WASHINGTON (AP) — The head of the Food and Drug Administration told lawmakers Thursday a closed baby formula plant could be up and running as early as next week, although he dodged questions about whether his agency should have stepped in sooner to address problems affecting the plant triggered the national shortage.
FDA Commissioner Dr. Robert Califf faced a bipartisan grilling from House lawmakers over the baby formula issue, which has angered American parents and become a political burden on President Joe Biden.
The problems are largely related to Abbott Nutrition’s Michigan formula factory, the largest in the US, which has been closed since February due to contamination problems. The FDA earlier this week announced a tentative agreement with Abbott to resume production pending safety improvements and certifications.
“We had to get this down with Abbott,” Califf told members of a House subcommittee. “I think we’re on track to open it within the next week or two.”
Once production resumes, Abbott says it could take about two months for the new formula to hit stores. Califf said it will take “a few weeks” for supplies to return to normal levels, particularly in rural areas.
When lawmakers asked why it took the FDA months to investigate a whistleblower complaint about safety breaches at Abbott’s facility, Califf said he couldn’t provide details due to the agency’s ongoing investigation. Several lawmakers dismissed that answer.
“It’s unacceptable to say you just can’t comment on it,” said Rep. Mark Pocan, D-Wisconsin. “That’s a problem I’ve seen time and time again with the FDA: you guys aren’t good at communicating.”
Califf is the first government official to testify before Congress about the shortage that has led some parents to scramble for infant formula and become a political talking point for Republicans. On Wednesday night, Biden announced sweeping new steps to improve U.S. supplies, including invoking the Defense Production Act and flying in imported formula from overseas.
Rep. Rosa DeLauro, D-Conn., repeatedly asked Califf to explain what the FDA had done after receiving a whistleblower complaint in October alleging numerous safety violations at Abbott’s plant, including employees falsifying records and did not properly test the formula before releasing it. The former Abbott employee wasn’t questioned by the FDA until late December, and the facility didn’t close until mid-February, she noted.
“Everything begs the question, why didn’t the FDA take action?” asked DeLauro. “Who in leadership had access to this report – who did not have access to the report – and why was there no response?”
Califf said he reviewed the complaint but did not specify when or what emergency action was taken.
“I’m committed to reaching out to you with details of what happened, but I’m just not prepared for that today,” Califf said.
One point lawmakers and Califf agreed on is that the concentration of the U.S. formula market makes it highly vulnerable to disruption. Just four companies produce an estimated 90% of the US formula, including Abbott, Gerber, Perrigo and Reckitt. These companies also dominate the federal contracts that provide about half of all US formula to low-income mothers, children and babies through a program called WIC.
Abbott closed its Michigan facility in February after FDA inspectors began investigating four bacterial infections in infants who consumed formula from the facility. The first of these cases was reported to the FDA in September, but agency officials didn’t begin inspecting the facility until late January.
Califf said earlier this week the agency’s investigation is ongoing and no conclusion has yet been reached on whether bacteria from the plant caused the infant infections. Abbott said there was no direct evidence linking its products to the diseases.
The baby formula shortage is the first major crisis for Califf since its return to the FDA in February. He briefly headed the agency under President Barack Obama and was reselected for the job because of his previous experience as head of the sprawling agency that regulates food, drugs, medical devices and tobacco.
Thursday’s hearing was set to consider the FDA’s budget request for next year, and Califf asked lawmakers for $76 million in new food safety and nutrition funding.
“I was well aware that we need to make big improvements on the food side of the FDA — not because people are bad — it takes consistent leadership and the right resources,” Califf told lawmakers.
The funding request comes amid longstanding concerns that the FDA’s food program — which oversees most U.S. foods except meat, poultry and eggs — has been underfunded and mismanaged compared to its medical departments.
On Wednesday night, House Democrats passed a $28 million spending bill that would increase FDA funding for inspecting national and international formula makers. His fate in the Senate is uncertain.
The subcommittee’s top Republican, Maryland Rep. Andy Harris, said many of the problems the FDA faces “can be solved with strong leadership, not money.”
While supporting increased funding, DeLauro also said the problems at the agency’s food center run deeper.
“They have serious structural leadership issues,” she told Califf. “Somebody in this agency needs to have serious, relevant food evidence. Otherwise, food will be a second-class citizen to the FDA.”
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Follow Matthew Perrone on Twitter: @AP_FDAwriter.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
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This story has been corrected to show that Rep. Mark Pocan is a Democrat and not a Republican.