[House Hearing, 118 Congress]
[From the U.S. Government Publishing Office]
FDA OVERSIGHT PART I:
THE INFANT FORMULA SHORTAGE
=======================================================================
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
__________
MARCH 28, 2023
__________
Serial No. 118-13
__________
Printed for the use of the Committee on Oversight and Accountability
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Available on: govinfo.gov
oversight.house.gov or
docs.house.gov
______
U.S. GOVERNMENT PUBLISHING OFFICE
51-718 WASHINGTON : 2023
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 March 28, 2023................................... 1
Witnesses
Mr. Frank Yiannas, M.P.H., Former Deputy Commissioner, Office of
Food Policy & Response, U.S. Food & Drug Administration
Oral Statement................................................... 4
Dr. Peter Lurie, M.D., M.P.H. (Minority Witness), President &
Executive Director, Center for Science in the Public Interest
Oral Statement................................................... 6
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
* Statement for the Record, Consumer Brands Association;
submitted by Rep. McClain.
* Statement for the Record, Consumer Reports; submitted by Rep.
McClain.
* Statement for the Record, Dr. Ostroff, Dr. Acheson, Mr.
Taylor; submitted by Rep. McClain.
* Statement for the Record, North American Society for
Pediatric Gastroenterology, Hepatology and Nutrition;
submitted by Rep. McClain.
* Questions for the Record: to Mr. Yiannas; submitted by Rep.
McClain.
* Questions for the Record: to Mr. Yiannas; submitted by Rep.
Porter.
* Questions for the Record: to Dr. Lurie; submitted by Rep.
Porter.
Documents are available at: docs.house.gov.
FDA OVERSIGHT PART I:
THE INFANT FORMULA SHORTAGE
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Tuesday, March 28, 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 10:03 a.m., in
room 2247, Rayburn House Office Building, Hon. Lisa McClain
[Chairwoman of the Subcommittee] presiding.
Present: Representatives McClain, Gosar, Grothman, Luna,
Langworthy, Porter, Ocasio-Cortez, Gomez, Balint, Lee, and
Crockett.
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.
Welcome to the Subcommittee on Health Care and Financial
Services. To the witnesses, thank you very much for your
attendance and participation today in today's oversight hearing
of the FDA's response to the infant formula shortage. Today, we
will hear from food safety experts to better understand how
this crisis happened, how it could have been handled better,
and determine whether the FDA is able to prevent a future
crisis from occurring.
As many of you know, I have been outspoken in my
frustration with the FDA's response to the infant formula
shortage. The infant formula crisis underscores a major problem
with the FDA. The FDA is responsible for 78 percent of the U.S.
food supply, but the FDA is not prioritizing food safety.
Instead of owning its failures, the FDA has used COVID-19 as an
excuse to neglect inspections and justify poor performance.
While states like Michigan were shut down, preventing
Michiganders from making a living, the Federal Government was
100 percent open and was paying too many of its employees to
stay home and not do their jobs adequately. How did this
critical shortage happen? Well, let us go back to the
beginning.
In the summer of 2021, the FDA was aware of significant
supply chain disruptions resulting in potential shortages of
several types of infant formula. By September 2021, the Abbott
nutritional infant formula plant in Sturgis, Michigan, had not
been inspected in two years. This plant produces 20 percent of
the Nation's supply of baby formula. Then in October, an Abbott
whistleblower submitted a 34-page complaint to the FDA
outlining the concerns at the Sturgis facility.
Despite this whistleblower and several reports of babies
becoming sick, it took until January 31 of 2022 for the FDA to
begin inspecting the Sturgis plant. A couple weeks later,
Abbott voluntarily recalled its product and voluntarily shut
down its Sturgis plant. Had the FDA or the Administration done
anything to prepare for the closure or ensure the availability
of infant formula across the country? No, they had not. The
health of vulnerable infants that rely on formula is a single
food source that was not a priority.
Today, we have more information that we didn't have before.
We know that the FDA ignored the Abbott's employee's 34-page
disclosure, detailing concerns about the Abbott facility in
Sturgis. We know that the FDA's telework policy and lax
approach to oversight left it unprepared to address the
shortages when the Sturgis facility was shut down. Americans
are tired of excuses, like blaming COVID-19 or claiming there
isn't enough money in the budget while inspectors telework and
fail to do their job. FDA regulators were paid to do a job, but
chose not to use its remote inspection authority, which was
specifically intended by Congress to ensure FDA could prevent
this type of crisis. They did not do their job and collected a
paycheck on the backs of hardworking Americans. Americans want
accountability, especially as it pertains to their children.
Today, we are going to conduct a long-overdue oversight of
the FDA's response to the infant shortage formula. We are going
to determine the extent of the internal failures within the FDA
that led to the crisis, and we are going to discuss ways that
the FDA can actually improve its internal controls to prevent a
supply chain crisis of this magnitude from happening again.
We are also going to examine whether the FDA's proposed
restructuring will improve its ability to keep food safe. We
owe it to parents, caregivers, and infants to get to the bottom
of what happened and, most importantly, prevent it from
happening again because nothing has changed. We owe it to the
families of the babies that died as a result of this
contaminated formula. So, thank you to our witnesses, and we
look forward to hearing your testimony. And I now yield to
Ranking Member, Ms. Porter, for her opening statement.
Ms. Porter. Thank you very much, Madam Chairwoman. Today, I
want to focus on answering this question. If a big infant
formula company like Abbott had a bacterial contamination
today, would the whole formula market be at risk again? And to
answer that question, we need to know exactly how equipped the
FDA is to be in the prevention business now that we have
weathered the 2022 crisis. Today, if the FDA received a
whistleblower complaint about contamination, would it take four
months, as it did then, to get to the Deputy Commissioner's
desk, and over the last year, have we done enough to give the
FDA the authorities and resources it truly needs to be
proactive about preventing supply shocks in critical food
markets?
I know that some of my colleagues today, probably on both
sides of the aisle, will be chomping at the bit to bash a
Federal agency. That is not where I am. Discrediting an agency
without figuring out what went wrong and how to fix it is
simply malpractice, but I am not afraid to say that the FDA has
a lot of work to do, no matter who that offends. At the same
time, I am also not afraid to say that Congress is part of the
problem. We have to empower the FDA for it to succeed. That
means that when there is a crisis, we need to give the FDA
resources.
Last year, 12 Republicans joined Democrats to pass the
Infant Formula Supplemental Appropriations Act to give the FDA
funding to address and prevent formula shortages. For the other
192 lawmakers who voted no and are wondering why the FDA
couldn't do more, you should put your money where your mouth
is. But empowerment goes beyond money. A strong FDA must have
the authority to know what is going on in production between
inspections, and a strong FDA must be able to review present
and past testing data to help it make decisions. Even with the
best structure, leadership, and resources, the FDA is only as
well equipped as its legal authorities allow it to be. An
improved FDA is going to take some work, and it is not on any
one person that we can fire or blame. This is a complex issue
that is going to take real work to solve.
Now, as much as I am dedicated to solving the FDA part of
the puzzle, we wouldn't be doing our job if we said that that
is the only issue in the formula crisis. Ultimately, formula
manufacturers are responsible for producing safe products. They
have very few incentives to self-regulate when they are so
powerful, but that doesn't mean we can let Abbott off the hook
for its negligent behavior. Last year, Committee Democrats
launched an investigation into Abbott's negligence that
Republicans, sadly for me, declined to join. This needs to
change. This is partially an FDA problem, but it is also
partially a Big Business problem, and Republicans and Democrats
can't pick and choose who to hold accountable.
What is more, we have to stop turning a blind eye to
consolidation in our food markets. Abbott is 1 of 3 companies
that control 90 percent of the formula market. If something
goes wrong in one factory, there aren't many other options to
turn to. That doesn't make for resilient markets. By
diversifying supply, competitive markets could cure many of the
formula shortage risks even with the other mistakes that were
made.
Today, let us not give anyone or anything a pass, but at
the same time, let us not make this hearing an attack. There
are many commonsense moves we can regulate to diversify and
strengthen the infant formula market. Let us learn those
lessons today, and let us be successful by setting aside
politics, to listen and learn, and take proactive approaches.
That is what I intend to do, and I am grateful to the
Chairwoman for convening this important hearing. I yield back.
Mrs. McClain. Thank you, Ms. Porter, and I am pleased to
introduce our witnesses today who are here to discuss the FDA's
response to the 2022 infant formula shortage. Mr. Frank Yiannas
was the Deputy Commissioner of Food Policy Response at the Food
and Drug Administration from December 2018 to February 2023.
Previously, he was Vice President of Food Safety at Walmart and
Director of Safety and Health for the Walt Disney Company. He
received his B.S., Bachelor of Science, in microbiology from
the University of Central Florida and his Masters of Public
Health from the University of South Florida.
