[Senate Hearing 117-399]
[From the U.S. Government Publishing Office]


                                                    S. Hrg. 117-399

                         INFANT FORMULA CRISIS:
                      ADDRESSING THE SHORTAGE AND
                       GETTING FORMULA ON SHELVES

=======================================================================

                                HEARING

                                 OF THE

                    COMMITTEE ON HEALTH, EDUCATION,
                          LABOR, AND PENSIONS

                          UNITED STATES SENATE

                    ONE HUNDRED SEVENTEENTH CONGRESS

                             SECOND SESSION

                                   ON

    EXAMINING THE INFANT FORMULA CRISIS, FOCUSING ON ADDRESSING THE 
                SHORTAGE AND GETTING FORMULA ON SHELVES

                               __________

                              MAY 26, 2022

                               __________

 Printed for the use of the Committee on Health, Education, Labor, and 
                                Pensions
                                
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        Available via the World Wide Web: http://www.govinfo.gov
        
                               __________

                                
                    U.S. GOVERNMENT PUBLISHING OFFICE                    
48-910 PDF                  WASHINGTON : 2023                    
          
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          COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

                    PATTY MURRAY, Washington, Chair
BERNIE SANDERS (I), Vermont          RICHARD BURR, North Carolina, 
ROBERT P. CASEY, JR., Pennsylvania       Ranking Member
TAMMY BALDWIN, Wisconsin             RAND PAUL, M.D., Kentucky
CHRISTOPHER S. MURPHY, Connecticut   SUSAN M. COLLINS, Maine
TIM KAINE, Virginia                  BILL CASSIDY, M.D., Louisiana
MAGGIE HASSAN, New Hampshire         LISA MURKOWSKI, Alaska
TINA SMITH, Minnesota                MIKE BRAUN, Indiana
JACKY ROSEN, Nevada                  ROGER MARSHALL, M.D., Kansas
BEN RAY LUJAN, New Mexico            TIM SCOTT, South Carolina
JOHN HICKENLOOPER, Colorado          MITT ROMNEY, Utah
                                     TOMMY TUBERVILLE, Alabama
                                     JERRY MORAN, Kansas

                     Evan T. Schatz, Staff Director
               David P. Cleary, Republican Staff Director
                  John Righter, Deputy Staff Director
                            
                            
                            C O N T E N T S

                              ----------                              

                               STATEMENTS

                         THURSDAY, MAY 26, 2022

                                                                   Page

                           Committee Members

Murray, Hon. Patty, Chair, Committee on Health, Education, Labor, 
  and Pensions, Opening statement................................     1
Burr, Hon. Richard, Ranking Member, a U.S. Senator from the State 
  of North Carolina, Opening statement...........................     4

                                Witness

Califf, Hon. Robert M., M.D., Commissioner, Food and Drug 
  Administration, Silver Spring, MD..............................     6
    Prepared statement...........................................     9

                          ADDITIONAL MATERIAL

Marshall, Hon. Roger:
    May 18, 2022, written letter signed by 22 Senators requesting 
      a response to questions from Hon. Robert M. Callif, 
      submitted for the Record...................................    52

 
                         INFANT FORMULA CRISIS:
                      ADDRESSING THE SHORTAGE AND
                       GETTING FORMULA ON SHELVES

                              ----------                              


                         Thursday, May 26, 2022

                                       U.S. Senate,
       Committee on Health, Education, Labor, and Pensions,
                                                    Washington, DC.
    The Committee met, pursuant to notice, at 10:32 a.m., in 
room 430, Dirksen Senate Office Building, Hon. Patty Murray, 
Chair of the Committee, presiding.

    Present: Senators Murray [presiding], Sanders, Casey, 
Baldwin, Kaine, Hassan, Smith, Rosen, Lujan, Hickenlooper, 
Burr, Paul, Collins, Cassidy, Braun, Marshall, Scott, Romney, 
and Tuberville.

                  OPENING STATEMENT OF SENATOR MURRAY

    The Chair. The Senate, Health, Education, Labor, and 
Pensions Committee will please come to order. Today we are 
having a hearing on a nationwide infant formula shortage. I 
will have an opening statement followed by Ranking Member Burr, 
and then we will introduce our witness. After the witness gives 
his testimony, Senators will each have 5 minutes for a round of 
questions.

    Again, while we were unable to have the hearing fully open 
to the public or media for in-person attendance, live video is 
available on our Committee website at help.senate.gov. And if 
you are in need of accommodation, including closed captioning, 
please reach out to the Committee or the Office of 
Congressional Accessibility Services.

    Let me be clear, the fact that we even have to have this 
hearing, the fact that shelves are empty, the fact that babies 
across the country are going hungry and parents cannot find 
what they need to feed their infants is a massive, unacceptable 
failure.

    I have said this before and I will say it again, the groups 
that families and caretakers depended on to help them in this 
moment, the FDA, infant formula manufacturers, all get an F in 
my book.

    There were plenty of warning signs about this crisis, and 
it seems like the people who are responsible for safety and 
supply here just blew through each and every one of them. And 
now parents and babies are the ones dealing with the 
consequences.

    Now, Dr. Califf, I get that the FDA needs more people and 
more funding, and I will keep pushing to get you the resources 
needed to support your work, but I still do not get why some of 
the steps we are seeing now didn't happen a lot sooner. It is 
not like the FDA needed more warnings here.

    It is not like the FDA didn't have any idea this could be a 
problem. As far back as last fall, last September, just as FDA 
was conducting an inspection at Abbott's formula manufacturing 
facility in Sturgis, Michigan, Abbott and FDA received the 
first report of an infant sickened by cronobacter bacteria 
after consuming infant formula. In October, an Abbott employee 
reportedly raised concerns with FDA about safety issues at that 
facility, which makes a huge amount of formula for U.S. 
families.

    But it took weeks for FDA to take action on the 
whistleblower's complaints and months for the agency's senior 
leaders to see the report. A matter of life and death 
importance due to, ``mailroom issues.'' Dr. Califf, that does 
not instill confidence. Nor does it explain away the many other 
warnings. In December, FDA and Abbott got a second report of a 
child infected by cronobacter. Sadly, that child passed away.

    In January, a third report. And in February, a fourth 
complaint and a major formula recall from Abbott. Senator Casey 
and I sent a letter to Abbott promptly after the recall 
announcement way back in February when we first learned of 
these issues.

    We pressed for information about why it took so long to 
respond to these reports and demanded assurances that Abbott 
was taking every effort to work with its state, Federal, and 
global partners to make this right and to make sure that it 
never happened again.

    We asked Abbott for documents about these safety issues by 
March 10th. That deadline came and went. Since early March, my 
office has been speaking with Abbott and with FDA about the 
issues related to that recall, including the supply of infant 
formula. But still, action was slow, and information has not 
been forthcoming. Weeks after that conversation, FDA released 
the results of an inspection it started in January, an 
inspection which found contamination at the plant.

    Later in April, reporting highlighted longstanding failures 
in the FDA's food program, years long delays, culture of 
inaction, decades of not prioritizing the food program, and it 
has all had a very real impact on families, including families 
who depend on formula. I will not allow the FDA to continue 
spinning its wheels on something as important as the food 
families feed their children.

    That is why I quickly sent a letter demanding answers from 
you, Dr. Califf. In that letter, I detailed the delay in FDA 
investigating the reports of potential contamination of Abbott 
formula, and I demanded information on how you will reform and 
improve the FDA food program. I have not yet seen a plan.

    Now, here we are, months after Senator Casey and I first 
pressed for answers from Abbott and from your agency, so I 
can't for the life of me understand why things have gotten so 
out of hand. Now the Administration has taken some important 
steps recently. President Biden invoked the Defense Production 
Act to make sure infant formula manufacturers are at the front 
of the line for the ingredients that they need.

    Operation Fly Formula is now bringing millions of 
containers worth of formula director directly to our shores, 
including yesterday's badly needed shipment. FDA has announced 
steps to increase the supply of safe and nutritionally adequate 
infant formula by increasing flexibilities on importation, and 
it has announced alongside Abbott that the Sturgis facility can 
soon start to safely resume formula production. This is all 
helpful, but let me be crystal clear, it all happened way too 
late.

    Back in 2021, when the first reports of potential 
contamination emerged, there should have been an immediate FDA 
response. And back in February, when Senator Casey and I 
recognized the need to get to the bottom of the formula recall, 
Abbott and the Federal Government should have been working 
together to make sure the shutdown of one plant did not explode 
into a crisis. Here we are.

    Now, I know parents won't rest easy until there is formula 
back on the shelves or until they can feed their kids. I will 
not rest either. I am going to keep pushing for more steps here 
in Congress, from the Administration, and from the industry to 
fix this as soon as possible. Senator Casey and I led another 
letter to infant formula manufacturers calling on them to step 
up and produce more.

    We also led a letter to President Biden making clear there 
needs to be a formula coordinator at the White House leading a 
national strategy, because we have witnessed now how 
multifaceted this problem is. We need a coordinated response to 
ensure better accountability from industry, stronger FDA 
response, and swift action from the Department of Agriculture 
to do everything it can give to give recipients the flexibility 
they need.

    We also need to make sure that hospitals, NICUs, 
pediatricians, and state and local Governments have the 
information and access to formula necessary to get the right 
formula to babies and infants with the most critical needs.

    We need to make sure retailers and suppliers are managing 
the supply in a way that is focused around families that need 
access to formula. We need to get parents clear information and 
direction on what products to use, which products are 
equivalent, and where those products can be found or will be 
coming soon.

    It is incredibly frustrating to me we have yet to see a 
detailed plan for this and that parents are having to 
coordinate things themselves on Facebook because the Federal 
Government still doesn't have a point person on this.

    I am going to keep pressing for answers for parents back in 
Washington State and across the country. Parents like Mac. He 
is a constituent of mine from Richland, Washington. He reached 
out to my office last week trying to find formula for his 
daughter and for other parents in the tri-cities area. Mac's 
daughter was born just 6 months into his wife's pregnancy.

    She remained in the NICU for 4 months before going home and 
she needs a special kind of formula to help her grow and stay 
healthy. Because of this shortage, Mac has been searching high 
and low, day and night to try and find it, stop shopping at six 
different stores, getting donations from other parents on 
Facebook. His dad even brought six cans from Milwaukee, nearly 
2,000 miles away.

    Mac is constantly worried about running out, and he has 
heard from parents across his community facing the same 
problem, parents who are driving to store after store, finding 
only empty shelves, who are searching online and finding price 
gougers who are trying to profit off the fact that babies are 
going hungry. Mac spoke with another mom who said when her baby 
was discharged from NICU, she was given a sample can, a 
specialty formula, and some ready mix bottles, enough to last 
maybe 4 days.

    The Facebook group Mac started now has over 800 members 
just trying to connect parents in the tri-city areas to 
formula. As a mother and a grandmother, I know parents in 
Washington State won't just go as far to Milwaukee to get the 
kids--their kids the formula they need, they will go to the 
ends of the earth, but they should not have to. We should not, 
we cannot leave parents to fend for themselves.

    We should be giving them the formula and the information 
they need as soon as we possibly can. People desperately want 
to know how soon can they get the formula their kids need to 
stay healthy, where should they go forward, especially for 
people who need specialty formulas like formula for preemies or 
for children with allergies, and what is the Administration 
doing to stop the price gouging, to end this shortage as soon 
as possible, and to ensure that this never happens again?

    Parents need help. They need answers. Most importantly, 
they need formula now. I have been pressing HHS and the formula 
industry to help make sure we get families the formula they 
need. Believe me, I am not going to let up until parents like 
Mac can rest easy and don't have to call their Senators for 
help finding baby formula.

    Dr. Califf, I hope to hear from you today about exactly 
what steps the Administration is taking to make this happen, as 
well as how FDA will address the pattern of delay and 
dysfunction we have seen throughout its food safety and 
nutrition efforts, not only its unacceptably slow response to 
complaints of contaminated formula, but also its stalled 
progress on other critical health, safety, and nutrition 
issues.

    With that, I will turn it over to Ranking Member Burr for 
his opening statement.

                   OPENING STATEMENT OF SENATOR BURR

    Senator Burr. Madam Chair, thank you for holding this 
hearing. It seems like you and I have been talking about plants 
a lot lately. I want to really thank the Members. The level of 
participation in this hearing outstrips anything we have seen, 
and I am appreciative for that. It is time that we hold the FDA 
accountable. There are millions of families that care for 
babies with the help of a formula.

    Babies with special needs, dietary restrictions, adopted 
families and foster families, orphan families, children with 
mothers who are immune-compromised, or are on life saving 
treatments, women who can't breastfeed and some cancer 
survivors. I want to share a story with my colleagues about one 
of those millions of Americans.

    A young woman called my office last week, after weeks of 
desperate searches to find a specific formula for her young 
child with special dietary needs. She cares for and protects 
her baby with fierce love and devotion and had done her 
research on the formula shortage. When she called my office to 
demand accountability from her Government, she was confused 
that the White House seemed to be blaming the formula 
manufacturer.

    Abbott began flying formula to the United States from 
overseas in February 11 million pounds since February, 50 
flights a week, 6 to 8 flights a day, 132,000 cans to 12 
different airports across the country. There is something we 
haven't heard.

    Abbott knew there was a shortage problem, but FDA seemed 
not to. Abbott has been very transparent about what problems 
they faced and what they are doing to fix the problems. Their 
CEO even published an op-ed apologizing for their part in this 
crisis.

    This month, CDC closed its investigation into the infection 
of four children, finding no direct link to the manufacturers' 
facility, but the FDA only just now began to use tools to 
increase the supply of formula. FDA still hasn't authorized the 
Abbott lab to resume manufacturing, even though CDC determined 
the original contamination did not come from Abbott's Sturgis 
plant.

    The question I could not answer for my constituent is what 
took FDA so long. Why wasn't action taken when the warning 
signs of this crisis started last fall? She asked if we knew 
what the FDA stands for. Before we could reply she said, 
formula doesn't arrive. Formula doesn't arrive, FDA. My 
friends, the FDA failed to do its job, plain and simple. This 
isn't a story about funding.

    Congress provides over $1 billion for the Food Center alone 
every year. This Congress even gave them an additional $700 
million in COVID money, $436 million of it is still available. 
The House passed a bill to give an additional $28 million to 
the FDA. Ladies and gentlemen, that is called political cover.

    This money is a stunt so people could go home and say they 
did something. That is dishonest at best and blatantly 
irresponsible at worst. The American people know better whose 
fault it is here. This isn't a story about authority. The Food, 
Drug and Cosmetic Act authorities are clear. The flexibility 
you have is real.

    No, this is a story, a sad story about FDA's unwillingness 
and inability to do their job. During the pandemic, the FDA 
apparently stopped its safety inspections. That seems like a 
bad decision. When the FDA finally resumed inspections, they 
failed to act with speed.

    Dr. Califf, you were confirmed in February when the 
nationwide formula shortage was at 26 percent. There was a 
problem. You and your agency failed to solve it. I challenged 
you at your confirmation hearing to learn lessons from the 
pandemic. The FDA did a great job for 18 months. But what I 
cautioned against is already happening. FDA is slipping back 
into its bureaucratic, bad old ways.

    The FDA gets $6 billion from Congress each year, over 
18,000 staff, yet you failed to prioritize the things that 
matter. For the past 2 years, the Food Center ignored formula 
crisis until it became a political liability. Instead, the 
Center focused on reducing salt and food, what kinds of salad 
dressing we can call French dressing, and the ingredients that 
can be used in yogurt.

    You had time to decide what color additives can be added to 
make farmed salmon look more pink and work on consumer 
acceptance of grated parmesan cheese. Infants, babies, and 
toddlers are starving, and parents are facing the reality that 
they can't feed their children in the United States of America, 
and your Food Center is more interested in policy marketing 
claims about cheese than ensuring American families have 
formula to feed their babies.

    When you finally took steps, the formula shortage had 
reached an alarming 43 percent. The FDA has imperiled the 
health and safety of American families. You have created a 
shortage in crisis. You have created panic and fear.

    Yesterday, in testimony to the House, you tried to shift 
the blame. The mailroom didn't deliver a whistleblower 
complaint. It is your mailroom. FDA knew there was a problem 
even before the whistleblower sent the letter, strike one. 
Yesterday, you said you were new, but the President hired you 
and the Senate confirmed you because you would been there 
before. Your Center Director has been there for almost a 
decade, strike two.

    Yesterday, he said the FDA could have done a better job. 
That is painfully obvious, but where is the accountability? 
Maybe that is strike three. By the time Abbott resumes 
production after finally getting approval from your agency, 
which it still doesn't have, it will take 2 months for their 
production to go back to capacity. That will be a success for 
the private sector.

    That you are acting only now under pressure from outraged 
parents around the country and from Congress deserves some 
serious searching. When I begin my round of questions, I expect 
that you will answer my first questions in your opening 
statement. What did you know? When did you know it? Why did you 
fail to act for so long?

    The Abbott CEO apologized for their mistakes. I wonder if 
the FDA apologized for their mistakes. I thank the Chair for 
her leadership on this issue. I thank her for her shared moral 
outrage at the failures of FDA.

    I thank her for getting the current FDA Commissioner to 
appear so quickly before the Committee. I yield back.

    The Chair. Thank you. Our witness today is Dr. Robert 
Califf, the Commissioner of the Food and Drug Administration. 
Thank you for joining us today to talk about this crisis. I 
know families in my state and across the country are following 
this very closely. So you may begin your testimony.

  STATEMENT OF ROBERT M. CALIFF, M.D., COMMISSIONER, FOOD AND 
             DRUG ADMINISTRATION, SILVER SPRING, MD

    Dr. Califf. Chair Murray, Ranking Member Burr, and Members 
of the Committee, thanks for inviting us to testify on the 
safety and supply of infant formula in the United States. I 
appreciate the 10-minute allocation.

    Ensuring that infant formula is safe and nutritious is the 
solemn responsibility of the Food and Drug Administration, and 
we are working with our Government partners and industry that 
produces infant formula to stabilize the supply. We are fully 
aware that many parents and caregivers have been unable to 
access the infant formula products that they need.

    Many of us are parents and grandparents, too, and we want 
to express our deepest empathy for parents and caregivers who 
are experiencing difficulty and stress as they attempt to find 
formula. I personally have been driven by memories of the month 
my daughter spent in the intensive care unit as an infant and 
the deep concern and anxiety of a parent driven to protect an 
innocent child.

    We provided you with an extensive written testimony that 
describes a recent history of this problem and gives a detailed 
timeline. During this hearing, I welcome reference to this 
document. On September 20th, 2021, FDA learned of a cronobacter 
sakazakii infection in an infant who consumed formula produced 
at Abbott nutrition's facility at Sturgis, Michigan.

    Our detailed written testimony and timeline specify the 
chain of events that culminated in a for-cause onsite 
inspection of the Sturgis facility on January 31st, 2022. While 
there are many stops along the way where different actions 
could speed up the sequence of events, to this date, I can find 
no evidence of intentional delay or malfeasance.

    I believe we have the facts delineated at this point, and 
we have initiated an internal after action review so that we 
can make improvements to prevent delays like this in the future 
and improve our decisionmaking. I have asked Dr. Steven 
Solomon, Director of our Center for Veterinary Medicine, to 
lead this review.

    Before leading the Center for Veterinary Medicine, Dr. 
Solomon served in the Office of Regulatory Affairs and has deep 
organizational knowledge of the processes in the food program, 
as well as compliance and enforcement. The FDA and CDC's 
investigation could not conclude, as you stated, that the 
egregiously unsanitary conditions in the Abbott facility caused 
the illnesses reported in our timeline.

