple of months maybe after you got
confirmed. ``By the time FDA officials figured out it was
spinach that was making people sick in 10 states, sending three
people into kidney failure, it was too late. It was mid-
November 2021, and the package salad's short shelf life had
passed. There was no recall. By the time FDA officials got
inspectors on the ground, spinach season was over, the fields
in the production facilities were empty, which made it
impossible to pinpoint the source of contamination. The cause
of the outbreak was likely never fixed.'' Have we fixed this
kind of issue, again, what was suspected because of previous
kind of contamination, it could be the water that touches the
food, used to clean the produce?
Dr. Califf. You know, when you say is it fixed, you know,
what I would say is the economist rated the U.S. Food Safety as
tied for first in the world----
Ms. Tlaib. I know, but, Commissioner----
Dr. Califf [continuing]. But is it completely fixed? Of
course not.
Ms. Tlaib. Yes. Look, I work on Get the Lead Out Caucus,
and my colleagues know I am a leader on this issue on quality
of water. I want to help you. This is more me trying to show my
colleagues that if we really cared about food safety, which
every single one of our constituents does not use every single
medication that everybody talked about, but they sure had
gathered produce, touch the food industry in every way. And so,
I just want to get to the bottom of what we can do together to
ensure that you have authorization to oversee water quality
that touches our food.
Dr. Califf. All right. We are just finalizing now. You
know, there are 10 rules of FSMA, Food Safety Modernization.
Ms. Tlaib. Yes.
Dr. Califf. The agricultural water rule is one that is very
pertinent, and it has to do with what farms should do, for
example, if there are cattle upstream from where the produce
is. And so, you know, there is a list of things we need. We can
be in touch with your staff.
Ms. Tlaib. So, we do not really have anything right now
that gives you any authority over the use of water on produce?
Dr. Califf. Only in reaction to what happens, but not----
Ms. Tlaib. So, after contamination?
Dr. Califf. Yes, not preemptive.
Ms. Tlaib. OK. Well, that is important for us to know, and
I hope the Chair and I and others can work on this. The other
question I have, and it is regarding food, too, and I am sorry,
I know your medical background, but food is so incredibly
important here. Does the FDA have authorization to oversee food
packaging, right? How about PFAS, the use of PFAS? What are we
doing about the use of packaging around PFAS, which is----
Dr. Califf. As PFAS relates to the surfaces of food
containers, and, like, I was surprised to hear that we even
regulate dishwashers when I came in because of this, yes, and
it is a big----
Ms. Tlaib. So, how do we do it?
Dr. Califf. We have studies that sample but at very low
rates because the funding is quite low.
Ms. Tlaib. We do not really enforce it?
Dr. Califf. Not to the extent we could. Let me just say,
you know we are going through, as we have discussed, the
largest reorganization in the history of the FDA food is the
entire focus of----
Ms. Tlaib. Yes, Commissioner. I mean, I hear that we have
some of the highest rates of cancer in the world. Is that
correct?
Dr. Califf. We do.
Ms. Tlaib. Yes. I really think we should really prioritize.
So, when we talk about reorganization FDA, I do hope we can
work all together in a bipartisan way to make sure that food
safety is at the center of making sure that we have resources.
Again, this is just me highlighting to my colleagues and really
educating the American public that we need to do more around
food safety.
Dr. Califf. I appreciate that. I do want to point out, our
new head of the Human Foods Program is Jim Jones, who had a
career at EPA. He is an expert on the kinds of things that you
have raised, and our reorganization plan would call for really
beefing up the chemical safety part of FDA because we have had
a very small staff historically in that area.
Ms. Tlaib. Yes, and I agree. I mean, I think the EPA is
moving, you know, it is slow, but they are moving toward trying
to, again, prevent exposure of PFAS through other rightways.
But the fact that we are trying to stop it within water within,
again, contamination on our environment, earth, and so forth, I
think we have to really be as aggressive when it comes to our
food quality. Last question, if I may, and I promise this last
question you gave somebody else. Do you believe our country is
experiencing a vaping epidemic?
Dr. Califf. To the extent, ``epidemic'' is defined as
millions of people. yes.
Ms. Tlaib. OK. What do you think we need to do as a
Congress to protect our residents, especially our children
right now? And I know we got questions about it, But, like,
what do you think we should do because vaping comes up so much
for all of us, no matter for a Republican, Democrat?
Dr. Califf. Well, I think it has to be prioritized. We need
more resources.
Ms. Tlaib. Is it the disposables? We are not authorizing--
--
Chairman Comer. That will be the last question. Feel free
to answer that.
Ms. Tlaib. Thank you, Mr. Chair.
Dr. Califf. The vaping industry does not pay user fees, and
so we have a limited staff dedicated to this. We really need to
ramp up our staff. That would be the most important thing you
could do, and you are doing a good job of staying on our case.
I will say that, so that needs to continue. It is part of the
process.
Chairman Comer. The Chair now recognizes Mr. Cloud from
Texas for 5 minutes.