Mr. Peter Lurie is President and Executive Director for the
Center of Science in the Public Interest. Previously, Dr. Lurie
was an Associate Commissioner for Public Health Strategy and
Analysis at the Food and Drug Administration. He received his
Bachelor of Science in chemistry from Cornell University, M.D.
from Albert Einstein College of Medicine, and M.P.H. from the
University of California, Berkeley.
Pursuant to Committee Rule 9, the witnesses will please
stand and raise their right hands.
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?
[A chorus of ayes.]
Mrs. McClain. Let the record show that the witnesses all
answered in the affirmative.
We appreciate all of you being here, and we sincerely look
forward to your testimony, to get to the bottom of how this
happened, and, more importantly, what do we do to make sure
this doesn't happen again.
So, let me remind the witnesses that we have read your
written statements, and they will appear in full in the hearing
record. Please limit your oral statements to five minutes. 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 in front of you will turn yellow.
When the red light comes up, your five minutes has expired, and
we would ask you to please wrap up.
So, with that said, I recognize Mr. Yiannas to please begin
with your opening statement.
STATEMENT OF FRANK YIANNAS
FORMER DEPUTY COMMISSIONER
OFFICE OF FOOD POLICY & RESPONSE
U.S. FOOD & DRUG ADMINISTRATION
Mr. Yiannas. Chair McClain, Ranking Member Porter, and
Members of the Subcommittee, thank you for inviting me here
today to testify before you and, more importantly, for your
interest in better understanding what happened, so we can
prevent an infant formula of this nature from ever happening
again. Our bosses, the American people, and especially the most
vulnerable among them, infants, deserve that from us.
In February of last year, already amid unprecedented supply
chain challenges brought upon by the pandemic, our Nation's
parents learned of several confirmed illnesses among infants of
a rare and potentially fatal bacterium called Cronobacter
Sakazakii. Those illnesses, linked to a single manufacturing
plant in Sturgis, Michigan, along with the findings of very
egregious conditions at the facility, led Abbott to execute the
largest recall of powdered infant formula in our Nation's
history. It has been over a year since that recall took place
and subsequent widespread infant formula shortage is that it
caused. There has already been a congressional hearing on this
matter. The FDA issued its own version of an investigation
report titled, ``Evaluation of The Infant Formula Response,''
and there has been, as you know, extensive media coverage.
Yet despite these actions, a clear and transparent
understanding of what took place and the contributing factors
that allowed it to occur have remained elusive. While we stand
here today, more than a year since the recall, it is my view
that the state of the infant formula industry today is not much
different than it was then. The public health surveillance
system for this pathogen remains insufficient. The necessary
safeguards have not been advanced at an inadequate pace to
prevent future illnesses, and the infant formula supply chain
continues to lack serious resiliency. In other words, the
Nation remains one outbreak, one tornado, flood, or cyberattack
away from finding itself in a similar place to that of February
17, 2022.
As we all now know, FDA's response to a series of reports
of multiple infants infected with Cronobacter, along with the
letter received from a whistleblower, spanned a period of
several months, beginning in September 2021. It wasn't until
January 31 of the following year, four months later, that the
FDA began an official inspection of the Abbott Sturgis
facility. Had the Agency responded quicker to some of the
earlier signals, I believe this crisis could have been averted
or at least the magnitude lessened.
As Deputy Commissioner for Food Policy and Response at that
time, I was not made aware of the series of illnesses nor of a
whistleblower complaint until February 10 of 2022. From the
time I first learned of the incident, on that date of February
10, to the time it took Abbott to conduct a voluntary recall to
protect infants, it was seven days, seven days contrasted to
four months of time in which the series of events unfolded.
Clearly, I really wish, and I should have been, notified sooner
so I could have initiated containment steps earlier. Had that
happened, I believe we might not be here today.
There is no question that FDA's siloed and decentralized
foods program structure and culture contributed to and
exacerbated these delays. However, after the series of events
that allowed these issues to escalate and build one upon
another, by the time February 2022 rolled along, the
containment of this incident became my charter. Clearly, I
agree Abbott Nutrition bears the primary responsibility for
this crisis. However, there are numerous other lessons learned,
too, and there is more that the industry and regulators can and
must do. In my written testimony, I have included a list of 11
specific recommendations that I hope you have had a chance to
review.
In closing, the infant illnesses and deaths due to
Cronobacter, the Abbott recall, and the cascading and
devastating effects it had on infant formula availability and
families in our country was all a preventable--let me
emphasize--a preventable tragedy. It is my hope that we seek
lessons learned and take the necessary actions to prevent such
a crisis from ever happening again. I thank the Subcommittee
for your interest, and I look forward to answering your
questions.
Mrs. McClain. Thank you very much, Mr. Yiannas, and I
recognize the next witness, Mr. Lurie, to please begin with
your opening statement.
STATEMENT OF PETER LURIE
PRESIDENT & EXECUTIVE DIRECTOR
CENTER FOR SCIENCE IN THE PUBLIC INTEREST
Dr. Lurie. Good morning. I want to thank Chairman McClain,
Ranking Member Porter, other Committee Members for inviting me
as a witness on behalf of the Center for Science in the Public
Interest. I am its President and Executive Director and a
former Associate Commissioner at the FDA.
If we are to apportion blame for the now resolved powdered
infant formula crisis, the best place to start is at the Abbott
nutrition plant in Sturgis, Michigan, that produced the formula
associated with the outbreak because it was there that infant
formula, contaminated with Cronobacter, was destroyed years
before the outbreak, without FDA being notified. It was there,
according to a whistleblower, that there were lax cleaning
practices, falsified records, and relevant information hidden
from FDA inspectors. And it was there, that repeated FDA
inspections revealed standing water, decaying dryers, failure
to follow sanitary practices, and eventually multiple
environmental samples testing positive for Cronobacter.
My testimony touches on the consolidation in the industry,
but I am not going to address that further. You can read that
in my written testimony, but we want to focus here on what the
FDA did. Much of the FDA's response was entirely appropriate.
The Agency convened an Agency-wide incident management group,
sought to identify alternative suppliers, exercised enforcement
discretion on a case-by-case basis to allow product to reach
market, facilitated the importation of products from abroad,
and used a risk benefit approach to release the most critical
products.
In other respects, however, FDA's performance failed to
live up to the high standards that American consumers expect
and deserve. The whistleblower report went undelivered to
senior Agency staff for months, and the Agency took too long to
schedule a repeat inspection of the Sturgis facility, thus
delaying the ultimate recall, the Agency audit, and internal
review of its own response. But that report, while offering
many strong recommendations, failed to provide a clear account
of the events surrounding the recall or the mistakes made by
Agency officials.
Better prevention and management of future crises requires
at least three elements: authority, funding, and an effective
organizational structure. On funding, the Food and Drug Omnibus
Reform Act of 2022 required formula and medical food
manufacturers to develop a supply redundancy risk management
plan, mandated the creation of an office of critical foods at
FDA, and it also required critical food manufacturers to notify
FDA of interruptions in manufacturing likely to lead to
meaningful disruptions in supply. But the Agency needs
additional authorities and should have the authority to require
manufacturers to notify the Agency of all positive test results
and to require more frequent environmental testing in
production facilities. It should also be able to compel
manufacturers to submit supply chain data, and although not an
FDA issue, Cronobacter should be made a notifiable illness.
Second, the food program requires more funding. Rising
costs have left the program with a number of FTEs, similar to
what it had in 1978. But since then, FDA has been given
increasing responsibilities, including broad new mandates over
infant formula, dietary supplements, food labeling, and food
safety. The President's FY 2024 budget calls for $152 million
in necessary new funding for the foods program, and this
includes $64 million for health and safe food for all, which
includes support for improved oversight of infant formula.
There is also $12 million to establish a Center for Nutrition
that will house its Office of Critical Foods.
We at CSPI believe that number should be closer to $24
million because of the importance of nutrition programs. But
together, these programs would support increased review
capacity for infant formula premarket notifications, improved
surveillance of formula related adverse events, and the
development of better laboratory methods for Cronobacter, as
well as a more rapid review of inspection findings.
Finally, Americans deserve a food program with a structure
that is transparent, effective, and accountable. The formula
crisis laid bare the high level of dysfunction, breakdowns in
communication, and lack of clear lines of authority that
characterized the FDA's response. The reorganization announced
by FDA Commissioner Califf in January is an important step on a
path toward addressing these issues. It captures the spirit of
the Reagan-Udall Foundation report that the Agency had
requested, and it does so in a manner that minimizes internal
disruption.
First, it elevates the food program to the Deputy
Commissioner level, which is higher than any other FDA food
product center. Second, it dissolves a dysfunctional structure
whereby three senior officials, with authority over the human
foods program, all reported to the Commissioner, and none had
clear authority over the program. Third, it clarifies the
relationship between the Human Foods Program and the Office of
Regulatory Affairs which inspects facilities, and, as noted, it
establishes a new Center for Excellence in Nutrition and an
Office of Critical Foods. While more detail is still necessary
on this proposal, it is a significant step forward and lays the
groundwork for a foods program led by a leader who is more
empowered and accountable than any FDA food program leader in
recent history.
