[House Hearing, 118 Congress]
[From the U.S. Government Publishing Office]
FDA OVERSIGHT PART II: RESPONSIBILITY
FOR THE INFANT FORMULA SHORTAGE
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HEARING
BEFORE THE
SUBCOMMITTEE ON HEALTH CARE
AND FINANCIAL SERVICES
OF THE
COMMITTEE ON OVERSIGHT
AND ACCOUNTABILITY
HOUSE OF REPRESENTATIVES
ONE HUNDRED EIGHTEENTH CONGRESS
FIRST SESSION
__________
MAY 11, 2023
__________
Serial No. 118-31
__________
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
52-165 PDF WASHINGTON : 2023
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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
Gary Palmer, Alabama Gerald E. Connolly, Virginia
Clay Higgins, Louisiana Raja Krishnamoorthi, Illinois
Pete Sessions, Texas Ro Khanna, California
Andy Biggs, Arizona Kweisi Mfume, Maryland
Nancy Mace, South Carolina Alexandria Ocasio-Cortez, New York
Jake LaTurner, Kansas Katie Porter, California
Pat Fallon, Texas Cori Bush, Missouri
Byron Donalds, Florida Shontel Brown, Ohio
Kelly Armstrong, North Dakota Jimmy Gomez, California
Scott Perry, Pennsylvania Melanie Stansbury, New Mexico
William Timmons, South Carolina Robert Garcia, California
Tim Burchett, Tennessee Maxwell Frost, Florida
Marjorie Taylor Greene, Georgia Becca Balint, Vermont
Lisa McClain, Michigan Summer Lee, Pennsylvania
Lauren Boebert, Colorado Greg Casar, Texas
Russell Fry, South Carolina Jasmine Crockett, Texas
Anna Paulina Luna, Florida Dan Goldman, New York
Chuck Edwards, North Carolina Jared Moskowitz, Florida
Nick Langworthy, New York
Eric Burlison, Missouri
Mark Marin, Staff Director
Jessica Donlon, Deputy Staff Director and General Counsel
Reagan Dye, 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
------
Subcommittee on Health Care and Financial Services
Lisa McClain, Michigan, Chairwoman
Paul Gosar, Arizona Katie Porter, California Ranking
Virginia Foxx, North Carolina Minority Member
Glenn Grothman, Wisconsin Alexandria Ocasio-Cortez, New York
Russell Fry, South Carolina Jimmy Gomez, California
Anna Paulina Luna, Florida Greg Casar, Texas
Nick Langworthy, New York Becca Balint, Vermont
Eric Burlison, Missouri Summer Lee, Pennsylvania
Jasmine Crockett, Texas
C O N T E N T S
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Page
Hearing held on May 11, 2023..................................... 1
Witnesses
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Susan T. Mayne, Ph.D., Director, Center for Food Safety and
Applied Nutrition, U.S. Food and Drug Administration
Oral Statement................................................... 5
Written opening statements and statements for the witnesses are
available on the U.S. House of Representatives Document
Repository at: docs.house.gov.
Index of Documents
----------
* Infant Formula Timeline, FDA; submitted by Rep. Grothman.
* Inspection Report dated March 2022, FDA; submitted by Rep.
Porter.
Documents are available at: docs.house.gov.
FDA OVERSIGHT PART II: RESPONSIBILITY
FOR THE INFANT FORMULA SHORTAGE
----------
Thursday, May 11, 2023
House of Representatives
Committee on Oversight and Accountability
Subcommittee on Health Care And Financial Services
Washington, D.C.
The Subcommittee met, pursuant to notice, at 2:07 p.m., in
room 2154, Rayburn House Office Building, Hon. Lisa McClain,
[Chairwoman of the Subcommittee] presiding.
Present: Representatives McClain, Grothman, Langworthy,
Porter, Balint, and Lee.
Mrs. McClain. The Subcommittee on Health Care and Financial
Services will come to order. Welcome, everyone.
And without objection, the Chair may declare a recess at
any time.
I recognize myself for the purpose of making an opening
statement.
Thank you, again, for being here. I appreciate it. Six
weeks ago, the Subcommittee held its first oversight hearing on
last year's infant formula crisis. During that hearing, we
heard from former Deputy Commissioner in charge of the Office
of Food Policy and Response, Frank Yiannas. Mr. Yiannas'
testimony highlighted many internal failures within the FDA
that led to the crisis, including the FDA's poor efforts to
carry out one of the most critical missions, which is food
safety. His testimony also raised questions of why key facts
about the crisis were omitted when Commissioner Califf and Dr.
Mayne and Mr. Yiannas testified before the Energy and Commerce
Committee last February and in the so-called independent
Solomon Report.
Today's hearing will continue the long and overdue
oversight of the Food and Drug Administration's response to the
infant baby formula crisis. We hope to get answers on why the
FDA has not been fully forthcoming with Congress and, really,
the public. Today's hearing will examine why it took more than
four months for inspectors to arrive at the Abbott facility
plant in Sturgis, Michigan after babies started getting sick.
We will determine why it took so long for the Biden
Administration to take action to secure the infant baby formula
supply after a recall left its shelves bare. Why was the FDA
unprepared for the crisis? Why did they only inspect 3 of 23
infant formula manufacturing facilities in 2023 of 23? Why did
they fail to investigate whistleblower warnings? Did the FDA
follow regulatory protocols? Did the FDA respond quickly
enough? Was the FDA's so-called independent review truly
independent or was it a cover up? Today, I will get answers to
these questions to better understand exactly what happened, so
it does not happen again.
American families must be confident that the FDA has the
ability to prevent a crisis like this from ever happening
again, and in our previous hearings, we learned a lot about how
the crisis happened and how it could have been handled better
from FDA officials. And here is what we know so far, just to
kind of lay it out. The FDA ignored Abbott's employees' 38-page
disclosure detailing concerns at the Sturgis plant. The FDA's
telework policies and lax approach to oversight left it
unprepared to address the supply chain shortages after the
Sturgis facility was actually shut down, and the FDA had failed
to prioritize food safety.
The FDA has not taken the action needed to prevent a
similar crisis from happening again, and the American people
paid the FDA $6.7 billion last year--$6.7 billion. And in next
year's budget, the FDA wants over 10 percent more, totaling
$7.2 billion. And I think the American people have a right to
know that if you only took a look at 3 out of 23 and you were
paid fully, now we had a crisis. We do not really have answers
to the crisis, but yet you want more money. Listen, we all want
everyone to be safe, and we all want to make sure we are safe,
but I think we all also want to make sure that our money is
going to do good work.
So, I think the American people deserve to know that if we
are going to have these agencies and we are going to spend a
lot of money on these agencies, these agencies need to make
sure that they are doing their job as just opposed to throwing
money at the problem. FDA field inspectors should have been
doing the jobs, and there were not serious consequences. I am
yet to hear what the consequence for the FDA is, other than
``give me more money.'' They did not do their job, they sat at
home, they still got their paychecks. They want more money,
which may help, but what is going to change?
Now it is time for the current FDA leadership to really be
held responsible, right? In business, their stockholders are
held responsible, people get fired, they lose money, they lose
profits. There is a consequence to the action. I have yet to
hear who is responsible at the FDA and what is the consequence
for their failure. I think we deserve that especially, for over
$6 million worth of money. Here, we will discuss what failures
within the FDA led to the crisis. We will discuss ways the FDA
can improve its internal controls to get ahead of potential
disruptions and prevent future supply chains. We will discuss
why the FDA omitted key facts from the public.
We owe it to parents, caregivers, and infants to get to the
bottom of what really happened, right, to fix it. We cannot fix
a problem that we first cannot admit exists. As I said in our
last hearing, the families of these babies that died from
contaminated formula deserve answers on how this tragedy was
allowed to occur in the first place and what we can do to
prevent it from happening again.
So, thank you, Dr. Mayne, for being here today.
Congratulations on your upcoming retirement, and we look
forward to your testimony.
Now I yield to my Ranking Member, Ms. Porter, for her
opening statement.
Ms. Porter. Thank you very much, Madam Chairwoman. Today we
are having the second part of our Subcommittee's hearing series
on the 2022 infant formula shortage, and so far, I think the
Chairwoman and I agree on something really important: an infant
formula shortage could repeat itself, and that is a deadly
serious problem.