Mr. Cloud. Thank you, Chairman, and thank you,
Commissioner, for sticking with us through the day. I
appreciate you being here. Your Agency, of course, is
responsible for the evaluating the safety and effectiveness of
medications that millions of Americans rely on, and I am sure
that your scientists and those working there view themselves as
committed public servants. I wanted to talk to you though,
about something that is concerning, I think, to a lot of
Americans, and that is potential conflicts of interest.
In 2018, the Journal of Science found that 11 out of 16
medical examiners who left the FDA ended up working for
companies they were previously responsible for regulating. That
is roughly two-thirds or more than two-thirds. These wealthy
and powerful pharmaceutical companies recruit former FDA
employees with lucrative job offers in order to leverage their
connections. Existing law imposes only a very limited
restrictions on this revolving door. Former employees are only
prohibited from lobbying the FDA for very few specific matters,
and they are only subject to a 2-year cooling off period.
Meanwhile, you know, former FDA employees can go and collect,
you know, pretty substantial paychecks from companies once
regulated.
Just 2 months after leaving the government service, the
lead medical officer for the FDA's Office of Vaccine Research
and Review took a high-level job at Moderna. There is another
one. Recently, the medical officer who decided on behalf of the
FDA whether the clinical data from Moderna vaccine medicine
approval standards also took a job shortly after that with the
company just months after the vaccine received license. And so,
I think you can see why many of Americans can look at history
of this and be very, very concerned about what is going on.
Especially, you know, coming out of COVID FDA, along with a
number of agencies, I think we can all look back and see there
were a lot of lessons learned and was not handled really in the
best. And so, right now, we are trying to restore the American
populace's faith in a lot of these institutions that you are
now leading and have just taken up the mantle on recently with
again.
Can you speak to that issue? You know, with regard to these
two FDA officials specifically, did either of these recuse
themselves from any matter at the FDA while seeking these jobs
that you are aware of?
Dr. Califf. Well, I mean, this last point you made is a
very important part of the system regardless of how you feel
about the other parts of people moving from FDA to industry or
industry into FDA. You are prohibited from seeking a job in the
area that you are regulating unless you recuse yourself. So
that is something that----
Mr. Cloud. The FDA has refused to acknowledge on these two
individuals, Dr. Doran Fink and Dr. Jaya Goswami, I believe is
the pronunciation, whether or not these two recused themselves
of their involvement in these areas that they were leading
before going to Moderna. So, why has the FDA refused to provide
the information?
Dr. Califf. I am unaware of what you are describing. I will
certainly go back and look into that. Again, if they were not
seeking employment while they were regulating, then they did
not violate anything.
Mr. Cloud. Do you know that they sought guidance on
approval with the FDA--I am sorry--the FDA's Ethics Office
before taking those jobs?
Dr. Califf. I would expect that they would have, but I do
not know that. You know, we will have to go back.
Mr. Cloud. Can you understand the concern, and what
recommendations would you provide? I think it was 1981 to 2019,
9 of the 10 commissioners went into work for pharmaceutical
companies from leaving their office. You were one of those as
well. I am not suggesting any impropriety at this point, but
you can certainly see, I think, how this would create a huge
concern, a conflict of interest, when the American people are
looking at this. What recommendations would you suggest that we
bring up to make sure that the American people can know that
the decisions being made because here is the thing. You are
supposed to give oversight to these companies, whether you are
in food or drug industry, and you know that you are not going
to get a job. Not you specific. I am speaking, you know,
someone who wants one of these high-paying jobs, after leaving
the Department knows that, you know, they are not going to be
hired by someone who was very strict on them, and so there is a
built-in incentive, of course, to be lax in these things. And
so, what can we do in Congress to provide a level playing field
that will help restore the public's trust in this area?
Dr. Califf. Glad to engage in a discussion with you on
that, but I do want to point out something about this. Inside
the FDA, we are dealing with highly technical issues that
require a lot of expertise. There are many people who work in
industry and then volunteer to come to FDA for a much lower
salary because they are attracted to the issue of understanding
the science and making good decisions based on it. By the same
token, there are people who work within the FDA for a period of
time. They have skills and knowledge about an area. And, you
know, it is an issue to say, well, they could never work in an
industry where they might develop a cure for cancer or whatever
the thing may be. So, this is a delicate area and needs to be
looked at. You are perfectly right to raise----
Mr. Cloud. I am not saying that there is no legitimate
reason. This is why I am asking what are your recommendations
as someone who is actually running, you know, the Agency right
now. What recommendations would you provide that would not be
onerous? But you know, 9 out of 10 going straight to the
pharmaceutical companies straight out of office is, you know,
pretty circumspect when the American people are looking at
that. So, what would you recommend for us as Congress that
would be reasonable provisions that would allow us to bring the
full faith of these agencies back to the United States?
Chairman Comer. His time has expired, but please answer the
question.
Dr. Califf. Yes. I mean, it is a complicated area. I would
say, No. 1 is just making sure we adhere to what we already
said. You have raised some questions about this.