No mother, no father should ever again face a desperate
store-by-store search for a product simply to nourish their
infants. Thank you.
Mrs. McClain. Thank you, Dr. Lurie. I recognize Ranking
Member Porter for five minutes.
Ms. Porter. Thank you, Madam Chairwoman, for your patience
with my schedule today. The goal of this hearing is to stop the
entire baby formula market from being at risk when there is
bacterial contamination in a factory. So, I want to figure out
how much progress we have made toward that goal by looking at
what would happen if the Abbott contamination were to repeat
itself.
So, Mr. Yiannas, let's say that a major formula
manufacturer, and there are only a handful as you know, finds
bacteria in their supply today. Does the law say the factory
has to tell the FDA?
Mr. Yiannas. The answer to that is no, other than the
Abbott Sturgis facility, which, as you know, is under consent
decree.
Ms. Porter. So, I think this is really important that
everyone hear this. So, I am going to ask you one more time.
Let's say that a major formula manufacturer or factory found
bacteria in their supply today. Does the law require them to
tell the FDA?
Mr. Yiannas. The answer is no. They should, but they are
not required by law.
Ms. Porter. But surely the FDA is now keeping a close eye
on supply, so that they are ready for any disruption. What
resources and authorities are now in place for the FDA, even
though they have no requirement that anyone tell them, but
should the FDA learn, what are the resources available for the
FDA to do supply monitoring?
Mr. Yiannas. That is an area of the program that needs
further development. Historically, the FDA has been focused on
food safety and nutrition, not supply chain availability. But
after the pandemic, which I describe as the biggest test on the
U.S. food system in a 100 years, we all realized that as an
Agency, we needed more intelligence and data on how companies
and supply chains actually worked. There were attempts to try
to build those capabilities internally. They were met with a
lot of resistance because it wasn't part of the core mission.
But I am grateful that Congress, through the omnibus, has asked
FDA to set up an Office of Critical Foods and to develop those
type of capabilities.
Ms. Porter. Do you think the Office of Critical Foods, as
structured in the omnibus, will go far enough in supply chain
monitoring, and are we making fast enough progress in getting
it going?
Mr. Yiannas. We started making progress before the infant
formula crisis. Early during the pandemic, we knew that while
the virus didn't cause transmission or illnesses through food,
we knew it would wreak havoc to the food supply chain because
ill workers, if not available, would affect supply chain
continuity. And, so, we started to build those capabilities on
what I describe as a shoestring budget without authorities, but
it hasn't gone far enough. Although requests for additional
fundings have been made to the commissioners and acting
commissioners, like I said, it has been met with resistance. I
think after the recall of 2022, now there is a greater
appetite. Progress is being made, but it is not being made fast
enough.
Ms. Porter. Mr. Yiannas, since the law doesn't require, as
we just learned, factories to report contamination, what
incentives do monopolistic or a small number of suppliers,
monopolistic companies have to self-regulate when the market
isn't forcing the level of competition on quality and the FDA
is still building out its monitoring apparatus?
Mr. Yiannas. I think there is one critical component that
was mentioned in the opening comments, is public health
surveillance. Our ability to detect illnesses in society and
learn about why they occur, what are the food vehicles that
cause them, what are the contributing factors is critical to
informing future prevention.
Today, Cronobacter Sakazakii is not a reportable disease
other than in two states. And so, that is a real disincentive
for the industry to know what is really happening and for them
to take corrective action. So, I would say the time is now for
us as a Nation to make Cronobacter Sakazakii a nationally
notifiable disease and reportable in all 50 states.
Ms. Porter. And I really appreciate it, in your testimony,
that you came to us with concrete actions that we can take to
actually address and better prevent this. So, I noticed that
was your No. 1 recommendation in your list of 11. Dr. Lurie,
with my remaining time, can I ask for your thoughts on how far
you think reorganizing the Human Foods Program will go toward
creating the proactive FDA that we all need to be safe?
Dr. Lurie. Yes. Well, I don't think one should overstate
what can be accomplished through a reorganization. But I do
think that what Commissioner Califf has come up with is a very
reasonable attempt to, on the one hand, strengthen the food
program, giving it the kind of prominence within the Agency
that it has for a long time lacked, and yet at the same time to
do so in a way that acknowledges the way that the Agency is
currently structured such that any new situation is not unduly
disruptive, and I think that they have done a pretty good
balance of that. We have never had a Deputy Commissioner over
the entire foods program before. Even when Mr. Yiannis was
there, I am sure he will be the first to say that he never had
that kind of authority. But the vision, currently, is to do
exactly that and to elevate foods within the program in a way
that has never been the case before.
Ms. Porter. Thank you very much. I yield back.
Mrs. McClain. Thank you, Ms. Porter. The Chair now
recognizes Mr. Grothman.
Mr. Grothman. Yes, I will ask Mr. Yiannas a few questions
again. Currently, what is the structure of the FDA and its food
programs?
Mr. Yiannas. Currently, the foods program is what I call a
very distributed in a decentralized organization. You have the
Office of Food Policy and Response within the Commissioner's
office, an office that I lead, of about 40 people. You have the
largest office involving food, the Center for Food Safety and
Nutrition, which to this day is led by Dr. Susan Mayne, who has
recently announced her retirement. You have the field force----
Mr. Grothman. OK. I hate to cut you out, but they only give
us five minutes. Would you, therefore, describe the current
structure as decentralized?
Mr. Yiannas. Absolutely.
Mr. Grothman. OK. Do you think that is a problem where it
is also decentralized if you have a crisis like we had last
year?
Mr. Yiannas. I do. I think the decentralized and
distributed nature of the organization caused information
silos, not allowing critical data and information to flow to
those that needed it quickly and that needed it most.
Mr. Grothman. Did you elevate your concern before this
crisis?
Mr. Yiannas. Yes, sir.
Mr. Grothman. OK. But nothing was done about your concern
or----
Mr. Yiannas. In the time that I was at FDA, which was a
little bit over four years, I have had six different bosses,
whether permanent or acting commissioners. It has been a
rotating seat, and every single person that I have reported to
has known my concerns.
Mr. Grothman. OK. FDA Commissioner Califf released a
restructuring plan for the program. In your opinion, does the
Commissioner's restructuring plan do enough to resolve the
Human Foods Program's organizational issues?
Mr. Yiannas. Well, I believe Dr. Califf's plan is well
intentioned. I do not think it will completely solve the issues
at hand. No. 1, and I know we are limited in time, quickly is
it has been referred to as a new foods program vision. A vision
and strategy are very different than an organizational
structure. It is a reorg. You need a strategy first, and you
need a structure to support that strategy. That is No. 1.
No. 2, I will disagree with my colleague here. The proposal
does not even go as far as previous deputy commissioners once
had. At one time, previous deputy commissioners had oversight
over CFSAN, over their offices in the Commissioner's office,
over CVM, but not ORA. This new reorg does not even go as far
as to what previous deputy commissioners had.
Mr. Grothman. That is kind of shocking. In your opinion,
because I think when I think of the FDA, I think of drugs and
medical devices. Do you think the current culture at the FDA is
such that by focusing on drugs and medical devices, they do
that to the detriment of the food and food safety programs?
Mr. Yiannas. I think the drug program being as big as it
is, the fact that it is supported by user fees does hinder the
foods program, and the overall Agency's focus on the foods
program. As I mentioned, it is a very decentralized
organization, something I had not experienced in the private
sector. And as such, there are many multiple or microcultures
within the broader organization, and it hinders our ability to
create a one FDA culture.
Mr. Grothman. OK. And do you feel, therefore, just as far
as the head of the FDA, they kind of, again, because they are
focusing on the drugs and all the money that flows there, do
they kind of consider food--maybe it is an exaggeration to call
it an afterthought--but a little bit of an afterthought.
Mr. Yiannas. My experience and decisions that have been
made, including financial ones on supply chain monitoring, food
has taken a backseat to drugs.
Mr. Grothman. OK. Is it appropriate for the FDA to inspect
foods in the same way the FDA inspects drugs and medical
devices, do you think?
Mr. Yiannas. The approach would be slightly different. It
is a different food with different risk factors, but we should
be inspecting food facilities for sure.
Mr. Grothman. OK. In December, the Reagan-Udall Foundation
for the FDA conducted an operational evaluation of the FDA's
Human Foods Program. Are you familiar with that report?
Mr. Yiannas. I am.
Mr. Grothman. OK. Could you go into it a little bit?
Mr. Yiannas. Sure. The Commissioner and the Principal
Deputy Commissioner selected Reagan-Udall because of the close
associations with them. I do think they attempted to create a
fairly independent report. They provided a series of options
for restructuring with the Commissioner having the latitude to
choose those different options. One of the things I really
liked in their report is that they emphasized culture. You
cannot fix FDA or strengthen FDA by just doing a reorg. You
also have to address cultural issues.
