05.26.22

Senator Murray Grills Califf On FDA’s Response to Infant Formula Crisis, Demands Further Action

Senator Murray: “The fact 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 can’t find what they need to feed their infants is a massive, unacceptable failure.”

 

***WATCH: SENATOR MURRAY’S OPENING REMARKS AND QUESTIONING***

 

(Washington, D.C.) – Today, U.S. Senator Patty Murray (D-WA), Chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, led a hearing on the Food and Drug Administration’s (FDA) response to the infant formula crisis, and further action necessary to get formula safely back on the shelves and ensure families can feed their children. At the hearing, Senator Murray grilled FDA Commissioner Dr. Robert Califf on the agency’s delay in inspecting the Abbott facility after reports of potentially contaminated formula, demanded answers about why actions to mitigate a formula shortage took so long, and urged Dr. Califf to do more to ensure parents have up to date information to find formula in their area.

“Let me be clear—the fact 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 can’t find what they need to feed their infants is a massive, unacceptable failure. And I’ve said this before but I’ll say it again: the groups that families and caretakers depended on to help them in this moment—the FDA, infant formula manufacturers—they all get an ‘F’ here in my book,” said Senator Murray. “There were plenty of warning signs about this crisis—and it seems like the people 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.”

During the hearing, Senator Murray pressed Dr. Califf over the FDA’s unacceptably slow response to reports of safety issues at Abbott’s infant formula facility and the nationwide infant formula shortage that followed the company’s recall of infant formula products. Senator Murray also pushed Dr. Califf on why the FDA failed to take action sooner to mitigate shortages following the Abbott recall—and what it is doing to ensure these failures never happen again.

“Parents and caregivers across the country rely on the FDA and the handful of dominant formula manufacturers to ensure the formula they feed their babies meets the highest standard of safety and nutrition. But the companies and the FDA let them down,” Senator Murray told Dr. Califf. “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?”

When Dr. Califf pointed to “systemic issues at FDA,” Senator Murray pushed Dr. Califf on whether he has a plan to fix the longstanding dysfunction within FDA’s food safety program—a plan she first demanded to see in a letter to the FDA in April.

“Do you have a plan to do that?” asked Senator Murray. “And when can we see it?” After Dr. Califf equivocated, noting that he would present a plan as soon as possible, Senator Murray made clear in her closing remarks that she expects to see it soon: “I’m going to keep pushing to see that plan I mentioned earlier. I asked for this plan weeks ago, and I will not stop pushing until I see it. This is life or death, and Dr. Califf, it simply should not have taken this long.”

Senator Murray also pushed Dr. Califf on what exactly parents across the country should know in order to get the formula they need—and made clear that Dr. Califf’s response, that parents should simply call the Department of Health and Human Services (HHS), is not nearly enough.

“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?” asked Senator Murray.

“Let me be clear, just asking parents to ‘call HHS’ is not an answer. Parents from the Tri Cities or anywhere else shouldn’t be trying to figure this out for themselves on Facebook,” said Senator Murray. “This is a national crisis—and it involves international supply chains as well as nationwide distributors and retailers—it’s just unacceptable to leave families fending for themselves.”

Lastly, Senator Murray made clear that she has been demanding answers on this failure for months and won’t stop until parents and caregivers can get the formula they need to feed their children.

“We need a coordinated response to ensure: better accountability from industry, a stronger FDA response, and swift action from the Department of Agriculture to do everything it can to give WIC recipients the flexibility they need. We also need to make sure 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. And 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,” said Senator Murray. “It’s incredibly frustrating to me that 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. So I’m going to keep pressing for answers for parents back in Washington state.”

Senator Murray has been following this issue and pressing for answers from early on. In February, Senator Murray sent a letter with Senator Casey demanding answers from Abbott Nutrition as it recalled infant formula, and she continued to press the issue when inspection reports revealed troubling practices at Abbott’s facility. Senator Murray has repeatedly pressed the FDA on its delayed response to concerns about food safety at Abbott’s facility. Most recently, Senator Murray led her colleagues in pushing infant formula manufacturers to step up and produce more formula to address the national shortage—and in calling on the White House to assign a coordinator to address the formula shortage and implement a national strategy.

Senator Murray’s full questioning of Dr. Califf is below:

Murray: 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 are never 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. And it took months—months—in fact, you’re telling us today it took six months for FDA to investigate. During that time, Abbott continued to produce formula at the Michigan plant. And when FDA finally completed an on-site 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 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 as your 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?