Mr. Cloud. Exceptions are given all the time to these is my
understanding, you know. So, there are rules, but hey, we waive
them all the time because it is a self-check kind of thing.
Dr. Califf. I do not think that is true at all. I would
speak very highly of our Ethics Office. Two-thousand-sixteen,
the first time around, I spent a lot of time bringing in new
people, and I do not think exceptions are given all the time to
these, but we can always do better and happy to engage on it.
Mr. Cloud. So, no recommendations so far?
Dr. Califf. Well, it is a very broad area, so I am
reluctant to just off the cuff make a specific recommendation.
Mr. Cloud. OK. Well, I look forward to working with you.
Chairman Comer. They have called votes, but we are going to
try to get go to Mr. Connolly and then Mr. Donalds, and then
just two votes will not take long. We will be right back. We
will recess.
Mr. Connolly. Chairman, I think Mr. Moskowitz is ahead of
me.
Chairman Comer. We will go to Moskowitz then.
Mr. Moskowitz. Do not worry, Mr. Chairman. It will not be
the usual, and I will try to use some time back, but first of
all, thank you for coming today, Commissioner. I think you have
established that if any of my colleagues get worms, you will
make sure that they get ivermectin, so we do not have to, like,
rehash all of that nonsense.
I want to turn your attention, though, to a little bit of
the aftermath of COVID in the pharmaceutical space. I mean, do
you think it is appropriate that with all the supply chain
issues that America had during COVID, that we have not really
fixed in a broader sense, but in the medical sense, in the
pharmaceutical space, I mean, should we still be getting a
majority of our own or counter drugs from Wuhan? Should they
still be produced there? Should we still be depending upon
Wuhan, China, to be making drugs that we sell in a significant
basis on shelves in this country?
Dr. Califf. Well, I mean, I would say I am not sure it is
specifically Wuhan, but the key starting materials for drugs
are mostly coming from China, and I do not think that is good
for us. We do not need to have no drugs from China, but we need
to have a firm manufacturing base that we can be confident
about in these times of stress.
Mr. Moskowitz. I know you were not necessarily there, but
during the two bills, one in the Trump administration, one in
the Biden administration, where we spent $7 trillion or $8
trillion combined after COVID, how come the FDA was not
advocating, or if they were--I would love to hear it
--with all that government money was spent, why were we not
establishing that we should start manufacturing those products
here?
Dr. Califf. I was not there at the time. I would just say,
you know, pretty much the time I came in February 2022, we
really saw how stark the problem was, and we started advocating
then, but, you know, we live in a country where the
pharmaceutical industry is for profit. If people are not
getting the prices they want or the purchaser is getting a
lower price overseas, that is where they go. So, to fix this,
it is going to take some kind of intervention, which is well
beyond the FDA. We are certainly advocating that intervention
is needed.
Mr. Moskowitz. All right. Let me turn your attention. I
know you got a bunch of questions on cancer drugs. My dad was
diagnosed with pancreatic cancer. He lived 18 months, and he
passed away about a month before I ran for office. He was on
cisplatin. At that time, there were no issues. Do you think it
is acceptable in America that families would get told by their
doctors that we are going to have to push off a treatment
because there is a shortage of a chemotherapy that is helping,
extending the lives, keeping people alive? Do you think that is
acceptable in this country, and why is it that we are not
better prepared to handle when there are these manufacturing
issues, whether it is in India or China? Why are we not better
prepared to handle these things?
Dr. Califf. Here is what I would say. First of all, it is
unacceptable. I mean, I have a close relative with pancreatic
cancer right now. I know how frightening it is. I would just
say, you know, what has happened is we have health systems,
hospitals, pharmacies, and we have manufacturers who are mostly
overseas now. If we take cisplatin as an example, 5 years ago,
it was $400 a dose. It is a generic drug. I gave it as an
intern in 1978. Now, it was $13 a dose. You cannot make
cisplatin for $13 a dose and maintain quality. So, people
running the company say, why should I make it? And we do not
have a system in place that says this is an essential drug. We
are going to put something into effect which causes the market
to behave.
Mr. Moskowitz. Well, I do not want to interrupt. I mean,
you are the FDA, you know, perhaps, you know, that is something
you guys should be looking at. I mean, there are all sorts of
ways to be working with manufacturers all day long on trying to
incentivize them to make lifesaving drugs that may not be----
Dr. Califf. Well, I mean, if I may, we have no authority to
give incentives. We are prohibited by law from dealing with
pricing. But I would refer you to the HHS report that came out
last week with our heavy input that goes through all the
details here. So, I am completely in tune with your concern,
and I think people around the Administration know every time I
am on a call I bring it up.
Mr. Moskowitz. There has been reports in some of the vaping
products in Florida seeing fentanyl in them, you know. What are
we doing about some of these things coming in from China, some
of the illegal vaping products?