    We cannot rule it out either, as the confluence of events 
is highly unusual. There is no dispute that the facility was 
unacceptably unsanitary, as evidenced by the consent decree. 
Frankly, the inspection results were shocking.

    Standing water, cracks in key equipment that present the 
potential for bacterial contamination to persist, particularly 
in the presence of moisture, leaks in the roof, a previous 
citation of inadequate handwashing, and current poor 
sanitation, bacteria growing from multiple sides, and many 
signs of a disappointing lack of attention to the culture of 
safety in this product that is so essential to the lives of our 
most precious people.

    As a clinician, I have used lifesaving, clot busting drugs, 
diagnostic tests, and cardiovascular devices made by Abbott. 
This is so far removed from my previous experience with the 
company that I remain very concerned.

    As soon as we received positive cronobacter results from 
environmental samples at the facility that we collected during 
the inspection, we contacted Abbott to ask the company to issue 
a voluntary recall. The need to take urgent action to protect 
the most vulnerable of all of our people, infants, presented a 
dilemma.

    This was the largest plant of the dominant manufacturer, 
and it was the sole source of a number of metabolic formulas 
essential for viability of infants with no substitution 
possible because Abbott had no backup plan. We knew that 
ceasing plant operations would create supply problems, but we 
had no choice given the unsanitary conditions.

    We took several critical steps within hours, including 
meeting with those who have been dealing with our supply chain 
throughout the pandemic. A memo was sent to relevant agencies 
signaling the supply chain risk. We acted early to ensure the 
specialty metabolic and amino acid products for which Abbott 
was the sole producer, were made available on a case by case 
basis, consulting with nutritionists, pediatricians, and safety 
experts.

    We contacted companies in the industry to encourage 
increasing their production to supply the market. We asked 
retailers to place temporary limits on how much any one person 
could buy to minimize excessive buying. We remain in frequent 
communications with our Government and industry partners about 
the status and risks.

    Because of the lack of diversification of this market and 
the absence of a central hub for integrating supply chains, we 
concluded early on that getting the Sturgis facility up and 
running safely was a top priority, but we had no confidence in 
the integrity of the Abbot quality program at this facility.

    Accordingly, we initiated proceedings toward a consent 
decree which requires Abbott to undertake steps to assure safe 
production of formula, including hiring outside expertise with 
reporting to FDA. Our oversight is critical, but make no 
mistake about it, the return to normal will only occur when 
Abbott takes the steps to resume production in a safe manner.

    As detailed in the charts included in your written 
testimony, we and our Federal partners have been monitoring the 
in shelf stocking of formula and the rates of infant formula 
consumption all along.

    Through the efforts of other companies to step up their 
production, sales of infant formula have remained steady, and 
in fact, volume and quantity of formula purchased are 5 to 15 
percent higher now than in the months before the recall, as 
demonstrated in charts included in the written testimony.

    Despite the overall numbers showing diminished but steady 
supply, we knew that distribution was an issue. Some areas were 
experiencing significant shortages, but overall there was 
enough formula to go around. About a month ago, the reports of 
shortages on the shelf proliferated, although there was not a 
drop in production.

    This increase in consumption most likely represents 
heightened concern of parents and caregivers about shortages, 
leading to understandable effort to purchase ahead to ensure 
adequate supply at home. I want to emphasize again, this is not 
blaming the parents and caregivers. This is rational behavior 
based on the concerns that they had.

    This type of cycle has happened with other products 
throughout the pandemic, and we realize that the only solution 
is to have adequate supply to make sure the shelves are 
stocked. To that end, we have employed a host of measures to 
increase supply. A consent decree was signed with Abbott 
Nutrition last Monday that will allow the starters plan to get 
back in production.

    I met with the Abbott CEO the day before yesterday, and he 
assured me they will be ready to go in early June. They have 
now given a date of June 4th as when they will be back in 
production. We continue to work with current U.S. based 
manufacturers to increase the production and distribution from 
FDA inspected facilities, both domestically and abroad.

    I commend them for their efforts in this regard as we have 
seen substantial increases. We are helping with the all the 
Government response, including Operation Fly Formula, 
encouragement and support of importation of product not 
currently in the U.S. market by using careful case by case 
easing of regulatory requirements to safely increase the number 
of manufacturers allowed to import formula, working with state 
health Commissioners to increase flexibility with WIC contracts 
to enable additional infant formula suppliers to enter the 
market, and to catch price gougers.

    Throughout the time since the recall, a highly dedicated 
group of experts within and outside the FDA have worked to 
manage the complex issues encountered for those caring for 
infants with complex metabolic issues requiring very special 
formula. I will leave you with several thoughts.

    First, FDA's timeliness of interviewing the whistleblower 
and getting into the facility for our for-cause inspection were 
too slow and some decisions in retrospect could have been more 
optimal. I did not return to FDA to preside over business as 
usual.

    After years of working in multiple private and public parts 
of the industry, I believe that success follows proper 
attention to structure, function, leadership, and resources to 
support the work of employees. All of these issues need 
attention in the chronically underfunded food side of the FDA, 
and you will see changes in the near future. Our requests for 
funding and authority are essential in concert with improved 
operations and leadership.

    Second, the return of the Sturgis plant to safe production 
of formula is critical. Abbott's enormous market share left it 
with a responsibility for producing safe infant formula that 
was not met. We will do everything in our power to work with 
Abbott to make that happen as quickly and as safely possible, 
but this timing is in Abbott's control.

    Third, the all Government effort and the enormous goodwill 
of Government partners and companies within and outside the 
U.S. has been heartening. While we are waiting for Abbott to 
fulfill its responsibility, we will meet the essential needs of 
American families with supplies from a variety of sources.

    Fourth, the supply of inadequacy did not happen overnight. 
Across the industries we regulate, we are seeing evidence that 
the just in time distribution system, market concentration, and 
sole source contracting are leading to shortages. Multiple 
reports to Congress call for improved supply chain management.

    Until regulatory agencies have digital access to critical 
supply chain information and personnel to do the work, we will 
continue to react to supply chain disruptions rather than 
intervening to prevent them. I want to conclude by reiterating 
that we will not rest until our shelves are replete with safe 
and nutritious infant formula.

    I am committed to improve the ability of the FDA to meet 
its mission to protect and promote the health of American 
people, particularly infants, our most vulnerable people. Thank 
you.

    [The prepared statement of Dr. Califf follows:]
                 prepared statement of robert m. califf
                              Introduction
    Chair Murray, Ranking Member Burr, and Members of the Committee, 
thank you for inviting us here today to testify before you on supply 
disruptions in infant formula. We have all seen the images of empty 
store shelves and heard the stories of parents of kids unable to find 
the food their children need to survive. This situation is 
unacceptable. The staff at the U.S. Food and Drug Administration (FDA 
or the Agency) feel this not just as public servants whose job it is to 
ensure that these critical products are safe and nutritious, but also 
as parents and grandparents. Our top priority now is addressing the 
dire need for infant formula in the U.S. market, and our teams are 
working night and day to help make that happen.

    At the same time, we have begun an after-action review to evaluate 
our own performance. We appreciate the opportunity to discuss 
conditions at the Abbott Nutrition facility in Sturgis, Michigan, which 
led to the recall that contributed to the current supply disruptions; 
our infant formula supply chain monitoring and mitigation efforts; and 
additional tools necessary if we are to prevent, monitor, and mitigate 
any future infant formula supply disruptions.
      Inspection of Abbott Nutrition's Sturgis, Michigan, Facility
    On September 20, 2021, FDA learned of a Cronobacter infection in an 
infant who reportedly consumed powdered infant formula produced at 
Abbott Nutrition's Sturgis, Michigan, facility. FDA immediately 
reported this case to Abbott Nutrition and immediately followed up on 
the complaint, including testing formula associated with this case 
complaint. No Cronobacter was recovered from the product after FDA 
testing.

    On November 17, 2021, FDA received a complaint involving an infant 
with Salmonella infection. FDA and our partners at the Centers for 
Disease Control and Prevention (CDC) eventually determined this event 
was unrelated to the other cases.

    FDA received the second complaint involving an infant with 
Cronobacter infection on December 1, 2021. We again collected intact 
samples of powdered formula; no Cronobacter was recovered. We also 
notified Abbott Nutrition about this case.

    Because Cronobacter is not a nationally reportable disease, 
isolates of the pathogens had not routinely undergone genomic analyses, 
as would occur with pathogens like Salmonella. In 2021 there was no 
genetic evidence available for us to know if these two cases from 2021 
were linked by whole genome sequencing.

    But given the two case complaints and the potential severity of 
Cronobacter infections, along with a complaint from a former employee 
at the Sturgis facility, on December 6, 2021, FDA initiated 
inspectional planning for a for-cause inspection at the Sturgis 
facility with an anticipated inspection date in early January 2022. We 
notified Abbott Nutrition of the planned inspection on December 30, 
2021. Abbott Nutrition responded by notifying FDA of approximately a 
dozen COVID-19-positive employees in its facility. Although we delayed 
our inspection temporarily because of these COVID-19 infections, FDA 
commenced our inspection on January 31, 2022.

    FDA received a third report of an infant Cronobacter illness on 
January 11, 2022, while the facility's COVID-19 outbreak delayed FDA's 
inspection. Again, FDA tested product associated with this illness, 
found no Cronobacter, and notified Abbott Nutrition.

    FDA learned of a fourth case of Cronobacter infection on February 
17, 2022, the date on which Abbott Nutrition initiated a voluntary 
recall and FDA issued a consumer advisory.

    Infants in all four cases were hospitalized, and Cronobacter may 
have contributed to deaths in two cases. All of the infants are 
reported to have consumed powdered infant formula produced at Abbott 
Nutrition's Sturgis facility. The Agency investigated each complaint 
and analyzed product from the consumers' homes when available. FDA also 
notified Abbott Nutrition after receiving each complaint.

    The CDC receives reports on foodborne disease outbreaks from state, 
local, and territorial health departments. On average, CDC receives two 
to four Cronobacter case reports annually; however, because Cronobacter 
infection is not reportable in most states, the total number of cases 
that occur in the United States each year is not known. Thus, the four 
cases that came to our attention between September 20, 2021, and 
February 17, 2022, raised concerns. Despite this very unusual 
combination of events, we do not have definitive evidence proving that 
insanitary conditions of the Sturgis facility actually caused the 
Cronobacter illnesses of these infants.

    We have included this timeline in Appendix A, and we have processes 
under review to develop better systems within FDA.

    In sum, awareness of the four Cronobacter cases offered an evolving 
fact pattern, leading us to initiate a for-cause inspection, but our 
inspection dramatically altered the fact pattern.

    Sanitary environmental conditions and well-maintained equipment are 
the most basic, minimal conditions needed for a manufacturer to produce 
dry powdered infant formula that is free of bacterial contamination. 
The FDA inspection team observed significant operational deficiencies 
in Abbott Nutrition's Sturgis facility during the January 2022 
inspection. The totality of evidence obtained during our inspection 
caused FDA to conclude that infant formulas produced at this plant were 
produced under insanitary conditions and may be contaminated with 
Cronobacter. We based our conclusions on the following evidence:

          FDA investigators collected multiple samples from 
        swabs in the facility's environment, which later tested 
        positive for Cronobacter sakazakii.

          FDA investigators observed serious cracks in the 
        firm's spray dryers, key pieces of equipment for producing 
        powdered products and an issue that has been linked to at least 
        one historical foodborne illness outbreak in powdered infant 
        formula at a different facility.

          FDA investigators also found water leaks and 
        condensation, which are risk factors for Cronobacter, in areas 
        where dry powdered formula was produced.

          Employees in the facility lacked adequate handwashing 
        technique.

          A review of the firm's internal records also 
        indicated environmental contamination with Cronobacter 
        sakazakii and the firm's destruction in 2019 and 2020, 
        respectively, of two batches of finished product due to the 
        presence of Cronobacter.

          FDA investigators noted that Abbott Nutrition did not 
        establish a system of process controls covering all stages of 
        processing designed to ensure that infant formula does not 
        become adulterated due to the presence of microorganisms in the 
        formula or in the processing environment.

          FDA also noted that Abbott Nutrition did not ensure 
        that all surfaces that contacted infant formula were maintained 
        to protect infant formula from being contaminated by any 
        source.

    FDA investigators collected numerous product and environmental 
samples during the inspection. Product samples FDA collected at Abbott 
Nutrition's Sturgis facility and analyzed for Cronobacter tested 
negative. It is well documented in the scientific literature, however, 
that end product testing is unlikely to detect low levels of 
contamination. In contrast, five environmental subsample surface swabs 
collected from the facility tested positive for Cronobacter sakazakii; 
four of these instances of contamination were detected by FDA-initiated 
testing, and one was detected through simultaneous firm-initiated 
testing. The positive Cronobacter sakazakii environmental samples 
collected at Abbott Nutrition's Sturgis facility have been analyzed 
using whole genome sequencing, revealing five different strains of 
Cronobacter sakazakii. While none of these environmental samples 
matched the limited (two) clinical samples from infants ill with 
Cronobacter, these findings remain a serious concern, as environmental 
sources of Cronobacter in infant formula manufacturing plants have been 
identified as one of the most likely sources of contamination.

    As soon as the Agency received these positive environmental 
sampling results in February 2022, we communicated with Abbott 
Nutrition about the need for the firm to issue a voluntary recall. 
Abbott Nutrition voluntarily ceased production at the Sturgis facility 
2 days prior to the recall, and FDA supported this decision given the 
insanitary conditions at the facility. On February 17, 2022, we issued 
a public communication advising consumers not to use the affected 
products. Abbott Nutrition initiated a voluntary recall the same day.

    Insanitary conditions of this kind are unacceptable in all food 
manufacturing facilities, but especially in areas producing dry 
powdered formulas that serve as the sole source of nutrition for 
infants. Finding pathogens in finished product during routine testing 
also generally indicates a potentially serious loss of sanitary process 
control during manufacturing. FDA would expect any manufacturer with a 
robust quality assurance program to identify and quickly take 
corrective action when such conditions are present.

    FDA knew that restarting the Sturgis, Michigan, facility was 
critical, because it was one of three plants run by a company with the 
largest market share, and many of its specialty formula products cannot 
be quickly manufactured at other facilities. We also became aware that 
Abbott Nutrition lacked a contingency plan to produce its lines of 
specialty metabolic and amino acid formulas that serve as a sole source 
of nutrition for thousands of infants with metabolic disorders. We lost 
confidence that Abbott Nutrition had the appropriate safety and quality 
culture and commitment to fix these problems quickly. FDA was left with 
limited options. Given the market share that Abbott Nutrition had for 
regular and critically needed specialty metabolic and amino acid 
formulas, FDA decided to negotiate a consent decree with the company 
rather than seeking a court order of permanent injunction through a 
contested process. A consent decree was the best option, giving FDA 
more control over the outcome, and was more likely to result in a safe 
resumption of operations by Abbott Nutrition at the Sturgis facility.

    With the urgent public health need in mind, FDA, along with the 
U.S. Attorney's Office for the Western District of Michigan, moved as 
quickly as possible through the negotiation process. In fact, the 
process here was shorter than it often is for obtaining a consent 
decree. FDA made clear its expectations for a safe reopening of the 
facility. Even still, because it was a negotiation process with a 
regulated firm, the U.S. Government did not completely control the 
timeline. Moreover, FDA's negotiations needed to be informed by our 
inspection of the Sturgis facility, which did not close until March 18, 
2022, to ensure that the consent decree would fully address all 
observed violations.
 FDA's and U.S. Government Actions to Increase the Supply of Specialty 
                           Metabolic Formulas
    When we talk about the infant formula supply chain, we really need 
to consider multiple supply chains, including, but not limited to, the 
supply of infant formula for healthy infants, another for infants with 
allergies and/or medical conditions who need hypoallergenic amino acid 
formulas, and another for infants who have very serious medical 
conditions, such as inborn errors of metabolism, and require unique 
specialty metabolic formulas. Abbott Nutrition dominates the market for 
many of the amino acid-based and metabolic formulas. Unfortunately, the 
only site where Abbott Nutrition produces these critical products is 
the Sturgis plant. Thus, the Agency immediately had to consider the 
potential impact a recall of these specialty formulas could have on 
infant health.

    FDA decided to exempt specialty metabolic products from the recall 
and required that the current stock of these formulas in storage would 
be subject to third-party review before release. Some of the infants 
who were using these non-recalled products could potentially be 
switched to comparable products, but transitioning is not always well 
tolerated or possible and thus requires clinical input from the child's 
health care provider. For this reason, we coordinated with groups such 
as the American Academy of Pediatrics, Genetic Metabolic Dietitians 
International, and the Society of Inherited Metabolic Disorders so 
providers would be prepared to advise their patients whether switching 
products was appropriate. We also coordinated with the U.S. Department 
of Agriculture's (USDA) Special Supplemental Nutrition Program for 
Women, Infants, and Children (WIC), and made them aware of the pending 
recall in advance of it occurring. To help support supply chains, our 
infant formula team had to determine for each of these products what 
comparable products might exist from other infant formula manufacturers 
and request that they increase production of these products as much as 
possible. These efforts included seeking available inventory outside of 
the domestic market.

    FDA worked with Abbott Nutrition to identify and prioritize 
specialty and metabolic formulas and asked Abbott Nutrition to 
establish a process to provide these formulas to those in need on a 
case-by-case basis. After the third-party audit concluded, Abbott 
Nutrition began releasing these critical products on a case-by-case 
basis. In these circumstances, the benefit of allowing caregivers, in 
consultation with their healthcare providers, to access these products 
may outweigh the potential risk of bacterial infection. FDA determined 
that the case-by-case release of these priority products is the best 
solution prior to resuming production of them at Abbott Nutrition's 
Sturgis facility. Since Abbott Nutrition did not have a plan or any 
capability to produce these critical, lifesaving products at another of 
their facilities, case-by-case release was the only option. FDA 
continues to use all levers we have, including Operation Fly Formula, 
to be able to increase the supply of these formulas, which come from an 
even more limited set of manufacturers than general infant formula. The 
first airlifts of infant formula as part of Operation Fly Formula are 
amino acid and hypoallergenic hydrolyzed formulas that are most 
critically needed. We note that having access to good data on the 
availability of specialty and metabolic formulas is challenging; 
measures useful to assess the supply of general formula such as those 
from Information Resources Inc. (IRI) (discussed below), are not 
informative for these products, as they are not always sold in 
traditional retail settings.
 FDA's Work with Partners to Increase the Broader Infant Formula Supply
    The United States was facing infant formula supply chain stress 
even before the Abbott Nutrition recall began on February 17, 2022. 
Abbott Nutrition's voluntary recall and subsequent voluntary cessation 
of operations at its Sturgis plant in February further destabilized the 
infant formula supply chain. Prior to the voluntary recall of several 
infant formula products produced at the Abbott Nutrition facility, FDA 
was working to address supply chain issues associated with the 
pandemic, including those impacting the infant formula industry. Our 
efforts to help support an all-of-government supply chain response 
included regular engagement with the Infant Nutrition Council of 
America (INCA), and its members, to identify challenges they were 
facing. Beginning immediately after the recall in February, this work 
greatly intensified, and the Agency has been working extensively with 
Abbott Nutrition and other manufacturers to bring safe products to the 
U.S. market as quickly as possible.

