Baby formula shortage: FDA chief admits federal regulators were 'too slow' to act

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WASHINGTON – Food and Drug Administration Commissioner Dr. Robert Califf admitted Wednesday that the agency has been "too slow" in responding to the baby formula shortage, a crisis that has hospitalized malnourished infants, emptied store shelves, and driven desperate parents from store to store and across state lines in search of food for their babies.

Califf and other FDA officials were excoriated as they testified before a frustrated panel of lawmakers on the House Energy & Commerce Subcommittee on Oversight and Investigations. Democrats and Republicans were equally determined to get answers and prevent the shortage from happening again, they said.

"Babies and children are suffering," Rep. Diana DeGette, D-Colo., said in her opening remarks as chair of the committee.

About 75% of U.S. parents and caregivers rely on baby formula to meet the nutritional needs of infants up to 6 months of age. The shortage has disproportionately impacted low-income families and babies that require specialty formulas.

It's also a situation that is "unacceptable – and worse – it was totally preventable," DeGette said.

The Abbott recall turned the U.S. shortage "into a tailspin," she said, but she also laid blame with the FDA, criticizing the agency for a slow response and slower communication to the public.

Rep. Morgan Griffith, R-Va., the ranking member on the committee, questioned why it took the FDA more than three months to address this shortage. Why didn't the FDA "move heaven and earth" to address this, he asked.

FDA's timeliness in interviewing a whistleblower and getting into the Abbott facility for inspections were "too slow," Califf said. "Some decisions in retrospect could have been more optimal."

To many questions from lawmakers on the agency's work flow and timeliness, Califf simply said, "We don't have a great answer."

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The Commissioner of the Food and Drug Administration, Robert Califf testifies virtually during a hearing on the baby formula shortage before the Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce at House Rayburn Office Building on Capitol Hill May 25, 2022 in Washington, DC. The subcommittee held a hearing on "Formula Safety and Supply: Protecting the Health of America's Babies".
The Commissioner of the Food and Drug Administration, Robert Califf testifies virtually during a hearing on the baby formula shortage before the Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce at House Rayburn Office Building on Capitol Hill May 25, 2022 in Washington, DC. The subcommittee held a hearing on "Formula Safety and Supply: Protecting the Health of America's Babies".

FDA testimony reveals how long it took agency to respond

Califf's testimony Wednesday revealed the FDA first had concerns about a baby formula shortage in March 2020, as the coronavirus pandemic choked global supply chains.

"The system seemed to be keeping up with demand until fairly recently, although there were spot shortages that we were responding to," Califf said.

Three companies control 95% of the baby formula market in the U.S.: Abbott, Gerber and Reckitt. Problems with formula supplies reached a fever pitch when Abbott, which supplies half of all low-income families through the Women, Infants and Children (WIC) program, had a contaminated supply at its Sturgis, Michigan, plant.

The FDA learned on Sept. 20, 2021, that a child was diagnosed with a cronobacter infection, which can be fatal in infants. The cronobacter bacteria that causes it has been detected in baby formula.

FDA inspectors conducted a routine inspection at the plant that day and for the next three days, ultimately finding the facility in a "clean and sanitary condition."

Abbott has said there is no conclusive evidence to link its formulas to the cronobacter infections in infants.

A whistleblower reached out to the FDA on Oct. 20, 2021, accusing Abbott of poor cleaning practices, untested formula, falsifying records and hiding information from federal regulators. The whistleblower, a former Abbott employee, was not contacted for an interview with the FDA until late December 2021, testimony revealed.

Frank Yiannas, FDA deputy commissioner for food policy and response, said Wednesday he didn't learn about the whistleblower report until about Feb. 10.

Multiple lawmakers asked why it took four months for the agency to respond to the whistleblower.

"I'm not sure why the record wasn't shared with me and how it didn't get escalated," he said.

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A "for cause" inspection was not conducted at the plant until Jan. 31, more than four months after the whistleblower reached out to the FDA. By then, three cronobacter infections in infants were detected. Two babies were hospitalized and one had died.

When Abbott closed the Sturgis plant and recalled several batches of formula on Feb. 17, four infections were detected and two babies had died. That same day, Califf was appointed as FDA commissioner.

The FDA completed 24 inspections at the Sturgis facility between Jan. 31 and March 18, ultimately determining that Abbott failed to prevent formula contamination. Cronobacter bacteria was found in five environmental samples from the plant, but none of the bacteria was found in the formula product. The bacteria strains found at the plant also did not match bacteria samples from the affected patients.

Abbott shut down its Sturgis facility but is on track to resume production in a few weeks, Califf said. He said he is still investigating the FDA's response.

Baby formula shortage was preventable, lawmakers say

When President Joe Biden was questioned by reporters on May 13 about whether his administration should have anticipated the baby formula shortage, his answer raised eyebrows.

"If we’d been better mind readers, I guess we could have, but we moved as quickly as the problem became apparent to us," he said. "And we have to move with caution as well as speed, because we got to make sure what we’re getting is, in fact, first-rate product. That’s why the FDA has to go through the process."

Rep. Cathy McMorris Rodgers, R-Washington, said the shortage is the result of the FDA and Biden administration's failure to act early enough. The FDA throughout COVID had a data and analysis tool to monitor supply changes. The agency and administration should have recognized the problems ahead.

"The FDA didn't have to read minds...they just had to read their own data," she said.

Abbott President of US and Canada Nutrition and Senior Vice President Christopher Calamari testifies remotely before a House Commerce Oversight and Investigations Subcommittee hybrid hearing on 'Formula Safety and Supply: Protecting the Health of America's Babies on Wednesday, May 25, 2022, in Washington.
Abbott President of US and Canada Nutrition and Senior Vice President Christopher Calamari testifies remotely before a House Commerce Oversight and Investigations Subcommittee hybrid hearing on 'Formula Safety and Supply: Protecting the Health of America's Babies on Wednesday, May 25, 2022, in Washington.

How long will the baby formula shortage last?

The baby formula shortage will drag on at least another month, according to testimony Wednesday.

Abbott, the largest producer of formula in the U.S., will start production at the Sturgis plant during the first week of June, according to Abbott Senior Vice President Christopher Calamari.

It will take 6 to 8 weeks before products are on the shelves, he said.

"We know we let you down, and we're going to do everything we can to re-earn your trust," Calamari said Wednesday.

But FDA officials and lawmakers pointed out there are ongoing challenges.

First, there are no requirements for baby formula manufacturers to alert the FDA if they are running short, Califf said.

And three baby formula manufacturers still control the U.S. market, Rep. Frank Pallone, D-N.J., said.

"We're too reliant on too few companies to do the right thing," he said.

Candy Woodall is a Congress reporter for USA TODAY. She can be reached at cwoodall@usatoday.com or on Twitter at @candynotcandace.This coverage is only possible with support from our readers. Sign up today for a digital subscription.

This article originally appeared on USA TODAY: Baby formula shortage: FDA chief Califf admits agency was 'too slow'

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