Dr. Califf. I am very concerned about what you raised. We
just had an annual meeting in Atlanta, mostly parents of
children who have died from overdose. Anne Milgram, the DEA
administrator, was there and gave the details about how these
products are getting into the mainstream of America through
cartels predominantly. This is really a combined effort. FDA
has a role that has now become mostly a law enforcement issue
with DEA and we are working together as closely as we can, but
I am not pretending that we have this problem solved at this
point. It is a big deal.
Mr. Moskowitz. Thanks, Mr. Chair.
Chairman Comer. The Chair now recognizes Mr. Donalds from
Florida.
Mr. Donalds. Thank you, Chairman. Commissioner, thanks for
being here. Listen, I support the FDA's efforts to reduce youth
smoking rates under their current authority granted by
Congress. However, I do not support the unnecessary and
unfounded regulations, like the FDA's proposed tobacco product
standard for characterizing flavors in cigars rule, which is
purely based on, frankly in my view, far more politics than
science. What are some of the examples of the unintended
consequences that might arise out of this rule?
Dr. Califf. Well, first, the intended consequences will be
reduction in death rates, which is a pretty important one, in
my view. In terms of unintended consequences there is always
going to be some illicit market when rules like this are put
into effect.
Mr. Donalds. So, then do you think it is wise for the FDA
to proceed?
Dr. Califf. I think it is very wise to reduce the death
rates and population----
Mr. Donalds. But, Commissioner, you did also acknowledge,
and we are seeing it, frankly, in a lot of markets associated
with smoking, but right now we are focused on flavored cigars.
So, your contention is that it is OK to put in this rule around
flavors in premium cigars because you have adults who are
choosing to smoke flavored premium cigars.
Dr. Califf. Now, if you want to talk about flavored cigars,
I would just say youth right now are smoking cigars more than
they are smoking cigarettes. Flavored cigars are highly
attractive to youth, and so it is a major concern that we have.
Premium cigars is a different issue that is in the courts right
now, so I cannot comment on it.
Mr. Donalds. All right. So secondarily, California enacted
a flavor ban on all tobacco products at the end of 2022.
California already suffers from the second highest rate of
cigarette smuggling where nearly 50 percent of all cigarettes
used by consumers are purchased out of state. Further, in 2020,
1 in 6 cigarette packs in California were smuggled into the
state from international markets. In which ways does an illicit
tobacco market impact the United States of America?
Dr. Califf. You know, I just was out in California about 4
months ago, and I met with the Public Health Department there.
Their longevity is so much higher than the average of the
United States. Largely, due to the reduction in things like the
use of tobacco, they have very low rates of use of tobacco
compared to the rest of the U.S. So overall, it is a net
positive.
Mr. Donalds. But, Commissioner, we are going to acknowledge
the fact that, yes, there are black markets propping up,
whether it is illicit cigarettes or, if we want to go back to
the previous topic of premium cigars, in part because of the
policies of the United States. Do we acknowledge that?
Dr. Califf. You know, as I have already discussed, I am a
cardiologist. I am used to life and death. Almost everyone
prefers to be alive. I would rather reduce total mortality and
deal with the illicit market than to tolerate 460,000 Americans
dying of tobacco-related illness per year, which is what our
current rate is, and that is at lower from what it used to be.
I am taking care of these people. We also have people dying. It
is not good.
Mr. Donalds. Commissioner, we also have to acknowledge the
fact that you are not omnipotent. You cannot control the
actions of people. Do you truly believe that you have the
ability to control the actions of Americans, if they choose?
Adults, now, move away from children for a moment. Adults, if
they choose to smoke a cigar or if they choose to smoke a
cigarette. And by the way, I do not agree with smoking
cigarettes. I am not a cigarette smoker, but at the same time,
do we acknowledge the reality that when you put up these
barriers, what you also do is create an illicit market for
these products, which could be more harmful to the users that
use them?
Dr. Califf. I would never pretend to be able to control the
behavior of people but imagine if we had taken that attitude.
When I started out as a cardiologist, the average patient I
took care of was 50 years old, typically a man smoking
cigarettes, dying at a rate of 30 out of every 100 people with
a heart attack in the first 30 days. Now the typical patient
with heart disease is in the 70's because the rates of use of
tobacco dropped so much, not because someone----
Mr. Donalds. Commissioner, do you think it is because of
informing the public, or do you think that is because of
government regulation?
Dr. Califf. I think it is a combination of both of those.
Mr. Donalds. Commissioner, I would argue it is far better
to get people to change behavior by informing them of the
consequences of said behavior as opposed to putting up
arbitrary rules from the FDA or anywhere else.
Dr. Califf. I like that in general, but this is a highly--
--
Mr. Donalds. It is not in general, Commissioner. That is a
reality of the human condition.
Dr. Califf. When you are dealing with people suffering from
addiction, nicotine is a terrible addiction, very difficult to
beat. This is an entirely different issue.
Mr. Donalds. Commissioner, we have not got to a
conversation about addiction. We are just talking about FDA
rules around, frankly, flavored cigars and also some of the
California, which are on cigarette bans.