Mr. Grothman. OK. And do you think to a certain extent that
it would be addressed if we separated the human foods and drugs
division that forces maybe a stronger culture?
Mr. Yiannas. I think that could be a factor that could
contribute to a stronger one food program structure. There are
other ways to do it as well.
Mr. Grothman. OK. Thank you.
Mr. Gosar. [Presiding]. I thank the gentleman. The
gentlelady from New York, Ms. Ocasio-Cortez, is recognized.
Ms. Ocasio-Cortez. Thank you, Mr. Chair. Mr. Yiannas,
Abbott Nutrition, Mead, and Perrigo control 90 percent of the
infant formula market, correct?
Mr. Yiannas. Yes.
Ms. Ocasio-Cortez. And at the time of the infant formula
recall last year, Abbott manufactured 43 percent of the
powdered infant formula produced in the U.S. Is that correct?
Mr. Yiannas. That sounds approximately correct.
Ms. Ocasio-Cortez. And so, I think it is fair to say that
any impact in supply from any one of these companies would
profoundly impact the supply of formula for all Americans. And
I wanted to dig into a little bit more of what happened at
Abbott last year. Now, you, of course, were at the FDA during
the Abbott recall last year, correct?
Mr. Yiannas. I was.
Ms. Ocasio-Cortez. And at that time, in October 2021, the
FDA received a whistleblower complaint regarding the sanitation
conditions of Abbott facilities in Sturgis, Michigan. Could you
recall some of the details of what that whistleblower complaint
alleged?
Mr. Yiannas. I can. It was a lengthy letter, 34 pages, I
believe. There were allegations of falsification of records, of
trying to keep information away from Federal inspectors. There
were very serious allegations, I thought, in that whistleblower
complaint.
Ms. Ocasio-Cortez. And after that complaint, the FDA did
launch an investigation in January 2022, correct?
Mr. Yiannas. Prior to that, they interviewed the informant,
but they did go and inspect that facility in January 2022.
Ms. Ocasio-Cortez. And, in fact, it seems that the
conditions were so horrible in this facility that the DOJ
initiated a criminal investigation into the unsanitary
workplace conditions in the Sturgis facility. Is that correct?
Mr. Yiannas. That has been documented in the public
literature, but I would say that is a conversation you should
have with the DOJ.
Ms. Ocasio-Cortez. We also know that Abbott faced a number
of lawsuits alleging tainted baby formula long before the
recall happened. Following a seven-year legal battle for one
family whose infant suffered debilitating brain damage, Abbott
successfully sought a court order sealing trial testimony and
evidence regarding Abbott's testing and food safety protocols
in that same plant. And that was seven years before the
consumption of unsafe formulas resulted in the deaths of
several more infants that led to the shortage.
We also see a pattern here that the Abbott company, which
produces Similac and other major formulas, used ruthless
tactics during their legal team to bury a lot of this
information that its baby formula was causing brain damage or
death in children for years before the recall happened. But I
wanted to look a little bit and dig into the FDA's authorities
that you were speaking into and what we need to do to prevent
something like this from happening again?
Mr. Yiannas, to kind of repeat the point earlier, does the
FDA currently have the authority to require firms to notify the
FDA of positive results even when it does not leave the
facility?
Mr. Yiannas. It does not.
Ms. Ocasio-Cortez. It does not. And is the FDA, in your
view, adequately funded and resourced to launch more aggressive
inspections in these types of facilities?
Mr. Yiannas. I believe we can do more with the existing
resources. Clearly, with more resources, there is even more you
can do, but I think with the current, existing resources, we
can do a good job within baby formula.
Ms. Ocasio-Cortez. And does the FDA currently have a clear
congressional authority to issue a mandatory recall, instead of
just relying on these corporations to voluntarily issue a
recall?
Mr. Yiannas. We do through something called the Food Safety
Modernization Act for foods under FSMA. Infant formula has its
own rule. My experience has been if you present a firm with the
evidence, you can execute a recall much faster than relying on
a mandatory recall. If needed, the Agency won't hesitate to use
it, but that takes longer, and usually the quickest path to
action is to present the evidence so that the company will do
so, and they usually do.
Ms. Ocasio-Cortez. And so, going back through this timeline
here, Abbott did issue that voluntary recall after the FDA
presented its evidence, correct?
Mr. Yiannas. They did.
Ms. Ocasio-Cortez. And so, in your assessment, kind of
looking through these things, it would be helpful, and one of
the things that we should probably move on this Committee is to
empower the FDA to require those firms to notify you. And, I
know you had mentioned earlier about perhaps some additional
measures, but for the purpose of the Committee and the
proceedings, are there any other additional provisions that you
would emphasize as well for us to consider?
Mr. Yiannas. I would. Thank you for that very good question
because I think we are all trying to prevent things like this
from happening in the first place. And I agree 100 percent, the
primary responsibility resides on Abbott. Abbott bears this
because they ran an operation that was under a lack of control,
insanitary, and producing products that were prone to
contamination. We need to make Cronobacter a nationally
notifiable disease, we need to strengthen infant formula
manufacturing standards, and we need to use state-of-the-art
modern manufacturing approaches.
Some of these plants, as you know, are very old. I refer to
them as legacy facilities, built in the 1940's. In the Abbott
Sturgis facility alone, there was a spray dryer that had
multiple cracks that was purchased and installed in 1960's.
That piece of equipment is older than I am. There is a lot that
has changed. We know a lot more now. We should require that
they strengthen their preventative controls.
Another thing we should do, is we should ask them to do
more robust verification that their procedures are working. One
of the Achilles' heel that has allowed the Agency to become
complacent is that our rule currently says infant formula must
be tested at a N equals 30 sampling plan. That means that 30
samples are taken, 10 grams of sample per each, 300 grams are
tested for Cronobacter Sakazakii. Some of these manufacturing
runs can be huge, 50,000, 60,000 pounds. Three hundred grams is
insignificant, and the probability of them finding
contamination is virtually zero. It has been a free pass for
them to say it is tested negative, we can sell this product.
Mrs. McClain. [Presiding.] Thank you, Mr. Yiannas. Thank
you. The Chair now recognizes, Mrs. Luna.
Mrs. Luna. Thank you guys for being here today. The
bacteria outbreak in Abbott's nutrition manufacturing facility
in Michigan is, in my opinion, just one of the many examples of
the FDA's lack of oversight regarding not just food standards,
but I would also argue, too, sometimes in the pharmaceutical
industries. The FDA, as I am sure you all know, is intended to
be the people's last line of defense, and although Abbott was
responsible for not reporting this earlier, I do believe that
there was a combination of issues that led to unfortunately
this happening.
In fact, the FDA's failure to adequately inspect Abbott and
listening to whistleblower's concern contributed greatly to the
formula shortage as a whole, and it took months for the FDA to
respond. Had they responded, infants could have been saved. And
I would like to note that it stated in the briefing that we got
that 40 percent of infants infected will die if they have this
bacteria, which means that of the 15 Members who sit on this
Committee, if 40 percent were infected as infants, six of these
Members would not be here, so that is incredibly alarming.
But it is clear that FDA is not doing their job and does
not prioritize food safety as well as many of the food
additives, including hazardous food dyes like Red 40, Yellow
Number 5 and Number 6, are banned in other countries around the
world because of their harmful side effects, yet permissible in
the United States.
The FDA continued to launch an ad campaign, lecturing
parents about how alternative infant food formulas may lack
nutrients vital to an infant's growth, yet has also, at the
same time, approved drugs such as mifepristone for pregnant
women that starves an unborn child of nutrients until they die,
or what about the 1960's debacle with FDA approving thalidomide
and actually covering up some of the investigations, according
to an article by The New York Times, in an effort to keep this
knowingly dangerous pharmaceutical on the market to the
American people. So, needless to say, as a Member of Congress,
I do not really trust the FDA.
It seems though that the FDA is for sale and will work with
corporations to keep harmful products on the market, knowing
the outcomes. We need to remove food additives that are
detrimental to our health, and pharmaceuticals, and improve our
inspections for foods across the board. Consumers buying food
should be able to buy food and be able to trust it, not
chemicals and additives that are toxic and known to carry
risks. I guess my main concern, because I have heard your
opening statement, and I appreciate your solutions to this, but
why is it that Abbott is still an FDA-approved manufacturing
facility for infant formula if they have knowingly covered this
up because that is what it seems like.
Mr. Yiannas. The facility did voluntarily shut down. Abbott
has several manufacturing facilities. This occurred at the
Sturgis facility. The facility did voluntarily shut down and,
through the consent decree, there were a series of processes
that they had to undergo to give us confidence that they could
produce safe product. And they met those requirements per the
consent decree, and so, now they are back in operation.
Mrs. Luna. Has the FDA made any changes because I
anticipate that due to COVID, you guys were not able to get
into some of these facilities, but to only go to three of the,
I believe, it was 23 facilities? It seems like, God forbid,
something like this happens in the future, that needs to be
changed. Frankly, if I was one of these parents, I would be
completely ticked off at the FDA for not listening to those
whistleblower complaints earlier.