Let us think back to a year ago today. Forty-three percent
of formula products were out of stock across the country. A
bacterial contamination in Abbott, which killed nine babies and
made hundreds of others fall ill, prompted a recall that
shocked our formula supply chain. That disruption, of course,
interrupted our economy but, more critically, threatened the
health, nutrition, and lives of our kids and the American
people's confidence in government. Today we are saying on a
bipartisan basis that it could happen again, and we have a duty
to do something meaningful about it.
This hearing is called ``Responsibility for the Infant
Formula Shortage,'' and as I said last time, there is a lot of
blame to go around. It is clear that, with today's witness
selection, that Republicans want to blame the FDA, and I will
level with you. I think some of that blame is well placed. We
have had two subsequent infant formula recalls in 2023 already,
and we are still seeing that the FDA can make further
improvements on its internal processes, intervene in issues
sooner, and follow through with more inspections to prevent
further contamination.
Other lawmakers today will blame formula manufacturers for
their negligence and failure to produce safe products, and that
is true, too. Still others will blame Washington for allowing
just three manufacturers to have monopolistic control over 90
percent of the formula market and for failing to invest the
resources and authorities in the FDA that it needs to produce
the results we demand. And I think those folks are correct too.
The thing about this issue, though, is it does not come
down to the fault of one person or one agency, one company or
one political party. We cannot fire or attack someone and
expect formula contaminations and shortages to just go away.
That is why today, I propose we go beyond the title of this
hearing. We need to move beyond just assigning responsibility
and toward delivering solutions that can prevent a shortage
from happening again, and I want to thank the Chairwoman for
her work with me on that.
We need to use these hearings to identify what are worthy
proposals, worthy innovations, and then we need to transform
them into legislation. If we do not do that, we are failing to
solve the future problems. We risk just blaming and shaming
rather than preventing and problem solving. If we work
together, though, we can address the deficiencies and
inefficiencies that risk the supply of safe, healthy infant
formula. Luckily, we have an FDA expert before us who can help
us with that. Look, Dr. Mayne can handle what we are going to
throw at her. We should ask hard questions. We should push her
on areas where we think the FDA can and should do better, but
we should also use Dr. Mayne's knowledge to figure out what
Congress should be doing better.
Right now, the FDA is reorganizing its Human Foods Program
to reduce fragmentation and approve coordination, but that is
not going to solve all of the fundamental issues. Even with the
best structure, leadership, and resources, the FDA is only as
well-equipped and as accountable as Congress makes it be, so
while we hold the FDA and others responsible, what can Congress
be doing to help?
First, we have to provide the FDA with resources to
increase its inspection and food safety capacity. You cannot
expect an agency to do better when you are taking away the
funding for the personnel and technology needed to make it
happen. That is why I think the 22-percent cut to the FDA the
Republicans have voted for would make this problem worse. Let's
not go down that path. If we expect the FDA to do better, we
need to set it up for success and then hold it accountable to
deliver on a better outcome.
Whether we reach bipartisan consensus on proper funding or
not, there are some no-cost reforms we should be able to agree
on. We need better processes for reporting and tracking
contaminations, whether that is making Cronobacter a nationally
notifiable disease or making sure all contaminations in
critical food factories are promptly and properly reported. If
we use Dr. Mayne as a resource, we can find solutions we can
all agree on to save kids and stop shortages. Let us come out
of this hearing with next steps, not just complaints about
missteps. I yield back.
Mrs. McClain. Thank you, Ms. Porter. And now I am pleased
to introduce our witness, who is here to discuss the FDA's
response to the 2022 Infant Baby Formula Shortage. Dr. Susan T.
Mayne is the Director of the Center for Food Safety and Applied
Nutrition at the Food and Drug Administration. She has been in
this role since January 2015. Dr. Mayne has received a B.A. in
chemistry from the University of Colorado. She has also earned
a Ph.D. in nutritional sciences with Minors in biochemistry and
toxicology from Cornell University.
And pursuant to Rule 9(g), the witness will please stand
and raise her right hand.
Do you solemnly swear or affirm that the testimony that you
are about to give is the truth, the whole truth, and nothing
but the truth, so help you God?
Dr. Mayne. I do.
Mrs. McClain. Thank you. Let the record show that the
witness answered in the affirmative.
And now we appreciate you being here today. I really do
look forward to your testimony, and let me remind the witness,
that we have read her written statements. It will appear in
full in the hearing record. Please limit your oral statements
to five minutes. And as a reminder, please press the button on
the microphone in front of you so that it is on, and the
Members can hear you. When you begin to speak, the light in
front of you will turn green. After four minutes, the light
will be yellow. When the red light comes on, your five minutes
has expired. We would ask that you please wrap up.
And for this, I recognize your opening statement, Ms.
Mayne.
STATEMENT OF SUSAN T. MAYNE, PH.D., DIRECTOR
CENTER FOR FOOD SAFETY AND APPLIED NUTRITION
U.S. FOOD AND DRUG ADMINISTRATION
Dr. Mayne. Chairwoman McClain, Chair Comer, Ranking Members
Porter and Raskin, and Members of the Subcommittee, thank you
for inviting me to testify on the safety and supply of infant
formula in the United States.
As a parent myself, I know nothing is more important than
the health and safety of our children, and last year's infant
formula recall and shortage put a strain on parents and
caregivers across the U.S. When we saw the egregious conditions
of Abbott's Sturgis facility, we knew a recall could stress an
already unstable marketplace, but we had to put our children's
safety first. FDA takes the situation extremely seriously and
has applied many lessons learned, resulting in greater
confidence in infant formula safety.
One of the most important lessons that we learned was that
the Agency must do all that it can to ensure that no infant
formula facility ever has the level of unsanitary conditions
that were present at Abbott Sturgis in early 2022. We have made
progress and are using the fullest extent of our authorities to
address lessons learned. Preventing another shortage in the
future will require a continued whole-of-government approach,
increased industry accountability and cooperation, and help
from Congress.
Today, I would like to talk about the future of infant
formula safety and our vision for a modern regulatory approach.
First, the ultimate responsibility to produce safe products
is on infant formula manufacturers. We need industry to comply
with our requirements and to adopt enhanced food safety
measures to deliver the safest possible infant formula. Two
months ago, we issued a call to action to industry to take
specific steps to improve food safety practices for the
protection of infants.
Second, we have worked diligently to increase the supply of
formula on the U.S. market. The in-stock rate for formula is
near 90 percent, which is higher than pre-recall levels, and
overall formula production exceeds sales week after week.
Market consolidation is a serious concern and contributed
significantly to shortages. There are currently only three
major domestic producers of infant formula. This means that any
disruption--a recall, international conflict, or natural
disaster--could impact formula supply.
Our temporary exercise of enforcement discretion enabled
safe products to enter the U.S. market, doubling the number of
firms producing infant formula for the U.S. Almost all the
manufacturers participating under the enforcement discretion
policy are taking the necessary steps to stay in the U.S.
market. Federal Agency partners also have an important role in
helping to address market consolidation, and we will continue
to work with them to encourage a stronger, diversified, and
more resilient U.S. infant formula market.
Third, FDA and industry should be able to address product
contamination in or near real time. Our inspections are
currently a snapshot in time. More real-time oversight can
transform infant formula regulation by ensuring firms promptly
investigate product contamination and destroy adulterated
product before it reaches consumers. To do this, we need modern
authorities, including explicit authority to require industry
to notify us when formula tests positive for Cronobacter, even
if the product has not left the facility, and the ability to
obtain records remotely from all food manufacturers.
Fourth, we continue to advance the science around
Cronobacter, a very common pathogen in the environment, but one
about which we have limited information. Cronobacter infection
should be a nationally notifiable disease so local, state, and
Federal public health partners can reliably collect information
on all cases, and so we can rapidly link cases to potential
sources of contamination.
Fifth, we are intent on delivering an empowered unified
Human Foods Program and a world-class field force that will
deliver modern, integrated oversight. As part of this will be
creating an office of critical foods as required by the Food
and Drug Omnibus Reform Act. We are also actively hiring for
specialized infant formula inspection staff that will execute a
modern preventive approach to infant formula inspections. Last,
in the early days of COVID in 2020 and well before the Abbott
recall and infant formula shortage, we recognized the critical
need to better resource our infant formula program. We are
grateful for the resources we have received, but our Human
Foods Programs are still in dire need of additional investments
and updates to meet current as well as future challenges.