Dr. Califf. Nicotine is a highly addictive substance that
we are talking----
Mr. Donalds. I am well aware that it is, Commissioner, but,
again, I would argue that information and education is far
better than regulation and elimination. I yield.
Chairman Comer. The gentleman's time has expired. Pursuant
to the previous order, the Committee stands in recess, subject
to the call of the Chair. The Committee will reconvene 10
minutes after the floor vote. The Committee stands in recess.
[Recess.]
Chairman Comer. The Committee will come back to order.
The Chair now recognizes Mr. Waltz from Florida for 5
minutes.
Mr. Waltz. Thank you, Mr. Chair, and thank you for your
patience, Commissioner Califf. I want to talk about kind of
your current policies in terms of hybrid telework. We have
here, just for American people watching from your website, that
says the White Oak Campus, your main campus, is open but yet is
open with maximum telework flexibilities. And Mr. Commissioner,
I sent you a letter back in January. I haven't received a
response yet, so I will just ask you these questions today. And
it is essentially, can you just talk about your telework policy
and why we are still teleworking, and when you plan to bring
everybody back in in-person?
Dr. Califf. Well, thanks for the question, and I think to
answer this question, it is useful to start from before the
pandemic because when I was Commissioner in 2016, we had a 4
out of 5 days on-campus policy because we did not have enough
offices for the number of people that we had. So, it is
actually a requirement, and we had our Zoom capabilities and
all that built up well before the pandemic.
But, you know, when I arrived in 2022, the pandemic was
well underway, and we had instituted a policy of measurement.
Now the primary accountability of the American public is
getting the work done. We are meeting all of our metrics and
our user fees quite well. That is a matter of public record.
And when you look at the output of the employees, it is quite
high. Now, within that, we have a number of people who work in
laboratories. They have always gone to the facility to work
because that is where the laboratory is. We actually have 270
facilities all around the U.S. because we have a large
inspectorate and other activities and labs that are located all
around the U.S., those people are obviously going to work every
day in-person.
Mr. Waltz. Just in the interest of time, Mr. Califf, my
understanding, and I am hearing consistently from industry, No.
1, that the FDA granted in-person meetings without a hybrid
component prior to COVID. So, have we gone to more hybrid
because of COVID? And are you back to pre-pandemic levels in-
person, because the concern is and the concern in my letter,
and I would appreciate an answer to some of the questions in
it, is that lifesaving drugs--I am getting this from chief
medical officers, I am getting this from providers and others--
cannot get the same type of due diligence. You cannot have the
same type of meeting. And in fact, I have talked to a number of
companies that said their meetings have been delayed because
they did not have the right type of Zoom capabilities when you
could just come in and have the meetings. So, it is actually
delaying the approval process.
Dr. Califf. Well, first of all, I know that----
Mr. Waltz. These are, like, people are dying, and the
pandemic is over. The Administration declared it over last
year.
Dr. Califf. The approval process is definitely not being
delayed because those metrics are kept, and we have got a
record number of approvals and our timelines have been met. We
offer the option of in-person or hybrid meetings now. Many
times, the industry chooses hybrid because to have an in-person
meeting, they got to fly everybody to White Oak to be there,
and it is more convenient and they get a better attendance
themselves from hybrid.
Mr. Waltz. I am hearing from industry that they would
prefer in-person, and then those are delayed because of
investments. We need more investments in Zoom, more investments
in those kinds of meetings, more investments in your
infrastructure.
Dr. Califf. That may be true of some of the industry, but
it is definitely not true of all of the industry. And I would
expect that in the future there will be much more in-person
from both sides wanting it, FDA and the industry. But I would
be shocked if we did totally away with hybrid because often
that is what the industry----
Mr. Waltz. Why in the future would there be more in-person?
Dr. Califf. Because people like to be in-person when they
can.
Mr. Waltz. So why are we not there now?
Dr. Califf. Because often, people really find it more
convenient to not have to fly everybody to White Oak, so there
is a transition, you know, period going on.
Mr. Waltz. And can you describe what is the transition
issue?
Dr. Califf. Well, you know, there are a limited number of
meeting rooms that are completely up to speed, that is, you
know, coming in the place for----
Mr. Waltz. Up to speed for?
Dr. Califf. For the hybrid meetings that we often have to
have because, often, industry people on both sides of that
equation, people who want to be there in-person and others who
want to participate.
Mr. Waltz. So, you are saying it is industry really driving
the demand for hybrid that you are making the investments?
Dr. Califf. I would not want to say that. I would say often
it is both sides. The industry, you know, would like to have
either option is what I would say.
Mr. Waltz. I think that from what I am hearing
consistently, and I would implore you to take a deeper look
into this, the industry just wants to have meetings, however
they have to happen. They certainly do not want them delayed
because of a lack of rooms that have been upgraded for hybrid,
especially for things like ALS where people are literally dying
month to month with these delays.
Dr. Califf. I am not arguing with your basic points other
than to say was from everything I can see, we are meeting our
timelines, and we have got a record number of approvals that
have occurred. So, by any metric you would use, the place is
pretty darn efficient right now.
