FDA chief struggles to explain slow response on baby formula

Abbott VP: ‘We are deeply sorry’

WASHINGTON — 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.

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 stems largely from Abbott’s Michigan plant, shut by the FDA 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 and President Joe 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’ visibility into company supply chains is limited.

The House panel also heard from three formula manufacturers, including a top Abbott Nutrition executive who apologized for the shortage. “We let you down,” said Abbott vice president Christopher

Calamari. “We are deeply sorry.”

Calamari repeatedly sidestepped questions about whether any employees were disciplined or fired over problems at the plant, which included standing water, a leaky roof and damaged equipment.

FDA staff began honing in on Abbott’s plant last fall while tracking several bacterial infections in infants who had consumed formula from the facility. The four cases occurred between September and January, causing hospitalizations and two deaths.

The FDA planned to begin inspecting the Michigan plant on Dec. 30, according to Califf. But Abbott warned that about a dozen employees had COVID-19 and requested a delay. As a result, the inspection did not take place until Jan. 31.

After detecting positive samples of a rare, but dangerous, bacteria at the plant, the FDA closed the facility and Abbott announced a recall of its formula Feb. 17.

“We knew that … would create supply problems, but we had no choice,” said Califf.