As we emerge from the public health emergency, the food
industry still has fragile supply chains. Preventing shortages
will take continued cooperation among all the players and
additional authorities and resources to modernize our programs.
We look forward to working with you all to make this a reality.
I welcome any questions you may have.
Mrs. McClain. Thank you, Dr. Mayne, and I now recognize Mr.
Grothman.
Mr. Grothman. Thank you. Dr. Mayne, are you familiar with
the FDA's internal agency review led by Dr. Solomon?
Dr. Mayne. Yes, I am.
Mr. Grothman. Were you interviewed by Dr. Solomon during
the course of the review?
Dr. Mayne. No, I was interviewed by the same group of folks
who were interviewing all the people who participated in the
interviews. That information was consolidated and put together
for Dr. Solomon.
Mr. Grothman. Why don't you think you were interviewed?
Dr. Mayne. I am sorry?
Mr. Grothman. Why don't you think he interviewed you?
Dr. Mayne. He did not interview any of the individuals. I
think there were a large number of people who were interviewed.
It was consistently done across all the interviewees.
Mr. Grothman. OK. Apart from Dr. Solomon, did anyone else
in the FDA or HHS author the report?
Dr. Mayne. I am sorry? Did anyone----
Mr. Grothman. Apart from Dr. Solomon, did anyone else at
FDA or HHS author the report?
Dr. Mayne. No, not to my knowledge.
Mr. Grothman. OK. What was Principal Deputy Commissioner
Janet Woodcock's role in the report?
Dr. Mayne. I believe she was one of the individuals who
called for the report so that we would look internally at our
processes and see what changes could be made expeditiously in
the spirit of continuous improvement.
Mr. Grothman. OK. Was she involved in the report?
Dr. Mayne. Other than asking that the report be executed,
not to my knowledge.
Mr. Grothman. OK. We have received witness testimony before
this Subcommittee that implies that she was involved in it. I
will give you another chance to answer. Did Dr. Woodcock
influence the Solomon Report in any way?
Dr. Mayne. She asked that the report be conducted. People
were interviewed, the data was compiled, produced into a
report. She asked that the report be conducted along with
Commissioner Califf.
Mr. Grothman. OK. The U.S. comptroller general, Gene
Dodaro, stated in an April 26, 2023, House Oversight hearing
that the FDA is ``not doing enough to improve food security and
food safety.'' Food Safety has been on the GAO's high-risk list
since 2007. Dr. Mayne, do you think the FDA is doing enough to
ensure food safety?
Dr. Mayne. We can always do more to ensure food safety, and
I am going to come here today with solutions on things we can
do to ensure better food safety in infant formula
manufacturing. Having said that, we worked very closely with
the U.S. Department of Agriculture as we ensure the food safety
for the U.S.
Mr. Grothman. OK. Did the Reagan-Udall Foundation for the
FDA conduct an operational valuation of FDA's Human Foods
Program?
Dr. Mayne. The Reagan-Udall Foundation did not conduct the
evaluation, but they convened a group of independent experts
that conducted that evaluation. So, it was not done by the
Foundation, but by independent experts.
Mr. Grothman. OK. And it describes their Food Division in a
culture of constant turmoil. Do you agree with the Reagan-Udall
Foundation's assessment?
Dr. Mayne. My indication of their assessment was that the
reporting and decision-making needed to be streamlined, which
is something I agree with, that organizational changes could
make a more efficient and effective program, which I also agree
with. So, those were the primary recommendations coming out of
the Reagan-Udall Foundation.
Mr. Grothman. OK. COVID-19 was used as an excuse for FDA
not receiving a whistleblower complaint about the Abbott plan.
Commissioner Califf testified before Congress that the
whistleblower report was not transmitted to key FDA food safety
officials, like yourself, because of a COVID-19 mailroom issue.
Do you believe the report was actually lost in the mail?
Dr. Mayne. I cannot speak as to what happened to the report
itself being lost in the mail, but what I can speak to is the
report was received at FDA. It was received by our field
inspectional force, and they worked on the report. They
acknowledged that they received the report. They then went
ahead and reviewed the report. There were some very serious
allegations in the report, so they sought information from the
Office of Criminal Investigations. And so, they did act upon
it. It is correct that senior leadership was not made aware of
that, so it was not that FDA didn't act upon it, but that,
simply, senior leadership was not aware of that.
Mr. Grothman. So, everybody acted on it, but they did not
tell the leadership?
Dr. Mayne. That is correct. It was not escalated. There was
no process within FDA to escalate this particular whistleblower
complaint. FDA receives a large number of whistleblower
complaints, so it was a failure of escalation. I do wish I had
been made aware of this particular whistleblower complaint, but
just to reiterate, the complaint was acted upon, but the
leadership was not aware of that.
Mr. Grothman. Did it surprise you?
Dr. Mayne. Which, that the complaint itself or----
Mr. Grothman. Yes.
Dr. Mayne. The complaint was very lengthy and very deep. It
had a lot of egregious claims in there, statements in there,
allegations in there. There were very troubling things in
there. What surprised me was language about data falsification
and trying to hide information from Federal regulators. Given
the nature of some of those allegations, that is why the
inspector engaged the Office of Criminal Investigations with
regard to that whistleblower complaint.
Mr. Grothman. Thank you.
Mrs. McClain. Thank you, Mr. Grothman. The Chair now
recognizes Ranking Member Porter.
Ms. Porter. In our first infant formula hearing, I asked
the Majority's witness a simple question, and the answer caused
a little bit of bipartisan shock. I saw Chairwoman McClain's
head shook upward, and so I even asked the same question again.
So, I am going to start by asking it one more time, this time
to you, Dr. Mayne. Let us say a major formula manufacturer
finds bacteria in its supply today. Does the law require it to
tell the FDA?
Dr. Mayne. The answer is no.
Ms. Porter. So, we all heard that correctly. The law puts
no one at the FDA in charge or on notice if a major formula
manufacturer finds bacteria in the supply. So, if we want to
solve formula safety issues, someone needs to be monitoring
real-time bacterial contaminations. Dr. Mayne, who can change
the law to put someone in charge of this? Is it up to the FDA
to change this rule, the manufacturers, or Congress?
Dr. Mayne. We need Congress's help to modify that, and we
have sought that from Congress.
Ms. Porter. So, I think lawmakers can and must point some
fingers at the FDA and manufacturers, but we need to also be
willing to point the finger back at ourselves. The truth is we
did not do enough in last year's omnibus. Yes, we gave the FDA
some new authorities, and one was requiring manufacturers to
notify the FDA of any interruption that would likely lead to a
meaningful disruption in infant formula supply.
Dr. Mayne, I am wondering if you spot the same problem that
I do. Let us think like parents here, like moms. If there is
deadly bacteria in formula that your infant could eat, would
you want the FDA to know about it only when it might cause a
supply shortage, or would you want the FDA to know any time
your infant could get contaminated formula?
Dr. Mayne. Just to be clear, what we really need is in the
production, in the manufacturing facility, before it ever
leaves that facility. That is what we are seeking, is the
industry would notify us before it ever would leave the
facility, so that we can make sure that the proper amount of
formula is destroyed to protect infants.
Ms. Porter. Yes. So, you would want to know if there was a
bacterial contamination, whether it would cause a supply chain
shortage or not. The FDA should know?
Dr. Mayne. Correct, and by knowing in real time, that is a
good way to prevent a supply chain shortage.
Ms. Porter. Exactly, so we keep kids safe and we protect
supply chain, but we just did not do enough in last year's
omnibus. And look, this was a Democratic-controlled Congress
last year. It is on us, I think, to lead the way here. Congress
did not provide the authority for a full reporting process, and
so now we have more work to do. In the meantime, this has real-
world consequences. We have had two major infant formula
recalls so far in 2023 from Reckitt and Gerber. Would either of
these have been reportable to the FDA under the new provision
of the law?
Dr. Mayne. No. That was no. I am sorry.
Ms. Porter. No. So, I am leading legislation that would
establish a process for the FDA to be notified when
manufacturer's critical food products test positive for
foodborne pathogens. Dr. Mayne, it is no secret that the FDA
has had some struggles in responding to instances of formula
contamination, but the FDA has identified this legal change as
something that it needs in order to do better. And I am ready
to push Congress to deliver for you and expect you to deliver
back to us, so I am ready to whip Republicans and Democrats to
join together to act, but I want to think through the oversight
piece of this.