    FDA's intra-agency group includes experts from the Office of Food 
Policy and Response (OFPR) and the Center for Food Safety and Applied 
Nutrition (CFSAN). They began evaluating infant formula supply chain 
implications prior to the recall, met with USDA, and ensured that U.S. 
Government supply chain partners were engaged at the highest levels. 
FDA and USDA, as co-leads for Food and Agriculture Sector Risk 
Management, provided regular updates to the White House regarding 
overall supply chain concerns, including information about infant 
formula. Since the first day, FDA has worked tirelessly with U.S. 
Government partners to mitigate the supply chain disruption for both 
regular and specialty formulas.

    It is important to understand that only facilities experienced in 
and already producing infant formula and specialty metabolic products 
are in a position to make products that would not pose significant 
health risks to consumers. Infant formulas for healthy, full-term 
infants are complex in terms of formulation, processing, and other 
considerations to achieve required levels of 30 different nutrients and 
to avoid excessive levels of 10 nutrients that can be toxic when levels 
are too high. Formulas for low birth weight or premature infants, or 
those with serious health conditions, are even more complex; for 
example, hypoallergenic formulas need to be manufactured to ensure 
cross-contact with other formulas made in a facility does not occur.

    FDA continues taking key steps to help increase the supply of 
infant formula in the United States. FDA is leveraging all tools at our 
disposal to support the supply of infant formula products:

          Meeting regularly with major infant formula 
        manufacturers to better understand and maximize their capacity 
        to increase production of various types of infant formulas and 
        essential medical foods. The infant formula industry is already 
        working to maximize their production to meet new demands. 
        Efforts already underway by several infant formula 
        manufacturers include optimizing processes and production 
        schedules to increase product output, as well as prioritizing 
        product lines that are of greatest need, particularly specialty 
        formulas.

          Helping manufacturers bring safe product to the 
        market by expediting review of notifications of manufacturing 
        changes that will help increase supply, particularly in the 
        case of the specialized formulas for medical needs.

          Monitoring the status of the infant formula supply by 
        using the Agency's 21 Forward food supply chain continuity 
        system, combined with external data. Originally designed to 
        address the broader food supply during the pandemic, FDA has 
        adapted 21 Forward to monitor and support infant formula 
        supplies by adding additional data sets to provide more 
        frequent and granular information about infant formula product 
        availability and sales.

          Compiling data on trends for in-stock rates at both 
        national and regional levels to help understand whether the 
        right amount of infant formula is available in the right 
        locations, and if not, where it should go.

          Implementing a new process to temporarily exercise 
        enforcement discretion, on a case-by-case basis, for certain 
        requirements that apply to infant formula. These flexibilities, 
        applicable to both imported and domestically produced infant 
        formula, will augment supply volume while meeting FDA's 
        criteria for labeling, nutrition standards, and safety testing. 
        Within a week, FDA informed two foreign manufacturers that they 
        could use this pathway to import their infant formula, and we 
        are evaluating multiple other promising requests.

          Expediting the necessary certificates to allow 
        flexibility in the movement of already permitted products from 
        abroad into the United States.

          Offering a streamlined import entry review process 
        for certain products coming from foreign facilities with 
        favorable inspection records.

          Exercising enforcement discretion on minor labeling 
        issues to help increase volume of product available as quickly 
        as possible.

          Continuing outreach to retailer stakeholder groups to 
        request that their members consider placing purchase limits on 
        some products to protect infant formula inventories for all 
        consumers.

    In broader whole-of-government efforts, agencies are working 
together to improve the supply of infant formula to American families 
by:

          Invoking the Defense Production Act, directing firms 
        to prioritize and allocate the production of key infant formula 
        inputs to help increase production and speed up supply chains.

          Launching Operation Fly Formula, coordinating the 
        Department of Health and Human Services and U.S. Department of 
        Agriculture (USDA) to leverage Department of Defense contracts 
        with commercial air cargo lines to pick up overseas infant 
        formula that meets U.S. health and safety standards, so it can 
        get to store shelves faster. Bypassing regular air freighting 
        routes will speed up the importation and distribution of 
        formula and serve as an immediate support as manufacturers 
        continue to ramp up production.

          Offering state health commissioners flexibilities 
        through WIC to determine products that may be substituted for 
        recalled products, allow families to purchase different 
        container sizes and physical forms, allow purchase of 
        noncontract brands, and waive retailer minimum stocking 
        requirements to allow formula to transfer to where it is most 
        needed. We thank Congress for passing the Access to Baby 
        Formula Act of 2022 to expand access to baby formulas for 
        certain American families during this supply chain disruption, 
        but we know that still more remains to be done to ensure 
        industry consolidation and sole-source purchasing contracts do 
        not put future American families in this situation again.

          Addressing price gouging and unfair market practices 
        by calling on retailers to issue purchasing limits, as well as 
        engaging with state attorneys general to encourage them to user 
        their power to monitor and act on price gouging and predatory 
        behavior. In addition, the Administration has asked the Federal 
        Trade Commission to use all of its available tools to monitor 
        and investigate illegal and predatory conduct.

    FDA has been working closely with all major infant formula 
manufacturers to mitigate supply disruption. All manufacturers already 
in the U.S. market have increased production to capacity. However, FDA 
lacks authority, resources, or dedicated staff to predict, detect, and 
respond to supply chain issues for infant formula and medical foods--
although we have requested authority to do so since 2020, including in 
our fiscal year (FY) 2022 and fiscal year 2023 budget requests. FDA 
developed this legislative proposal because we were well aware that the 
U.S. infant formula supply chain was dominated by a small number of 
actors with only a handful of manufacturing facilities--making it at 
high risk for disruption by any single event or stressor. Even without 
the authorities to compel submission of supply chain data, FDA took 
numerous steps to request these data and shore up supply to the extent 
we received cooperation of firms.

    Following FDA's efforts, the major infant formula manufacturers are 
producing at increased capacity and have been further optimizing their 
lines to produce more infant formula to meet current demand. In the 
month of April, consumers purchased more infant formula than they did 
in the 4-weeks prior to the recall, which is a good indication that 
powdered infant formula availability is headed in the right direction. 
Data from IRI show nearly 80 percent in-stock rates for the week ending 
May 15, 2022, (compared to 89 to 90 percent in-stock rates before the 
Abbott Nutrition recall; see figure 1). This means that if a local 
supermarket normally carries 50 different infant formula products, an 
80 percent in-stock rate translates to 40 of those 50 product types 
being available. But we understand--as parents and grandparents 
ourselves--that many have been unable to access the products they need 
and that they are understandably frustrated and anxious.
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]

   Figure 1: National In-stock Rate 2022 Year-to-Date: Infant Formula
    While in-stock rates have dropped gradually because of Abbott 
Nutrition's inability to resume production as quickly as we all would 
like, there are some positive trends because of FDA's call to action to 
the rest of the industry. National infant formula sales by volume for 
the most recent 4 weeks of data through May 8, 2022, increased 12 
percent compared to the 4-weeks prior to the recall (see figure 2). And 
national infant formula sales by unit increased 5 percent for the most 
recent 4 weeks of data through May 8, 2022, compared to the 4-weeks 
prior to the recall (see figure 3).
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]

 Figure 2: Total National Volume Sales Infant Formula 2022 Year-to-Date
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]

  Figure 3: Total National Unit Sales Infant Formula 2022 Year-to-Date
    Through our weekly intensive discussion with manufacturers, we also 
know that all producers that supply the U.S. market have already 
stepped up to the challenge and are telling us they are producing at an 
expanded capacity. For example, Nestle Gerber increased the amount of 
its infant formula available to consumers by approximately 50 percent 
in March and April, and Reckitt is supplying more than 30 percent more 
product so far this year.

    What these data tell us collectively is that while there is more 
product being produced and sold, it is of less variety than prior to 
the recall. These metrics also indicate that we are on a positive 
trajectory. However, we know that one parent not being able to find the 
products they want is one parent too many, and we, also, have seen the 
photos of empty shelves and heard of the stressful stories of parents 
having to work extra hard to find product. This is unacceptable.

    Importantly, we know that some data suppliers who use less 
standardized metrics have reported lower in-stock rates, and we believe 
those news reports, recited without validation, may have exacerbated 
the situation in recent weeks. Throughout the pandemic, retailers have 
experienced a new type of consumer behavior--which we can appreciate 
and understand--where consumers may purchase additional units to ensure 
they can stock their pantries, because of a loss in confidence that 
their desired products will be available during their next grocery 
shopping trip. And when it comes to ensuring their infants have access 
to a sole source of nutrition, this behavior is understandable.

    As discussed above, data available to FDA show that volume sales of 
infant formula, as a category, are currently higher than they were 
before the Abbott Nutrition recall. However, there have been dramatic 
shifts in which products (e.g., brand, type, and size) are being sold, 
and the recent increases in consumption create empty shelves that 
require further ramp up of supply. In addition, there are significant 
concerns related to the availability of certain specialty formula 
products, such as amino acid-based products and formulas for 
individuals with inborn errors of metabolism--these are products on 
which FDA has been especially focused. Indeed, the availability of 
specialty and metabolic formulas remains a fluid and evolving 
situation.

    The Agency's best current assessment is that with all of the 
current actions, and the potential for Abbott Nutrition's Sturgis 
facility to resume production safely in the near term, the supply of 
infant formula will continue to improve over the next several weeks. In 
the meantime, FDA is encouraged to see that as of early May, the amount 
of infant formula sold in the United States continues to rise.

    On May 16, 2022, the U.S. District Court for the Western District 
of Michigan entered a consent decree of permanent injunction between 
FDA and Abbott Nutrition, as well as three Abbott Nutrition principals. 
Under the consent decree, Abbott Nutrition has agreed to take 
corrective actions following FDA's inspection of its Sturgis, Michigan, 
facility. The consent decree obligates Abbott Nutrition to take actions 
that are expected to ultimately result in an increase of infant formula 
products, while ensuring that the company undertakes certain actions 
that would ensure safe powdered infant formula is produced at the 
facility. When the company restarts production at this facility, it 
must conform with the provisions of the consent decree and meet FDA 
food safety standards. If contamination is identified, the company must 
notify FDA, identify the source of the problem, and conduct a root-
cause investigation before resuming production.
      Modernizing Infant Formula Safety and Supply Chain Security
    We take seriously our duty to prevent and respond to foodborne 
illnesses and food contamination events. FDA will be conducting an 
evaluation of our response to this incident and determine what 
additional steps should be taken to ensure the maximum effectiveness of 
Agency programs and policies related to infant formula and medical food 
complaints, illnesses, and recalls.

    More than 3.5 million babies are born in the United States each 
year, many of whom rely on formula at some point as their sole source 
of nutrition. FDA has nine staff devoted to reviewing infant formula 
premarket submissions for safety and nutrition. Even before the 
voluntary recall and production halt at Abbott Nutrition's Sturgis 
facility, FDA's infant formula staff faced increased workload due to 
COVID-19 supply chain issues and increased product innovation in the 
infant formula industry. Furthermore, the war in Ukraine has caused a 
disruption in the supply of sunflower oil, an ingredient in many 
formulas, which has further increased FDA's review responsibilities as 
manufacturers assess their supply chains and needs to reformulate 
product. Recent actions to increase imports will also increase FDA's 
workload, as the review team must review incoming applications and 
collaborate with the food safety team to ensure that these products are 
both safe and nutritionally adequate.

    The wide-reaching impacts of a recall from a single infant formula 
manufacturing facility underscore the risks and vulnerabilities in the 
supply chain when production is consolidated among few major 
manufacturers utilizing few manufacturing facilities. Building 
resiliency across the infant formula supply chain will better enable 
the industry to withstand any future disruptions without a significant 
breakdown in supply. To this end, we are exploring additional 
mechanisms to incentivize flexibility and redundancy of the infant 
formula supply chain infrastructure to increase resiliency in the 
infant formula industry over the long term. Recommendations from the 
White House's 100-day supply chain review report \1\ with regard to 
pharmaceutical and active pharmaceutical ingredient supply chain 
resiliency may prove insightful here. In partnership with other 
agencies across the U.S. Government, we also hope to initiate a broad 
dialog on how contracting models for these products could be enhanced 
to incentivize greater resiliency for infant formula supply, encourage 
new entrants into the market, and diversify the supply chain, without 
adversely impacting programmatic costs and the number of infants served 
by the WIC contract models.
---------------------------------------------------------------------------
    \1\  The White House, Building Resilient Supply Chains, 
Revitalizing American Manufacturing, and Fostering Broad-based Growth: 
100-day Reviews under Executive Order 14017, June 2021, available at 
https://www.whitehouse.gov/wp-content/uploads/2021/06/100-day-supply--
chain-review-report.pdf.

    While infant formulas--and particularly specialty and metabolic 
formulas--are regulated by FDA as food, they are in many ways 
comparable to life-saving medications. Viewing these products through 
the lens of how FDA addresses drug shortage monitoring and mitigation 
supports the need for a more responsive mechanism to monitor for and 
mitigate against potential supply chain disruptions. FDA's foods 
regulatory program has and can continue to benefit from the expertise 
and experience available within the Agency's medical product centers in 
this regard. The importance of a team with clinical, nutritional, and 
---------------------------------------------------------------------------
analytical expertise cannot be emphasized too much.

    Strengthening data and technology tools at FDA and other agencies 
is also critical to enhancing infant formula supply chain resiliency. 
The industry has sophisticated supply chain data enabling modeling and 
predictive analytics for the individual manufacturers and suppliers, 
but there is no data system to combine the information into a composite 
picture that would enable an understanding of the resiliency of the 
entire system to stresses, disruptions, and changes in demand. We need 
a sustainable mechanism for infant formula supply chain monitoring to 
allow us to better identify and address existing and future potential 
supply chain disruptions. A dynamic, interconnected supply chain 
monitoring platform and robust data sets are necessary to enable the 
Agency to be most effective in monitoring food supply chains, managing 
risks, and identifying and quickly addressing supply chain disruptions 
to reduce impacts on consumers.

    One example of a beginning to this effort is FDA's 21 Forward 
platform, which has been essential to our infant formula supply chain 
efforts. Further development of the technology will allow us to 
integrate, analyze, and monitor multiple data sets--including data on 
consumer purchasing, in-stock product availability, food facility 
registration, and imports--in real time to inform our response and help 
us focus on the areas of greatest need.

    In the President's fiscal year 2023 budget request, we have also 
identified legislative changes that would provide new tools to help FDA 
signal our partners who control supply chain dynamics to take action 
that would prevent or mitigate shortages of infant formula and 
essential medical foods. Our proposal would require firms to notify FDA 
of anticipated significant interruptions in the supply of infant 
formula or essential medical foods, similar to how drug manufacturers 
do today. These notifications would allow the Agency to receive 
relatively imprecise--but helpful--indicators about likely or confirmed 
shortages in the U.S. marketplace, better enabling us to alert the 
system and stimulate the industry and government partners to take steps 
that promote the continued availability of these important foods, which 
often are a sole source of nutrition.

    Another component of this proposal would be requiring manufacturers 
to develop and implement risk management plans. These are routine in 
most industries and have been used in our drug shortages supply chain 
oversight. These plans would identify, evaluate, and manage risks to 
the supply of infant formula or essential medical food. These plans 
would serve supply chain resiliency within each manufacturer, but they 
would also be available to FDA for its real-time monitoring efforts of 
the way they fit together to produce a complete picture of resiliency 
and vulnerability of this vital supply chain.

    None of these improvements would be as useful as a digital platform 
that monitors the supply chain constantly and in real time. This 
industry and most others have been resistant to efforts to develop such 
a system, but until such steps are taken, the American public will be 
vulnerable to threats from natural disasters and cyberattacks as well 
as the quality problem that created the current infant formula 
situation.

    Another legislative change identified in the President's fiscal 
year 2023 budget request is access to records in lieu of or in advance 
of an inspection, or, in other words, the authority to conduct remote 
regulatory assessments. Presently, FDA has such authority for drug 
inspections, and the Agency often relies on voluntary participation for 
remote regulatory assessments of many non-drug establishments. However, 
reliance on voluntary requests is not sufficient to achieve effective 
and efficient oversight, as firms can refuse to provide records or 
other information in advance of or in lieu of an inspection or to 
participate in remote regulatory assessments. We are seeking to expand 
the explicit statutory authority in section 704(a)(4) of the Federal 
Food, Drug, and Cosmetic Act to require firms to provide records or 
other information pertaining to all FDA-regulated products. An 
expansion across the board, in advance of or in lieu of inspections, 
would significantly enhance FDA's ability to obtain access remotely to 
records and other information from facilities producing infant formulas 
and essential medical foods, and would help the Agency investigate 
emerging supply chain issues, promote regulatory compliance, and 
protect the public health.
                               Conclusion
    Ensuring the availability of safe, sole-source nutrition products 
like infant formula is of the utmost importance to FDA. Our teams have 
been working tirelessly with all the responsible entities across 
government to address and alleviate supply issues while protecting 
safety, and we will continue doing everything within our authority to 
ensure the production of safe infant formula products.

    Thank you, and we look forward to answering any questions you may 
have.
    Appendix A: Timeline of Infant Formula Recall and Supply Chain 
                               Disruption
                                Summary
    Below is the timeline associated with ongoing stressors on the 
infant formula supply chain and FDA's investigation and response to 
complaints associated with and conditions at Abbott Nutrition's 
Sturgis, Michigan, facility.

    In this investigation, FDA received a total of five case complaints 
(four Cronobacter cases and one Salmonella case). Of these complaints, 
four were received prior to FDA's January 2022 inspection (three 
Cronobacter cases and one Salmonella case). FDA and CDC later 
determined the Salmonella case to be unrelated to the Abbott Nutrition 
facility. FDA had clinical isolates for only two of the Cronobacter 
cases. Investigating case complaints takes time--product samples are 
taken, interviews are conducted, records are collected, and pathogens 
are sequenced. In three of the Cronobacter case complaints, the product 
samples taken during the case investigations all tested negative for 
Cronobacter. However, as FDA received additional complaints and 
associated details over time, a pattern emerged that suggested a 
potential problem at the Sturgis facility. The timeline below sets 
forth the actions that FDA took to investigate these cases and Abbott 
Nutrition's Sturgis facility, as well as to obtain agreement from the 
company to cease production and enter into a consent decree containing 
a legally enforceable path forward to resume safe operations at the 
facility.

    FDA has taken aggressive action to attempt to address the infant 
formula supply chain issues. Days after the World Health Organization 
declared COVID-19 a pandemic, FDA experts became concerned that a 
disruption at a single infant formula or medical foods facility could 
lead to a shortage of critical products--especially specialty metabolic 
and amino acid formulas. FDA developed and submitted to Congress a 
legislative proposal in March 2020 requesting supply chain authority. 
Despite not receiving such authority nor having dedicated resources, 
FDA stood up a system to monitor potential food supply chain 
disruptions, 21 Forward, which was funded by Acting Commissioner Janet 
Woodcock out of Office of the Commissioner's reserve funding.

    Prior to Abbott Nutrition's voluntary recall, FDA began having 
supply chain discussions with our Federal partners and stakeholders, 
and these continued on a frequent basis. FDA ensured specialty 
metabolic formulas at Abbott Nutrition were excluded from the recall, 
held, and made available for those in critical need. Just after the 
recall, for example, FDA engaged with the relevant infant formula 
manufacturers to begin regular conversations about bolstering 
production and supply.