Mr. Yiannas. I think that is a fair criticism. Thank you.
The FDA developed an internal policy that it would monitor
COVID transmission around the country, and if it was above a
certain level, they would not do inspections, even though they
were deemed critical. If you look at other segments of the food
safety profession, USDA inspectors continue to show up. They
were considered critical infrastructure. If you look at many of
the states, state inspectors considered to show up, so I think
that is a fair conversation to have. Heaven forbid there is a
future pandemic? If our FDA inspectors, critical
infrastructure, critical personnel in critical structure, and
is there a role for them to play?
Mrs. Luna. But also, to something outside of COVID because
it is very possible. I mean, I hate to say it, but I do not
trust China, and biochemical is a very real threat in this
country. So, obviously something outside of COVID would be
important to keep you guys able to do your jobs.
Mr. Yiannas. We also need to fully explore other means to
gather intelligence, whether it is remote access of data and
records.
Mrs. Luna. OK. Thank you very much. Chairwoman, I yield my
time.
Mrs. McClain. Thank you, Mrs. Luna. The Chair now
recognizes Ms. Balint.
Ms. Balint. Thank you, Madam Chair. Before I begin, I just
want to say a colleague earlier mentioned mifepristone. I just
want to say it is a safe and effective medication. We have to
focus on infant formula today and not get distracted by
essential medications that we know are safe and women should
have access to them. I want to get that on the record.
Next thing, you know, I can really empathize with parents
who had to deal with the shortage. Breastfeeding was very
challenging for me and my son, and I can certainly understand
the intense fear and stress that comes when you are a parent
and you do not know how you are going to take care of your kid.
I mean, there is nothing more stressful as a parent than that.
And one Vermont mom described bone-deep anxiety during the
crisis--bone-deep anxiety, wondering whether she would be able
to find formula for her child, and that really resonates with
me.
We absolutely owe it to parents and, of course, children to
make sure that we do not face another crisis, and I want to
thank you for being here today so that we can ensure that this
does not happen again. I represent Vermont, which is a rural
state, and I am very concerned about how the crisis impacted
low-income folks and rural Americans in particular. According
to the Kaiser Family Foundation, infants born into lower-income
and rural households are much more likely to rely on infant
formula than other babies. Formula shortages hit these
communities harder. More than 50 percent of infant formula
across the country is purchased through the WIC Program, an
excellent program which helps us to take care of children in
this country. Far too many parents were forced to drive and
drive and drive to try to find formula, to try to find food for
their kids, and this is especially challenging in rural
communities.
So, Dr. Lurie, how can we help ensure that going forward,
low-income and rural families are a focus of our national
strategy and response for preventing future shortages?
Mr. Lurie. Well, I think, as you probably know, the
government has an enormous role to play when it comes to the
provision of infant formula in this country since more than
half of all infant formula is actually paid for by the WIC
Program.
Ms. Balint. Yes.
Mr. Lurie. So, that is absolutely critical. I think that,
from what I can tell from the outside, the FDA did a pretty
good job once the rubber really hit the road in this problem,
to communicate with USDA, which runs the WIC Program, and to
try to communicate with them in ways that kept the supply going
best they could. But in the end, with the concentration in the
market, there was just no way to keep up. And parents,
understandably, began to hang on to product for fear that they
would not be able to find it in the future, and that ended up
with the kinds of empty shelves that we wound up seeing.
Ms. Balint. And the other thing that I think we are all
still reeling from, is there was the crisis of needing to drive
from store to store trying to get ahead of the run on infant
formula. But there is also a deep concern that I have about
price gouging, and I have talked about that in this Committee
before. And, so, you know, as you saw desperate parents
realizing they could not find it in their local area and
driving to the next town and the next town and the next town,
they would then turn to the internet to find the formula that
they could not find in the stores. And we began to hear stories
of price gougers, getting up to 300 percent more for a can of
infant formula. And I know that the Biden-Harris Administration
worked to crack down on the price gougers, but I do think
Congress can do more to ensure that these scammers, individual
scammers, and also greedy companies do not prey on the
vulnerable families in these situations when all they are
really thinking about is how do I feed my kid, right? How do I
feed my kids?
So, Dr. Yiannas, why is a whole-of-government approach to
this, a better response to this crisis? How do we need to look
across government to have a response that really is meeting all
of these individual issues?
Mr. Yiannas. Thank you. That is an excellent question,
especially as it relates to infant formula supply and
resiliency because FDA is limited in what it can do. Clearly,
FDA sets safety and nutrition standards, and we have spent an
amount of time talking about that. FDA plays a role in market
availability by accelerating approvals, and there is more that
we can do, but there is only so much the FDA can do.
And a lot of the factors that drive the structure of the
infant formula supply chain, its availability and resiliency,
rely on other parts of government, for example, USDA and the
WIC Program, as you mentioned. American taxpayers through the
WIC Program buy over 50 percent of that infant formula, and
there is something called sole-source state contracts, really
creating an artificial market incentive for certain players to
dominate in particular states.
If you have a crisis, with certain players dominating
market share in a state, it is hard to be nimble and recover,
and so, we have to look at the WIC contract process. The
executive office of the Biden Administration was very helpful
with the DPA and allowing us to make priority purchases to make
sure critical ingredients that were in short supply went to
these infant formula manufacturers. So, I found that this
response requires an all-of-government effort, and we should
continue to look at ways to strengthen how an all-of-government
response occurs for shortages of critical foods.
Ms. Balint. Thank you.
Mrs. McClain. Thank you. The Chair now recognizes Mr.
Langworthy.
Mr. Langworthy. Thank you so much, Madam Chairwoman, and
thank you to the witnesses that have joined us here today. I
mean, this is a topic, as my colleague from Vermont just
outlined, I mean, that has really tackled families. I have
staff members that have newborns that are still struggling with
supply. I am a parent of a young son, five months old, myself.
I mean, while this has not affected our family, it has affected
so many of our constituents, and that helpless feeling of a
parent that does not know how they are going to be able to feed
their child is one that I think it is incumbent on this body to
make sure it never happens again in this great country that we
live in.
Mr. Yiannas, when was the FDA made aware of the Cronobacter
outbreak at Abbott Sturgis plant?
Mr. Yiannas. Well, the very first report of a Cronobacter
illness linked to that plant was September 20.
Mr. Langworthy. OK. Of 2021?
Mr. Yiannas. 2021.
Mr. Langworthy. And, Mr. Yiannas, is it true that soon
after, in October 2021, the FDA received a whistleblower
disclosure message regarding Abbott Nutrition's plant?
Mr. Yiannas. That is true.
Mr. Langworthy. OK. Now, to your knowledge, when was the
earliest date that you received the notice of the whistleblower
disclosure?
Mr. Yiannas. I personally was not made aware of it until
February 10 of the following year.
Mr. Langworthy. OK. Now, Mr. Yiannas, that is four months
after it was initially reported. What did the FDA blame this
delay on?
Mr. Yiannas. Several things. Initially, as you heard in the
original congressional hearing, there was a lot of focus and
discussion about mail rooms and that the mail rooms lost it.
That whistleblower complaint was sent by FedEx, hard copies to
multiple individuals and multiple offices, so that means it
would have been lost at multiple office: at the White Oak
Campus, at the CFSAN Campus in College Park, also a field
office located in the north. So, allegedly, it was lost in the
mailroom.
We do know that some individuals received copies by emails,
and in hindsight, those should have been escalated to my office
very rapidly, but those are some of the reasons that were
reported. And then finally, in the report that the FDA put out,
they said that we lacked the systems to actually detect these
signals and escalate them.
Mr. Langworthy. So again, it is the decentralization of the
FDA that may be an issue here. I mean, it is 2023. The White
House has declared the pandemic is over. It is almost two years
since the first infant formula shortage, and our country is on
the verge of perhaps another. In your opinion, how can this
still be happening?
Mr. Yiannas. I think that we have not taken enough urgent
action. I think there are some things that we need to do. The
long-term resiliency of the infant formula market is not
something that can be solved overnight, so we are going to have
to be intentional, and I hope Congress will request it. I am
grateful that through the omnibus, you have asked that there be
a resiliency report conducted, analysis of the infant formula
supply chain resilience, and reported back to Congress. That is
a good step, and we have to look at what are the market
incentives and what are the contracts that WIC uses. For
example, I think WIC contracts actually contributed to this
crisis. But WIC might very well be part of the solution to the
crisis, and so, but there is more we can do on the prevention
that we can do faster. The resiliency and market consolidation
is going to take a little bit longer to resolve.
Mr. Langworthy. Now, I am aware that our infant formula
supply is not even back at full capacity yet. Now, why is that
taking so long? Is there not enough urgency delivered through
the court of public opinion to these companies to wake up and
ramp this up?