Can you tell us a little bit about how required reporting
of contamination would better equip the FDA to address
contamination issues before the impact? You mentioned
identifying the right amount of formula to be destroyed? Are
there other features with regard to cleaning or other
protocols?
Dr. Mayne. Yes. So, by knowing in real time that there has
been product contamination in the manufacturing facility, our
experts, our food safety experts, our compliance experts can
work with the manufacturers to determine to essentially bracket
or scope the amount of product that needs to be destroyed. And
that essentially means any product that was produced since the
last sanitation break and before the next sanitation break. And
that is where we have seen issues with recent recalls, where
companies had destroyed product that they identified to be
contaminated, but we didn't determine that they destroyed a
sufficient amount between those sanitation breaks.
So, working in real time with the industry to make sure
that proper amount of product is destroyed is critical to help
support future supply chains and enhance food safety. It also
allows industry to do a root cause analysis, working with FDA
and our experts, to identify why did it get contaminated closer
in time to when the actual contamination event occurred.
Ms. Porter. Thank you very much. I know that Members on
this Subcommittee care a lot about this issue, and I know that
Subcommittee Chairwoman McClain does too. And I am excited
about the potential to move this legislation forward on a
bipartisan basis, and I just want to invite all of our
colleagues on the Subcommittee and on the Oversight Committee
to join in this legislation. We need to give the FDA the
information it needs in real time to be able to both prevent
supply shortages but, more importantly, to keep everybody safe.
Together, we really can help solve this problem. I yield back.
Mrs. McClain. Thank you, Ms. Porter. I now recognize
myself.
It is amazing to me, and it saddens me a little bit, that
we actually have to legislate this, but if that is what it
takes to keep people safe, I mean it is a shame that we have to
legislate. If there is a problem, fix it. With that said, I
think we also know that there is enough blame to go around.
This is not a one specific, you know, I have the Lucky Star
here and I will fix everything, but I have you in front of me
today, so I want to focus my questions around the FDA.
I am concerned by the lack of inspections at the Abbott
facility. I am not saying you are the only one to blame, but
between the fall of 2019 and 2021, there was just not a lot of
inspections going on. The FDA's May 2021 resiliency roadmap
claimed that the Agency prioritized ``mission critical
inspections during the pandemic.'' And according to the FDA,
the criteria for mission critical inspections is a product is
used to treat a serious disease or medical condition and there
is no substitute. Is that partially correct?
Dr. Mayne. That is my understanding.
Mrs. McClain. So, a product with no substitute, to me, that
sounds like baby formula, other than mother's breast milk, but
some mothers cannot breastfeed for whatever reason. Inspections
are also mission critical when there is an evidence of serious
adverse events or outbreaks of a foodborne illness, and, again,
that sounds to me like the Abbott plant.
Dr. Mayne. At the time in 2020, there was no evidence of
outbreaks or illnesses, at that time when the routine
surveillance inspections were not in progress.
Mrs. McClain. So, can you just repeat that one more time?
There was no evidence in 2021?
Dr. Mayne. This was in 2020. I think when you were talking
about the missed inspection in 2020, there was an inspection in
2021.
Mrs. McClain. In the fall of 2021?
Dr. Mayne. Correct.
Mrs. McClain. Four months after, I believe?
Dr. Mayne. The first complaint came in September 2021,
which is when we were actually doing the inspection, so they
were at the same time.
Mrs. McClain. I think from what I show, it was discovered
in February, but there were no inspections done. In fact,
despite this, 20 of the 23 infant formula production packing
and distribution plants in the U.S. were not inspected for
nearly two years. So, if you go back to critical, and I think
we need to change what is critical, why is infant formula not
considered mission critical to the FDA?
Dr. Mayne. So, first of all, I do not oversee the
inspectional branch of the Agency. The resiliency roadmap did
come out of the inspectional branch. I can share with you what
I know, but there may be things I need to take back.
Essentially, the inspections in March 2020, the routine
surveillance inspections were not executed during the early
phases of COVID. They were reinstated in July 2020.
Mrs. McClain. So, let me stop you right there, and I think
this is part of the concern, is we had inspectors not doing
inspections because of COVID?
Dr. Mayne. That is correct. During that brief interval at
the beginning----
Mrs. McClain. Right. Were they getting paid during that
period of time?
Dr. Mayne. Well, let me be clear. That was routine
surveillance. Mission critical inspections were conducted
throughout the pandemic.
Mrs. McClain. I appreciate that.
Dr. Mayne. Yes.
Mrs. McClain. Can you answer my question now? Were they
paid so----
Dr. Mayne. Yes.
Mrs. McClain. OK.
Dr. Mayne. The inspectors continued to be paid. They were
doing mission critical inspections and----
Mrs. McClain. But baby formula is not mission critical.
Dr. Mayne. Baby formula manufacturers were inspected in
2020. My records indicate there were five infant formula
inspections during 2020. Under FSMA, the Food Safety
Modernization Act, we are supposed to inspect them once every
three years. Our practice has been to inspect them annually.
Mrs. McClain. OK. But you did not inspect them annually,
and I am going to ask my question again. Is baby formula
critical? Deemed mission critical? Yes or no.
Dr. Mayne. I would take that back to the Office of
Regulatory Affairs because I do not know all of the criteria
that determine mission criticality for an inspection.
Mrs. McClain. OK. OK. I just want to make sure that I have
everything because I understand that it took until January 31,
2022, for the FDA to inspect the Abbott facility in Sturgis. Is
that not correct?
Dr. Mayne. No, we inspected in September 2021. At that
inspection, we noted several violations for Abbott nutrition.
We issued a 483, noting those violations. They came back to us
with a 28-page report saying that they would investigate and
correct those actions, committing to make those changes. When
we went back in January 2022, they had not made those
corrections. In fact, rather than correcting the deficiencies
we identified in September 2021, the situation deteriorated,
which is what led us to the situation leading to the recall.
Mrs. McClain. OK. With that, I am out of time, and I want
to be respectful. So, the Chair now recognizes--one moment--Ms.
Balint from Vermont.
Ms. Balint. Thank you, Madam Chair. I am focused on the
future, like my colleagues here, in preventing this from ever
happening again. Now, our colleagues across the aisle have
promised to collaborate with us to prevent a future infant
formula shortage, and I appreciate that. However, at the height
of the formula shortage, the crisis, 192 House Republicans
voted against investing $28 million in funding to help the FDA
conduct oversight and hold companies accountable. And in May
2022, Republicans chose not to join Democrats on this Committee
in our investigation into Abbott's role in the infant formula
shortage. Now with the House Republicans' Default on America
Act, they are proposing massive cuts to non-defense
discretionary spending, which to a layperson means all that
other stuff that takes care of Americans. Dr. Mayne, how would
a budget cut of approximately 22 percent affect the FDA's
ability to employ inspectors and conduct inspections of formula
manufacturing facilities?
Dr. Mayne. Broadly across the FDA, I can say it would be
devastating. That would translate into about a $790 million cut
in our budget authority and broadly across the Agency. That
means that, that could result in a loss of 32 percent of our
domestic inspections and 22 percent of our foreign inspections,
including in countries like India and China. In terms of the
Foods Program, where I am, our budget is largely based upon
budget authority. Ninety-seven percent of our budget is budget
authority. We have very few user fees in the Human Foods
Program, and so what that means is that cut would
disproportionately impact the Human Foods Program.
It would also impact our ability to support innovation.
Food industry needs a strong regulator as they are embarking on
innovation. So, it would damage industry. It would damage us.
What we constantly hear from industry, is they want strong
regulators for predictability, for timeliness, and we do have a
pre-market approval program as well. All of those would be
adversely impacted, and we would be unable to do what I think
American consumers expect us to do, given that they eat food
every single day.
Ms. Balint. Yes. Dr. Mayne, just to be clear, you said $790
million. Is that correct?
Dr. Mayne. That is correct.
Ms. Balint. Thank you. In January 2023, FDA Commissioner
Califf began implementing the recommendations of internal and
external reviews by announcing the restructuring of the Human
Foods Program and by unifying several offices under a single
new Deputy Commissioner. And so, I am wondering how would the
budget cuts affect FDA's ability to implement those
recommendations from its internal and external reviews to make
sure that we have better oversight over infant formula, which
is what we all want.
