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The head of the Food and Drug Administration (FDA) told a House panel Thursday that the infant formula shortages will begin to ease over the next few days, but had few answers for how the agency allowed a manufacturing plant with known safety issues to continue operating for months without stepping in.
FDA Commissioner Robert Califf was the first administration official to answer questions before Congress about the formula shortage, which has recently caught lawmakers’ attention. Now facing pressure from frustrated families, those lawmakers are finding no easy solutions.
The scarcity is partly due to the closure of a manufacturing plant operated by Abbott Nutrition. The plant has been shut down since February, after four infants who consumed formula made there were hospitalized with a rare bacterial infection.
The FDA earlier this week announced a preliminary consent agreement with Abbott to restart production, pending safety upgrades and certifications.
“I am pleased to say we’ve made very significant progress” on reopening the plant, Califf told members of a House appropriations subcommittee, “and I think we are on track to get it open within the next week to two weeks, most likely at the outbound two weeks.”
Califf said the combination of increased production from other manufacturers and new authority on importing formula means “we should see improvement within days.”
However, he acknowledged “it will be a few weeks before we’re back to normal.”
Abbott has said once production resumes, it will take between six and eight weeks before new formula will get to store shelves.
Lawmakers grilled Califf about why it took months to inspect the plant, even though agency officials knew about longstanding safety conditions. But Califf declined to answer in any detail, citing an ongoing internal investigation.
The lack of disclosure did not sit well with lawmakers.
“This is something parents are asking us about; they want to know what happened. It’s not acceptable to say you can’t comment on it,” said Rep. Mark Pocan (D-Wis.). “This is a problem I’ve seen over and over with the FDA: You guys aren’t good at communicating.”
Califf’s appearance comes the day after the House passed $28 million in emergency funding for the agency aimed at addressing the supply concerns, and after the Biden administration announced new measures to boost supply, including invoking the Defense Production Act.
Califf said much of the agency’s problems stem from a lack of resources, most notably a lack of inspectors and an outdated IT system. If the extra money is appropriated, he said the agency will use the bulk of it to hire more inspectors.
Republicans have turned the shortages into a political blame game for the Biden administration, though members of both parties have expressed frustration at what they said was a lack of accountability from the FDA.
Leading the charge was Rep. Rosa DeLauro (D-Conn.), chairwoman of the Appropriations Committee. She pressed Califf for details about which officials saw a whistleblower report sent to the agency in October, and why there was no action taken.
“You can’t hide behind an investigation, we need answers now,” DeLauro said.
The report from a former Abbott employee detailed major observed violations of safety rules, including falsifying records and releasing untested infant formula.
Yet even before the report, FDA was aware that infants had become sick after consuming formula made at Abbott’s Michigan plant.
FDA staff did not interview the whistleblower until December, and the facility wasn’t inspected until January.
“It all begs the question, why did the FDA not spring into action? Why did it take four months to pull this formula from shelves?” DeLauro said.
“It makes me question which side the FDA is on. Are they on the side of Abbott, the industry, or on the side of the American consumer, in this case babies, and their moms and dads?”