    This timeline demonstrates areas where FDA can and must do better 
or be faster. A detailed internal review is ongoing to determine what 
process, policy, and authority changes can improve FDA's response to 
infant formula investigations and recalls. For example, the FDA 
investigator who performed the September 2021 inspection at the Abbott 
Nutrition facility followed standard process to search for associated 
case complaints days prior to inspection, and thus during the 
inspection was unaware of the first Cronobacter complaint that FDA 
received. If FDA had modernized IT systems that could have instantly 
linked the first Cronobacter complaint to the IT system the 
investigator was using during the inspection, it is likely FDA's 
timeline would look very different.

    However, FDA's investigation was impacted by events not fully in 
the Agency's control, such as the emergence of the omicron variant that 
likely led to an outbreak of COVID-19 cases at the Sturgis plant that 
resulted in the delay of this inspection. Since Cronobacter is not a 
reportable pathogen, FDA is not able to know if clinical cases share 
the same pathogen, suggesting a point source, and there is not a robust 
data base of sequenced samples, which meant that FDA is not able to 
make rapid comparison of clinical, product, or environmental samples 
during an investigation to determine whether matches exist that can 
link a product or facility to an illness. There was also delay in the 
confidential complainant's availability to meet with FDA. And while FDA 
pursued the consent decree as quickly as possible, FDA does not have 
control over how quickly negotiations resolve.

    FDA's path forward is informed by our experience. Even while 
responding to this supply chain crisis, we are working to improve our 
agency to make sure that we are protecting the most vulnerable members 
of our society. We are committed to coming back to this Committee after 
our review is complete to share more details on the ways we believe 
that FDA can improve our processes and programs, as well as any areas 
where we may need the Committee's support for additional authorities or 
resources.
                                 ______
                                 
    The Chair. We will now begin a round of 5 minute questions. 
I ask my colleagues to keep track of the clock. Stay within 
those 5 minutes. Dr. Califf, parents and caregivers across the 
country rely on the FDA and the handful of dominant formula 
manufacturers to make sure that formula that they feed their 
babies meets the highest standard of safety and nutrition.

    But the companies and FDA let them down. I am ready and 
willing to work--to continue working with you and absolutely 
anyone to get this right and make sure we never are in this 
situation again. But I want to be clear about where we are in 
the current moment. Babies have gotten sick. Two have died 
after drinking formula from Abbott nutrition Michigan facility. 
It took months, months, in fact, you are telling us today it 
took 6 months for FDA to investigate.

    During that time, Abbott continued to produce formula at 
the Michigan plant, and when FDA finally completed an onsite 
inspection, months after the first baby became ill, it found 
evidence of the cronobacter bacteria on surfaces where formula 
was being produced and a history of cronobacter in finished 
baby formula products.

    That is incredibly alarming. So it makes sense the plant 
was shut down as Abbott and FDA tried to figure out why babies 
were getting sick and ensure inspectors uncovered substantial 
long term problems at the facility. What doesn't make sense, 
what I can't for the life of me figure out is why it took so 
long to investigate in the first place.

    Why did so much time pass before the FDA took serious 
action to investigate this contamination in baby formula?

    Dr. Califf. Well, Senator Murray, I appreciate the 
question. I think we all have a great degree of sorrow over the 
difficulties that you are describing. Many people at FDA are 
not sleeping at night, they are working weekends and trying to 
get this corrected. There is no question, it is not--it is just 
not a good----

    The Chair. Well, I mean, I am asking the question, why did 
it take so much time?

    Dr. Califf. Yes, I want to parse one issue with you. I have 
many more disagreements with Senator Burr about some things 
that were said. But from the very first case, there was 
investigation going on. It didn't take 6 months to start the 
investigation. That very first case, you have to collect 
samples----

    The Chair. No, I am asking why it took 6 months to take 
serious action.

    Dr. Califf. Because--the answer to that question is in our 
document, there are systemic issues at FDA and in our 
interactions with the industry and our authorities that need to 
be corrected. It is clearly----

    The Chair. Do you have a plan to do that?

    Dr. Califf. Yes.

    The Chair. When can we see it?

    Dr. Califf. When can you see the plan?

    The Chair. To correct these problems, yes.

    Dr. Califf. I mean, we have a plan, but a complete plan 
right now, we will have to get to you as soon as we can. I 
can't give you an exact date right now.

    The Chair. Well, has Abbott told you why it kept producing 
formula when it knew it might be dangerous for babies?

    Dr. Califf. They have not. I will remind you that we ended 
up in legal proceedings with Abbott. We could not get control 
of the quality in the plant without going through a consent 
decree process which has limited our ability to discuss it, 
because it is a serious legal proceeding, as you know. What I 
do know is that they now have good plans underway to correct it 
that we are overseeing every step of the way.

    The Chair. For parents of preemies like Mac, my constituent 
in Richland, what is the clear message from FDA and HHS on how 
and where he is going to get Neosure or an equivalent formula 
for preemies?

    Dr. Califf. For any infant requiring specialty formula, we 
have a committee and a whole host of pediatricians and 
specialists who are constantly in contact. The physician 
involved should be able to contact through the specialty 
societies access to the needed formula.

    The Chair. What I am asking is exactly what should parents 
know? I want to be able to say to Mac that you, Secretary 
Becerra, are telling him directly where he can go to get the 
formula. He and many other parents.

    Dr. Califf. A parent needing specialty formula should start 
with a pediatrician. If the pediatrician is not in the loop, 
one should go to the HHS website and call HHS, and we will 
intervene directly to help out. There is a committee in place 
to do that for each individual infant.

    The Chair. Well, I--look, when this hearing is over, I 
expect you and the Secretary to do everything possible to make 
it very clear to parents like Mac across the country what they 
should know to be able to get--going to be able to do to keep 
their babies out of the hospital. Very clear, direct to parents 
across this country.

    Dr. Califf. I understand.

    The Chair. Senator Burr.

    Senator Burr. Thank you, Madam Chair. Dr. Calif, Abbott 
submitted its paperwork for reopening Sturgis facility to the 
FDA on April the 8th. Seven weeks later, the facility is still 
closed. Do you have permanent inspectors every day in the 
Sturgis facility helping Abbott identify the contaminations 
that the inspectors found?

    Dr. Califf. You have some incorrect information. Abbott did 
not submit adequate documentation on the date that you 
referred. That was only----

    Senator Burr. Do you have inspectors today in the facility 
every day helping Abbott get the plant up and running?

    Dr. Califf. We have inspectors working with Abbott every 
day----

    Senator Burr. Not in the plant?

    Dr. Califf. No, not in the plant.

    Senator Burr. Why haven't you waived labeling requirements 
from trusted manufacturers in countries like the UK, Australia, 
or Canada? Couldn't manufacturers provide temporary labels on 
imported formula cans if the label is printed in a language 
other than English until U.S. manufacturing is restored? Some 
countries have higher nutritional requirements. Why can't we 
provide a waiver for their products to come into the country?

    Dr. Califf. We have waived many of the requirements, the 
ones that make sense. But the directions have to be clear to 
Americans in language that is understandable so that the 
formula can match up correctly. An error in mixing up the 
formula, for example, can lead to a very sick infant not 
getting the right nutrition.

    Senator Burr. Dr. Califf, complacency is apparently the 
FDA's catch phrase when it comes to infant formula. In Fiscal 
Year 2021, the FDA received 42 submissions for new infant 
formulas. The agency was able to review only 15 of those 
submissions within 90 days. That is one-third. What happened to 
the other submissions?

    Did you expedite the review of the new formula submissions 
when you took the helm at the FDA amidst a growing shortage? By 
law, by law, the FDA has 90 days to review new infant formula 
manufacturing submissions. What is the average number of days 
it actually takes for the FDA to review these?

    Dr. Califf. Senator Burr, FDA employees are working around 
the clock, and they are hardworking people, so I somewhat 
resent the implication of part of that, but----

    Senator Burr. Dr. Califf, there is no Member that has 
defended the FDA more than this one and there is no Member in 
Congress that has tried to fix areas when they are broken than 
this one. If you want to get into this with me, I am happy to 
do it. I got 28 years' worth of it.

    Dr. Califf. I know you are quite capable of that. So let me 
just say, right from the start, any good application was 
expedited by the FDA since the shortage became evident.

    Senator Burr. So 42 minus 15, the rest of them were not 
good for application.

    Dr. Califf. Application like you were referring to 2019 or 
something, you said----

    Senator Burr. No, it is Fiscal Year 2021.

    Dr. Califf. Yes, I will have to get back on the details on 
that.

    Senator Burr. Listen, the FDA Food Center, let's talk about 
it. It has a staff of 4,000 people, but according to your own 
budget documents, there are only 9 staff reviewing infant 
formula applications. Did you or other FDA leaders assign any 
staff to review infant formula as the shortage percentages rose 
sharply?

    Dr. Califf. We pulled in people from all over the agency to 
help that short staffed group, which of course----

    Senator Burr. To process applications.

    Dr. Califf. I will have to go back and see exactly how they 
spent their time but looking at all of the activities of that 
group, they were supplemented by staff from across the agency, 
which of course means that other things didn't get done.

    Senator Burr. Do you have the authority as Commissioner to 
move people around as needed?

    Dr. Califf. Yes.

    Senator Burr. Okay. Dr. Califf, I have looked at initial 
review of some of the activities of the Food Center, and I am 
concerned with your prioritization of the activities with the 
staff you have since the voluntary recall.

    Since the voluntary recall infant for infant formula, FDA 
Food Center spent time making changes to the definition of 
yogurt, opining on color additives in Antarctic krill meat, 
that is fish food, so farms can raise salmon that looks more 
pink, making announcements about the use of the term--of the 
definition healthy.

    Since the first infant hospitalization, the same Center has 
issued a rule on the definition of French dressing and issued 
guidance on chocolate, cheese and chocolates that stray from 
the FDA's official definition. This is a pattern over the last 
decade.

    The same Center has gone after salt, sprinkles, and even 
the definition of frozen cherry pie. So my question is simple, 
in conclusion, what are your priorities of the Food Center?

    Dr. Califf. The Food Center has a broad set of mandates, as 
you well know, but there is nothing of higher priority than 
this particular issue that we are discussing today. It is the 
highest priority. We are assigning every resource that we can 
to work on this problem.

    Senator Burr. Well, I hope that the Chair's request did not 
fall on deaf ears, that a detailed, comprehensive plan should 
be something that you could produce now, if, in fact, the 
agency is working at the expedited pace that you addressed. If 
it is not ready today, I hope it is in the very, very near 
future. Thank you, Madam Chair.

    The Chair. Thank you.

    Senator Sanders.

    Senator Sanders. Thank you, Madam Chair. Dr. Califf, 
concentration of ownership in our economy is a major, major 
problem in many sectors. It is true on Wall Street. It is true 
in energy. It is true in food production in general. It is 
certainly true in the production of infant formula, which is so 
terribly important to millions of parents with babies. Right 
now, we have three companies, Abbott, Mead, and Nestle, who 
dominate the entire market.

    We have recently been discussing contamination at an Abbott 
facility. Tomorrow it could be Nestle. Are you concerned and 
what are you doing about broadening the number of companies who 
are producing infant formula?

    Dr. Califf. I am very concerned, and as I said in my 
opening remarks, it is not unique to this industry that we are 
seeing concentration that puts everything at risk. I will 
remind you, as you well know, there is no requirement that 
companies show us their backup plans----

    Senator Sanders. Right, but all I am asking, I have got 
other questions, is what are you doing right now to 
aggressively make sure that more companies are producing infant 
formula so we will not see this problem regardless?

    Dr. Califf. You know, and I am sorry, Senator, to 
interrupt, but yes, on a temporary measure, we have lowered 
some of the--reduced some of the paperwork so that many more 
foreign manufacturers can import. We have got 26 applications 
since we opened the portal just over a week ago. The largest 
producer, Nestle, worldwide, and hardly had any presence in the 
U.S., and they are going to help out quite a bit. They are very 
capable----

    Senator Sanders. I hope that you will focus on increasing 
the number of companies who are producing so we don't run into 
this problem again. Let me ask you this, on October 20th of 
last year, a whistleblower sent a 34 page report to the FDA 
describing in detail how the equipment in Abbott's 
manufacturing plant in Michigan, ``was failing and in need of 
repair, and that the company knew that this was a problem for 
at least 5 years.''

    According to this report, Abbott falsified records to cover 
up deficiencies at its plant, improperly train employees, and 
successfully hid health and safety risks from FDA auditors in 
2019. Even though this report was submitted to your agency last 
October, FDA did not interview the whistleblower until late 
December.

    Now, my question is, during that same period of time, 
Abbott saw a $7 billion increase in its profits and its CEO, 
Mr. Ford, saw very substantial increases in his compensation 
packages. If a company lies to the FDA about its safety 
situation, at the same time it does massive stock buybacks, 
gives the CEO used compensation packages, are you going to fine 
them?

    What are you going to do to make sure the industry 
understands that you simply cannot lie to a Government agency?

    Dr. Califf. The whistleblower's complaint was received, and 
the usual staff reviewed it and did the interview. It was not 
escalated to the leaders of the FDA who were responsible, and 
that was an error that has now been rectified in terms of 
process. In terms of the status of the whistleblower complaint, 
I am not in a position to comment on whether they may be legal 
proceedings.

    Senator Sanders. What I am asking is--I am not even asking 
about the whistleblower complaint. If a major corporation lies 
to the FDA about something as terribly important, the safety of 
infant formula, what are you going to do? At the same time, 
they do billions in stock buybacks, huge compensation packages 
for its CEO.

    Is the Government, is the agency going to say, sorry, it is 
more important to protect the babies of this country than to 
give huge compensation packages to your CEOs? Are you going to 
stand up to them?

    Dr. Califf. Senator Sanders, we are standing out them. As I 
said, I am not in a position to say whether criminal 
proceedings are underway or not.

    Senator Sanders. Is that something in consideration?

    Dr. Califf. I am just not in a position to comment.

    Senator Sanders. Well, I would hope that manufacturers of 
baby formula, which is so terribly important to parents and 
obviously the babies, understand they cannot lie to the Food 
and Drug Administration. I hope you are strong about that.

    Dr. Califf. Senator, as you know, I have worked on all 
sides of this. I have been inspected. Everyone understands, 
when you lie to the FDA and you get caught, there is going to 
be big trouble.

    Senator Sanders. Well, I hope there will be. Thank you.

    The Chair. Senator Collins.

    Senator Collins. Thank you. Doctor, like many of my 
colleagues, I have heard from desperate parents all over the 
State of Maine, particularly those that need specialty hybrid 
allergenic formulas for their babies. One family from Sidney, 
Maine, for example, contacted my office after the mother had 
been spending 2 months making a round trip of 2 hours just to 
get formula for her baby from her baby's pediatric specialist.

    That is just not sustainable. Why wasn't there better 
communication with parents right from the beginning? Why did it 
take so long for FDA to start being public about this very 
serious problem?

    Dr. Califf. Well, I guess my best to answer that is that as 
we were monitoring the supply, up until about a month ago, 
there were issues, but they were manageable for the vast 
majority of people. Then things turned to empty shelves very 
quickly. That is when we really ramped up the public 
communication.

    There were concerns if there was a lot of public 
communication before that, when things were manageable, that it 
would be understandable that families might purchase more than 
they needed to be safe. Which as I have already said, I am not 
blaming them. That would be a normal response that we have seen 
in other areas with the pandemic. And so that is really 
basically the situation.

    Senator Collins. Well, I really think it would have been 
better if FDA had done what you said, which is put limits on 
how much could be purchased but been more forthright with the 
parents who are really desperate. I want to follow-up on press 
reports that indicate that the senior levels of FDA did not 
receive the alarming whistleblower's report due to, ``mailroom 
issues.''

    You blamed COVID-19 staffing issues for preventing FDA 
leadership from receiving direct copies of the whistleblower 
report, despite the fact that FDA's district office in Detroit 
received a hard copy from a confidential informant way back in 
October of 26--October 26. Inexplicably, it took 4 months for 
that report to receive the attention and get to senior FDA 
leadership in mid-February.

    Let's look ahead to happen. By that time, one infant had 
already died, two others were hospitalized, and the nationwide 
out-of-stock rate for infant formula had risen to 26 percent. I 
understand that the copy that was sent to then acting 
Commissioner Janet Woodcock still has not been located to this 
day.

    What exactly do you mean by COVID staffing issues? Are you 
telling us that FDA still does not have people back to work in 
the mailing room and other portions of your agency?

    Dr. Califf. Well, let me be clear about two things. The 
first is, the hard copies of the document didn't get to the 
leaders that should have gotten it for the reasons that you 
just gave. But there was a second issue, which is the 
escalation procedures, because the people on the staff did get 
it and they were dealing with it. And so there was not a 
procedure in place for them to inform the leaders who should 
have seen it.

    Neither the Center Director nor the head of the Office of 
Policy and Response, nor the head of ORA. And so we now--I have 
dealt with this in hospitals and the quality systems where 
nurses were not reporting surgeons errors, for example. We 
fixed it and we have essentially had to do the same thing at 
the FDA.

    I am not blaming the mailroom, but there definitely are 
problems in the mailroom. This is not FDA staff. These are 
contractors hired by the FDA to handle the Federal Express.

    Senator Collins. Well, are those contract employees and are 
the 18,000 FDA employees back to work?

    Dr. Califf. Yes, they have always been at work. The 
productivity of the FDA staff is higher than it has ever been.

    Senator Collins. But are they back--excuse me for 
interrupting, but are they back to work at their offices, in 
the mail rooms? I am not talking about remote work. Are they 
back to work?

    Dr. Califf. For the jobs that require being onsite, they 
are onsite like the mailroom being one example. But for many 
of--remember, our inspectors are distributed all around the 
country. They are mostly on the road. And our reviewers are 
reviewing documents using computers. So they are actually very 
efficient doing what they are doing.

    Senator Collins. But we need everybody to be back to where 
they would have been working pre-pandemic.

    Dr. Califf. Well, I will look forward to discussing that 
with you later. I think, I came from Silicon Valley, where it 
is very clear that for many of these kinds of jobs, that you 
are much more efficient working in a hybrid situation where you 
are in the office some, but also at your computer for a longer 
period of time.

    Senator Collins. Thank you.

    The Chair. Senator Casey.

    Senator Casey. Dr. Califf, last Friday I was in Pittsburgh, 
Pennsylvania, at UPMC Children's Hospital and had a chance to 
listen directly to parents, in this case, two parents, talk 
about their experiences with this infant formula crisis. Just 
note one for the record, because this is the reality for so 
many families. The father, first name is Manuel, he has got 
three daughters. One of his three daughters has complex medical 
needs. Her name is Francesca. She depends on a combination of 
IV nutrition and formula for her nutrition.

    Not having the right formula means two things, costly 
treatments and very high risk to her health. He said, ``she is 
stable this week, but we live in fear--live in fear, not 
knowing if we will have enough of the right formula next week 
or every week.''

    He went on to describe the challenges they face. So you and 
everyone in this room has heard some version of those stories, 
especially for children that have complex medical needs, but 
all children who need formula. I don't think there is any 
question that when Senator Murray and others have pointed to 
that timeline between in your testimony September 20th, when 
the FDA learned of a cronobacter infection at the Sturgis 
plant, that time lag between September and then when the 
inspection was done and other actions were taken, there is--you 
haven't provided a good answer for that and the FDA needs to be 
held accountable for that, among other things, for that. But 
there is a lot of blame to go around here.

    We, Senator Murray, made reference to the fact that on 
February 24th, she and I sent a letter to Robert B. Ford, 
Chairman of the Board and Chief Executive Officer of Abbott in 
Abbott Park, Illinois. This is a February 24th letter from the 
Chairman of a Senate Committee, the Health, Education, Labor, 
and Pensions Committee, Senator Murray, and we have not gotten 
the information that we asked for in that letter.