Dr. Mayne. I think it would be devastating. We would not
have the people. We would not have the necessary oversight. A
cut of that magnitude in Human Foods Program, we would be back
to the same number of FTEs that we have had at our lowest
points in the last 40 years. Just as a point of reference, in
CFSAN that I lead, in 1978, we had 1,000 FTEs. Right now, we
are at 1,100. So, if we took a 22-percent cut, given most of
our budget is in payroll, we would be below the number of
employees that we had in 1978, and, of course, our mandate has
expanded dramatically since 1978.
Ms. Balint. Sure. Dr. Mayne, let us talk about the bottom
line. Who, in fact, will get hurt if FDA's Human Foods Program
does not get the resources that it needs? Let us make it really
clear for people.
Dr. Mayne. I think the American consumers would be impacted
adversely by that. All of our surveillance, all of the
sampling, all the things we do, the interception through the
international mail facilities, those all require resources and
people, and that would be adversely impacted, but I also think
it would adversely impact industry.
Ms. Balint. Tell me about that.
Dr. Mayne. Every time industry wants to put new innovation,
whether it be cell-cultured meat, whether it be genetically
engineered crops to support drought resistance, climate change,
challenges into the future, our reviewers work to help bring
these products to market safely and successfully. If there are
concerns about food safety, these products will never be
successful in the market. So, it is imperative that we are
there to do that.
With regard to our Infant Formula Program, as you know, we
run a notification program where we review new infant formulas
before they come into the U.S. market. We had been doing that
with nine infant formula reviewers. We saw an increasing
complexity coming in. Applications that in the past would have
been 30 pages long, are now 1,000 pages long. How would we have
the capability to review those products appropriately before
they come into the market as a sole source of nutrition for our
infants?
Ms. Balint. Thank you, Dr. Mayne. I yield back.
Mrs. McClain. Thank you. The Chair now recognizes Ms. Lee
for five minutes.
Ms. Lee. Thank you, Madam Chair. The infant formula
shortage has been horrible for all parents, but it has been
even more devastating for low-income families who do not have
the luxury of switching to more expensive brands or easy access
to multiple stores to search for in-stock formula because they
lived in food deserts. My district was hit particularly hard,
with Pittsburgh among the top 10 areas with the worst
shortages. I cannot imagine the stress and uncertainty that
those families felt as they did everything they could to find
food for their babies. We need to learn from this shortage and
do better. The answer is, of course, not the 22 percent across-
the-board cuts as passed by Republicans last month, a cut that
would mean 1.7 million women, infants, and children would lose
nutrition assistance, through WIC.
In March of this year, the FDA issued an immediate national
strategy geared toward increasing the resilience in the infant
formula supply chain. Dr. Mayne, how do the long-term and
short-term plans ensure that both low-income and rural families
get the formula supply they need in the future?
Dr. Mayne. So, I think for the immediate future, we have
been building up the supply chain. So, as you heard me say, the
in-stock rates are now at 90 percent, which is better than they
were before the recall. Formula manufacturers are producing
more than is being purchased week after week after week. So,
the supply is building up and has been building up steadily,
and that is really important. There are still challenges with
distribution right now. And what we keep hearing is that it is
not equitable across this country, that rural areas have harder
challenges getting the formula they need and especially people
who are served by private or independent grocers.
What we are doing is working with the National Grocers
Association, to use whatever data they can give us to give to
the infant formula manufacturers and say this is where the
distribution is most challenging. We do not control that
distribution, but we can certainly help provide information to
make sure that areas--food deserts, rural areas, areas that are
more challenged to getting access to product--can access that.
For the future, obviously, I think there are things looking
at--you mentioned the USDA WIC Program. I know many Members of
Congress are looking at that program to see how can that help
support better resilience. As you know, for many of our lowest-
income women, that is a critical source, the WIC program, to
provide formula for those infants. So, gaining greater
resiliency through WIC is another critical aspect, and I know
Congress is interested in that. It is another thing we can do.
Ms. Lee. Thank you. That was my next question, so I will
move to another. Reagan-Udall Foundation's independent
evaluation suggests reorganization of the Human Foods Program.
How will that improve how FDA operates and oversees infant
formula safety and production?
Dr. Mayne. Infant formula safety is one part of that, but
the Reagan-Udall Foundation is looking at the overall Human
Foods Program, and it is really taking a very deep dive at how
we can do things more effectively. We have heard from so many
of our employees--what would make your jobs easier, where are
there inefficiencies, and how do we redesign a modern program
to be more effective and efficient for the future.
With regard to infant formula, that is a special case that
we are really very, very laser-focused in on how to do that
better. So, we have, for example, made a commitment to have an
inspectorate that is really dedicated to infant formula and
increasing the numbers. So, these are inspectors who would only
be doing or dedicated to infant formula manufacturers. The
training, working through our scientific experts, we are
committed to doing so much more, working with industry, making
sure they understand all of our standards, how to produce
infant formula in a very safe way.
So, there are a number of actions that we have identified
in the national strategy on the steps that we can take to get
to a better place in the future, and I think that is a good
roadmap for the future.
Ms. Lee. Thank you. I understand that your Agency is
considering asking Congress to give it the authority to require
companies to submit positive results for contamination as we
were discussing with Ranking Member Porter. How would granting
that authority prevent another shortage in the future?
Dr. Mayne. I think it is an important authority. So, that
means we can be working with the manufacturers in real time to
make sure no contaminated product enters the market. And as I
noted earlier, to make sure that industry is trying to get to
the root causes. We need to prevent contamination in the
manufacturing facility in the first place. And doing that in
real time is a heck of a lot easier than waiting until many
months later when we may become aware of positive product
contamination.
In addition to seeking that authority, we are also asking
industry to do more environmental monitoring. That means
sampling your food facility and finding that bacteria, and
eradicating it, getting it out of the facility in the first
place, and retaining the isolates. We rely on whole genome
sequencing as a major scientific advance in food safety, but we
need to get the bacterial isolates in order to utilize these
new technologies for better food safety.
Ms. Lee. Thank you, and that is my time. I yield back.
Mrs. McClain. Thank you. The Chair now recognizes Mr.
Grothman.
Mr. Grothman. Thank you. In previous congressional
testimony before the Energy and Commerce Committee in May 2022,
you and Commissioner Califf provided an official document
entitled, ``Timeline of Infant Formula Related Activities,''
which is here, and I would like to ask unanimous consent to
enter this document into the record.
Mrs. McClain. Without objection.
Mr. Grothman. Thank you. Is this timeline complete
according to the Agency's activities up to that point?
Dr. Mayne. The timeline didn't entail every single activity
we did because we were working round-the-clock day in and day
out, but it is a synopsis of the major activities that the
Agency conducted during the months leading up to and following
the February 17 recall.
Mr. Grothman. OK. In a document recently provided by HHS to
the Committee, there appears to be more than two extra pages of
information that have been added to this original timeline.
Most of the additional information predates the May 2022
hearing. Why was this information omitted in the previous
congressional testimony?
Dr. Mayne. I do not know what the timing of those new
informational events were. I have not seen that document. So, I
would assume it is a more updated document, but I have not seen
the document, so I cannot comment.
Mr. Grothman. OK. One piece of information I found
astounding is the FDA actually received a complaint about the
conditions of the Abbott facility in Sturgis in February 2021,
yet they did not take it seriously. Why do you feel this
important fact was not shared with the American people at that
time?
Dr. Mayne. We were not aware that that complaint had been
sent into the FDA. It was forwarded from OSHA into a mailbox at
the FDA. I do not have firsthand knowledge of that particular
mailbox, but my understanding is it was not processed and
addressed promptly. And in fact, I was not aware of that
complaint at all when we testified in May 2022.
Mr. Grothman. Somebody should have told you. It has been
also brought to our attention that the FDA had the opportunity
to highlight the vulnerability of infant formula in USDA report
on American supply chains in August 2021. Why did your office
ultimately oppose the inclusion of infant formula in that
report?
Dr. Mayne. I have no information about that. I am not sure
what report that was, but what I can say is that we work, FDA
with USDA, on a Supply Chain Task Force. And we have been
working with USDA throughout the pandemic on supply chain,
including consideration of various commodities that were at
risk, and USDA and FDA were both aware that infant formula was
a potential commodity at risk. That is one of the reasons I
came to the appropriators in 2021 seeking additional resources
for infant formula, and we were grateful to receive those in
2022.
