FDA admits slow response to formula shortage

The Food and Drug Administration’s (FDA) response to multiple reports of contamination at a baby formula manufacturing plant was delayed due to a COVID-19 outbreak and numerous logistical failures, the agency’s director told a House panel Wednesday.

 

FDA Commissioner Robert Califf admitted the agency made a number of missteps that exacerbated a nationwide shortage of baby formula and pledged to reform the agency’s often criticized food safety division.

 

The FDA’s response was “too slow, and some decisions in retrospect could have been more optimal,” Califf said.

 

Early warnings: Califf said FDA first noticed strains in the formula supply chain in March 2020, but were confident the market would be able to handle it.

 

“The system seemed to be keeping up with demand until fairly recently, although there were spot shortages that we were responding to,” Califf said.

 

Lawmakers grilled Califf about the agency’s actions leading up to the subsequent shutdown of Abbott Nutrition’s Sturgis, Mich., manufacturing facility and the recall of the formula that was made there.

 

They wanted to know why it took months to inspect the plant, even though agency officials knew about long-standing safety conditions. They also pressed Califf about why the agency did not appear to respond to the shortage until it gained national attention.

 

“Babies and children are suffering,” said Rep. Diana DeGette (D-Colo), chairwoman of the Energy and Commerce Oversight subcommittee.

 

FDA discovered a variety of safety issues at Abbott’s plant in September but didn’t conduct a follow-up inspection until January.

 

Cronobacter sakazakii, which can be deadly to infants, was found in four babies who had consumed formula from the plant. Two died. Abbott maintains there is no conclusive evidence linking the contamination at its plant to the illnesses.