    I know they have provided some, but it is totally in terms 
of a response, totally inadequate, especially, especially in 
light of the findings that you have in your testimony on page 
two about the evidence of contamination.

    This is a contamination problem for sure. It is also a 
notification problem when it comes to what the FDA didn't do 
enough of in terms of notification, but also what the company 
didn't do. I have got legislation to impose obligations on 
both. One, is to require manufacturers to provide timely 
notification of circumstances that are known to the company 
that are likely to lead to a disruption in supply chain.

    Companies got to do that, and they should be mandated to do 
that. But the FDA also needs to expand and accelerate these 
notification requirements. And the FDA has got to work with 
these companies to provide that notification. I also think you 
should have more authority to request records in advance of or 
in lieu of an in-person inspection.

    My question is this, talk about those authorities that you 
would need to oversee the infant formula supply chain. What is 
the authority you have now? What are the blind spots or the 
defects that we should fix by way of legislation?

    Dr. Califf. We have almost no authority now other than to 
review the products as they come in, as noted. When it comes to 
this sort of an issue, there is no requirement now that firms 
notify us when they have an impending shortage. There is no 
requirement that if they find a contaminant in a sample in 
their facility that has not yet been shipped out, that they 
need to let us know. That happened in this case.

    There were cronobacter contaminants previously identified 
that they didn't notify us about. They are not required to have 
a backup plan, a contingency plan, which I thought was--in 
every industry I have been in, there is always a plan for what 
if the plant goes down? If that plant had been hit by a tornado 
instead of a quality problem, the same issue would be in front 
of us now.

    You have reports, I think, three different reports to 
Congress now saying in a digital era, right now, what we have 
is every company has its own supply chain that is considered 
proprietary. There is no central switch. And so there is no way 
to look and see a distressed asset and ask the question, what 
would happen if a plant went out here? Is there somewhere else 
that could do it?

    The idea that an individual company with 40 percent of the 
market share doesn't have a backup plan to me was 
inconceivable, especially since I have a history of feeling 
like Abbott was a reliable product maker for me in my 
profession. I was just very--it is upsetting and disappointing. 
But we need authorities to have that kind of information.

    When we have to ask and beg companies to give us the 
information about the supply chain and they don't have to give 
it, every little bit takes a long time.

    Senator Casey. Well, I would say in conclusion, doctor, 
there is no question that you should have that authority and 
companies should be responsive to you, just like they should be 
responsive to this Committee. But you have got to up your game 
and you can't allow that timeframe to--that lag of time from 
when that damn inspection is done so that you can act on it. 
Thank you, Madam Chair.

    Dr. Califf. Yes, sir. You said we didn't have a good 
response. I think we have a thorough response. It is not good. 
It was too slow and there were errors made. I want to be clear 
that we acknowledge that.

    Senator Casey. Thank you.

    The Chair. Senator Cassidy.

    Senator Cassidy. Hey, Dr. Califf. I am sorry we are having 
to have such a contentious hearing. I think this graph 
demonstrates better than the graphs in your paper the issue. 
The summer before this began, or a summer ago, there was an 8 
percent increase in the shortage rate on shelves.

    It actually was increasing prior to this latest episode, 
and this is when Abbott was closed. So it seems as if there was 
something happening here. Now there is a political--you can put 
that down, thank you--there is a political article from May 
9th, and I will quote it, one of the takeaways was that a 
food--the food division has structural and leadership problems.

    Aside from the lack of attention of food at the top, unique 
problems in the Center for Food Safety and Applied Nutrition, a 
deep seated culture of avoiding hard decisions and a near 
paralyzing fear of picking serious fights with food industry. 
Then it describes a power struggle between the top two 
officials, further strengthening the status quo of inaction.

    Now to follow-up on Senator Collins' comment, Zoom can work 
if people are actually communicating. But if there is a silence 
between the two, maybe actually being in the office and rubbing 
shoulders is somewhat conducive to information being passed.

    Now, so I am gathering from your answer that these two top 
leaders were probably Zooming, they were not in the office, and 
that their chief lieutenants were probably Zooming, and they 
were not in the office. Is all that correct?

    Dr. Califf. They were in the office some. But in general, 
it is correct that most of them----

    Senator Cassidy. Some, as you and I know, I don't mean to 
be insulting, but some can be 1 day a year, 1 day a month or 1 
day a week. Do you have a sense of what some is?

    Dr. Califf. I would say it depends on the individual that 
you are talking about.

    Senator Cassidy. Now these two top who apparently their 
structural problems and the deep seated conflict between the 
two most likely is implicated here. How frequently were they in 
the office?

    Dr. Califf. I don't have the data on that.

    Senator Cassidy. I understand that, but that would be 
useful to know. Now, it does make sense to me that if you have 
a dysfunctional mailroom and you have got a dysfunctional 
leadership and no one has actually seen each other, that it 
could take time for such a report to be done. I will just point 
that out, knowing that you as a leader will have to address 
that.

    Second, what percent, going back to you mentioned how the 
inspectors are commonly in the field, but we know that HHS 
stayed shut down for far longer than the private sector. How 
many inspectors--hold this up once more. We had a problem a 
summer ago.

    How many inspectors were actually not in the field working 
because of Coronavirus--I am not talking about the specific 
December function where there was COVID at the Abbott plant, 
but just in general, how many were Zooming their inspections as 
of--what percent of the workers, whatever, as opposed to 
actually showing up for work?

    Dr. Califf. As you know, we have very limited authority to 
do inspections virtually. We actually need to have that as part 
of inspections. But the inspections were hands on, in the 
plants.

    Senator Cassidy. What percent of your inspectors were 
actually working as opposed to not being at work? Because HHS 
had a huge problem of people not showing up for work for 2 
years.

    Dr. Califf. I think from every piece of data I have seen, 
we have a very high rate of work. I might also mention, I was 
at a pretty highly functioning business called Alphabet, which 
has done pretty well where when you have----

    Senator Cassidy. I have limited time, I accept that, but 
inspecting onsite is different than what Alphabet does.

    Dr. Califf. I agree.

    Senator Cassidy. I don't mean to be rude. Regarding 
importation and labels. Canada, New Zealand, U.K. all speak a 
form of English. Have we attempted to import from there from 
non-FDA inspected facilities knowing that getting FDA 
inspection can be prolonged, difficult, timely, etcetera, time 
consuming?

    Have we attempted to alleviate by importing from English 
speaking countries with standards similar to ours?

    Dr. Califf. The short answer is yes. We are open to all the 
applications. We have got 26 already.

    Senator Cassidy. But I am told that for that to occur, 
there is a 90 day wait--a 90 day lead in period for the FDA to 
accept.

    Dr. Califf. That is not correct.

    Senator Cassidy. So if somebody from the U.K. said, I have 
got formula, it meets our standard, you can fly it in?

    Dr. Califf. Yes. I mean, we can document most of what needs 
to be done without doing a hands on inspection ahead of time 
and we are doing that. I do want to address the Canadian 
situation----

    Senator Cassidy. Can I finish--one more thing. Are we 
actually importing from non-FDA inspected facilities in English 
speaking labeled countries who meet our standards intuitively?

    Dr. Califf. We are looking at those applications and it is 
likely that we will where we have high degree of confidence in 
reciprocal inspections that are being done by others.

    Senator Cassidy. So we have not started yet. Do you have a 
timeline of when that might begin? Because applications pending 
is a kind of in an agency described as dysfunctional, could be 
months from now.

    Dr. Califf. It will not be months, it will be days. Every 
day you will see a new--one come on board.

    Senator Cassidy. Okay. Thank you. I yield.

    The Chair. Senator Hassan.

    Senator Hassan. Well, thank you, Madam Chair and Ranking 
Member Burr. Dr. Califf, like all of my colleagues here, I am 
hearing from my constituents. Granite Staters have shared with 
me their struggles to obtain formula for their infants. And as 
we all know, formula for many, if not most of these babies is a 
matter of life and death.

    Their parents are desperate and terrified. I have called on 
the Administration to invoke the Defense Production Act and 
allow the importation of additional formulas. I am encouraged 
that the Administration has taken these actions.

    But shortages continue and infants remain at risk. So what 
my constituents want to know is when can New Hampshire families 
expect the shortages to end? How quickly will they be able to 
walk into a store and be confident that they will find formula 
on the shelves?

    Dr. Califf. Well, I am sure you know, Senator Hassan, I 
can't be exact about this, but I would--my expectation is that 
within 2 months, we should be beyond normal and with a 
plethora. And what you will see is, due to all these measures 
being taken, the shortage is going to be getting better and 
better.

    You will also see the big focus is on these specialty 
formulas that all of you have mentioned. Back in the Abbott 
facility, that is the first thing to come off the line because 
they were such a dominant company in that regard, and they have 
been able to move their timeline up now to within a month they 
will have that specialty formula out.

    Senator Hassan. Thank you. So do you have a--does the FDA 
have a plan and a timeline that shows how you plan to get to 
that point 2 months from now?

    Dr. Califf. This is across HHS, and it is a lot of data 
points. So as you said, is it a simple chart? The answer is no 
because there are many contingencies. But there is a committee 
that has all the data in hand. And if you would like something 
that is a little more specific about how the pieces fill in, I 
am sure we can produce it.

    Senator Hassan. I think it would be very helpful for us to 
get an actual plan, because without a plan, without goals, it 
is hard to know that you are actually going to meet them. It is 
also really important for the public to be able to understand 
when they can expect to have a little bit more peace of mind as 
they search for formula.

    Let me go to the issue of the specialty formula and the 
Operation Fly Formula that President Biden announced. He 
announced that we are now using Department of Defense planes to 
pick up overseas formula and deliver it to the areas in need.

    At least two of these flights have arrived in the U.S. 
carrying several tons of formula. How is the Administration 
prioritizing the distribution of the imported formula to rural 
areas and other regions where families have few alternative 
purchasing options?

    Dr. Califf. Each application also has to include a 
distribution plan, which is reviewed at the level of HHS to 
make sure that the most needy places are getting the formula. I 
can assure you there is hyper awareness of the problems in 
rural America right now with health in general and access to 
care. So that is one of the priority areas.

    Senator Hassan. Okay. Well, I would love to follow-up on 
that as well. I just want to turn to thinking through what we 
need to do once this current crisis is over. The FDA and other 
Federal agencies need to take steps to make sure, obviously, 
that this never happens again. Supply chain challenges 
exacerbated by the pandemic made clear the need to build out 
domestic capacity to manufacture critical goods quickly.

    That goes for infant formula, as well as a number of other 
critical goods. What steps should FDA and other agencies take 
to prevent these shortages going forward? For instance, should 
the Administration work to build out extra manufacturing 
capacity, stockpile the ingredients needed to make formula, 
require manufacturers to produce a reserve of formula, or to 
have the capacity to make extra in short order to prevent 
situations like the ones we face now?

    Dr. Califf. Well, we have a number of measures that are 
before you now in pending legislation, as you well know, and 
those are enumerated, and we will make sure you have a list of 
those. But you have mentioned a couple that are not yet decided 
where we do need to make a decision once we get on top of this 
crisis, and that has to do with stock--the word, stockpile.

    There has been no stockpile of infant formula. It was not 
conceived of going back. I think it is something that we really 
need to consider. Of course, if we had diversification of the 
market, and some Federal agency, whether it is FDA or some 
other Federal agency, had insight into the supply chains and 
how they fit together, the likelihood we would need the 
stockpile would be quite low because we would have a vibrant 
system that was resilient to stress, but we don't have that 
now.

    Between stockpiling and having a resilient system, we 
should be able to prevent this from happening again.

    Senator Hassan. Well, we certainly need to. Thank you very 
much. Thank you, Madam Chair.

    The Chair. Senator Tuberville.

    Senator Tuberville. Thank you very much. Thank you, Dr. 
Califf, for being here today.

    Dr. Califf. It is Califf by the way.

    Senator Tuberville. Califf--Califf. My name gets 
mispronounced----

    Dr. Califf. I understand.

    Senator Tuberville. 18,000 staff members. How many of those 
are back working full time, not from home? You know, have a 
clue?

    Dr. Califf. Well, that is the thing, they are all working 
full time.

    Senator Tuberville. But back in the office. Do you know?

    Dr. Califf. It is may--I just, I don't know the exact 
percent, but it is not a large percentage.

    Senator Tuberville. It is not a large or it is large?

    Dr. Califf. Not a large percentage.

    Senator Tuberville. I am just asking, you know. A lot of 
people are starting to work from home. Out of these 18,000 
staff members, how many of these employees that you have been 
relieved of duty because of this, 18,000? Somebody has got to 
be fired, right.

    Dr. Califf. You know, I have been involved in running a lot 
of successful organizations. Firing is not necessarily the 
solution to a problem like this. Correcting errors is----

    Senator Tuberville. Dr. Califf, people have died from this. 
Kids have died.

    Dr. Califf. Kids have definitely died, but I don't believe 
there is a direct link between the plant and the sickness of 
these infants that has been proven.

    Senator Tuberville. So everybody in your office has done 
100 percent right? They have been----

    Dr. Califf. Absolutely not. And we are clear in the report 
that that is not the case, and that we are doing a review and 
putting systems in place and also reviewing individual 
decisions.

    Senator Tuberville. Okay. So let me ask you this, 
yesterday--last week, you suggested the shortage would be over 
in a few days. Yesterday, you said it might be weeks. Where are 
we at today with that?

    Dr. Califf. As I just reviewed with Senator Hassan, it is 
going to be a gradual improvement up to probably somewhere 
around 2 months before the shelves are repleted again.

    Senator Tuberville. Two months? So you are in damage 
control here. What is the FDA going to do to restore public 
confidence, No. 1 in safety, and then the availability of the 
formula in the days ahead?

    Dr. Califf. Well, I think one of the main lessons of the 
pandemic with cyclical shortages is that the only thing that 
will restore confidence is having adequate formula on the 
shelves. We are fully, fully aware of that. The safety, we are 
not letting unsafe products on the market.

    Senator Tuberville. I understand that. But how do we get 
that out to the consumer?

    Dr. Califf. Constant communication. We are going to have to 
constantly communicate about----

    Senator Tuberville. Do you have a marketing department in 
the FDA? Is there anything that consists of that?

    Dr. Califf. We have a very hard working external relations 
group and communications group.

    Senator Tuberville. Yes. Who is your direct person under 
you that is overseeing this? The No. 1 person you call every 
morning say, hey, what is going on? What do we need to do? 
Where we at?

    Dr. Califf. It is actually twice a day. The person who is 
heading out the Incident Management Group as Frank Janis, who 
used to work at Wal-Mart and is an authority in the supply 
chain area. The person running the Center is Susan Mayne. We 
all meet together, along with our teams, twice a day to review 
what is happening and make sure we have got working orders for 
the day and also for the----

    Senator Tuberville. So the team of how many are working on 
this one specific, that you directly work with?

    Dr. Califf. Dozens.

    Senator Tuberville. Dozens? You all work--and you meet 
every day, talk about it two or three times a day?

    Dr. Califf. Yes. Each one has--if you just take the 
specialty metabolic formula that we discussed, this might be an 
effort with a hepatology problem where you got to have a liver 
specialist, a nutritionist, and a regulatory expert to make 
sure the infant gets the right formula. So it is a lot of 
people.

    Senator Tuberville. Okay. Thank you. Thank you, Madam 
Chair.

    The Chair. Senator Smith.

    Senator Smith. Thank you, Madam Chair. Welcome, Dr. Califf. 
So the Minnesota Department of Health was the first to link the 
foodborne illness to the powdered infant formula manufactured 
at the Abbott nutrition facility in Sturgis, Michigan, in 
September 2021. And they informed the CDC and the FDA of that 
link in September. That infected Minnesota baby survived but 
was hospitalized for 22 days.

    As we all know, the FDA did not initiate an inspection of 
the Sturgis facility until January 21st, which led to the 
voluntary recall and the shortages situation that we are 
experiencing now. So this is my question--my question is about 
how the FDA coordinates with state and local health departments 
on early detection of foodborne illnesses.

    Is this process that happened with the Minnesota Department 
of Health, is that the standard process? Did something go wrong 
there? What can you tell us about what that link between state 
health departments and the FDA is and what it should be like?

    Dr. Califf. Thanks for asking that question because it is 
really important. The minute that a report comes in, usually 
the CDC, because that is where the reports typically come in. 
There is an investigation launched and it is very intensive. 
You have to get to the site. You have to get the cultures, if 
they are available. You have to interview everyone concerned. 
And often you need to review the medical records.

    In this case, the Minnesota Health Department, from all the 
reports I have gotten, did a splendid job. The problem is it 
was one case, and it was chronobacter positive. But 
chronobacter, for example, is found in up to 15 percent of 
sponges in kitchens at home. It is a ubiquitous organism. It is 
not necessarily--so that case was very well documented.

    Senator Smith. Was it linked to the formula?

    Dr. Califf. It was----

    Senator Smith. I mean, they suspected a link.

    Dr. Califf. The infant had ingested that formula, so it was 
a matter of concern.

    Senator Smith. Yes.

    Dr. Califf. I would also point out chronobacter is not a 
reportable organism. And so we have banks of now DNA sequencing 
that if we look at the peanut butter case that just occurred, 
that was solved within days because we had, we were able to 
link the genetics of the peanut butter and the sickness of the 
people, the genetics that were in the infections in those 
people, and the plant within days because we had the 
information. I think we need to do something about cronobacter 
because it is a well-known, although infrequent, cause of 
contaminant of infant formula.

    Senator Smith. So but are you saying that you think that 
the process--that the length of time that it took from when 
MDH, Minnesota Department of Health issued the, you know--
provided this information and when the FDA ended up where the 
recall happened, is that like--is that as long as it should be 
according to the way your policies work? Could it be shorter? I 
am trying to understand if there is something in that that 
isn't working from the perspective----

    Dr. Califf. I am sorry, I am trying to give a nuanced 
answer in a bit. I mean, the Minnesota Department of Health did 
its job and what it should have done. We had one case. You 
don't recall a product unless you have a direct link that 
proves that the product actually caused the problem. So usually 
we get a cluster as has happened in peanut butter where a bunch 
of people have it at the same time, then it is easy to make the 
case. In this case, we had the information and we had to wait 
and see what happened.

    Now the time to the recall, as I have already said in my 
document, the more blunt answer, it was too long. You know, we 
are clear about that in our documentation, and we aim to fix 
it.

    Senator Smith. Okay. Let me ask you about something else. I 
want to--this is about coordination with USDA, which is 
responsible, as you know, for purchasing nearly half of the 
infant formula in this country through the WIC program.

    My understanding is that the FDA didn't communicate with 
the USDA until around the time of the recall. I am wondering 
why you think that happened. Should the FDA be working more 
closely with the USDA sooner, and whether you see this as an 
area where there could be improvements?

    Dr. Califf. Well, let me divide us into two tranches. Prior 
to the recall, there was a lot of communication between FDA and 
USDA on the general supply chain issues related to infant 
formula. There was not about this specific case, but as I have 
already told you, even the leaders in FDA didn't get the 
information until February 9th about what was going on.

    That was an escalation error, as I have said, and we have 
documented that and are fixing that is a systemic quality 
problem within the FDA. And so it was shortly, as you said, the 
recall happened right after that.

    We were then in the detailed discussion with USDA. So there 
has a been a supply chain group of supply chain committees for 
Government throughout the pandemic, and infant formula has been 
on the list. That has been covered by the relevant agencies, 
including USDA.