Mr. Grothman. Are there remaining facts the FDA is
withholding from Congress or the American people?
Dr. Mayne. I am not aware that we withheld any facts from
Congress or the American people. As I said, we did not know
about the whistleblower complaint. That was not covered up. We
had no information about that complaint.
Mr. Grothman. OK. One final thing. Today, we are talking
about the vulnerability of the infant formula supply chain.
During the COVID-19 pandemic, FDA funded the 21 FORWARD
Initiative to assess pandemic supply chain vulnerabilities. Why
was this program or other supply chain analytics not utilized
to evaluate in-stock rates of infant formula at the national
level until it was too late?
Dr. Mayne. Part of our Food, Drug and Cosmetic Act
authorities are food safety and nutrition. We do not have
authorities or resources to do supply chain monitoring. We did
what we could with the information we had. So, we purchased
through our budgets, without any resources received, publicly
available data, such as the IRI data, to try to understand what
was happening with regard to the supply chains. And that was an
initiative we took on, out of concern for what could happen
with the infant formula supply chain.
Mr. Grothman. OK. It has been reported that a staff request
was made in 2021 for funding from COVID-19 supplemental funds
to further develop 21 FORWARD, a data analytical platform to
monitor the food supply chain. However, then Acting
Commissioner, Janet Woodcock, cut the food supply chain
monitoring request, opting to fund a similar request for
increased monitoring of drug supply chains. Why was the food
supply monitoring request cut, yet one for the drug supply
chain monitoring approved?
Dr. Mayne. I cannot confirm anything about that. I have no
information on that. I did not participate in any of that.
Mr. Grothman. OK. Thank you.
Mrs. McClain. Thank you, Mr. Grothman. The Chair now
recognizes Ms. Porter.
Ms. Porter. To understand how the infant formula shortage
happened, I want to take a look at a little more detail at
Abbott Sturgis, Michigan production facility. Let us go back to
2021 and 2022 when, Dr. Mayne, you led the Center for Food
Safety and Applied Nutrition. According to the FDA's timeline
of the infant formula shortage, FDA conducted an initial
inspection of the Abbott manufacturing facility in Sturgis in
September 2021. Is that correct?
Dr. Mayne. That is correct.
Ms. Porter. And that inspection revealed multiple
unsanitary and improperly maintained working conditions,
correct?
Dr. Mayne. That is correct.
Ms. Porter. The FDA then initiated a further inspection of
the Sturgis, Michigan plant from January to March 2022,
correct?
Dr. Mayne. Yes.
Ms. Porter. Dr. Mayne, what did those additional
inspections in early 2022 reveal?
Dr. Mayne. So, we noted many deficiencies in the plant,
sanitation, plant conditions, in September 2021. Those were
delivered to the company through a 483 and in regulatory
meetings with their leadership. They committed to address our
concerns in writing back to us through an investigation and a
commitment to make those controls. When we got there in January
2022, those things had not happened, and, in fact, the plant's
conditions had deteriorated. That led us to do our own
environmental monitoring. Abbott also did environmental
monitoring in the plant, given the conditions we saw. That is
when we identified five different strains of Cronobacter in the
manufacturing facilities. So, all of that information, along
with the whistleblower complaint and the consumer complaints
that we had received, led to the voluntary recall in February
2022.
Ms. Porter. I would like, Madam Chairwoman, permission to
enter into the record the March 2022 FDA inspection report and
the timeline of infant formula-related activities from U.S.
FDA.
Mrs. McClain. Without objection.
Ms. Porter. This March 2022 FDA inspection report, which
detailed the FDA's observation of these multiple unsanitary
conditions that you just described, it says the FDA inspection
team observed that Abbott ``did not establish a system of
process controls designed to ensure that infant formula does
not become adulterated.'' The team also found that Abbott ``did
not ensure that all surfaces that contacted infant formula were
maintained to protect infant formula from being contaminated by
any source.'' The inspectors found employees, who worked
directly with formula, failing to wear the necessary protective
apparel and that Abbott's own self-investigation failed to
conclude whether its operations were a health hazard.
It is unacceptable, and I think you agree based on how you
described what you saw in September 2021 and what you saw in
early 2022. It is unacceptable for a company that manufactures
more than 40 percent of the infant formula sold in the United
States and is a major recipient of government dollars via the
WIC program to keep its facility in such poor conditions. It
puts babies at risk and as a result of all of this, failure to
follow the rules, failure to respond to regulators, despite
promises to do, so we wound up with a recall in February 2020.
Dr. Mayne, what lessons learned from Abbott's failure to
keep its plant in appropriate condition, commitments, but
failure to follow through on those commitments to do better by
2020 to 2022? What can we learn from this experience to make
sure that the next time the FDA tells a formula manufacturer to
clean up their plant, they do not arrive six months later and
find that things have actually gotten worse?
Dr. Mayne. Yes, and we agree, the conditions were
egregious. And, in fact, that was why we took the exaggerated
step of putting into place a consent decree where their
resumption of manufacturing would be overseen by an independent
expert and when working with our investigators and our subject
matter experts to make sure they could resume safe production.
That is an unusual step that we would take, but given the
conditions we saw, we took it.
But what we have worked on is really trying to recalibrate
the infant formula manufacturers broadly. That is the call to
action we released in March of this year. We identified many
deficiencies in the Abbott inspection. We identified certain
deficiencies and other infant formula manufacturers as well,
and so the call to action is for all infant formula
manufacturers to do better. We have been engaging with them
regularly. We have issued a prevention strategy. Our food
safety experts are working directly with their food safety
experts to explain what we expect for safe formula production.
And so, we are on a path to be into a better food safety
situation and not running into the situation we found ourselves
in, in the Abbott plant situation in January 2022.
Ms. Porter. Thank you. I yield back.
Mrs. McClain. Thank you, Ms. Porter. The Chair now
recognizes Mr. Langworthy for five minutes.
Mr. Langworthy. Thank you, Madam Chair. It seems like the
more information that we get, the more questions that are
created, and it really seems like there is a pattern of delay,
delay, delay here. The Chairwoman already asked you why it took
so long for the FDA to inspect the Sturgis plant. Why was there
a three-month delay between the Abbott recall, and the closure
of February 17, and the decision to waive FDA's strict formula
labeling and importation requirements in May 2022, despite the
national shortages?
Dr. Mayne. So, I think if I heard your question, there are
many questions embedded in there. So, let us take one at a
time.
Mr. Langworthy. Sure.
Dr. Mayne. You mentioned labeling. We put in place an
enforcement discretion policy to allow safe nutritious formula
to come into this country to help make sure that parents could
find product on store shelves during this period of this
national shortage. We did have certain labeling requirements,
and they are primarily for things like safety. For example, a
baby that has a cow's milk allergy needs to know if a formula
is based on cow's milk or soy, so there are certain label
issues that are critically important for safety, like allergen
information. Also, how to prepare a formula. Some formulas need
to be diluted to different amounts than others. Over diluting
risks having infants not get enough nutrition. Under diluting
means the product will not flow through a bottle and babies
will not get the desired nutrition.
Mr. Langworthy. Dr. Mayne, I understand why we would have
labeling, but why is there a delay from February 17 to three
months later when that labeling action took place? Why was
there such a delay in the labeling?
Dr. Mayne. The formula recall started on February 17. We
then went through a series of steps to try to address shortages
regarding infant formula, and given the market concentration in
this country, that is not an easy step. There were a number of
things we did. For example, we received product from across our
borders from domestic manufacturers that have plants in other
countries. We expedited the entry of those coming into the
country. We worked with the infant formula manufacturers that
were not at the Abbott plant, not the Sturgis plant, to
increase their production. We did a number of different steps
to get that into place.
We wanted to bring in safe product from abroad. We had to
put out a guidance document, tell others, tell us if you want
to bring product into this country, this is what we need to see
from you. We need to know those products meet our nutritional
criteria. We need to make sure those products have been tested
for safety, the same way we expect our domestic products to be
tested. We got applications and we started bringing those
products into this country. In total, we issued, I think it was
20 letters, 36 different products, including specialty and
medical products that were allowed to come into this country
under enforcement discretion. And now we have doubled the
number of infant formula manufacturers bringing product to this
country, and that is through FDA's actions.
