FDA chief struggles to explain slow response on baby formula – Lowell Sun

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The head of the Food and Drug Administration faced bipartisan fury from House lawmakers Wednesday over months of delays investigating problems at the nation’s largest baby formula plant that prompted an ongoing shortage.

FDA Commissioner Robert Califf laid out a series of setbacks in congressional testimony that slowed his agency’s response, including a COVID-19 outbreak at the plant and a whistleblower complaint that didn’t reach FDA leadership because it was apparently lost in the mail.

Califf testified before a House subcommittee investigating the shortage, which has snowballed into a national political controversy and forced the U.S. military to begin airlifting supplies from Europe.

The shortage largely stems from Abbott’s Michigan plant, which the FDA shut down in February due to contamination issues. Under fire from Congress, parents and the media, Califf gave the first detailed account Wednesday of why his agency took months to inspect and shutter the plant despite learning of potential problems as early as September.

The FDA’s response was: “Too slow and there were decisions that were suboptimal along the way,” Califf told lawmakers.

The FDA and President Biden face mounting political pressure to explain why they didn’t intervene sooner to head off the supply crisis.

“Why did it take an onslaught of national media attention for the Biden administration to act with a sense of urgency required to address an infant formula shortage?” asked Rep. Morgan Griffith, R-Virginia, the committee’s ranking Republican.

Califf said the agency had been trying to monitor formula supplies since 2020 when COVID-related disruptions first emerged, but regulators have limited visibility into company supply chains.

The House panel also heard from three formula manufacturers, including a top Abbott Nutrition executive who apologized to parents for the shortage.

“We let you down,” said Abbott vice president Christopher Calamari. “We are deeply sorry.”

Also Wednesday, Jill Biden and Surgeon General Vivek Murthy welcomed the delivery of a second shipment of tens of thousands of pounds of baby formula that the Biden administration is importing from Europe to ease critical supply shortages in the U.S.

The first lady and the nation’s doctor each sought to empathize with anxious parents nationwide who have been scrambling to find enough formula for their children.

Workers unload a Fedex Express cargo plane carrying 100,000 pounds of baby formula at Washington Dulles International Airport, in Chantilly, Va., on Wednesday, May 25, 2022. (AP Photo/Jose Luis Magana)
Workers unload a Fedex Express cargo plane carrying 100,000 pounds of baby formula at Washington Dulles International Airport, in Chantilly, Va., on Wednesday, May 25, 2022. (AP Photo/Jose Luis Magana)



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