Mr. Yiannas. One of the things we did--it is a great
question--very rapidly building on this data analytic platform
that I have described that we call 21 FORWARD to monitor food
supply chains. We started adding additional functionality very
quickly to deal with the current crisis. And one of the things
the FDA has today is really impressive, that they did not have
before, we have manufacturers in this country of infant formula
reporting production volumes to the FDA on a weekly basis, not
required by law, but they are doing it.
FDA knows how much infant formula is being produced. We
have good quantitative data and what is the national need to
feed all infants in this country. So, we know production and
consumption. We are tracking sales data. We are tracking how
much infant formula is on shelves and where it is located
through in stock improvement rates. And I can tell you that the
call to action has been met. All the private sector companies
that I have talked to have ramped up production. There has been
what we call SKU consolidation. They limited the types of
products they produce, so they can get more product out, so
store shelves still will look scarce because there are less
SKUs, stock keeping units, available, there is less variety.
But I think in short order, we should find ourselves in a very
much better situation.
Mr. Langworthy. Thank you, Mr. Yiannas. I yield back.
Mrs. McClain. Thank you. The Chair now recognizes, Ms.
Crockett.
Ms. Crockett. Thank you, Madam Chair, and thank you so much
for being here today. Mr. Yiannas, I want to give you a little
bit of an opportunity to flesh out some of the things that you
have been talking about. But obviously, we have these
constraints, because I think that you are offering us a really
good glimpse into solutions, which sometimes in this building,
as a freshman, I feel like we don't really get to solutions.
And I think, I know at least in my district, they do not want
us just kind of jumping on the bandwagon of rhetoric. They
actually want us to solve problems.
And so, one of the things that you have mentioned that I
think is interesting, as someone who also serves on the Ag
Committee, and it is technically in Ag right now, is you talk
about WIC, and you say that WIC was part of the problem as well
as it could be part of the solution. Now, the way that my ears
interpret that is that we have an opportunity in WIC because
these are Federal contracts, right? And so, with that, we can
then put certain constraints, regulations, things like that on
our baby formula, and honestly, kind of like what we saw in the
last session.
There was a vote that said that we would not be charging
over $35 for insulin. And next thing you know, guess what? The
private sector, Eli Lilly followed suit because there are so
many government contracts that, honestly, where are you going
to compete, right? And so, if we have got 50 percent--I think
that was the number that you gave us--of the folk that are
actually getting this formula, they are getting it through WIC.
So, can you just expand a little bit or expound a little bit
upon how you think we can also be a solution?
Mr. Yiannas. Sure. I think USDA is very open to this, and I
would encourage you to have this conversation with them. They
are reimagining the WIC Program, but if you think of the infant
formula supply chain, the fact that it is very in-elastic, and
very fragile and consolidated, generally supply chains form
this way through market incentives, its resources, its dollars.
The WIC contract of sole-source contracting, picking winners
for certain states, there have been studies that show, if you
get a contract, if a manufacturer gets a contract in a state,
they dominate in that state. Even for the infant formulas that
are purchased outside of WIC, they just dominate.
So, we have created an artificial intelligence on picking
winners and losers for who is going to have the majority of
infant formula share in a particular state. But we can use this
artificial market incentive, the fact that the government buys
about half of all infant formula, to create a more diversified
contract system, so you don't have sole ownership or sole
dominance in particular states. When a crisis like this
happens, if you are in, let us say, an Abbott-run state, all
the grocery stores had SKUs and supply chains that were
dependent on Abbott. And that is not very easy to change very
quickly, and so, I think diversifying the contract process is a
key to the solution.
The other thing I was very sensitive was to parents that
could not get WIC products online. And many of you know this,
WIC availability wasn't available online, and people had to
travel many miles to find products. It would have been nice
that even if you were a WIC customer, you could have gone
online and searched for the infant formula that you needed.
And so, I would encourage this Subcommittee, Congress, and
all relevant regulatory agencies to really work hard on how do
we create the types of flexibilities and market incentives to
create a more resilient infant formula supply chain in this
country. It can be done. I don't think it is going to be that
difficult, but we need to make sure that the groups are working
together, that they are held accountable, and they are given
timelines to make it happen because in my sense, the past year,
things have moved along too slow.
Ms. Crockett. Thank you so much for that. And finally, I
just want to talk for a second, you mentioned that the FDA
can't, essentially,--I am paraphrasing--that the FDA can't just
do whatever they want to do. I mean, they have to have the
authority to do various things. And so, you know, the FDA gets
its guidance from our Administration as well as from the
Congress, and it seems like you are suggesting fixes that would
implicate more regulations. What I hear you talking about is,
maybe, listing this particular bacteria as one of those things
that has to be reported because we can't rely on those that
have a financial incentive to always do what is right. That is
what regulations are for. So, it sounds like you are suggesting
that we implement a few more regulations. Am I understanding
you correctly?
Mr. Yiannas. There are additional regulations needed to
strengthen protections, no doubt. I would also say the entire
infant formula industry needs to wake up and say what they are
doing is not adequate enough. I am a strong believer for
regulations, but I am also a strong believer for the free
market to set the right type of conditions and standards
because they are responsible and not being held accountable.
Ms. Crockett. Thank you so much.
Mrs. McClain. Thank you, and, Mr. Yiannas, I do agree with
you, accountability is a wonderful tool, and I appreciate when
the accountability is there for all parties, so thank you for
that. The Chair now recognizes Mr. Gosar for five minutes.
Mr. Gosar. Thank you. Today's testimony only highlights the
FDA's negligence in the response to the compromised baby
formula. A lag time of four months from the time the FDA first
received the news of food safety violations in the Michigan
plant to inspection, is obviously unacceptable. Instead of
ensuring safe food consumption, the FDA focused on approving
COVID-19 vaccines that have led to devastating consequences for
Americans.
As of January of this year, over 22,000 deaths and over 1
million adverse events caused by COVID-19 vaccines have been
voluntarily reported to the CDC and the FDA. These numbers make
COVID-19 vaccine 226 times as deadly as the flu vaccine, but
these scary numbers may be on a low estimate. A 2010 study from
the Agency of Health Research and Quality, found that the CDC
Vaccine Adverse Event Reporting System undercounted vaccine
deaths by a factor of 100. It is high time the FDA returned to
its focus on protecting people's health rather than pushing
experimental dangerous vaccines.
Mr. Yiannas, when did you first learn of the food safety
violations occurring in the Michigan plant?
Mr. Yiannas. February 10.
Mr. Gosar. Now, the whistleblower relayed violations in FDA
in October 2021. If you had known about these violations, what
immediate actions would you have taken?
Mr. Yiannas. Yes, I would have demanded that an inspection
be done sooner. As you know, the inspection didn't occur until
late January 2022. I would have demanded that the informant be
interviewed sooner. As you know, there was a two-month gap
between which the informant was interviewed. I would have
questioned the termination or outcome of that interview, which
concluded by the investigators that conducted it, that it was
too vague for follow up or action. If you read that 34-page
report and the allegations in there, I don't think you would
say it is too vague. So, there would have been, I believe, with
certainty quicker action, quicker inspection, follow up,
additional testing. And, I believe that had we responded
sooner, we could have curtailed or minimized this from reaching
such a catastrophic level.
Mr. Gosar. So, why do you believe the FDA officials ignored
the emails containing these allegations of food safety
violations from the whistleblower?
Mr. Yiannas. I can't speak for the individuals that saw and
why they didn't act on it more seriously, but I----
Mr. Gosar. I mean, in other details where we have
whistleblowers, I mean, we respond very quickly to them, so, I
mean----
Mr. Yiannas. We should have.
Mr. Gosar [continuing]. it seems very odd.
Mr. Yiannas. We should have.
Mr. Gosar. Could you please explain the extent of the food
safety violations occurring in the Michigan plant and what
exactly were the violations?
Mr. Yiannas. Well, I will tell you the conditions. I don't
have a copy of the inspection report in front of me, but a lot
of people have questioned how egregious were the conditions at
Sturgis? And I would say they were very egregious. First of
all, we had four reported cases of Cronobacter Sakazakii, all
linked to products produced in Sturgis. Sturgis is one of 21
plants servicing the U.S. market. While they had a large market
share, the fact that all four illnesses consumed products
produced in Sturgis was significant.
Upon our inspection, we found very egregious conditions. We
found critical equipment, such as spray dryers, that had major
cracks and disrepair. I mentioned this and I wrote them in my
testimony. We found water leaks and water. Standing water in a
dried infant formula plant is not a good mix. Our own
inspectors found abundant samples positive for Cronobacter
Sakazakii itself. We found up to five different genetic strains
of Cronobacter Sakazakii, and we found evidence that Abbott
itself had found Cronobacter in finished product, not just the
environment, in finished product and never reported to it to
us.