Mr. Waltz. Just on the time I have remaining, I think maybe
we need to relook at the metrics. I do not know. But I am just
telling you what we are consistently hearing, and if they were
being improved and you were having in-person meetings, and they
were not being delayed----
Dr. Califf. You can evaluate it, so let us be clear about
that. Our job is to evaluate, not just to approve. I mean, we
approve it when the data supports approval.
Mr. Waltz. But you cannot get to really have those
conversations about the data if you are delaying because of
meeting rooms.
Dr. Califf. Again, I would be surprised if there are delays
occurring because of meeting rooms.
Mr. Waltz. OK. Thank you, Mr. Chairman. If you could please
ask your team to look at the letter. I am on four committees
and I have never had to wait 4 months for a response just to
some basic questions.
Dr. Califf. All right.
Mr. Waltz. Thank you.
Dr. Califf. I appreciate that.
Mr. Waltz. Thank you, Mr. Chairman.
Chairman Comer. The Chair now recognizes Mr. Langworthy
from New York.
Mr. Langworthy. Thank you, Mr. Chairman. Commissioner
Califf, my constituents, many of whom do not have the same
access to a doctor's office as my colleagues in urban or
sprawling suburban areas, often they are the ones most impacted
by the FDA's inaction and lack of clarity on prescription to
over-the-counter, or in other words, Rx-to-OTC switch. What
this can often result in is a lack of expanded over-the-counter
access for medicines that have already gone through an approval
process at the FDA and deserve serious and timely consideration
so that constituents, our taxpayers can have more easy access
to the care into the help that they need. Commissioner Califf,
can you explain why we only see a small percentage of the
prescription to over-the-counter switch annually, and what can
we do to increase that number?
Dr. Califf. Sure, appreciate that, and I also appreciate
the importance of rural people, especially, of having access to
medications. I mean, what the regulations require is that the
company that wants to make that switch has to produce the
evidence that if they go to over-the-counter, that the person
purchasing the product can understand the instructions and use
it appropriately, and therefore, does not need an intermediary
to do the prescribing and the interaction with a person as a
patient. So, I would say whenever a manufacturer produces that
evidence, you know, we are anxious to get it and to take
action, if they have got the data to support what they want to
do. So, it is really a matter they actually cannot just make
the switch because they have to show that a consumer can
actually understand the instructions and apply the medication
appropriately.
Mr. Langworthy. No. Unfortunately, what we are hearing, Dr.
Califf, is that for too long the switch process has been
muddled by, you know, moving goalposts, challenges, engaging in
a dialog with the FDA, and a culture at the FDA that seems to
reward denying reviews and approvals rather than trying to get
things done. But I have limited time, so I would like to move
on.
Essentially, pharmaceutical companies are disclosing their
inventions to the FDA years before disclosing them to the
Patent Office, which can elongate commercial monopolies
inappropriately by 10 years. Due to inconsistent filing with
both the FDA and the Patent and Trademark Office by branded
companies, many of the most expensive drugs on the market are
artificially blocked from generic competition. Now this leads
to billions of dollars in lost savings to patients and to
taxpayers.
President Biden released the pharmaceutical competition
executive order that encouraged the FDA and the patent
tradeoffice to collaborate on this issue, and FDA has also
conducted listening sessions where the issue was apparently
discussed extensively. However, there seems to be no recent
progress on this front. So, what real solutions is FDA in fact
considering to address this problem, and when can we expect to
receive an update?
Dr. Califf. We would be happy to give your staff an update
any day. I disagree with the view that there is no progress
being made. There is a very active collaboration with the
Patent Office in an effort to reduce the number of
inappropriate patents that get in there and block the generic
competition. So, we will give you an update on what has
happened with that. We had a long discussion about this earlier
this afternoon but let me just say that the Patent Office as a
primary responsibility for determining if there is something
unique that merits a patent. That is not an FDA call.
You are correct that we see the pipeline of what is coming
from Pharma. That is commercial confidential information that,
by law, we cannot release to anyone else. But what we want to
do is make sure that there is good communication so the Patent
Office understands when it is actually a valid new patent that
would extend that protection from competition.
Mr. Langworthy. OK. Thanks. In my remaining time, I really
want to switch gears here. According to the American Academy of
Pediatrics, numerous studies have linked the range of health
issues with the consumption of plant-based beverages by
children. Furthermore, there is considerable confusion and
misinformation about the substitution of non-dairy products for
cow's milk. The FDA itself determined that based on 13,000
public comments, ``Consumers do not understand the nutritional
differences between milk and plant-based milk alternatives.''
So, Commissioner, can you comment on the FDA's efforts to
enforce dairy product standards of identity, particularly the
use of the term ``milk'' and the actions your Agency is taking
to mitigate the risks posed by the chronic mislabeling of non-
dairy products using established dairy terms?