So, we jumped into action. We used what levers we had to
try to address the formula shortage, but there are some levers
we could not address, the market concentration, but as you have
heard, we have taken steps to try to address those. More things
are needed to prevent this into the future, and we are very
willing to work with Congress and in an all of government
response to make sure that we do not have this problem again in
the future.
Mr. Langworthy. A week before the formula recall on
February 10, FDA leadership activated the coordinated outbreak
response and evaluation network core. To your knowledge, were
senior White House officials notified at that point?
Dr. Mayne. I know that White House officials were notified
on February 16. I do not know if they were notified on February
10, but I am aware that we did send a communication to the
Supply Chain Task Force, which would include the White House on
February 16, which was the day before the recall.
And just to be clear, the science was evolving on February
10. We did not have the information in place that we had had
Cronobacter. That information was not available. We were doing
the inspections. We had collected samples. The information
about Cronobacter and the sequences actually came in on
February 13. So, at that point, we had more information that
this plant was contaminated on February 13. That led to the ask
of Abbott to voluntarily recall. We notified the White House
and others on February 16, prior to the recall occurring.
Mr. Langworthy. If the White House was aware, why did it
take three months for them to step in and help address the
shortage of baby formula?
Dr. Mayne. I cannot speak to what the White House, what
their actions were, but what I can speak to is that we were
working in an all-of-government way throughout this process,
including with regard to the enforcement discretion products.
We worked very closely with Health and Human Services on
Operation Fly Formula to bring those products to the U.S.
market as quickly as possible, to help rectify the shortages
that parents in this country were experiencing.
Mr. Langworthy. And last, yes or no, did you talk to the
White House about the possibility of a formula shortage? If so,
when?
Dr. Mayne. I am aware that we talked to them through a
written memo on February 16. Whether there were previous
conversations with the White House, I cannot say, but I can say
that that information was shared to the White House before the
recall occurred.
Mr. Langworthy. Thank you, and I yield back, Madam Chair.
Mrs. McClain. Yes. Thank you. The Chair now recognizes Ms.
Balint for five minutes.
Ms. Balint. Thank you, Madam Chair. In September 2022, FDA
issued an internal evaluation of the Agency's response to the
infant formula shortage, and Dr. Steven Solomon, FDA's Director
of the Center for Veterinary Medicine, drafted the report.
Following the Subcommittee's March 2023 hearing, so just a few
weeks ago, on the infant formula shortage, some of my
Republican colleagues made some claims about how FDA conducted
its internal review of the infant formula response. Dr. Mayne,
to your knowledge, why didn't FDA tap you, Mr. Yiannas, or Ms.
Woodcock to write the internal review and instead selected Dr.
Solomon?
Dr. Mayne. So, Dr. Solomon was not involved in any way in
the infant formula response. Mr. Yiannas, myself, and Dr.
Woodcock was the Acting Commissioner leading up to February 17,
so all of us were involved in the response, and so having us
evaluate ourselves is illogical.
Ms. Balint. Got it. So, you needed somebody impartial. You
cannot have the fox watching the henhouse, so to speak.
Dr. Mayne. We asked for someone who knew the FDA well and
knew the processes and procedures of the FDA well, so that
someone would not have to translate all of the acronyms,
everything as we discussed the processes, but he was not
involved in the infant formula response in any way. And one
other thing, is this was an internal response because we were
very committed to improving our processes and our procedures as
expeditiously as we could. There were a large number of
recommendations that came out of that report. And we have been
working hard every day every week to move further some of those
recommendations, and we have made great progress in addressing
many of the recommendations.
At the same time, there was also an external review of our
program that was convened by the Reagan-Udall Foundation, and,
as well, there is an OIG review as well. So, we are going to
benefit from an internal review as well as two external
reviews. We are always committed to continuous improvement to
do better.
Ms. Balint. So, just to follow up on that, can you just
explain really quickly how did the FDA improved its consumer
complaint and whistleblower complaint process?
Dr. Mayne. Yes, the processes have been changed. So, for
example, with regard to consumer complaints, we get a lot of
consumer complaints at the Agency, thousands of consumer
complaints. But certain criteria, for example, if a consumer
complaint comes in and it involves an infant, if it involves a
death or hospitalization, anything like that, that is
immediately escalated to the leadership, so I now see those.
So, there is an elevation process based upon criteria--
vulnerable populations, hospitalizations, deaths, things like
that--so those processes have been put in place, and the
processes are important given the volume of work that we have.
So, in the Foods Program, we address something like over 9,000
adverse event consumer complaints every year. We have a call
center that responds to 25,000 calls every single year. We need
strong processes and technology to manage that volume of
workload as optimally as we can.
Ms. Balint. I appreciate that. The internal review, as I
understand it, also revealed that scientific gaps and
understanding of the contamination spread and illness of
Cronobacter also hindered FDA's response. What steps has FDA
taken to remedy some of the knowledge gaps and to improve
Cronobacter sampling and testing procedures so that we can
prevent this from happening again?
Dr. Mayne. Yes, we were truly in an information deficit
here because Cronobacter is not a notifiable disease. And when
we saw four consumer complaints and our physician complaints
about Cronobacter, we did not know if that was unusual or not
because we do not know what the denominator is. So, having a
nationally notifiable disease would completely change the way
we could have approached this particular situation. So, not
much was known about the pathogen.
One of the things we did is, we convened the National
Advisory Committee on Microbiological Criteria for Food to ask
them a whole series of questions about Cronobacter. We have
given them a charge. They are working on that right now. I am
the vice-chair of that committee. The committee is meeting next
week, to give us some progress on what they have learned about
Cronobacter, so that is critically important. So, the work on
national notifiability is critically important as is the work
to understand this bacteria. What do we know about its
prevalence? Where is it located? What are the sources of
contamination? Our lack of information on whole genome
sequencing for this pathogen has hindered us. We do not have
anywhere near the tools that we have, like Listeria,
Salmonella, or E. coli, but we really want to advance the
science here. And we have made great progress already in the
months since this has occurred.
Ms. Balint. I really appreciate that. So, it is clear that
FDA needs adequate resources to prevent this from happening
again. And I just want to say, as a mom, who had to supplement
my breastfeeding in order for my son to thrive, I know how
important this issue is for parents all over this country, and
this Committee, I know, is really focused on making sure this
does not happen again. Thank you, Dr. Mayne.
Dr. Mayne. Yes, thank you. We agree, and we appreciate
that. We never want to have this happen again.
Mrs. McClain. Thank you. I now recognize myself. I am still
confused, and I need you to help me connect the dots. Why did
it take until January 31 for the FDA to inspect the Abbott
facility in Sturgis, Michigan? Not only did reports of
Cronobacter infections start in September 2021, but we now know
that OSHA transmitted a workplace complaint to FDA in February
2021, outlining the unsanitary conditions.
So, I just need some help on filling in the gaps. I mean,
the FDA's 2021 investigations operation manual states, ``All
complaints involving either infant formula or baby food are to
be thoroughly investigated on a high priority basis.'' I just
think four months is a big delay. Can you help me fill in the
timeline there?
Dr. Mayne. Yes. So, typically, our goal is to inspect
annually for infant formula manufacturers. Our normal high-risk
food facilities are inspected once every three years, and non-
high risk food facilities are inspected once every five years
under the Food Safety Modernization Act that Congress gave us.
But infant formula is a high priority, and that is why our goal
is annually. But with regard to the Sturgis facility, we were
in there in September. We found deficiencies. The industry
committed to address those. We typically give time to industry
to address those. They did not, but then we----
Mrs. McClain. When you went in there at the original
September of 21, that was a normal regular-scheduled visit, so
to speak, right?
Dr. Mayne. Correct. Right.
Mrs. McClain. Then after that is when, unfortunately, some
babies passed away and there were more complaints, right,
between really that September and January. Why the four-month
lag? I think that is what I need----
Dr. Mayne. Yes, at a high level, and I am happy to address
the timing. First of all, again, I am not head of the
inspectorate, but I can tell you what I understand and what the
dates are and what I know. So, we received that first consumer
complaint at the same time the investigators were there. That
was followed up on. We always try to interview the parents,
obtain product, find medical records----
Mrs. McClain. But you did not know about Cronobacter on the
21st----
Dr. Mayne. No.