    Senator Smith. Dr. Califf, I understand that you have only 
been at the FDA for a short time, but I do think that you have 
a unique capacity, because you know the agency so well and 
because of your industry connections, to be a reformer at the 
FDA.

    I am struck, as I listen to you today, about how you have 
been explaining what happened with regard to this supply issue 
as well as the health issues, rather than taking the posture of 
a reformer, which is what I think that we definitely need, and 
I do believe that you have a capacity, a unique capacity to be 
that reformer, I am--I believe that this infant formula crisis 
is a symptom of the broader, systemic structural problems with 
food safety in the food division that we have at the FDA. And 
so I urge you to adopt that reforming posture as we move 
forward.

    Dr. Califf. Can I comment, with permission on that?

    Senator Smith. Yes, if----

    Senator Kaine. Continue.

    Dr. Califf. As we discussed in detail yesterday in the 
hearing, I do consider myself to be a reformer here. I knew 
coming in. I have gotten multiple phone calls. I was--I saw the 
problems in the food side of the FDA before. It has been 
massively underfunded. And what I am appearing to be maybe 
defensive about is I do not think castigating the FDA employees 
is the appropriate approach to reforming an organization.

    What we got to do is to have a carefully thought out plan 
going forward and an after action review of all the decisions 
that were made with working with people to understand what is 
being done. If you take beleaguered employees and castigate 
them in an organization that is already under stress, I don't 
think that is a helpful way to fix an organization.

    I have been involved in many such organizations, but I 
agree 100 percent with what you said. If I am not a reformer--I 
don't know, I mean I wasn't planning to come back to FDA, as 
you know. I would not have come back if I wasn't planning on 
changing it.

    Senator Kaine. Senator Marshall.

    Senator Marshall. Thank you, Chairman. I appreciate it. Dr. 
Califf, welcome. It took--takes a lot of guts to come here and 
face this situation. And we appreciate you being here in 
person. You and I are both physicians. We both know that no 
matter what happens in the OR, the delivery room, or the E.R., 
that we are responsible for it, regardless of what the people 
beneath us did, their actions, their inactions, that we feel, 
that sense of responsibility. I am sure you do, too.

    I want to start here by just reading a couple statements. 
This is a small sampling of what we have received. This is 
Stacy from Newton, Kansas. I have a 5-month old grandson and 
another on the way. The shelves are empty in Newton, Kansas and 
the surrounding areas. Please help. This should be top priority 
for all Americans. Next, Anna from Wichita. This is 
unacceptable in America. How we let this get to this point.

    No parent should be worried about not having food available 
in stores to feed their child. The empty shelves is what I 
expect to find in Havana, Cuba, not Wichita, Kansas. Judy from 
Overland Park. The new press Secretary laughed today when a 
reporter asked her who the point person was for the formula 
shortage. She had no idea who the point person was. All I can 
say is, may God help the babies.

    Jenny from Cimarron, Kansas. The shelves are--the stores 
are empty. How are we supposed to feed our babies? I believe 
the Government needs to step in and get answers to the public 
and get the formula shortage resolved. Next, Katie from 
Manhattan. There is no room for bureaucracy when it comes to 
our Nation's babies.

    Last, Lisa from Seneca. I am an expectant mother due in 
June, and I am terrified I will not be able to find formula for 
my newborn. We already have to worry about gas prices, 
inflation, I don't need anything else to worry about. What 
would you suggest I tell these moms, grandmoms?

    Dr. Califf. Well, first of all, we are physicians, and the 
physician in a hospital or a health care setting is a captain 
of the ship and takes accountability. So that is why I am here. 
I would tell them that we are sorry that we are in this 
situation, and we are working night and day to try to fix it at 
this point.

    We know there is going to be further inconvenience and 
beyond inconvenience in terms of desperation that parents feel. 
But they also should contact us because we are dedicated when 
we hear about an individual case to fix it and make sure that 
everyone does get access to the formula that they need.

    Senator Marshall. Thank you. I do want to submit for the 
record a letter that we sent to you. You haven't time to answer 
it yet. With some questions. I think it was signed by 21 
Senators. So we will submit this for the record.

    Senator Kaine. Without objection.

    [The following information can be found on page 52 in 
Additional Material:]

    Senator Marshall. Next, I just want to point out that from 
an action standpoint, what has the FDA, what is the White House 
done to correct this problem? We are kind of bragging about a 
shipment, I think of 78 million, was it pounds or ounces? 
Pounds of formula. Just to put some numbers to that, that is 
probably enough formula to feed the babies in Kansas for three 
or 4 days and a fraction of what has been shipped in here.

    How much of the of the problem could have been solved if 
people weren't working from home in the FDA, if they would have 
been willing to go examine, well, what was going on at the 
laboratory in in Michigan, or they could have possibly went 
over to Europe and certified some of the manufacturing plants 
in Europe that Abbott has.

    You know, we were all expected to work--people had 
vaccinations. There was every reason, I think, to go in there 
sooner. But I am just afraid, and I guess the follow-up 
question is, is the FDA still working from home or are people 
engaged now?

    Dr. Califf. Well, Senator, you are not just a doctor, you 
are an OB-GYN person, and that has special, special 
responsibilities, I know. But it is also the case in most of 
the jobs at FDA people are working 100 percent of the time or 
more. I will just remind you that I come from, in my last job, 
one of the most successful companies on the face of the earth, 
where people were working from home and more productive than 
ever.

    I really don't agree with the contention that the work from 
home policies that FDA had anything to do with the outcome 
here. But I am also not saying the outcome was a good outcome. 
I don't want to be misinterpreted that way. We just have a 
disagreement. I think the right solution going forward is going 
to be a hybrid arrangement, as I said, as most of the industry 
is going to.

    Which is if you have a job like in a lab that requires that 
you be there or in the mailroom you have got to be there. If 
you are reviewing documents or reviewing processes, you can do 
that from home. Just demonstrate that you are doing the work.

    Senator Marshall. Thank you. Just a quick comment. I think 
this is a great opportunity for us to encourage breastfeeding. 
A great opportunity to encourage those moms who are thinking 
about weaning their babies today, tomorrow, and next week. This 
is one more reason to try to breastfeed a little more, a little 
extra. And by the way, it is healthier for your babies. 
Anything you can do to help us with that, I am all in.

    Dr. Califf. I am totally in support of what you say there. 
I did want to remind you--I forgot what I was going to say. We 
do have a history on the importation front of very tragic 
outcomes with formula melamine, as you may remember, from 
imported formula not that many years ago. That is the reason we 
have got to be careful and make sure that we are reviewing 
these documents.

    Senator Marshall. Safety first. Thanks, Senator.

    Senator Kaine. Senator Lujan.

    Senator Lujan. Thank you, Mr. Kaine. I want to thank Chair 
Murray and Ranking Member Burr as well for holding this 
important hearing, and to Commissioner Califf for joining to 
share your insight and answer these tough questions. Sir, thank 
you for being here.

    Now, I, like many of our colleagues, come from rural parts 
of America and that is where my question begins, sir, is in 
rural regions of New Mexico, picking up the formula needed to 
feed our infants isn't as easy as going a few blocks to the 
closest grocery store. Many families have to drive hours to be 
able to take that trip to purchase infant formula.

    When the supply chain fails and essentials are not 
available, it is not merely an inconvenience, but a crisis for 
those living in rural and underserved communities. Commissioner 
Califf, on May 10th, the FDA released a statement saying that 
the agency is, ``compiling data on trends for in-stock rates at 
both national and regional levels to help understand whether 
the right amount of infant formula is available in the right 
locations, and if not, where it should go.''

    My question is this, is this system equipped to track the 
availability of formula in rural and tribal communities, some 
of which do not have access to broadband?

    Dr. Califf. Thank you, Senator. It is good to see you back. 
Looking good, too. I--what I would say is the system is better 
than anything we had before. We asked for funding for a system 
to track this back at the early phase of the pandemic.

    We got no funding. We took money from other things, which I 
want to emphasize again means that other things are not getting 
done. And we built a system which does give us some data, but 
not the data that we would really like to have down to the 
level of the individual location. You know, soon there will be 
broadband in every community, as you know, thanks to the good 
work that you all did to get the bills passed for that, but we 
don't have that now.

    We are following at the granular level that we can. And as 
I have made the point before, the industry actually has very 
detailed data about where its products are going. We have no 
right to compel the industry to give it to us and no right to 
demand increase in production until the President put in place 
the Defense Production Act.

    The answer would be, yes, we have a system. It is nowhere 
near what we need.

    Senator Lujan. Well, I hope, Dr. Califf, that everyone is 
listening to that. The staff that you have here, we can work 
together to remedy that, make sure that the tools are in place 
for tracking, and then work with your staff to incorporate 
rural communities and tribal communities as well. I really 
appreciate that, and we have some work to do there as well, 
sir.

    Dr. Califf. Yes, sir. I just might add. Over the last 5 
years, I have written a number of academic papers about rural 
health. There is a disturbing drop in life expectancy in rural 
America compared to urban that we all need to pay a lot of 
attention to.

    Senator Lujan. You are spot on, sir. I appreciate that 
reminder. Now, the shortage of infant formula comes as New 
Mexico is experiencing the largest wildfires in our state's 
history. On top of the loss of their homes, cars, and 
livelihood, some New Mexicans are now struggling to source the 
formula they need to meet the nutritional needs of children. 
How is the FDA taking the impact of this disaster into account 
as they advise the Federal Government on the distribution of 
formula?

    Dr. Califf. Thank you for that question. Having lived in 
San Francisco the last 5 years, the wildfires are quite an 
astounding thing. It is hard to appreciate unless you see the 
size of these fires that we are now experiencing. I just want 
to make the point that the supply chain part of what we do is 
HHS wide and involves all other part--it is an all of 
Government effort. I do want to commend colleagues around 
Government.

    They are constantly getting reports of where the shortages 
are and directing product to those shortages, and any area 
experiencing a shortage due to wildfire where people can't get 
around, please get in contact with HHS to make sure that they 
are aware, but I am pretty sure they have got active feelers 
out to get this information.

    Senator Lujan. Well, that is a good reminder to reach out 
to Secretary Becerra as well. And Dr. Califf, to everyone that 
will listen, I remind them that this fire was started by the 
U.S. Government. It was a controlled burn started by Federal 
employees, by the U.S. Forest Service. And so we just want to 
make sure that there is attention on this one. But that is an 
important reminder.

    The other questions that I have, Mr. Chairman, I will 
submit them into the record. But I am hoping that we can do 
more in non-English language education and outreach, namely 
Spanish and Native American communities, where in most areas 
across the Federal Government we are still failing in that 
area, but especially with educating families to earn their 
trust back to say these are safe products, this is where you 
can get them, and this is how to do it. So that is one area I 
look forward to working with you on as well, sir.

    Dr. Califf. Thank you. That is a good example, by the way, 
the labeling issues that we are facing as we import. So a lot 
of logistics here that have to be coordinated. Thank you.

    Senator Lujan. Thank you. I yield back, thank you Chair.

    The Chair. Thank you.

    Senator Paul.

    Senator Paul. There have been some discussion about whether 
the Abbott plant was not closed soon enough or whether it was 
closed prematurely or whether it was closed too long. There is 
no definitive evidence that the children who died, the bacteria 
came from the formula.

    Dr. Califf. That is correct.

    Senator Paul. Yes. I think it is important to know that. I 
mean, it is very sad that the children died. But as the 
investigation has gone on, the unopened samples from the 
household, which would be part of the same batch, did not have 
any of the bacterium.

    The open bottle had bacterium, but cronobacter can come 
from the environment in when you manufacture it, but it also 
can come from the home environment. When they do their 
investigation, I know they go back to the plant and take swabs 
everywhere too. Do they also take swabs in the home 
environment?

    Dr. Califf. In the home environment? I would have to check 
to see whether that happens every time. But is there suspicion 
about the home environment, they would.

    Senator Paul. I think it would be worth doing that because 
we are not--nobody is wanting--we want to know where it came 
from so we can prevent it happening from again. If you have 
other children in the house or you are having another child, it 
would be important, and it is nobody's fault, but it would be 
important to know if there was chronobacter found that matched 
the strain.

    But what we do know is what was found in the plant when you 
do the DNA analysis did not match the bacteria that 
unfortunately killed the children. On the issue of formula, how 
is a European formula different than American formula? Why do 
we prohibited from coming into the U.S.?

    Dr. Califf. We don't--we have never prohibited European 
formula from coming into the U.S., but we do have requirements 
that have arisen over time. There are 30 nutrients that need to 
be in a specified label and a specified amount, and 10 that if 
they are too high are dangerous.

    We just need to make sure that the requirements are met. We 
have been importing, by the way. The American manufacturers 
that we talk about have plants in Europe and Mexico that have 
been importing all along.

    Senator Paul. Are we waiving any of the requirements to try 
to fix the shortage?

    Dr. Califf. We are not waiving basic nutritional 
requirements or safety requirements. We are waiving some of the 
labeling requirements that are time consuming to get exactly 
right.

    Senator Paul. When you say that we don't prohibit it, you 
are right. It is not a law or an FDA edict saying you can't 
have it, but there are a lot of restrictions on it that do 
effectively prohibit it. Some of those are labeling. So we are 
waiving the labeling things. Do you think it might be a good 
idea to maybe permanently getting rid of some of these labeling 
requirements that are keeping European or Japanese formula out 
of our market?

    Dr. Califf. Well, I disagree that that is what is keeping 
them out of the market, but we will continue to look at the 
labeling to make sure it is leading to safety. Remember that an 
error in mixing up the formula can be devastating to an infant.

    Senator Paul. Yes, but I think Europe has those same 
concerns too, so does Japan. I think this gets back to the 
basic question of whether we trust international standards on 
things or whether we don't. I think it is part of it. If you 
are loosening the labeling requirements now to get more in, 
then the labeling requirements obviously you believe are 
limiting it.

    By loosening them, you are expecting that you will get more 
formula. Some of the differences, I think, would be and could 
be considered a matter of opinion. You know, how much iron is 
in the formula? I think we have more iron than in Europe has. 
Europe has more omega three fatty acids.

    I don't think there are doctors over there consider or 
there is an outbreak of iron deficiency in Europe because their 
formula is less. I would say that there could be honest expert 
differences on exactly what formula should hold. Would you 
agree?

    Dr. Califf. Yes, Dr. Paul. I mean, I am a huge advocate of 
global coordination for the basically the reason you gave. We 
are all human beings. The diseases we have don't know borders. 
And where the requirement is good, we should take it into 
account. And of course, the availability of cloud computing and 
internet makes it possible to do this in real time, but we are 
not there yet.

    Senator Paul. Right. But I will venture to say we are 
there. I mean, I think that part of what you are going to do is 
try to evade the rules that have restricted the flow of foreign 
formula in. It also would serve to have more competition. If 
you do have a problem, I am not so sure whether the Abbott 
plant should have been shut down for so long. But the thing is, 
we have more foreign formula flowing in.

    I think that there is nothing wrong with a European 
formula. There is probably nothing wrong with the Japanese, 
there is nothing wrong with the New Zealand. So there does need 
to be more coordination. I don't think it's like, oh, we have 
got to wait until sometime in the future. I think it right now 
is completely safe and people ought to get the choice of where 
they buy it from.

    We have proposed legislation that would get rid of tariffs 
also. There is a 17 percent tariff on it. I think the tariff, 
the agreement between Mexico and Canada in the United States, 
it was signed in the previous Administration, put an extra 
tariff on Canadian formula and Mexican formula. So those are 
economic barriers to it, and we have to look at the whole 
picture.

    Closing down Abbott, I think, probably too long since there 
is no proof that the deaths actually were related to Abbott, 
and sort of I think the overreaction in some ways to the link 
and not really following the science has led to a lot of this. 
But I think also the economic barriers of tariffs, but also I 
think the overly zealous regulatory environment as far as what 
goes into it.

    Nobody wants dangerous formula, but nobody also believes 
that the European Union is like delivering millions of babies 
in Europe dangerous formula. I think there does need to be more 
international acceptance of things.

    I think you are doing some of that, and I commend you for 
doing it, but you are evading your own regulations right now, 
which is good, because I think some of your regulations don't 
make any sense.

    I think we should, by legislation, address the needs of 
formula and see where there is a dispute. I will bet you we can 
bring in a whole panel of scientists that agree that the 
European formula is just as good as ours or better. And it 
would be a dispute and probably hundreds of papers written back 
and forth over what the level of ions should be.

    I don't think there is any ironclad truth. It is another 
reason why we shouldn't have anyone dispensing what truth is, 
because truth is debatable, and people look back and forth and 
actually have opinions as to what the truth is. I think we need 
to be more open minded as far as this goes.

    But I do commend you for trying to get outside the 
regulations to get more formula in. But I think we have to look 
at whether or not it was an appropriate length of time that 
Abbott was closed down given that the evidence does not 
definitively say that the bacteria came from the plant. Thank 
you.

    Dr. Califf. Madam Chair. Can I make two quick points on 
that?

    The Chair. Yes.

    Dr. Califf. No. 1, for those who argue that onshoring is 
the solution to all of our problems with our supply chains, 
this is a classic example of why that is not the case. This was 
almost all onshore material, and the industry couldn't produce 
what people needed.

    The second, on the Abbott plant, Abbott will complete--now 
that Abbott is taking into account their own failings, I think 
they would agree completely with us, they are not ready to 
open. They have known for 3 months since they have been shut 
down that we were going to go through this court proceeding to 
gain control of their quality system.

    They have been working on it all along and I do think they 
are doing a good job now. But they had to replace the roofs, 
replace the floors. They are still not done. And we went over 
with the CEO day before yesterday, the detail list of hundreds 
of things that they had to fix. And you just can't open a plant 
with bacteria growing in it.

    I mean, would you go in a kitchen next door if there were 
bacteria growing all over the place and standing water and 
people tromping through with mud on their feet, which is 
essentially what the inspection showed. I do agree with some of 
the main points you made, Senator, but I just on those two, I 
wanted to make sure my feelings, at least, were known.

    The Chair. Thank you.

    Senator Hickenlooper.

    Senator Hickenlooper. Yes. Thank you, Dr. Califf. It is 
great to have you back. I appreciate your willingness to come 
back and not just subject yourself to these questions, but for 
your service. I was going to try and catch Dr. Paul before he 
left, Senator Paul just because I thought it was unique, first 
time I heard him make a pun like that, where he was talking 
about the amount of iron in formula and getting to an iron clad 
solution, but somehow that got passed over.

    Obviously, the grief that we feel on behalf of those kids 
is only compounded this week just after what has happened in 
the Uvalde. And these are circumstances and situations we wish 
we could repair.

    But I think I do appreciate what you are trying to do to go 
back through the entire process and see where the mistakes were 
made, and then figure out how do you build back a better 
structure so that we catch--the next time we catch it sooner, 
or perhaps we even avoid it completely. I thought your comment 
about how to reform an agency made my heart sing because that 
is exactly what you have got to do, you have got to look at the 
culture.

    You have got to make sure the culture can't--and they are 
beleaguered. Now, they have been underfunded. They are short 
staffed. They have got to believe in their future. I think that 
you are--you understand that and are going to move forward.

    Now back to the supply chain management, we continue to 
react to supply chain interruptions rather than proactively 
plan ahead, which is, I think, your inclination to intervene so 
as to prevent them. Does the FDA have adequate access to the 
critical supply chain information that you need not only to 
address the current formula shortage, but also to help minimize 
the risk of similar shortages of other lifesaving and life 
sustaining products?