Dr. Califf. Well, I am glad you referred to the nutritional
content because that is a primary deficit here, and we are
requiring that that nutritional information be prominently
displayed as part of the effort. What we are not doing is
specifying exactly what can be called milk because--how do I
say--the cow is out of the barn already. It has been decades
that terminology has been used, and whenever those kinds of
issues, when we make a rule to require it, we call it something
when it has been different, we have lost such cases in core.
But what I think is really important is when people purchase
something, they actually understand the nutritional content,
and that is heavily emphasized in what we are currently putting
forth.
Mr. Langworthy. Thank you very much. I appreciate you
answering my questions, and, Mr. Chairman, I yield back.
Chairman Comer. The gentleman yields back. Now I recognize
myself for 5 minutes. I have had a lot of members yield me
time, but now I will ask my questions.
Commissioner, in this hearing, you have said that the term,
``harm reduction,'' is an industry term or a term that industry
uses, but to be clear, the Institute of Medicine used this term
in the title of its report titled, ``Clearing the Smoke:
Assessing the Science Base for Tobacco Harm Reduction.'' So, it
is not just the industry that uses this term. The Institute of
Medicine uses it, and the concept of harm reduction has been
embraced in other countries. That is, they accept and
communicate that there are options that are less risky than a
traditional cigarette. Are we ever going to get to that point
in this country? Do you accept this idea?
Dr. Califf. I definitely accept the idea. Your point is
well taken, and industry is not the only entity to use it. But
what I want to avoid in speaking of harm reduction, we have
talked about combustible tobacco kills people. Neither using
vaping or combustible tobacco is the healthiest thing you can
do. Vaping compared to none of the above has residues that are
quite concerning for long-term use. So, if you are a
combustible tobacco user, if you switch to vaping, that is less
harm. That is good as long as the product is not packaged in a
way that is encouraging you to get addicted to nicotine. One of
the main harms I want to get away from is millions of youth
being addicted to nicotine by vaping products. So, we got to
find that middle ground, and I accept there is a point here. I
am just worried that when we use the term, ``harm reduction''
now, it is often part of a vast advertising campaign. That is
not taking account of the addiction side in youth.
Chairman Comer. But you admit that vaping is less harmful
than cigarettes. I mean, we all----
Dr. Califf. ``Admitting.'' It sounds like I am confessing
of something. No, I agree. I agree.
Chairman Comer. So, let us talk about all the applications
that have been submitted, millions of applications. I think you
have approved 25 or something?
Dr. Califf. Almost 27 million.
Chairman Comer. Have been applied?
Dr. Califf. Right.
Chairman Comer. Have requested application, but you have
not approved but just a handful. The reason for the backlogs,
are you working on it? Are you trying to approve more, or you
just throw in the towel in and say we are just not going to
have anything or?
Dr. Califf. No, no. We are working every day and----
Chairman Comer. So, you think there will be more approvals?
Dr. Califf. As a Commissioner, I meet with the Center for
Tobacco Products leadership every week and we go over this, but
again, we can only approve a product by law. If the company
produces the data that demonstrates that they meet the public
health standard, that is the reduction in risks that we just
talked about, to adults who use combustible tobacco offsets the
addiction risk.
Chairman Comer. Right. And you have heard a lot of people
ask this question. On both sides of the aisle, we do not agree
on a whole lot in this Committee in a bipartisan manner, but
the FDA's refusal to approve these new tobacco products has
created a thriving market for illegal and unsafe products,
primarily from China. These products received warning letters
from FDA, but I do not think China loses a whole lot of sleep
over a warning letter from a U.S. Governmental Agency,
especially in the Biden Administration. So, a lot of people
have questions as to why there are so many of these Chinese
products, counterfeit products on the market, they ask us. That
is why so many different members have asked you about it. What
is the reason? What are we supposed to say? We say it is FDA's
responsibility, so why is the FDA enabling these Chinese
products? I believe there is a solution here.
Dr. Califf. I would not use the term, ``enabling,'' but I
would say that this is a huge production issue coming out of
China into our ports. We need to stop the use of illegal
products.
Chairman Comer. But this Administration has proven it is
unable to do anything at the border with respect to security,
but would a foreign manufacturer rule not address this problem,
a rule that pertains to foreign manufacturers from the FDA for
this?
Dr. Califf. I mean, as we have said many times today, you
are the referees, you make the rules, so if you choose to do
that, you may. I would also say a lot of profit is being made
in the vaping industry. If they had user fees, we would put a
lot more----
Chairman Comer. Are these Chinese companies paying the user
fees?
Dr. Califf. Whoever sold the product would have to pay the
user fee.
Chairman Comer. Last question with respect to CBD. What do
you foresee over the next 12 months from FDA with respect to
CBD? Do you see any action? You know, you mentioned you are
close, you are communicating on the Center for Tobacco, but
what about the shifting gears here with CBD oil, industrial
hemp and things like that? Is FDA close to making any decision
on anything?
Dr. Califf. I think it is Congress' decision to make. So,
we would really look forward to working with you all as quickly
as possible to come up with a regulatory pathway that you think
is reasonable and enables us to take action.