I have already explained that it is unlikely to test it in
finished product. So, I think the abundance of evidence
suggests that Abbott was operating under very unsanitary
conditions and likely was sporadically contaminating infant
formula. And it evaded final product testing because of
probabilities and served to infants across the----
Mr. Gosar. So, I'm going to fast track these. You made
mention of monopolistic contracts, and I would like to explore
that a little bit with you in regards to maybe how we could do
this, maybe a fast track mechanism where you have more upfront
dictations and then predicated follow-throughs. But, you know,
I have a substantial ag community, and their response is very,
very quick. With E. coli on lettuce, it is very, very timely.
So, could you explain that? Because these contracts are very
similar to what DOD has as their problem in sole sourcing.
Mr. Yiannas. Yes, those contracts are run through USDA. So,
I am not an expert on it and I won't be able to articulate it
fully, so I highly recommend you talk to them, but I do think
where there is a will there is a way, and we can accelerate
action on WIC contracts.
Mr. Gosar. Thank you, Mr. Yiannas.
Mrs. McClain. Thank you, Mr. Gosar. The Chair now
recognizes Ms. Lee.
Ms. Lee. Thank you, Madam Chair. So, we spent the morning
listening to people attack a formula supply chain they
described as premature and inefficient recalls that worsen the
issue, but when we are talking about sick babies, can we be too
cautious? The reporting mechanisms did not work. We must do
more to make sure this doesn't happen again. It is beyond
regulation. This is a need to protect our most vulnerable
population--infants--so we cannot allow weak regulations to
allow children to die. Dr. Lurie, how should infant formula
manufacturers have notified us of suspected contamination?
Mr. Lurie. Well, as you know, there is no requirement at
present for them to do so. And so, you know, if I were an
infant formula manufacturer, at the moment I have a sample that
tests positive, my response is not to destroy product and tell
nobody. My response is to test more widely. My response is to
tell the regulatory agency involved, but that is not what they
did.
Ms. Lee. Thank you. So, changing gears, as has been
mentioned, infant formula manufacturers played a critical role
in keeping babies fed and safe from foodborne illnesses. But
when 90 percent of our supply is provided by three
manufacturers like Abbott, American consumers lose. It took
just one Abbott factory closure to throw this market into
disarray. This industry is lacking the competition to maintain
a robust market and protect our most vulnerable populations,
infants who are being put at risk.
Dr. Lurie, how can Congress foster competition within the
infant formula market to promote safety and accessibility?
Mr. Lurie. Well, I will just say first that, you know, I
worked on drug shortages when I was at FDA, and it was quite
the same problem when it came to generic injectables. It was a
concentrated market, and you had a supply chain that was very
friable that could break at any moment and there would be very
few people who could step in, and that is very much what we saw
on infant formula.
I do want to say one thing, though, about the WIC Program,
which I think, you know, it is not a sole-source program. It is
a single contractor in each state program. That is different.
But, as important as it is to look at the WIC Program and
whatever role it might have played in the concentration of the
market, it is also important to remember that the way the
contracts are currently constructed is saving this government
about $1.6 billion a year. And if we have to pay, somehow, you
know, either this Congress is going to have to come up with
$1.6 billion or there is going to be a $1.6 billion smaller
amount of infant formula produced.
So, we need a solution. I think the Federal Trade
Commission should be taking a close look at this, but we should
be careful, you know, when we talk about reform at WIC, that we
make sure that access to the infant formula is part of the
formulation as well.
Ms. Lee. Thank you. You know, if our Congress is serious
about this, we also want to investigate Abbott to get at the
heart of what prompted the recalls and shortages, so we must
continue to work to diversify our domestic suppliers and
increase the resiliency of the infant formula market. Americans
can't afford to keep relying on three manufacturers to prop up
such a vital industry. I yield back.
Mrs. McClain. Thank you. The Chair now recognizes Mr. Gomez
for five minutes.
Mr. Gomez. Thank you, Chair. First, let me just thank the
Chair for having this important hearing and focusing on the
issue, although she can't control all her Members. You know,
bringing in COVID and vaccines, I think is not an appropriate
place here, especially when it comes to this issue, because the
American people have a profound interest in this.
And I have a profound interest in this. I became a new dad
for the first time last August, and as we were approaching the
due date, I was watching the issue with a very, very interested
eye, because it was like, OK, of course, we can try to
breastfeed, but sometimes you got to make up the difference.
And that was something that scared me, and something that
concerned me, so I was watching it very, very, very carefully.
One thing I want to kind of really focus on is even if we
had the ideal--your FDA with appropriate staffing, reporting--
can that make up for the fact that there is market
concentration? And I am also on the Ways and Means Committee
that deals with trade issues. Can we really make up for the
market concentration of 90 percent of the formula with these
three companies even if we had an ideal, perfect, pristine FDA
working in an exquisite form, Mr. Yiannas? And then I will ask
Mr. Lurie.
Mr. Yiannas. And the answer to that question is no. As I
stated earlier, there are limited authorities and limited
levers that FDA can pull to affect the market concentration and
diversity. Again, the FDA approves these products. They set the
safety standards and the nutrition standards, and the only way
they can accelerate this is by making approvals go a little bit
faster. The true levers on how you affect market resilience and
market diversification reside outside of FDA.
Mr. Gomez. Mr. Lurie, you mentioned you had some comments
in your written testimony.
Mr. Lurie. No, I think I have had the opportunity to make
them, but I agree with what Mr. Yiannas is saying. This is not,
in that sense, primarily an FDA problem. It is a trade problem.
It is a market problem. And, FDA has very few levers when it
comes to that. But, you know, the President's budget does have
some funding that would allow faster approval of new infant
formula entrants, and the Agency has done a lot in the current
crisis to permit the entry of foreign products into the market.
And so, that has diversified, at least for a short while, the
available products, but it won't sustain us in the long term.
Mr. Gomez. And is that temporary, or is that a permanent--
--
Mr. Lurie. That is temporary.
Mr. Gomez. What needs to occur in order to make it
permanent? Would you tell----
Mr. Lurie. Yes. My understanding is that it is an authority
that has elapsed. Isn't that correct?
Mr. Yiannas. Yes, they are looking at trying to create
permanent pathways. Anybody right now could apply for a new
infant formula product to hit the U.S. market. Having stated
that, despite the heroic efforts, and they were heroic by the
Administration, Operation Fly Formula and the enforcement
discretion. And, if you looked at the total quantity of infant
formula that was brought into the country in that manner, it
was just like icing on the cake. It didn't make a significant
material difference, and so, domestic manufacturing is
something that we really need to focus on.
Mr. Gomez. So, after my son was born, I actually did face a
situation where I had to go store to store, and the shelves
were empty. You know, I can't remember--those first few months
are kind of blurry--I can't remember if it was September,
October. And even today, they still seem bare, the shelves. Are
we still facing a supply problem, or are we facing a
psychological shortage problem, like people are stocking up
because they think that there could be another disruption?
Mr. Yiannas. I will take a shot at that because I was so
involved in actually creating the systems to track this. And
this is an excellent question, and it provides us an
opportunity to explain to the American public what was
happening.
There is something called an in-stock rate. The different
infant formulas that you might have, what percentage of them
are in-stock at your favorite grocery store or drug chain.
Before the pandemic, in-stock rates were in the mid-90's. That
is good. That is considered good. 95 percent of the types of
infant formulas you desired would be present when you went to
the grocery store. The pandemic caused supply chain
disruptions, and those in-stock rates started to drop to the
low 90's, maybe even 89, even before the recall. That massive
recall, with Abbott's Sturgis facility being so big, caused
that to drop even further, and it dropped well into the 60's at
one point.
The worst it probably got was in the month of May, when a
lot of news reports started being published, and we had a run
with people buying more than their normal amount. Instead of
buying 1 unit for the week, you were worried there wouldn't be
enough, and you do what we call pantry loading. We do not
criticize parents for doing that. It is a totally rational
behavior, but thereafter, we started to improve, and before I
left the Agency about a month ago, we were at those 90 percent
in-stock rates.
Now having stated that, I told you that the shelves will
not look the same because the assortment has been reduced.
Manufacturers are producing less high volume in certain types.
As a Nation, we are producing more infant formula than ever
before, but variety has been reduced. I hope that explains it.
Mr. Gomez. Thank you so much.
Mrs. McClain. Thank you, and I now recognize myself for
five minutes.
I think you made a very excellent point on the domestic
manufacturing of this, not only for mothers, and fathers, and
babies themselves. To be able to control the domestic
manufacturing, I think, is critical for obvious reasons as well
as, you know, national security as well. It is good to invest
in business, and it is good to invest in business domestically.
If the pandemic taught us anything, it was that.
But, I am going to shift gears a little bit. On May 25,
2020, Commissioner Califf testified before Congress that there
were nine staff working on infant formula at the FDA. Is that
an accurate statement? Yes, sir, Mr. Yiannas?
Mr. Yiannas. I think that statement deserves clarification.
