U.S. Food and Drug Administration Commissioner Dr. Robert Califf answered questions about the safety of human milk formula and mifepristone on Wednesday.
Sen. Martin Heinrich chaired the Agriculture Appropriations Subcommittee on Wednesday, which asked questions of Califf about a variety of FDA-related issues including what the FDA has done to improve the safety of human milk formula. During the COVID-19 pandemic, a baby formula manufacturer recalled some of its products after reports that a number of babies had gotten sick with Cronobacter infection and at least nine died after consuming tainted formula.
The recall and a subsequent plant closure led to a severe shortage of baby formula. For parents of infants and others with severe disabilities and allergies who could only rely solely on the specific recalled brand, the shortage was terrifying.
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Heinrich asked Califf to go over what the FDA has done since the recall in February 2022 to ensure baby formula is safe for infants to drink.
Califf said the FDA is in the process of reorganizing to create a new division that would be a human foods program and would oversee food science. That work is ongoing, he said. Califf said the FDA has “beefed up” its number of investigators and now all baby formula plants receive an inspection at least once a year. He said that the plant that recalled the baby formula is now under a consent decree, which is a legal document that ensures a performance improvement plan.
Heinrich also asked Califf about the safety of mifepristone, the FDA approved drug for medication abortion. The future of mifepristone’s use in the U.S. is currently being decided by the U.S. Supreme Court. A Texas-based group sued the FDA last year, claiming that it rushed its approval process 24 years ago.
Related: U.S. Supreme Court hears case to restrict access to medication abortion
Heinrich said he didn’t want to put Califf on the spot. Generally speaking, when agencies or other entities are involved in a lawsuit, they cannot speak about a case that is pending.
But Califf assured the senators that the drug is safe and effective.
“We stand by the decisions of FDA over the years and the constant looking of the surveillance data as it comes in… It’s safe and effective. We stand by that,” he said.