Chairman Comer. Well, my time has expired, and I am going
to yield to the Ranking Member. This concludes the questioning
phase, unless Mr. Connolly is on his way back or anything. OK.
Well, we appreciate you being here, and I am going to let yield
to Ranking Member Raskin if he has any closing remarks.
Mr. Raskin. Thanks, Mr. Chairman, and, Commissioner Califf,
I just want to thank you for your great devotion to the task
here and you are a model public servant trying to advance the
public interest at every turn. The scope of issues that you
have to address on daily basis is staggering, and the
challenges faced by the FDA are mammoth. And we should not be
adding to your burdens by beating you up for pet ideological
causes, and I was disappointed that some of our colleagues went
that direction today.
I just wanted to clear up a couple of little things. One is
the Inflation Reduction Act is not responsible for drug
shortages, and contrary to Republican claims, it has already
substantially lowered costs for lifesaving medications even as
it is projected to reduce the deficit by $237 billion. And you
ask how we pulled off the feat of reducing to $35 a month where
people have to pay for insulin shots if they are diabetic,
while at the same time saving hundreds of billions of dollars
for the taxpayers. It is simple. We took a strong stand that
the Federal Government should be able to negotiate with Big
Pharma for lower drug prices. And so, we have saved hundreds of
billions of dollars, at the same time that we have dramatically
reduced the cost of prescription drugs despite the unfortunate
and categorical partisan objection of our Republican
colleagues.
So, the shortages we are seeing today are primarily in
generic medications, and Republican opponents of the Inflation
Reduction Act claim it has already stifled the production of
brand name drugs, which is just false. HHS recently published a
white paper with multiple recommendations for what needs to be
done to address drug shortages, none of which involve repealing
the Inflation Reduction Act. Rather, they focus on ways in
which the private sector can work with the FDA to shore up drug
supply chains. And the commissioner has laid out a number of
other ideas here today, and we would do well to defer to his
expertise and to take it to heart.
We would also be remiss not to clarify that ivermectin is
not effective against COVID-19, and there is no reason to think
anything wrong of people who wanted to check it out for those
purposes, as the good commissioner testified today, but it did
not work. The Fifth Circuit never said otherwise. And it is not
the role of the Fifth Circuit to determine whether a drug is
safe and effective, be it ivermectin or mifepristone. That is
FDA's job, and it is a job that relies on the quality and the
integrity of the science and the research.
Some of our colleagues chose to blame the FDA exclusively
for infant formula shortages when they could have joined us on
our side of the aisle in our investigation into Abbott
Nutrition and its role that it played. Democrats never received
all the documents we were promised by Abbott, and our friends
across the aisle could choose to help with that and provide the
American people the accountability and the transparency we all
deserve. Across the aisle, we share concerns about the illegal
vapes coming into the country from China. I hope our colleagues
will join the Democrats in supporting a whole-of-government
approach to counter smuggling of illicit substances and
products including adequately funding Federal law enforcement
agencies. We should be concerned not just about illegal
substances coming in from China, but from any country and every
country of concern.
So, we thank you for your patience and your seriousness
today. Mr. Chairman, I thank you for calling the hearing, which
I think has been very productive, and I yield back to you.
Chairman Comer. The gentleman yields back, and I will
conclude by again, Commissioner, thank you for being here
today. I think this was a very substantive hearing. We covered
topics from seafood inspection, all the way to just about every
other topic that I think could be imaginable throughout the
past five-and-a-half hours.
I will attempt to correct my colleague across the aisle.
The Inflation Reduction Act was the title, but I think it will
be known throughout history as the Inflation Creation Act, and
that is why I do not believe a single Republican voted for it.
And with respect to transparency that Mr. Raskin said that we
deserve, I agree. We deserve transparency. Hopefully, in our
investigations, the administration will turn over the pseudonym
emails, and the tapes, and all the other items have relevance
to our other investigation that we have ongoing. With respect
to----
Mr. Raskin. But is that one still ongoing? I was not sure.
Chairman Comer. Yes. Oh, it is. Yes, I know you need to
stop watching CNN. You need to go to Main Street and ask
people.
But at the end of the day, we appreciate your attendance.
We have requested a lot of information, and hopefully, we will
follow up with each individual member that asked questions. As
I travel America and travel Kentucky, we have a lot of people
in the private sector that are concerned with the pace at which
FDA moves to approve medical devices. There is a lot of
concern, as I have stated to you in the last 2 days, with
respect to the uncertainty around the tobacco products, the
lack of enforcement of the Chinese illegal vape products that
are the ones that are creating so much havoc with our young
people and across America, and so much uncertainty in the CBD
industry as well. So, we look forward to working with you on
that.
With that, and without objection, all members will have 5
legislative days within which to submit materials and to submit
additional written questions for the witnesses, which will be
forwarded to the witnesses for their response.
Chairman Comer. If there is no further business, without
objection, the Committee stands adjourned.
[Whereupon, at 5:43 p.m., the Committee was adjourned.]
[all]