There was nine individuals at that time working in the Office
of Nutrition and Labeling. These individuals are specifically
involved with approving new infant formula submissions. But the
reality--I led the IMG. There were dozens and dozens of people
working on infant formula at FDA: the field staff that does the
inspections, the laboratory staff that does the testing, the
administrative staff that responds in a crisis. And so, I feel
that that statement could have been misleading, and it deserves
clarification. There are more than nine people working on
infant formula at FDA.
Mrs. McClain. Were they working on the right things?
Mr. Yiannas. You know, in hindsight, I wish they would have
been working on some additional things. I mean, if you are
responsible for approving new infant formulas, one of the
things we saw in the crisis is that that team knew very little
about the market. They didn't have data, which is readily
available, on who owns what share, very quickly, where is it
produced, how is the market performing. This data is readily
available--what is the in-stock rate? And we found ourselves,
in the midst of a crisis, having to scramble to collect data
and build systems that I think should have been there before
the crisis.
Mrs. McClain. Did they approve any new?
Mr. Yiannas. That is a great question to ask, is how many
new products have been approved and how long does it take them
to do. It is a good question. I don't know the answer to that
question.
Mrs. McClain. OK. In your opinion, does the Solomon report
objectively evaluate the FDA's response to the infant formula
shortage?
Mr. Yiannas. The way I will answer that, is that I felt it
was a very controlled report. A couple of things that I will
say. One, it was not independent, correct? It was created
internally by FDA. Whenever a crisis of this magnitude happens,
it is good to have some independence. No. 2, I think you have
already heard comments, it was presented at a very high level
and doesn't get to really the root issues for you understand
what really happened. I would just ask you to compare my
written testimony, compare it to the Solomon report, and say
did you learn new things that were a little bit more detailed.
So, I don't think it went far enough, deep enough, and that it
offered the appropriate solutions.
Mrs. McClain. Why do you think that was? I mean, we had a
major crisis in our country that affected the most vulnerable,
infants, and it seems like we just kind of glossed over some
things. Why?
Mr. Yiannas. I think because it lacked independence. It was
conducted internally, and, you know, clearly, there was a very,
what I would call, rose-covered lens approach to writing that
report.
Mrs. McClain. So, were you permitted to contribute to the
report?
Mr. Yiannas. You know, when the crisis first happened,
since the fact that I wasn't notified on February 10 and my
office was the Office of Food Policy Response, I immediately
wanted to know how could something like this happen and what
could we do to prevent it from ever happening again. And so, I
asked all program components to start developing a timeline,
but shortly thereafter, the Principal Deputy Commissioner and
the Chief of Staff told me that they would develop the
timeline. And shortly thereafter, we learned that the Principal
Deputy Commissioner would write the report or create the
report.
I specifically recall mentioning to the Commissioner that I
get it, since I am in the food program, if you want
independence. But the Principal Deputy Commissioner that was
leading the report was the Acting Commissioner on whose watch
all of this happened, and I didn't think that was a good idea.
So, in the May hearing, I learned for the first time that it
would be Steve Solomon writing it. So, I wish I would have had
the opportunity to conduct that investigation, but I was not
offered. I was not interviewed by Steve Solomon. I was
interviewed by direct reports to the Principal Deputy
Commissioner. I did have a meeting with Steve Solomon after the
report was written, but had I written it, I would have written
it quite differently.
Mrs. McClain. Thank you, Mr. Yiannas. We are going to
switch gears. In closing, I want to thank our panelists once
again for their important and insightful testimony today, and I
really commend you both on doing something that does not really
happen a lot here, and that is you came with some solutions on
how to correct the problem. I mean, we all know that there is a
problem. I mean, anybody who has had a child or known somebody
who has a child--I mean, there is a problem.
So, I often say we cannot fix a problem that we first do
not admit exists. We all admit that it exists, and I applaud
and commend your efforts on some ideas on how do we work to
make sure that this problem does not help again. So, with that,
I commend you both for that.
I yield to the Ranking Member now for her closing remarks.
Thank you.
Ms. Porter. Thank you, Madam Chairwoman. I agree, and want
to echo what she said about the professionalism that you both
brought to this hearing and really helping Members focus not on
the partisan nature of this, but on the solutions. And, anyone
who has seen how I do hearings know that I will call out wrong
where I see wrong, and no matter who is in charge or who it may
offend, and the truth is, nobody gets a pass today.
Yes, the FDA must do better. It could have been faster. It
could have been more adept in anticipating the formula crisis.
It could have been more thorough in its after-action review and
learning from the mistakes. So, there is no pass for the FDA
here. Lawmakers, though, also have to do better by providing
the FDA with the resources and authorities that they are
telling us they need in order to get the results the American
people deserve, so no pass for government.
What is more, big businesses can do better regardless of
who is looking over their shoulder. It is their job to produce
safe, quality products. That is the cost of doing business in
food. Abbott engaged in negligent behavior, full stop. It
prompted a formula recall. It put Americans at risk, and it
undermined the stability of the formula market, so no pass for
big businesses.
And, finally, even with shortcomings from the government
and from industry, we wouldn't be here today talking about
supply shortages if baby formula were sold in the strong,
competitive marketplace. For too long, Washington has allowed
markets to consolidate, domestic manufacturers to offshore, and
critical infrastructure, including regulators, to crumble.
Luckily, the Biden Administration has done a great deal in the
last year to respond to disruptions and invest in our supply
chains and to enforce competition policy. They are thinking
toward the future.
That is what our Committee is doing here today. And I think
that is the mindset that Washington-at-large needs to have, so
that we never have to wonder if infant formula will be
available for anyone or what other critical food may face a
shortage from contamination or other health risks, so no pass
today for Washington. No pass today for manufacturers. No pass
here for anyone except, I think, the professional and helpful
suggestions from both of our witnesses.
So, I am eager to take what we have learned at the hearing
today, strengthen the FDA, hold big business accountable, and
focus on policy solutions. I yield back and, again, thank the
Chairwoman for this hearing.
Mrs. McClain. Thank you, Ms. Porter, and I thank you for
your help as well.
I ask unanimous consent to enter three statements into the
record. The first one is a Statement by the former FDA
officials; Statement by Consumer Reports; and No. 3, a
Statement by Consumer Brands Associated.
So, ordered.
Mrs. McClain. I now recognize myself for closing statement.
Republicans and Democrats agree that Abbott is responsible
for the Cronobacter outbreak at the Sturgis facility. I don't
think there is any getting around it. They own it. But what I
want to make sure that we are doing, is we hold government to
the same standards, at least the same standards, as we hold
private businesses too. That is our job. There is no question
about that.
Abbott is facing SEC, FTC, and DOJ investigations. Abbott
is also facing lawsuits, as they should, from grieving families
who have lost a child. They are, and will be, held accountable
for any negligence, but the FDA is just as guilty. The FDA is
guilty of neglecting its inspection duties. The FDA is guilty
of neglecting its duty to fully understand the fragile infants
formula supply chain. The FDA is guilty for failing to prepare
for the potential shutdown of the Sturgis facility, but, unlike
Abbott, the FDA has not been held accountable. Clearly, there
is a double standard.
And now, the FDA wants Congress to reward its negligence
with more money to the tune of $372 million for not doing their
job. When Congress appropriates funding to the FDA for food
safety and inspection efforts, it has a duty to conduct those
efforts. We would not be here today talking about this if the
FDA had done what it is supposed to do. Today's hearing has
illustrated just how ineffective the FDA's food safety efforts
are, and I want to put the emphasis on food safety, right? I
said earlier 70 some percent of their job is food safety. Yet,
they are not really doing a real good job of that, and I think
you both agreed with me in your testimony on that.
The FDA Commissioner is turning a blind eye to the reality
that its Agency is in turmoil. American families deserve to
trust that their baby formula is safe. Instead, Americans are
facing the uncertainty of continued recalls of baby formula.
Just last week, several lots of Gerber formula were recalled
for potential Cronobacter contamination, just last week. What
has been shared by the witnesses today has been extremely
remarkable. The FDA needs to be held accountable for its lack
of transparency to the Congress and the American people, just
as we are holding Abbott accountable as well.
FDA officials discounted and ignored the whistleblower
report. That is concerning to me. They failed to react quickly
to reports of the Cronobacter infections. They failed to
conduct an objective internal review, and they failed to take
ownership of their actions. Now, they are trying to hide behind
a weak proposed restructuring plan to distract from their
failing and deflect blame, of which I commend you two for
actually coming up with some solutions that I think we actually
can work with. We will not allow them to avoid accountability
for their failure to do their job. We have invited FDA
officials to appear in a follow up on April 19, and we will
hold them accountable.
So again, I thank you both for your time. I thank you both
for your insight. I thank my Ranking Member, Ms. Porter, for
her help on this Committee hearing. And I hope we can make the
necessary changes to instill faith in the American people, and
especially with parents out there with newborn babies.
So, 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 is adjourned. Thank you again.
[Whereupon, at 11:33 a.m., the Subcommittee was adjourned.]