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

Murray: Well, I’m asking the question: why did it take so much time? 

Califf: Yes. So, I don’t … 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 an investigation going on. It didn’t take six months to start the investigation. That very first case, you have to collect samples...

Murray: No, I’m asking why it took six months to take serious action.

Califf: 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’s clearly...

Murray: Do you have a plan to do that?

Califf: Yes.

Murray: And when can we see it?

Califf: When can you see the plan?

Murray: To correct these problems, yes.

Califf: Um. I mean. We have a plan. But a complete plan, written out, we’ll have to get to you as soon as we can. I can’t give you an exact date right now. 

Murray: Well, has Abbott told you why it kept producing formula when it knew it might be dangerous for babies?

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

Murray: 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?

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…

Murray: But what I’m 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 to go to get the formula. And he and many parents.

Califf: A parent needing a 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’s a committee in place to do that for each individual infant.

Murray: Well 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, um, going to be able to do to keep their babies out of the hospital. Very clear. Direct to parents across this country. 

Califf: I understand.

Senator Murray’s opening remarks, as prepared for delivery, are below:

“Let me be clear—the fact 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 can’t find what they need to feed their infants is a massive, unacceptable failure.

“And I’ve said this before but I’ll say it again: the groups that families and caretakers depended on to help them in this moment—the FDA, infant formula manufacturers—they all get an ‘F’ here in my book.

“There were plenty of warning signs about this crisis—and it seems like the people 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 FDA needs more people, and more funding—and I’m going to keep pushing to get you the resources needed to support your work.

“But I still don’t get why some of the steps we’re seeing now didn’t happen a lot sooner.

“It’s not like FDA needed more warnings here.

“It’s not like 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 answer 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 this never happened again.

“We asked Abbott for documents about these safety issues by March 10th—but 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, a culture of inaction, and 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 that families feed their children.

“That’s 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.

“But I haven’t seen a plan yet.

“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 they need.

“‘Operation Fly Formula’ is now bringing millions of containers worth of formula 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 didn’t explode into a crisis. 

“But here we are.

“Now, I know parents won’t rest easy until there is formula back on shelves—until they can feed their kids.

“And I will not rest either.

“I’m 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 have led another letter to infant formula manufacturers calling on them to step up—and produce more.

“And we’ve 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’ve witnessed how multifaceted this problem is.

“We need a coordinated response to ensure: better accountability from industry, a stronger FDA response, and swift action from the Department of Agriculture to do everything it can to give WIC recipients the flexibility they need. 

“We also need to make sure 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.

“And 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’s incredibly frustrating to me that 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.

“So I’m going to keep pressing for answers for parents back in Washington state.

“Like Mac, a constituent from Richland, Washington, who 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 six months into his wife’s pregnancy.

“She remained in the NICU for four months before going home, and she needs a special kind of formula to help her grow and stay healthy.

“Because of the shortage, Mac has been searching high-and-low, day-and-night to try and find it—stopping at six different stores, getting donations from other parents on Facebook. His dad even brought six cans from Milwaukee—nearly two thousand miles away.

“Mac is constantly worried about running out—and he’s heard from parents across his community who are facing the same problem.

“Parents who are driving to store after store—and finding only empty shelves, or who are searching online—and finding price gougers who are trying to profit off the fact babies are going hungry.

“Mac spoke with another mom who said when her baby was discharged from the NICU, she was given a sample can of specialty formula, and some ready-mix bottles—enough to last her maybe four days.

“And the Facebook group Mac started has over 800 members just trying to connect parents in the Tri-cities area to formula.

“As a mother, and a grandmother, I know parents in Washington state won’t just go as far as Milwaukee to get their kids the formula they need, they’ll go to the ends of Earth.

“But they shouldn’t have to. We should not—we cannot—leave parents to fend for themselves.

“We should be getting 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 kid needs to stay healthy? Where should they go for it—especially for people who need specialty formulas—like formula for preemies, and for children with allergies.

“And what is the administration doing to stop price gouging, to end this shortage as soon as possible, and to ensure this never happens again.

“Parents need help, they need answers, and 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.

“And 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.

“And so, Dr. Califf—I hope to hear more 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’ve 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.

“And now I’ll turn it over to Ranking Member Burr for his opening remarks.”

 

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