    Dr. Califf. Short answer is no. If I could take just 30 
seconds to just go on about this. I am a huge advocate of free 
enterprise and of the individual companies making their 
decisions that are in their interests. It has worked great for 
America. But what has happened is each company has its own 
supply chain, its own optimization, and when someone says, if 
company x gets in trouble, will we have a supply for that 
community.

    On the drug side, we just got authority to require the 
companies notify us when there is a shortage. We had over 300 
last year that we had to help with. And if you talk to 
hospitals and health systems around the country, they are every 
day dealing with significant shortages. I would refer you to 60 
Minutes, the last Sunday.

    Yet for food, we have no authority to compel companies to 
give us any information, and we even have to pay for it, very 
often, to get it, which just seems ridiculous. They have 
digital information. There is no reason it couldn't be 
transferred, and there is no reason for the Government to 
intervene except in the case where there is a public health 
need.

    Senator Hickenlooper. That is something we might be able to 
help you with, I suspect. How can we, and this is just a 
continuation of that thought, at the Federal level support 
platforms like 21 forward, and analyze supply chain data.

    Dr. Califf. I really appreciate that question. I have to be 
careful here because I came from the best computing environment 
in the world back into the Federal Government, which is--as I 
keep saying, I just want to say it over and over, very 
hardworking people, not people who are sitting at home, 
lounging around. These are hardworking people, but they are 
greatly impaired by legacy systems.

    Anyone that has been involved in the technology industry 
knows that you have to update your systems. Companies have 
capital budgets. As you know, you run companies and you put it 
into capital equipment, and that is an expense that you take. 
We are woefully short. We are doing the best we can with gum 
and chicken wire to put things together. But ultimately, there 
is going to be a reckoning on this in the Federal Government.

    I would also point that CMS is group that needs help. With 
them, we are doing a lot of work, but on the food side, we just 
need fundamental funding and technology to enable us to do our 
work. Imagine an FDA inspector armed with the kind of equipment 
I saw at Google, how much more efficient they would be in 
getting their job done because they are not hand entering data 
into an old computer.

    Senator Hickenlooper. Exactly. Well, at some point we did 
an infrastructure bill this year in the Senate that was 
bipartisan, and I think that they would be one of the next big 
things we should look at would be a technological 
infrastructure for Government, because we are in almost every 
agency decades behind, not just a few years out of date. I have 
got, maybe I will just lay this question out and you don't have 
to answer because I think I am out of time.

    Based on the information you have, what do you see as 
potentially--maybe I will let you have 15 seconds to answer 
with the Chair's permission. What is the next supply chain 
crisis for critical foods or drugs under the purview of FDA? 
What do you see as looming problems?

    Dr. Califf. Well, I mean, we already have one, which is 
contrast media, which is the opposite of the offshoring problem 
that we had here. We had a major manufacturers, GE, which had 
its only plant, I don't know all the details, making contrast 
media in Shanghai. And when the COVID problem hit there, they 
shut down.

    All of a sudden we have had a number of medical illnesses 
in Congress lately. Someone with a stroke or heart attack 
wouldn't be able to get an angiogram. I mean, it is just 
unbelievable. But it is happening. I could give you a list of 
dozens where we are precariously--this is just in time, which 
is very efficient when things work well with very little 
inventory, that's the most efficient way to run a company.

    But then when something goes wrong, if it is not a critical 
supply you need for health, Okay,so you don't have tennis shoes 
for a couple of weeks, knowing you make up for it. But when it 
is a critical thing, like----

    The Chair. I am going to interrupt you. We do need to move 
on, thank you.

    Senator Scott.

    Senator Scott. Thank you, Chair. Thank you, Ranking Member, 
for holding such a really important hearing. One of the things, 
as I have watched this hearing all morning, frankly, I keep 
hearing, is who should be to blame for what didn't happen? The 
one thing I think Americans are really not very interested in 
is the watching each side point fingers at the other side. Some 
say it is the private sector, some say it is Government.

    The fact of the matter is that the average person in this 
country is not as interested as we are in figuring out how to 
make a Republican responsible for what happened, or the 
Democrat to be responsible for what happens, or the private 
sector to be responsible for what happens.

    This, frankly, seems to be an all hands on deck kind of 
problem. Everybody did something that they ought not have been 
doing or didn't do enough of what they should have been doing.

    From my perspective, I am not sure of your opinion on that, 
but the truth of the matter is, it is pretty frustrating for 
the average person in our Country who sitting at home watching 
a crime wave that they haven't seen in decades, looking at the 
price of gas at the pump, and they are scratching their heads 
and they are digging into their pockets and they are coming up 
a little too short, a little too often, month in and month out, 
and then they see the absolute crisis of inflation that is 
weighing on their shoulders and their inability to meet the 
needs that they were able to meet just 18 months ago.

    Then finally, for mothers, fathers, new kids, they see this 
shortage of formula that seems to exasperate their situation in 
such a way that they simply can't imagine it happening here at 
home in America.

    Dr. Califf, I hope that we spend less time pointing fingers 
at who is to blame and take responsibility for where we can 
make things better. You are a South Carolinian, born in 
Anderson, South Carolina. And as Senator Lujan was talking 
about the rural aspects of his state, I will speak to the rural 
aspects of our state. You went to A.C. Flora High School. I 
went to Stall High School. And the fact of the matter is, we 
play ball against each other, different decades, but same 
schools.

    The truth is that too many Americans and too many places 
and specifically at home are looking at the crises that befall 
them and they want solutions, not really the blame game. I hope 
that we spend a few minutes on, how do we make sure this 
doesn't happen again?

    But before we get there, I just want to highlight the fact 
that in your home state, as I just suggested, in my hometown of 
Charleston, South Carolina, we have four babies in hospitals 
due to the shortage because they have had an allergic reaction 
to the generic forms, or they need a specialized formula.

    What can we do to accelerate the path to those families 
having what they need? And how can we ensure that this doesn't 
happen again?

    Dr. Califf. Well, to your first question on what can we do, 
for those specialty formulas, as I have reported, we have 
groups of FDA people, pediatricians, specialists and critical 
care who meet every day and talk about each case and try to get 
the right formula to the baby.

    In the case of Abbott, which was the major manufacturer of 
these, for the hyper specialized formulas that had no 
substitutes, we actually have allowed on a case by case basis. 
The formula will be sent out after careful weighing of the risk 
and benefit since they were made in an unsanitary plant. For 
the next tranche that you are describing, it is right to try a 
different brand, which is considered to be interchangeable.

    But we all know that when it comes to particular drugs, for 
example, sometimes what looks like the same thing doesn't sit 
well. And then what has to happen is trial and error. But there 
are specialists involved every day in helping to navigate 
these. You have great ones at MUSC. I know the institution 
well.

    I am sorry that people, infants have to be in the hospital. 
But for that kind of critically dependent infant, it is 
probably the best place for them to be until we get everything 
back and running.

    Senator Scott. Transitioning to the latter question as it 
relates to how do we ensure that this doesn't happen again? The 
safeguards, the whistles, the bells that should be going off 
when we are 11 percent shortage, 20 percent shortage, 30 
percent shortage, 40 percent shortage. How do we look back and 
learn lessons that we use for the future?

    Dr. Califf. Well, there is an old statement, there are 
lies, damn lies, and statistics. So Senator Casey and I have 
very different data. He showed the most extreme estimate. Our 
estimates are nowhere near what he showed. But having said 
that, we have a very specific list, some of which are in 
consideration in upcoming legislation that we are glad to share 
with you.

    The big question that I think is going to have to be 
addressed is do we create a stockpile as a backup in case 
something doesn't work in the future. I do worry. What happens 
is that we are getting the Abbott plant back up there. Positive 
cultures would be one example. I think we are going to have to 
have a surplus. We are certainly planning on a surplus within a 
couple of months, as I have already told you.

    Question is, should we maintain that surplus as a 
Government activity for the foreseeable future? That is a 
question we are all going to have to discuss together and make 
a decision about.

    The Chair. Thank you.

    Senator Baldwin.

    Senator Baldwin. Thank you. Thank you, Dr. Califf, for 
being here. I am aware of the resource constraints that the 
agency is under, but I want to make sure moving forward that 
the FDA has the resources it needs to keep all of us safe. But 
I am not sure that this crisis is solely due to a lack of 
resources.

    As was indicated earlier, there was a sort of in-depth 
review in the Politico back in April of food safety not being a 
high enough priority, a big enough priority at FDA, and it is 
part of why we are here. So the failure to prioritize food 
safety has put infants at risk.

    I know we are hearing examples of what is happening in our 
home state. I have heard from the Children's Hospital of 
Wisconsin, families coming to the E.R. because they couldn't 
find specialty formulas for their children.

    There were babies who were hospitalized in Wisconsin 
because they did not have access and enough formula. This is 
not the first time that we have experienced a recall for a 
product made at Abbott's Sturgis facility, correct?

    Dr. Califf. I think that is correct.

    Senator Baldwin. I am aware of a recall that occurred in 
2010 and a citation that was issued to the facility in 2019. 
Was that a strike?

    Dr. Califf. Yes.

    Senator Baldwin. Okay.

    Dr. Califf. Yes, I have a--actually, I have a chart, but I 
have forgotten the exact date, I apologize.

    Senator Baldwin. Yes. So in the past decade, given those--
that history, how many inspections did FDA conduct at the 
Sturgis plant, given a poor track record evidenced by the prior 
citation and recall?

    Dr. Califf. There were a whole series of inspections, as 
you know, leading up to 2019, most of which did not show any 
major problems. And then we had the most recent inspection, 
September 2021. I think I could get the exact date. You know 
what it is. It found five citations, including inadequate 
handwashing and standing water in the facility and several 
other infractions. That led to what is called a 483, which is a 
written citation. And then the company's responsibility is 
using its quality systems to fix it.

    Senator Baldwin. You are already anticipating my next 
question. But before we jump into the September 2021 
inspection, would you agree that additional inspections and 
better oversight of this plant were warranted based on past 
performance, but especially because of knowing just how 
critical this plant is to our Nation's supply of infant 
formula?

    Dr. Califf. Yes.

    Senator Baldwin. Okay. So in September 2021, FDA officials 
entered the Sturgis facility and as you indicate, found, pooled 
water. And they also discovered that the plant had found 
cronobacter in a finished powder formula lot from June 2020. 
But according to reports, the inspectors did not swab for the 
bacterium during this September 2021 visit. Is that true?

    Dr. Califf. They sampled the product, but not the 
environment. I think the way you ask the question, you are 
correct.

    Senator Baldwin. Okay. So to be completely clear, we are 
talking about powdered infant formula being manufactured in a 
facility with a leaky roof, with cracked spray driers, with 
puddles on the floor, and this same manufacturer knowingly 
disposed of a contaminated product. And yet FDA inspectors did 
not swab for samples.

    Dr. Califf. Well, at the time, the leaky roof was, I don't 
think it was known, but everything else was. So the intent of 
your question, you are correct.

    Senator Baldwin. Okay. Thank you, Madam Chair.

    The Chair. Senator Braun.

    Senator Braun. Thank you, Madam Chair. I am going to have 
two lines of questioning here. One is about the industry 
itself. I have been a proponent since I have been here because 
I come from the realm of full competition, price transparency, 
markets that have hundreds of players in them.

    I know it is not your bailiwick, so to speak, but do you 
feel comfortable where you have three companies that control 98 
percent of the supply of baby formula? And when it comes from 
the special--specialty formula, 75 percent by one company, 
Abbott. Is that a good place to be?

    How much of that concentration is due to regulations and 
the involvement of FDA along the way? It is kind of a broad 
question, but----

    Dr. Califf. Well, I will give two--I mean, there is a short 
answer to the first part of your question. No, I am not 
comfortable. It is not good for the country to have such an 
undiversified supply chain and manufacturing chain for a 
critical product like that that's used by so many people. I 
don't think FDA regulation is at the basis of that. We, anyone 
who meets the criteria within the U.S. or outside the U.S. that 
wants to import can bring formula in--into that market. We 
don't restrict the market and we have absolutely no control 
over the market.

    Senator Braun. I think that just--I want to be on record 
that that is not a free market. That is an oligopoly, 
minimally, it is a monopoly, very nearly. So, and that is not 
only the case in baby formula manufacturing. It is a case and a 
lot of our ag markets, our broader health care markets for 
sure.

    Something has got to be done if we are not going to have 
issues like this, even if a company does pretty well most of 
the time. I have got a question about the WIC program. Is there 
a peculiarity where on anything that goes into it can only be 
gotten from one company or in that particular, which I think is 
about 50 percent of where baby formula goes--is that something 
that the FDA has directed or am I off base that that is even 
part of the way the system works?

    Dr. Califf. The WIC program is run by the Department of 
Agriculture. So it is completely outside of the scope of the 
FDA.

    Senator Braun. Okay. So well, I will deal with that with 
the Ag Department. Let's look at the timetable of when it 
looked like things were heading in the wrong direction. Of 
course, we shut down so much of the supply chain, I think, in a 
misguided way along the way. But there were cues a year ahead 
when it went up to 8 to 10 percent.

    Senator Scott mentioned that it got up to where it was, 
close to 50 percent, not having the right amount of inventory 
on shelves. I think that part of that time when this all 
occurred, including the dustup with Abbott, Dr. Woodcock was in 
charge. Is that correct?

    Dr. Califf. Yes, that is correct.

    Senator Braun. Okay, then haven't you appointed Dr. 
Woodcock to now be the troubleshooter kind of on this, or is 
that--is she back in the program or working for the FDA?

    Dr. Califf. She is a principal deputy. She is a career FDA 
employee who is----

    Senator Braun. Well, I think that would beg the question, 
when you had somebody that was there, when most of the problem 
occurred about midway through, at least the Abbott issue, how 
it makes sense that she would be back in. But let's look at----

    Dr. Califf. Senator, if I may, we did appoint someone else 
to oversee--look back at decisions that were made there. Steve 
Solomon, who is not working under Dr. Woodcock in this 
capacity.

    Senator Braun. Let's get back to the incident itself. So 
roughly--first of all, Abbott was vindicated on the 
particulars, the merits of the issue. They had no contribution 
to those sicknesses, correct?

    Dr. Califf. With all due respect, I wouldn't use the word 
vindicated. We can't say with certainty that the cause was 
there. But it is so rare to have four cases of cronobacter all 
from the same----

    Senator Braun. But you haven't been able to connect the 
dots, and they may still be in that position to where there was 
culpability.

    Dr. Califf. That is correct.

    Senator Braun. Why did it take roughly 2 months after 9 to 
10 months of the formula shortage saying that, hey, we better 
be on full alert to actually get through the particular issue 
itself? And then once you seemed to come up with a result--or 
an idea that there was not a connection, at least in the short 
run analysis, that took another couple of months. And at that 
time the shelves were empty. To get Abbott back in the business 
of doing what they were doing.

    Dr. Califf. We saw the lack of quality in the system and 
the lack of accountability for the problems that were there, 
and so we had to invoke the Justice Department to negotiate a 
consent decree, which is essentially Abbott saying, yes, we had 
all these problems.

    Here's exactly what we are going to do to fix them. For 
legal reasons, I can't discuss the exact details of the 
negotiation, but let's just say that it took a lot of arm 
wrestling to get to the point where the Justice Department got 
Abbott to sign the consent decree.

    Senator Braun. Well, I think it is clear that we got too 
many eggs in one basket when it comes to producing this stuff. 
I think it is also clear that it got caught in a regulatory 
morass that took more time than what was necessary, and now we 
are dealing it with it after the fact.

    Dr. Califf. We completely agree. It took too long, and I 
also want to agree with Senator Scott that we are not trying to 
blame everybody else. We have our own issues, which I think are 
clearly laid out in the documents that we have given you. And 
we will be accountable for fixing those going forward.

    Senator Braun. Thank you.

    The Chair. Thank you.

    Senator Rosen.

    Senator Rosen. Thank you, Chair Murray and Ranking Member 
Burr for holding this hearing, Dr. Califf, for your 
participation and your clear answers for everyone. You know, my 
home State of Nevada has been hit especially hard by our 
current formula shortage. There is a reduction of at least half 
of available supply.

    A recent report ranked Las Vegas as the metro area facing 
the worst shortage in the Nation. So our local community 
organizations in Nevada, we have three square babies Bounty, 
the Women and Children's Center of the Sierra, among so many 
others. They are really doing incredible work to get the 
formula to those who need it the most, but they are stretched 
so thin and so recent actions by the Administration are a 
start.

    We--I know they have come too late. I know you have 
addressed some of that. But what I am concerned about here is, 
we talked a little bit about the forward 21 program, and that 
is a pilot program you are setting up to monitor and report on 
food supply chain disruption and vulnerabilities. So where is 
the status of that? Where are we at?

    I really want an answer to--before I go to some other 
Nevada issues, is there a national phone number that parents 
can--who can't find formula, who can get help? Are families 
being--is there a place where they can do--find about homemade 
recipes? We don't want people making dangerous things. So maybe 
if you could answer those.

    Dr. Califf. Yes, HHS has a website, HHS. gov/formula and it 
has all the issues of the manufacturers. For example, you have 
an infant that has been using a particular kind of formula, you 
can call in. The hotlines are there. And if there's not an 
answer otherwise, there is a number you can call there for HHS 
to get help. So that would be the most immediate thing to do if 
there is a problem. You are asked about 21 forward. Would you 
like me to comment on that or--

    Senator Rosen. Yes, please. Because I think that would--if 
we can implement that, then that may help us out going forward 
with vulnerabilities and supply chain disruption.

    Dr. Califf. As I said funding was asked for that. It wasn't 
given so we have borrowed from other FDA programs. We are not 
where we need to be. Just for example, there are 220,000 
registered food facilities in the United States.

    A system that is used for infant formula but also has more 
general applicability to the foods program, it has got to be a 
robust system. The kind I am used to working with in the 
private sector. We are making progress, but we are nowhere near 
where we need to be.

    Senator Rosen. Maybe we can help you with some funding 
there, but I want to follow-up on something Senator Hassan 
asked about, the distribution of the formula coming in for 
military flights. How is it being decided beyond existing 
supply chain routes? Are the areas that are hardest hit with 
the worst shortages like Las Vegas and other parts of Nevada, 
are they being prioritized?

    Dr. Califf. Right now, those specialty formulas are the 
priority. So they are going to wherever babies are who need 
specialty formula, which could be anywhere. My expectation--I 
am not on the supply chain committee, which, as I think you 
know, is a Government wide committee that has been guiding us 
through the whole pandemic, I would say quite successfully, 
considering the problems that we had early on in the pandemic.

    I would expect that they are going to send the more general 
formula to the places in greatest need at first, including I 
think a special problem has been alluded to. If you are in a 
rural area, you may be a small place, so you wouldn't show up 
in a general measure. I know that is going to be taken into 
account.

    Senator Rosen. Thank you. You mentioned that you weren't on 
the supply chain committee, but I do want to talk about 
staffing and FDA staffing, because according to the American 
Academy of Pediatrics, FDA has 13 staff members to regulate and 
monitor safe production of infant formula and no staff assigned 
to supply chain issues.

    Is this currently still the case? Have you reassigned the 
staff to oversee the supply chain issues for baby formula with 
21 forward? This formula is essential, and children can't--
children can't wait. Like you said, it is the prepared gym 
shoes.

    Dr. Califf. As I have already mentioned, we brought in 
staff from other areas of FDA, which means other things are not 
being attended to that the public would expect. But this is the 
top priority, and you know that there is legislation pending 
that would fund additional people for this purpose. They are 
desperately needed.

