WASHINGTON — The head of the Food and Drug Administration faced congressional lawmakers for the first time Thursday over the shortage of baby formula that has rattled American parents and become a growing political liability for President Joe Biden.
FDA Commissioner Robert Califf’s appearance before a House subcommittee came just hours after Biden announced a stepped-up response to the issue: invoking the Defense Production Act to speed domestic manufacturing and authorizing flights to import formula from overseas.
Califf is the first administration official to testify before Congress on the issue, which has left some parents hunting for formula and become a talking point for Republicans. There are many reasons for the shortage, such as supply disruptions due to the coronavirus pandemic or the recent shut down of the biggest U.S. Formula factory .
Earlier this week, the FDA announced several steps to address the problem, including a preliminary agreement with formula maker Abbott Nutrition to reopen its plant, which has been shuttered since February due to contamination.
Members of a House Appropriations subcommittee opened Thursday’s hearing by asking Califf why the FDA didn’t step in last fall when there were signs of problems at Abbott’s plant.
Rep. Rosa DeLauro (D-Conn.) pointed out a whistleblower complaint that alleges numerous safety violations at Abbott’s plant. This included employees falsifying records, failing to test the formula properly before releasing them, and many others. According to her, the Abbott former employee alerted FDA in October about the situation but wasn’t interviewed until December.
“It all begs the question, why did the FDA not spring into action?” DeLauro asked, in her opening statement. “Who in the leadership had access to that report — who didn’t have access to the report — and why was there no reaction?”
There are other questions about the FDA’s timeline for dealing with Abbott. The company shut its Michigan plant in February after FDA inspectors began investigating four bacterial infections in infants who had consumed formula from the plant. Although the FDA received the first report of the cases in September, agency inspectors didn’t start inspecting the plant until January. Califf stated earlier in the week that the FDA’s investigation was ongoing, and has not yet come to a conclusion about whether the bacteria found at the facility caused the infant infection.
Abbott has said there is no direct evidence linking its products to the illnesses.
The baby formula shortage is the first major crisis for Califf since returning to the FDA in February. The agency was briefly headed by President Barack Obama. He was again selected for the position based upon his previous experience with the vast agency that regulates tobacco, food and drugs.
Thursday’s hearing was originally scheduled to review 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 well aware coming in that we need to do major improvements on the food side of the FDA — not because the people are bad — but there is a need for consistent leadership and the right resources,” Califf told lawmakers.
The funding request comes amid longstanding concerns that the FDA’s food program — which oversees most U.S. foods except meat, poultry and eggs — has been underfunded compared with the agency’s drug and medical divisions.
On Wednesday evening, House Democrats passed a $28 million spending bill that would boost FDA funding to inspect domestic and international formula producers. It’s fate in the Senate is uncertain.
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Follow Matthew Perrone on Twitter: @AP_FDAwriter.
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