FDA chief: Baby formula factory could reopen next week

The head of the Food and Drug Administration told lawmakers Thursday that a closed baby formula factory could be up and running as soon as next week, though he dodged questions about whether his agency should have stepped in earlier on the plant in downtown national shortage.

FDA Commissioner Robert Califf faced bipartisan grilling from House lawmakers over the baby formula issue that has angry american parents and become a political liability for President Joe Biden.

The problems are largely related to Abbott’s plant in Michigan, the largest in the US, which has been closed since February due to contamination problems. The FDA announced a preliminary agreement with Abbott earlier this week to restart production, pending updates and safety certifications.

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

After production resumes, Abbott said, it could be about two months before the new formula starts hitting stores.

When lawmakers asked why the FDA took months to investigate warnings about safety violations at the plant, Califf said he couldn’t say much because of an ongoing investigation into the issues. Several lawmakers rejected that response.

“It’s not acceptable to say you just can’t comment on it,” said Rep. Mark Pocan, D-Wisconsin. “This is a problem I’ve seen over and over again with the FDA: You guys are not good at communicating.”

Califf is the first administration official to testify before Congress about the shortage, which has left some parents searching for formula and become a talking point for Republicans. On Wednesday night, Biden announced sweeping new steps to improve American supplies, including invoking the Defense Production Law and fly in formula imported from abroad.

Members of the House Appropriations subcommittee opened Thursday’s hearing by asking Califf why the FDA didn’t intervene last fall when there were warnings about problems at the Sturgis, Michigan, factory.

Rep. Rosa DeLauro, D-Conn., pointed to a recently published whistleblower complaint alleging numerous safety violations at the Abbott plant, including employees falsifying records and failing to properly test formula before releasing it. She said the former Abbott employee alerted the FDA to the situation in October, but agency staff did not interview him until late December.

“It all begs the question, why didn’t the FDA take action?” DeLauro asked. “Who in the leadership had access to that report, who didn’t have access to the report, and why was there no reaction?”

Califf said he had reviewed the complaint, but did not specify when or what immediate action was taken. He said the allegations raise serious concerns about Abbott’s operations.

Biden seeks to quell baby formula crisis with logistical help
A worker restocks shelves with baby formula at a store in Pinole, Calif., U.S., on Tuesday, May 17, 2022.


“The most concerning charge is that the integrity of the organization was compromised,” Califf said. “Once that integrity is compromised, the question is how can any of the existing systems be trusted?”

The subcommittee’s chair, Rep. Sanford Bishop, D-Georgia, called the FDA’s delay in action “inconceivable.”

“Americans trust the FDA to protect the health of babies by ensuring they have access to safe formula,” Bishop said.

Abbott closed its Michigan plant in February after FDA inspectors began investigating four bacterial infections in infants who had consumed formula from the plant. The first of those cases was reported to the FDA in September, although agency staff did not begin inspecting facilities until late January. Califf said earlier this week that the agency’s investigation is ongoing and that it has not yet reached a conclusion about whether bacteria from the plant caused the childhood infections.

Abbott has said there is no direct evidence linking its products to disease.

The baby formula shortage is the first major crisis for California since return to the FDA in February. He briefly led the agency under former President Barack Obama, and was re-elected to the role based on his previous experience leading the sprawling agency, which regulates food, drugs, medical technology and tobacco. .

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

“I was well aware that we need to make major improvements on the food side of the FDA, not because people are mean, but because consistent leadership and adequate resources are needed,” Califf told lawmakers.

The funding request comes amid long-standing concerns that the FDA’s food program, which oversees most American foods except meat, poultry and eggs, has been underfunded compared to medical and drug divisions of the agency.

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

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