    We have really only nine because the other four, we just 
got the funding a couple of months ago and it is--it is going 
to take a little while to identify and hire the people. So we 
have had to bring in other people but from other programs.

    Senator Rosen. Thank you. I see my time is up, Madam Chair.

    The Chair. Thank you.

    Senator Burr.

    Senator Burr. Thank you, Madam Chair. Let me just say this, 
Dr. Califf. I am not sure that there is a seated Member of 
Congress that has defended the FDA workforce more than the one 
sitting in front of you and in the role of the FDA. I got to 
admit, I was quite amused to see two doctors use the same data 
to come to two different conclusions. I was shocked that that 
would happen. I think it happens every day. But here is some of 
the real beefs. Will you provide for this Committee all the 
inspection reports on the Sturgis facility since 2019 and the 
deficiencies that were raised with the Sturgis facility?

    Dr. Califf. I will commit to provide everything I legally 
possibly can. I don't know if there is anything that is 
enjoined because I have said I can't comment on----

    Senator Burr. Let me put the end date of September 21st of 
1921 so it doesn't get into the current time period that we are 
talking about.

    Dr. Califf. I think it is--as long as it is legally 
permissible, I am committed to do that.

    Senator Burr. It is my understanding that there wasn't even 
an inspection that was done in 2020. Do you know whether that 
is accurate?

    Dr. Califf. That is accurate.

    Senator Burr. It is accurate. You said Abbott didn't submit 
paperwork on April 30th. I just want to dig a little bit 
deeper. Did Abbott not respond on April 8th to the 483 that FDA 
issued where they detailed corrective action at the Sturgis 
facility?

    Dr. Califf. That was their first take on corrective action, 
but----

    Senator Burr. They submitted to FDA a detailed corrective 
action paper on April the 8th.

    Dr. Califf. Not an adequate corrective action report.

    Senator Burr. Okay.

    Dr. Califf. I mean, Senator Burr, I have been on the other 
end of inspections in almost every industry. And usually when 
something has not gone right, the company has a particular 
perspective. It may be a little oriented toward the well-being 
of the company, not necessarily the needs that the FDA saw. So 
there is always adjudication back and forth that has to go on.

    Senator Burr. It is my understanding that in every case 
that we have tried to fill a nutritional need that only Abbott 
made with foreign products, that Abbott has paid for those 
products. Is that an accurate statement?

    Dr. Califf. I don't deal with the funding of those, but I 
do believe that Abbott has made a good faith effort to cover 
the costs. I just don't know the details.

    Senator Burr. You said earlier that you weren't going to 
throw the mailroom under the bus. But yesterday, FDA statement 
basically did that. Square for me the last 24 hours as it 
relates to that.

    Dr. Califf. First of all, let me just comment. I do believe 
that despite our contentiousness at times, you have supported 
the employees at the FDA. I don't want it to be taken that I 
don't believe that. I just believe it is my job to defend 
hardworking people. But as for yesterday, I just want to be 
clear, and I think we were yesterday, there are two issues 
here. One is that something went wrong in the mailroom.

    The other is we didn't have an escalation policy that 
caused the employees who were dealing with the complaint to 
escalate it to the relevant leaders, including all three of the 
leaders who should have gotten it. I am not blaming this on the 
mailroom. Either one of those methods would have gotten the 
report to the proper people.

    Senator Burr. So let me just read it for you because I 
found this sort of shocking. FDA leadership did not receive 
direct copies of the complaints due to an isolated failure in 
FDA's mailroom.

    Dr. Califf. That is direct copies of the complaints. 
Specifically, FedEx sent the package that had five people 
addressed. There were five packages. There are two different 
facilities, one in White Oak. The food part of the FDA, as you 
may know, is up in a different part of Maryland. The direct 
copies didn't get to the people. They were actually sitting in 
the receiving dock. But that doesn't mean the employees----

    Senator Burr. I was reading what was said yesterday. That 
it was----

    Dr. Califf. But Senator Burr, that is one statement out of 
an entire report that goes through the other aspects of this 
about the escalation procedure.

    Senator Burr. All right. Let's go to budgets, because you 
have been pretty across the board budgets. We don't have enough 
money. We don't have enough money. We don't have enough money. 
So you got $718 million in COVID emergency money. The omni, 
which it was in March, gave you $11 million for maternal and 
infant health and $10 million for inspections. That was 60 days 
ago. How many additional inspectors have we hired as of today?

    Dr. Califf. I don't have that number in front of me, but I 
would be glad to get it to you.

    Senator Burr. Provide it for us, if you will. Let me end on 
this, the Food Center's budget is $1.1 billion. I don't think 
that is gum and wire. You stated that you were putting together 
things with gum and wire earlier. I think it was to Senator 
Paul or somebody. I think $1.1 billion is a pretty substantial 
amount of money.

    Now, the Chair and I--and I realize I am over my time, 
Chairman, but I will be brief. The Chair and I are negotiating 
the next round of user fees and we are extremely close. FDA is 
sitting before us in the midst of a large failure as an agency 
since it was created. And once again asking for money with more 
authority, more money, less accountability.

    I say to you and say to the Chair, I am going to go home, 
and I am going to try to think about this as to whether now is 
the time for us to move forward on finishing our user fee 
negotiations. It may be that finding all the answers to this 
question is increasingly more important than expediting 
something that really doesn't have a finality until the end of 
this year.

    Madam Chair, I will work with you as aggressively as I can 
on this. But I also want to work with you as aggressively as I 
can to get the answers to the questions that are unanswered 
today on infant formula. I yield the floor.

    The Chair. Thank you, Senator Burr. That will end our 
hearing today. But let me be clear, Dr. Califf, it will not end 
our focus on this. I am going to keep pushing to see that plan 
I mentioned earlier. I asked for it weeks ago, and I will not 
start pushing until I see it. This is life or death, and Dr. 
Califf, it simply should not have taken this long. I am going 
to keep pushing to get formula on shelves and to families and 
babies.

    I am going to keep pushing to get answers for parents in 
Washington State like Mac, my constituent, about how they can 
get what they need. Because Mac did speak with his pediatrician 
weeks ago and they could not even find a sample can. And let me 
be clear, just asking parents to call HHS is not an answer.

    Parents from the tri-cities, where he is, or anywhere else, 
should not be trying to figure out this for themselves on 
Facebook. This is a national crisis. It involves international 
supply chains, as well as nationwide distributors and 
retailers. It is unacceptable to leave families fending for 
themselves.

    Parents like Mac need one simple place to find information 
they need and get help. We need one clear coordinating--
coordinator managing this multifaceted problem and helping 
parents and hospitals and pediatricians and state officials and 
everyone get what they need to figure this out.

    This should have happened days--this should have happened 
months ago. This shortage should never have gotten so out of 
control. And understand, I am ready to work with you or anyone 
else to fix this.

    But I am not going to stop pushing everyone I can you, HHS, 
President Biden, Abbott, and other formula manufacturers to do 
everything you can to fix this as soon as possible and to make 
sure that this never happens again.

    With that, for any Senators who wish to ask additional 
questions, questions for the record will be due in ten business 
days, June 10th at 5 p.m.

    This Committee stands adjourned.

                          ADDITIONAL MATERIAL

                          Hon. Robert Califf, M.D.,
                                      Commissioner,
                      Food and Drug Administration,
                                   Silver Spring, MD 20993.
                                               May 18, 2022

    Dear Commissioner Califf:

    Thank you for your efforts to ensure food safety at the 
Food and Drug Administration (FDA). For decades, the FDA has 
been the gold standard for approving and regulating medical 
products and food. Yet this year, the actions of the FDA's 
Center for Food Safety and Applied Nutrition (CFSAN) has raised 
questions regarding its ability to fulfill its core oversight 
responsibilities. The safety of, and access to, infant formula 
should be among CFSAN's highest priorities, as this food is 
vital for the growth and development of infants. To this end, 
we write to request a response from FDA on its activities that 
may have contributed to the exacerbated infant formula 
shortages and specific questions in the following paragraphs. 
It is our responsibility as U.S. Senators to do everything with 
our authority to hold the FDA accountable and legislate in 
areas that will enable the agency to meet the expectations of 
the American people.

    Our hearts and prayers are with the parents and their 
families whose babies tragically died due to infant formula 
bacterial contamination. We understand and want to support the 
FDA in thoroughly evaluating all reported and potential infant 
formula contaminations. However, based on the timeline and 
where we are today, it is unclear as to why nearly 3 months 
have gone by and the FDA has failed to expeditiously conduct 
and conclude its investigation. On February 17, Abbott 
Nutrition initiated a proactive, voluntary recall of three of 
its powdered formulas manufactured at their facility in 
Michigan following four consumer complaints of potential 
Cronobacter bacteria contamination. \1\
---------------------------------------------------------------------------
    \1\  Abbott, Abbott Voluntarily Recalls Powder Formulas 
Manufactured at One Plant, February 17, 2022, https://
abbott.mediaroom.com/2022--02--17-Abbott-Voluntarily-Recalls-Powder-
Formulas-Manufactured-at-One-Plant. See also U.S. Food and Drug 
Administration, Company Announcement: Abbott Voluntarily Expands Recall 
of Powder Formulas Manufactured at One Plant, February 17, 2022, 
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/
abbott-voluntarily recalls-powder-formulas-manufactured-one-plant.

    The following day, FDA warned consumers not to use these 
products. \2\ On April 15, the U.S. Centers for Disease Control 
and Prevention concluded the bacteria isolated from two of the 
sick infants and the Michigan facility had no connection. And 
as of last week, no connection has been found, yet the facility 
remains idle. \3\, \4\
---------------------------------------------------------------------------
    \2\  Kansas Department of Health and Environment, KDHE & FDA warn 
consumers not to use select Similac, Alimentum & EleCare powdered 
infant formula, February 18, 2022, https://www.kdhe.ks.gov/
CivicAlerts.aspx'AID=147.
    \3\  Abbott, Press Release: Abbott Provides Infant Formula Update, 
May 11, 2022, https://www.abbott.com/corpnewsroom/nutrition-health-and-
wellness/abbott-update-on-powder-formula-recall.html.
    \4\  U.S. Centers for Disease Control and Prevention, Cronobacter 
and Powdered Infant Formula Investigation, accessed May 12, 2022 
(updated May 12, 2022), https://www.cdc.gov/cronobacter/outbreaks/
infant-formula.html.

    We are also concerned as to why FDA leadership failed to be 
proactive in mitigating the shortage crisis parents are now 
facing. The COVID-19 pandemic revealed many vulnerabilities 
across all sectors of industry, and our food supply chain was 
woefully unprepared to handle challenges here and from foreign 
partners. Infant formula supplies at local grocery stores were 
relatively stable for the first half of 2021. The out-of-stock 
percentage started to climb steadily in the later half and 
continued to worsen throughout this year. \5\ Abbott 
Nutrition's voluntary recall exacerbated the shortage, and yet 
no policies were taken to mitigate the sharp increases to the 
current out-of-stock 43 percent the Administration is now 
scrambling to address. It's also concerning that FDA and key 
officials in the Administration did not anticipate this crisis 
or take action within days following Abbott Nutrition's 
voluntary recall considering the company holds 48.1 percent of 
the U.S. market in infant formula. \6\
---------------------------------------------------------------------------
    \5\  Datasembly, Nation-wide Out-Of-Stock is now at 43 percent for 
the week ending May 8th, May 10, 2022, https://datasembly.com/news/out-
of-stock-rate-in-april-2022-copy/.
    \6\  IBISWorld, Industry Report: Infant Formula Manufacturing, by 
Jack Curran, August 2020, https://www.ibisworld.com/united-states/
market-research-reports/infant-formula-manufacturing-industry/.

    Families are getting to the brink of pursuing unsafe and 
potentially dangerous options to feed their infants including 
homemade infant formula. And physicians are, once again, 
running defense on misinformation due to a lack of Federal 
action to get the word out on safe alternatives. \7\, \8\, \9\ 
In addition, the shortage will trickle into other Federal 
agencies, diverting and stretching resources from other crises 
like illicit fentanyl. In April, the U.S. Customers and Border 
Protection (CBP) seized $30,000 worth of unapproved infant 
formula across 17 shipments at the Philadelphia, Pennsylvania 
port of entry. \10\
---------------------------------------------------------------------------
    \7\  The New York Times, Why Doctors Don't Recommend Homemade Baby 
Formula, by Catherine Pearson, May 11, 2022, https://www.nytimes.com/
2022/05/11/well/homemade-baby-formula.html.
    \8\  KAKE ABC, Homemade infant formula can be dangerous. Experts 
share how to feed your baby through the shortage, by Madeline Holcombe, 
May 11, 2022, https://www.kake.com/story/46472922/homemade-infant-
formula-can-be-dangerous-experts-share-how-to-feed-your-baby-through-
the-shortage.
    \9\  Bloomberg, Parents Are Trying Homemade Baby Formula. Doctors 
Say They Shouldn't, by Allison Nicole Smith and Kelsey Butler, May 12, 
2022, https://www.bloomberg.com/news/articles/2022-05-12/why-parents-
making-homemade-infant-formula-should-beware-of-serious-health-risks.
    \10\  U.S. Customs and Border Protection (CBP), Philadelphia CBP 
Seizes Nearly 600 Cases of Infant Formula Unapproved for Import to the 
United States, April 5, 2021, https://www.cbp.gov/newsroom/local-media-
release/philadelphia-cbp-seizes-nearly-600-cases-infant-formula-
unapproved.

    Based on the timeline, it is unclear why Federal health 
agencies have not been able to complete this investigation in a 
more expeditious manner or plan ahead to mitigate this 
additional supply chain disruption. Therefore we respectfully 
---------------------------------------------------------------------------
request your responses to the following questions:

         L1. The manufacturing facility in Michigan is 
        segmented where manufacturing designated areas are 
        required to adhere to specific safety and infection 
        control standards. The facility also maintains areas 
        that are administrative and do not directly handle 
        manufacturing or exposure of open products. Please 
        describe the areas in which the FDA has taken samples 
        and how many samples were taken that would empirically 
        validate the results of the investigation. In your 
        explanation, please also include the expected timeline 
        for each task and if CFSAN has met its obligations.

         L2. As noted in the paragraph above, the CDC concluded 
        that the samples taken did not match the bacteria in 
        the facility. How does the FDA partner with other 
        agencies at the Federal, state, and/or local level to 
        expedite investigations to forestall potential supply 
        chain crises? To what extent do other agencies or 
        organizations advance or hinder a timely investigation?

         L3. Why has it taken more than 3 months to complete 
        the obligations required to finalize a safety 
        inspection?

         L4. At what point did the FDA alert the White House of 
        the bacteria and the product recall?

         L5. Did the FDA, along with the White House, have a 
        strategic plan in place to mitigate formula shortages? 
        If yes, please provide a brief description, date of 
        implementation, actions the agency has taken, and 
        expected timelines to enable manufacturers to produce, 
        process and deliver food during supply chain 
        disruptions.

         L6. Did or has the FDA made any recommendations to the 
        White House about what actions the agency can take to 
        prepare or handle the shortage?

         L7. The manufacturing facility in Sturgis, Michigan is 
        the only Abbott plant to produce specialized formula 
        for infants with metabolic disorders. How is the FDA 
        going to work with Abbott and other formula 
        manufacturers to ensure that the special medical needs 
        of infants can be met?

         L8. Abbott Nutrition, along with other infant formula 
        manufacturers, have registered domestic and foreign 
        sites to manufacture infant formula for interstate 
        commerce in the U.S. Abbott Nutrition's facility in 
        Ireland is an FDA-registered facility. It also has 
        several other facilities in the Netherlands, Spain, and 
        France that manufacture infant formula. What steps has 
        FDA taken to increase importation by accrediting more 
        manufacturing facilities overseas?

         L9. At what point was the White House made aware that 
        these importation options were available to ease the 
        strain on domestic capacity?

         L10. Whose decision was it to ease these requirements 
        on formula from foreign manufacturers?

         L11. In White House press briefings last week, the 
        Press Secretary and others within the Biden 
        Administration appeared to blame Abbott Nutrition for 
        the deaths and shortages, despite the fact that the 
        investigation is not concluded. \11\, \12\ Did the FDA 
        state to the White House that Abbott Nutrition was 
        responsible for the illnesses or deaths?
---------------------------------------------------------------------------
    \11\  The Hill, White House goes on defense on baby formula 
shortage, by Alex Gangitano, May 13, 2022, https://thehill.com/news/
administration/3487765-white-house-goes-on-defense-on-baby-formula-
shortage/.
    \12\  The Hill, Buttigieg points blame at Abbott for baby formula 
shortage, by Monique Beals, May 15, 2022, https://thehill.com/news/
administration/3489439-buttigieg-points-blame-at-abbott-for-baby-
formula-shortage/.

    The shortage, felt by all families in need, is 
disproportionately impacting vulnerable populations. As you 
know, Medicaid is a major source of coverage for low-income 
vulnerable populations including pregnant women, infants, and 
children. In 2020, Medicaid covered 42 percent of births. \13\ 
In addition,
---------------------------------------------------------------------------
    \13\  March of Dimes, Health Insurance/Income, https://
www.marchofdimes.org/peristats/
data'reg=99⊤=11&stop=154&lev=1&slev=1&obj=18.

    49 percent of infants born in the U.S. participate in the 
Special Supplemental Nutrition Program for Women, Infants, and 
Children. \14\ While breastfeeding has been on the rise, many 
infants rely on formula partially or as their sole source of 
food.
---------------------------------------------------------------------------
    \14\  National WIC Association, The state of WIC: Investing in the 
Next Generation, February 2022, page 40, https://s3.amazonaws.com/
aws.upl/nwica.org/state-of-wic--2022.pdf

    The FDA must do everything within its statutory authority 
to ensure it facilitates access to safe, quality foods. We 
would appreciate a reply no later than Wednesday, May 25, 2022. 
Thank you for your attention to this matter and please do not 
hesitate to reach out to us or our staff should the agency 
require resources or cooperation from other agencies to fulfill 
---------------------------------------------------------------------------
its obligations.

            Sincerely,
                                      Roger Marshall, M.D.,
                                                      U.S. Senator.
                                      Shelley Moore Capito,
                                                      U.S. Senator.
                                          Susan M. Collins,
                                                      U.S. Senator.
                                                Mike Braun,
                                                      U.S. Senator.
                                       John Barrasso, M.D.,
                                                      U.S. Senator.
                                              Kevin Cramer,
                                                      U.S. Senator.
                                            Lisa Murkowski,
                                                      U.S. Senator.
                                               Jerry Moran,
                                                      U.S. Senator.
                                          Marsha Blackburn,
                                                      U.S. Senator.
                                              John Boozman,
                                                      U.S. Senator.
                                        Bill Cassidy, M.D.,
                                                      U.S. Senator.
                                               Deb Fischer,
                                                      U.S. Senator.
                                            Cynthia Lummis,
                                                      U.S. Senator.
                                                 Tim Scott,
                                                      U.S. Senator.
                                               Thom Tillis,
                                                      U.S. Senator.
                                          Cindy Hyde-Smith,
                                                      U.S. Senator.
                                                John Thune,
                                                      U.S. Senator.
                                            James Lankford,
                                                      U.S. Senator.
                                              Steve Daines,
                                                      U.S. Senator.
                                                  Ted Cruz,
                                                      U.S. Senator.
                                                 Roy Blunt,
                                                      U.S. Senator.
                                              John Kennedy,
                                                      U.S. Senator.
                                ------                                


    [Whereupon, at 12:46 p.m., the hearing was adjourned.]

                                  [all]