Local NewsFDA head: Baby formula factory could reopen by next...

FDA head: Baby formula factory could reopen by next week

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WASHINGTON — The head of the Food and Drug Administration told lawmakers Thursday that a shuttered baby formula factory could be up and running as soon as next week.

FDA Commissioner Dr. Robert Califf, however, sidestepped questions about whether or not his agency should have intervened earlier at the plant at the center of the national baby formula shortage that has sent desperate parents into a scramble for food and prompted President Biden to invoke the Defense Production Act.

The problems are largely tied to Abbott Nutrition’s Michigan formula plant, the largest in the U.S., 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 safety upgrades and certifications.

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

After production resumes, Abbott has said, it could take about two months before new formula begins arriving in stores.

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

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

Califf is the first administration official to testify before Congress on the shortage, which has left some parents hunting for formula and become a major point of criticism of the Biden Administration.

On Wednesday, Biden announced sweeping new steps to improve U.S. supplies, including invoking the Defense Production Act and flying in imported formula from overseas.

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

Rep. Rosa DeLauro, D-Conn., pointed to a recently released whistleblower complaint alleging numerous safety violations at Abbott’s plant, including employees falsifying records and failing to properly test formula before releasing it.

Subcommittee Chairman Rep. Sanford Bishop, D-Georgia, called the lag in FDA action “unconscionable.”

“American people rely on FDA to protect infant health by ensuring that they have access to safe formula,” Bishop said.

FILE - Robert Califf testifies before a Senate Committee on Health, Education, Labor and Pension hearing on the nomination to be commissioner of Food and Drug Administration on Capitol Hill in Washington, on Dec. 14, 2021. Vacant high-ranking positions across the executive branch could be taking a toll on the Biden administration. At risk are President Joe Biden's plans to improve the economy, fight the pandemic and implement the $1 trillion infrastructure law. (AP Photo/Manuel Balce Ceneta, File)FILE – Robert Califf testifies before a Senate Committee on Health, Education, Labor and Pension hearing on the nomination to be commissioner of Food and Drug Administration on Capitol Hill in Washington, on Dec. 14, 2021. Vacant high-ranking positions across the executive branch could be taking a toll on the Biden administration. At risk are President Joe Biden’s plans to improve the economy, fight the pandemic and implement the $1 trillion infrastructure law. (AP Photo/Manuel Balce Ceneta, File)

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