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Thursday, September 29, 2022

FDA: Baby formula plant may reopen by next week

by Matthew Perrone | The Associated Press

WASHINGTON – The head of the Food and Drug Administration told lawmakers on Thursday that a closed baby formula factory could start as early as next week, though he brushed aside questions about whether his agency should have intervened earlier at the plant at the center . national shortage.

FDA Commissioner Dr. Robert Califf faced bipartisan grilling from House lawmakers over the baby formula issue, which angered American parents and became a political liability for President Joe Biden.

The problems are largely tied to Abbott Nutrition’s Michigan Formula plant, 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 resume production, pending safety upgrades and certifications.

“We had to wrestle with Abbott to get into the field,” Calif told members of a House subcommittee. “I think we are on track to open it within two weeks from next week.”

After production resumes, Abbott has said, it could take about two months for the new formula to arrive in stores.

When lawmakers asked why it took the FDA months to investigate warnings about safety breaches at the plant, Calif said he couldn’t say much more because of the ongoing investigation into the issues. Many lawmakers rejected that response.

“It’s not acceptable to say that you can’t comment on this,” said Representative Mark Pokan, D-Wisconsin. “It’s a problem I’ve seen with the FDA over and over again: You guys aren’t good at communicating.”

Calif. is the first administration official to testify before Congress on the shortage, which has left some parents looking for formula and has become a thing for Republicans. On Wednesday evening, Biden announced new steps to improve US supplies, including invoking the Defense Production Act and flying in formula imported from overseas.

Members of the House Appropriations Subcommittee opened Thursday’s hearing by asking Calif.

Representative Rosa Delaro, D-Conn, pointed to a recently released whistleblower complaint alleging multiple safety breaches at Abbott’s plant, in which employees falsified records and used sources before releasing it. Failed to test properly. She said that Abbott’s former employee alerted the FDA about the situation in October, but she had not been interviewed by agency employees until late December.

“It all begs the question, why didn’t the FDA spring into action?” Delaro asked. “Who in the leadership had access to that report – who didn’t have access to the report – and why was there no response?”

Calif said they had reviewed the complaint, but did not say when or whether immediate steps were taken. He said the allegations raise serious concerns about Abbott’s handling.

“The most concerning allegation is that the integrity of the organization was compromised,” Calif said. “Once that integrity is compromised the question is how can you trust any system at all.”

Representative Sanford Bishop, D-Georgia, chair of the subcommittee, called the gaps in FDA action “unconscionable.”

“The American people trust the FDA to protect infant health by making sure they have safe formula,” Bishop said.

Abbott closed its Michigan plant in February after FDA inspectors began investigating four bacterial infections in babies who ingested formula from the plant. The first of those cases was reported to the FDA in September, though agency staff didn’t begin inspecting the facility until late January. Calif said earlier this week the agency’s investigation was ongoing and it had not yet concluded whether the plant bacteria caused the infection in the baby.

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

Baby formula shortages are California’s first major crisis since it returned to the FDA in February. He briefly headed the agency under President Barack Obama and was tapped for the job again based on his previous experience leading the giant agency that regulates food, drugs, medical technology and tobacco.

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

“I knew very well that we needed to make major reforms on the food side of the FDA — not because people are bad — but what needed to be consistent leadership and the right resources,” Calif told lawmakers.

The funding request comes amid longstanding concerns that the FDA’s food program — which oversees most US foods except meat, poultry and eggs — has been underfunded compared to the agency’s pharmaceutical and medical divisions.

On Wednesday evening, House Democrats passed a $28 million spending bill that would boost FDA funding to oversee domestic and international formula producers. Its fate in the Senate is uncertain.

World Nation News Desk
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