WASHINGTON (AP) — The head of the Food and Drug Administration told lawmakers on Thursday that a shuttered infant formula plant could be operational as soon as next week, though he avoided questioning whether his agency should have stepped in. sooner to fix the problems at the plant that triggered the national shortage.

FDA Commissioner Dr. Robert Califf faced a bipartisan discussion by House lawmakers on the infant formula issue that angered American parents and became a major political liability for President Joe Biden. .

The problems are largely related to Abbott Nutrition’s formula factory in Michigan, the largest in the United States, which has been closed since February due to contamination concerns. The FDA announced a preliminary agreement with Abbott earlier this week to restart production, pending safety upgrades and certifications.

“We had to fight Abbott,” Califf told members of a House subcommittee. “I think we’re on track to open it within the week to two weeks.”

After production resumes, Abbott said, it could take about two months before the new formula starts hitting stores. Califf said it will be “a few weeks” before supplies return to normal levels, especially in rural areas that are not close to distribution centers.

When lawmakers asked why it took the FDA months to investigate a whistleblower complaint about safety breaches at Abbott’s plant, Califf said he couldn’t share details. due to the agency’s ongoing investigation. Several lawmakers rejected this answer.

“It’s not okay to say you just can’t comment,” said rep Mark Pocan, D-Wis. “It’s a problem I’ve seen time and time again with the FDA: you’re not good at communicating.”

Califf is the first administration official to testify before Congress about the shortage, which has left some parents looking for a formula and has 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 stealing in formulas imported from overseas.

Rep. Rosa DeLauro, D-Conn., has repeatedly asked Califf to explain what the FDA did after receiving a whistleblower complaint in October alleging numerous safety violations at the plant. ‘Abbott, including employees falsifying records and not properly testing the formula before releasing it. The former Abbott employee wasn’t interviewed by the FDA until late December and the plant wasn’t shut down until mid-February, she noted.

“All of this begs the question, why didn’t the FDA step in?” DeLauro asked. “Who in management had access to this report – who did not have access to the report – and why was there no reaction?”

Califf said he looked into the complaint but did not say when or what immediate action was taken.

“I undertake to get back to you on the details of what happened, I’m just not ready for today,” Califf said.

One point lawmakers and Califf have agreed on is that the consolidation of the U.S. formulas market makes it highly vulnerable to disruption. Only four companies produce about 90% of the American formula, including Abbott, Gerber, Perrigo and Reckitt. These companies also dominate federal contracts that supply about half of all US formula through a program called WIC, targeted to low-income mothers, infants and children.

Abbott closed its Michigan plant in February after FDA inspectors began investigating four bacterial infections in infants who had consumed formula from the plant. All four were hospitalized and two died. The first such case was reported to the FDA in September, but agency staff did not begin inspecting the facility until late January.

Califf said earlier this week that the agency had not yet come to a conclusion about whether bacteria from the plant caused the childhood infections. Abbott said there was no direct evidence linking its products to disease.

The infant formula shortage is the first major crisis for Califf since returning to the FDA in February. He briefly led the agency under President Barack Obama and was again in demand for the job due to his past experience leading the sprawling agency, which regulates food, drugs, medical technology and tobacco. .

Thursday’s hearing was to consider the FDA’s budget request for next year, and Califf asked lawmakers for $76 million in new funding for food safety and nutrition.

“I was very aware coming in that we needed to make major improvements on the food side of the FDA — not because people are bad — but it takes consistent leadership and the right resources,” Califf told lawmakers.

The funding request comes amid long-standing concerns that the FDA’s food program — which oversees most US foods except meat, poultry and eggs — has been chronically underfunded and undermanaged compared to its medical divisions.

On Wednesday night, House Democrats passed a $28 million spending bill that would increase funding for the FDA to inspect domestic and international formula producers. His fate in the Senate is uncertain.

The subcommittee’s top Republican, Rep. Andy Harris of Maryland, said many of the problems facing the FDA could be “solved with strong leadership, not money.”

While supporting increased funding, DeLauro also said the problems at the agency’s food center run deeper.

“You have serious structural and leadership issues,” she told Califf. “Someone in this agency needs to have serious and relevant food credentials. Otherwise, the food will be a second-class citizen at the FDA.

The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute Department of Science Education. The AP is solely responsible for all content.

This story has been corrected to show Rep. Mark Pocan is a Democrat, not a Republican.

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