FDA chief struggles to explain slow response to baby food | Health, medicine and fitness

By MATTHEW PERRONE – AP Health Writer

WASHINGTON (AP) — The head of the Food and Drug Administration faced bipartisan anger from House lawmakers on Wednesday over months of delays in investigating problems at the country’s largest baby food plant that led to an ongoing shortage.

FDA Commissioner Robert Califf documented a series of setbacks in congressional testimony that delayed his agency’s response, including a factory COVID-19 outbreak and a whistleblower complaint that failed to reach FDA leadership because it was apparently lost in the mail.

Califf testified before a House subcommittee investigating the deficit, which has sparked a national political controversy and forced the US military to begin airlifting supplies from Europe.

The shortfall stems largely from Abbott’s Michigan plant, which the FDA closed in February due to contamination concerns. Under fire from Congress, parents and the media, Califf on Wednesday issued the first detailed account of why his agency took months to inspect and close the plant, despite learning about potential problems as early as September.

The FDA’s response was, “Too slow and there were decisions that weren’t optimal along the way,” Califf told lawmakers.

The FDA and President Joe Biden are facing mounting political pressure to explain why they haven’t intervened sooner to avert the supply crisis.

“Why did it take a bout of national media attention for the Biden administration to act with a sense of urgency to address infant formula shortages?” asked Rep. Morgan Griffith, R-Virginia, The Commission’s Republican Rankings.

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

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

“We’ve disappointed you,” said Abbott Vice President Christopher Calamari. “We are very sorry.”

Calamari repeatedly sidestepped questions about whether employees were being disciplined or fired because of problems at the plant, including standing water, a leaking roof and damaged equipment.

FDA employees began grinding Abbott’s factory last fall while tracking various bacterial infections in infants who had consumed formula from the facility. The four cases occurred between September and January, resulting in hospitalizations and two deaths.

The FDA planned to begin inspecting the Sturgis, Michigan plant on Dec. 30, according to Califf’s testimony. But Abbott warned that about a dozen factory workers had tested positive for COVID-19 and requested a postponement. As a result, the FDA did not begin the inspection until January 31.

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

“We knew that shutting down the plant would lead to supply problems, but we had no choice given the unsanitary conditions,” Califf said, calling the problems “shocking” and “unacceptable.”

Abbott and the FDA have agreed to reopen the factory next week, which will require the company to undergo regular external safety audits.

Califf also struggled to explain delays in following up on a whistleblower complaint alleging numerous security violations at Abbott’s factory, including employees who falsified data and failed to test the formula before shipment.

Several FDA officials reviewed the complaint in late October when it was sent to a regional FDA office, but an interview was not held until two months later, in part because of the whistleblower’s scheduling conflicts.

Senior FDA officials eventually received the complaint via email, but not until February due to “an isolated failure in the FDA’s mailroom, likely due to COVID-19 staffing problems,” the FDA statement said. A mailed copy addressed to then Acting Commissioner Dr. Janet Woodcock still hasn’t been found.

Political outrage over the deficit has gone straight to the FDA and Califf, who were confirmed in the FDA’s role for the second time in February. The problems have escalated into a political firestorm for the White House, which has invoked the Defense Production Act and emergency import measures.

According to the FDA’s timeline, the FDA contacted the U.S. Department of Agriculture about a potential shortage on Feb. 11, just days before Abbott’s recall.

Califf said the FDA has requested new authorities, funding and personnel to track supply chain data that could have helped solve the problem, but noted Congress has not provided it.

Several lawmakers have long expressed concerns that the FDA’s food program — which oversees most U.S. foods except meat, poultry and eggs — is underfunded and in need of restructuring.

The program has a complex leadership structure in which there is a director of the FDA’s Center for Food Safety and Applied Nutrition and a separate deputy commissioner for “food policy and response.” about food center personnel or field personnel inspecting farm plants.

Both officials testified on Wednesday, along with Califf.

When Representative Nanette Diaz-Barragan, D-Calif., asked who is responsible for food safety, Califf and director of the food center Susan Mayne provided detailed answers, describing various roles and responsibilities.

“I don’t think there is one person responsible,” Diaz-Barragan replied. “I just think it shows that restructuring needs to be done and it needs to be clearer who is ultimately responsible.”

Later Wednesday afternoon, Abbott’s Calamari told lawmakers that his company plans to build additional capacity and layoffs into its supply chain to avoid future disruptions. He reiterated the company’s point that the FDA has not made a direct link between the illnesses reported in infants and bacterial samples collected from the plant.

After the company restarts production next month, it will be able to produce more formula than before the recall, he noted.

“We are going to learn from this. We will get better because of this,” said Calamari.

Reckitt and Gerber executives also testified to their efforts to increase production.

The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

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