WASHINGTON — U.S. Food and Drug Commissioner Robert Califf told Congress on Thursday that the infant formula shortage would likely begin to improve in the coming days, though he declined to explain to lawmakers. unhappy why his agency hadn’t acted sooner on a whistleblower report that detailed the security. problems at an Abbott Laboratories facility in Michigan.
“We have an ongoing investigation into the details of exactly what happened, you know, from point A to point B along the way,” Califf told a tense U.S. House hearing. . “As it is ongoing, I cannot give further details on this part.”
Democrats and Republicans on the U.S. House Subcommittee on FDA Funding were also annoyed by the response, urging Califf to explain why it took the FDA months to inspect the plant and Abbott to issue a voluntary recall.
Georgia Democratic Rep. Sanford Bishop, chairman of the subcommittee, said during the audience he was “disturbed by how long it took the FDA to really start addressing this issue” and the “unspecific and vague way” officials implemented a plan to address the shortage .
The FDA received a whistleblower report in October 2021 alleging Abbott officials falsified records, released untested infant formula, and withheld information during a 2019 FDA audit.
Officials did not interview the whistleblower until late December and did not inspect the plant until January 31, according to US lawmakers.
Abbott did not halt production at the Sturgis, Michigan plant until mid-February to address safety concerns. The three-month shutdown has exacerbated supply chain issues with infant formula, leading to an increasingly severe shortage nationwide.
DeLauro presses for answers
Connecticut Democratic Rep. Rosa DeLauro, chair of the entire appropriations committee, was furious with Califf for refusing to detail who received the whistleblower’s report and what that person did with it during the months that Abbott’s facility remained open.
Califf said he would go into much more detail during a hearing with another US House committee next week, further infuriating members of the appropriations committee.
“You are in front of the committee that funds what you are doing. So this information is relevant to this subcommittee,” DeLauro said.
Illinois Democratic Rep. Lauren Underwood asked Califf why fixing the problems at the plant was not part of the “critical work” the FDA continued at the height of the omicron surge.
Califf said he couldn’t disagree with Underwood that infant formula safety should have been part of that classification.
When asked what the FDA would change going forward to ensure infant formula facilities are inspected in a safe and timely manner during public health emergencies, Califf said, “No matter what, we We will be aware of this issue until we are back to normal.”
Califf then lobbied for more funding and more staff, saying as the FDA is looking for other infant formula makers, it “will need people who can assess whether the formula is safe.”
“Not only that, but whether it’s effective, especially in these metabolic formulas. There are only a handful of people who understand these illnesses that these children have,” Califf continued.
FDA wants more funding
The American House vote mostly along party lines Wednesday night to pass a $28 million bill to bolster funding for the FDA to address the current infant formula shortage and prevent another shortfall from occurring at the ‘coming.
The legislation currently has no way forward in the US Senate amid Republican opposition.
The FDA has broad responsibilities to ensure that most foods and pharmaceuticals sold nationwide are safe. The list of products the agency must track includes food (excluding meat from livestock, poultry and some egg products), vaccines, medical devices, veterinary drugs, cosmetics, food supplements and tobacco products.
DeLauro disputed Califf’s assertion that more funding is essential.
“I’ve worked to augment FDA resources, but your issues are structural,” DeLauro said. “You have serious structural leadership issues.”
FDA management must ensure that someone in the agency has the relevant food credentials, “because otherwise food safety will continue to be a second-class citizen at the agency,” DeLauro added.