FDA weighs oversight changes after formula, Juul troubles
WASHINGTON — The head of the Food and Drug Administration has asked for a review of the agency’s food and tobacco programs following months of criticism over their handling of the baby formula shortage and e-cigarette reviews. “Fundamental questions about the structure, function, funding and leadership need to be addressed” in the agency’s food program, Califf said in a statement. Califf said the Reagan-Udall Foundation — a non-governmental research group created by Congress to support FDA’s work — would convene experts to deliver evaluations within 60 business days of both the food and tobacco operations. “There’s a consistent concern out there that we need to really fix the fundamentals, which includes all those elements.” Califf said he agreed with critiques that the food program has been underfunded compared with FDA’s drug program, which receives more than $1 billion annually in industry user fees. “I don’t think anyone anticipated that there would be 6.7 million vaping product applications that came rolling in during a pandemic that was stressing the entire agency,” Califf said.
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