Mrs. McClain [continuing]. In your normal, right? You got
reports after that.
Dr. Mayne. Correct.
Mrs. McClain. And that is when it----
Dr. Mayne. The case report came in, but we would not have
necessarily pulled the product, tested the product, seen what
the evidence pattern was. That information did not come in
until October, just to be clear.
Mrs. McClain. OK. I will give you October.
Dr. Mayne. Right.
Mrs. McClain. We did not do anything until January. I
mean----
Dr. Mayne. Correct. So, that is the first step, and then in
October, a whistleblower complaint came in. As I indicated, the
staff received it, they acknowledged it, they reviewed it.
Mrs. McClain. It just did not get to you.
Dr. Mayne. That is correct, but the staff were working on
it, and then they attempted to interview the whistleblower, and
as I think you know, the whistleblower, based upon timing on
their end, was not available.
Mrs. McClain. But they had it since October, and they did
not do anything from January.
Dr. Mayne. Then they tried to schedule the inspection. In
December, the inspection was attempted to be scheduled. Abbott
declined to have the inspection done because they had a COVID
outbreak in their facility, and then we finally got in there.
But looking at that, we agree with you. Those timelines are
less than ideal, and that is why we have put in place a whole
series of processes based upon the lessons learned from this.
Once we got in there and we saw the conditions, all of our
timelines were met very expeditiously. But I agree with you, in
the months leading up to that time, that those timelines could
have been more ideal.
Mrs. McClain. Thank you. And then in my few minutes, I am
still troubled by ``during COVID.'' I mean, I think baby food
is essential, especially in this day and age, and especially
for underserved communities. I show that 20 of 23 of the infant
formula production packing and distribution plants in the U.S.
were not inspected for nearly two years. Why? Are we blaming
that on COVID?
Dr. Mayne. So, those numbers do not agree with what I have.
Mrs. McClain. We got those numbers from the FDA.
Dr. Mayne. I think we should take that question back.
Again, that would come from the data from our Office of
Regulatory Affairs.
Mrs. McClain. What do you have as your numbers? Were the
23, were they all inspected in a timely fashion?
Dr. Mayne. And again, some of it may be calendar years
versus fiscal years. We should take the numbers and get back.
But my understanding is that we did inspect, even in the early
part of COVID, five different infant formula manufacturing
facilities.
Mrs. McClain. But there are 23, so I am going to even give
you on the five.
Dr. Mayne. At that point in time, I think we had 21, but
that is why we should take it back.
Mrs. McClain. OK. Let us even say with 5 of 21. Can we at
least agree that is kind of a problem?
Dr. Mayne. I am sorry. I did not hear the last thing you
said.
Mrs. McClain. Can we agree even if it is 5 of 21 and your
numbers are correct, 5 of 21? What was everyone doing?
Dr. Mayne. Those----
Mrs. McClain. And I know it was COVID, but----
Dr. Mayne. They were inspecting the prioritized
inspections. There are many criteria----
Mrs. McClain. And baby formula is not prioritized, so maybe
that is something else we need to change?
Dr. Mayne. Certain manufacturers were. It was based upon
their inspectional history, whether there had been complaints
associated with products. So, if a formula manufacturer had a
long history of no complaints, they might not have just been
prioritized in that period of time in 2020.
Mrs. McClain. All right. Did Abbott have complaints?
Dr. Mayne. Did Abbott have complaints? We asked Abbott when
we go into the facilities. In fact, every time we----
Mrs. McClain. Did they have complaints?
Dr. Mayne. I think you should ask Abbott that question,
but----
Mrs. McClain. I am asking you. Do you know of any
complaints from Abbott? You are the FDA. You are the
inspection. You are the regulatory agency.
Dr. Mayne. We get the consumer complaints. We----
Mrs. McClain. Did they have any?
Dr. Mayne. We report them to Abbott. We tell Abbott if we
get a consumer complaint, then----
Mrs. McClain. Did you get any?
Dr. Mayne [continuing]. Then we talk. Yes, those are the
ones that we talked about.
Mrs. McClain. OK. Thank you.
Dr. Mayne. When we are in a plant, we asked Abbott if they
had any similar complaint.
Mrs. McClain. But you had not done an inspection with
Abbott, who had to had complaints for the prior two years? So,
my time is up. I will yield back.
Voice. I think we are done. Questions?
Voice. Yes.
Mrs. McClain. I will now recognize Ms. Lee for closing
statements. Thank you.
Ms. Lee. Thank you, Madam Chairwoman, for holding this
hearing on such an important issue. Thank you, Dr. Mayne, for
your testimony. Half of our Subcommittee hearings have been on
this topic so far, and we have identified some necessary areas
for improvement, but now we need to put this information into
action.
First, we need to pass bipartisan legislation to create a
process that makes FDA aware of bacterial contaminations in
real time. Then the FDA will have no excuse but to take action
on the contaminations immediately. Second, we need to continue
working with the FDA and actually listen to them. The FDA
should not be hampered by congressional inaction. We need to
keep these lines of communication open to ensure the FDA can do
its job. Third, we need to collect better data on Cronobacter,
so that we can better stop its spread. While I appreciate the
steps FDA has taken so far to increase our understanding of
Cronobacter, this public health issue will not be solved with
just one agency or one approach.
Finally, we have to put our money where our mouth is. If we
want a stronger system, we need to fully fund the FDA to
protect infants who use formula. Now is not the time for cuts
to the FDA while expecting them to modernize and streamline
their systems. That is definitely not going to happen with the
22 percent across the board cuts. A cut that would also mean
1.7 million women, infants, and children will lose nutrition
assistance through WIC.
Look, I believe the Chairwoman and I, we all have the same
goals here, avoiding an infant formula shortage repeat. There
are things that should be easy for Members of both of our
parties to agree to do now, and there are some things that will
require longer conversations. But if we can find a path forward
that saves kids' lives and stops shortages, then it will all be
worth it. Thank you, and I yield back.
Mrs. McClain. Thank you, Ms. Lee. I now recognize myself
for a closing statement.
Today we have heard some excuses, excuses from the FDA's
inability to do its job, excuses for the FDA's unwillingness to
prioritize food safety, excuses from the FDA's lack of
preparation to address the infant baby formula shortage the FDA
prioritizes as critical. There is no excuse for these failures.
I do recognize that the failures are not just one-sided, but I
am talking to the FDA right now, and we need to first admit we
have a problem before we can fix it.
There are just no excuses. The FDA has an important job,
one that American people pay them to do and, more so
importantly, trust them to do. If the FDA is not going to do
their job, we have some serious decisions to make. The FDA is
responsible for keeping Americans' food safe. We need to make
sure we give that food safety enough responsibility, enough
attention, right? Especially when it comes to baby formula.
Last year, the trust was broken, and families lost precious
children as a result. Those lives can never be replaced, and we
owe it to those families to demand answers, and I think that is
what we are doing. The crisis exposed significant failures
within the FDA's regulatory and oversight process, some of that
which we are in the process of fixing. Others we need to fix.
Frankly, I am still concerned that this has happened again,
right? Can Congress do better? Yes. Can Abbott do better? Yes.
Can the FDA do better? Yes. I think working together, we can
all get to a better spot. The FDA has promised it can do
better. Time will tell, and I hope it will. We will be closely
following the FDA's effort to revamp its Human Food Program. I
think that is critical.
As Dr. Mayne retires at the end of this month, there are a
growing list of vacancies in the FDA's Food Safety Programs.
These vacancies are concerning, but ultimately, there needs to
be a culture change at the FDA. The FDA needs to reconsider
what they deem critical and what the American people deem is
critical. I think some of those changes will help bridge the
gaps in those timelines. I am and will continue to be in
communication with the FDA to monitor the process of hiring a
new Deputy Commissioner of Human Foods, and oversight will
continue.
In closing, I want to thank our panelist once again for
your important testimony today. I appreciate it. I really hope
that you enjoy your retirement. It is well deserved.
And without objection, the Members will have five
legislative days to submit materials and to submit additional
written questions for the witnesses, which will be forwarded to
the witnesses for their response.
Mrs. McClain. If there is no further business, without
objection, the Subcommittee stands adjourned. Thank you so
much.
[Whereupon, at 3:25 p.m., the Subcommittee was adjourned.]
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