Food and Drug Administration Commissioner Robert Califf testifies via video during a hybrid hearing of the House Commerce Oversight and Investigations subcommittee on the national infant formula shortage Wednesday in Washington. (Kevin Wolf, Associated Press)
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WASHINGTON — The head of the Food and Drug Administration faced bipartisan fury from House lawmakers on Wednesday after months of delays in investigating problems at the nation’s largest infant formula plant that prompted a continuing shortage.
FDA Commissioner Robert Califf exposed a series of setbacks in congressional testimony that have slowed his agency’s response, including a COVID-19 outbreak at the factory and a whistleblower complaint that did not reach FDA management as it was apparently lost in the mail.
Califf testified before a House subcommittee investigating the shortage, which 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, which the FDA shut down in February due to contamination concerns. Under fire from Congress, parents and the media, Califf gave the first detailed account Wednesday of why his agency took months to inspect and shut down the plant despite learning of potential problems as early as September.
The FDA’s response was, “Too slow and there were some suboptimal decisions along the way,” Califf told lawmakers.
The FDA and President Joe Biden are facing mounting political pressure to explain why they didn’t act sooner to avert the supply crisis.
“Why did it take a national media onslaught for the Biden administration to act with the sense of urgency needed to address a shortage of infant formula?” asked Rep. Morgan Griffith, R-Virginia, the committee’s ranking Republican.
Califf said the agency has been trying to monitor formula supplies since 2020, when COVID-related disruptions first emerged, but regulators have limited visibility into companies’ supply chains.
The House panel also heard from three formula makers, including a senior Abbott Nutrition executive who apologized to parents for the shortage.
“We let you down,” said Abbott Vice Chairman Christopher Calamari. “We are deeply sorry.”
Calamari repeatedly dodged questions about whether employees had been disciplined or fired for the plant’s problems, including standing water, a leaky roof and damaged equipment.
FDA staff began focusing 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 Sturgis, Michigan plant on Dec. 30, according to Califf’s testimony. But Abbott warned that a dozen factory workers had tested positive for COVID-19 and asked for a delay. As a result, the FDA did not begin its inspection until January 31.
After detecting positive samples of a rare but dangerous bacteria in several parts of the plant, the FDA closed the facility and Abbott announced a mass recall of its formula on February 17.
‘We knew shutting down plant operations would create supply issues, but we had no choice given the unsanitary conditions,’ Califf said, calling the issues ‘shocking’ and ‘unacceptable’. .
Abbott and the FDA reached an agreement to reopen the plant next week, under which the company must undergo regular external safety audits.
Califf also struggled to explain delays in following up on a whistleblower complaint alleging numerous safety breaches at the Abbott plant, including employees falsifying records and not testing formula. before shipping.
Several FDA staff members reviewed the complaint in late October when it was sent to a regional FDA office, but an interview did not take place until two months later, in part because of scheduling conflicts. of the whistleblower.
Senior FDA officials eventually received the complaint via email, but not until February due to “an isolated failure in the FDA mailroom, likely due to staffing issues related to COVID-19.” , according to FDA testimony. A copy mailed to Acting Commissioner Dr Janet Woodcock has still not been located.
I don’t think there is one responsible person. I just think it shows that there needs to be restructuring and it needs to be clearer who is ultimately responsible.
-Representing. Nanette Diaz-Barragan, D-Calif.
Political outrage over the shortage landed squarely on the FDA and Califf, which was confirmed to the FDA role for the second time in February. The problems turned into a political storm for the White House, which invoked the Defense Production Act and emergency import measures.
The FDA contacted the US Department of Agriculture on February 11 about a potential shortage, just days before Abbott’s recall, according to the FDA’s schedule.
Califf said the FDA had requested new authorities, funds and personnel to track supply chain data that could have helped anticipate the problem, but noted that Congress had not provided it.
Several lawmakers have expressed longstanding concerns that the FDA’s food program — which oversees most US foods except meat, poultry and eggs — is underfunded and needs to be restructured. .
The program has a convoluted 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.” The deputy commissioner focuses more on safety, but has no direct authority over the food center staff or the field staff who inspect the company’s factories.
The two officials testified Wednesday, along with Califf.
When Rep. Nanette Diaz-Barragan, D-California, asked who was responsible for food safety, Califf and Food Center Director Susan Mayne gave detailed answers, outlining different roles and responsibilities.
“I don’t think there is one person responsible,” Diaz-Barragan replied. “I just think it shows there needs to be some restructuring and it needs to be clearer who is ultimately responsible.”
Later Wednesday afternoon, Abbott’s Calamari told lawmakers that its company plans to build additional capacity and layoffs in its supply chain to avoid future disruptions. He reiterated the company’s view that the FDA has not directly linked reported illnesses in infants to bacteria samples taken from its plant.
After the company restarts production next month, it will be able to produce more formula than before the recall, he noted.
“We’re going to learn from this. We’re going to improve from this,” Calamari said.
Executives from Reckitt and Gerber also testified to their efforts to increase production.
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