The FDA received a whistleblower report in October 2021 alleging Abbott officials falsified records, released untested infant formula and hid information during a 2019 FDA audit (Scott Olson/Getty Images).
WASHINGTON — U.S. Food and Drug Commissioner Robert Califf told Congress Thursday that the infant formula shortage will likely begin to improve in the coming days, though he declined to explain to unhappy lawmakers why his agency didn’t act sooner on a whistleblower report that detailed safety issues at an Abbott Laboratories facility in Michigan.
“We have an ongoing investigation about the details of exactly what happened, you know, from point A to point B along the way,” Califf said at a tense U.S. House hearing. “Since it is ongoing, I can’t give extensive more details on that part of it.”
Democrats and Republicans on the U.S. House subcommittee in charge of the FDA’s funding were equally annoyed with that answer, pressing Califf to explain why it took months for the FDA to inspect the plant and for Abbott to issue a voluntary recall.
Georgia Democratic Rep. Sanford Bishop, the subcommittee chair, said during the hearing he was “disturbed by the length of time that it took for FDA to really start to address this problem” and for the “nonspecific and vague way” officials have 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 hid information during a 2019 FDA audit.
Officials didn’t interview the whistleblower until late December and didn’t inspect the plant until Jan. 31, according to U.S. lawmakers.
Abbott didn’t stop production at the Sturgis, Michigan, facility until mid-February to address safety concerns. The three-month shutdown has exacerbated supply chain issues with infant formula, leading to an ever worsening nationwide shortage.
DeLauro presses for answers
Connecticut Democratic Rep. Rosa DeLauro, chair of the full Appropriations Committee, was furious with Califf for declining to detail who received the whistleblower report and what that person did with it during the months the Abbott facility remained open.
Califf said he would go into much more detail during a hearing with a different U.S. House committee next week, infuriating members of the Appropriations Committee even more.
“You’re before the committee that funds what you do. So this information is relevant to this subcommittee,” DeLauro said.
Illinois Democratic Rep. Lauren Underwood questioned Califf about why addressing issues at the plant wasn’t part of the “mission critical work” the FDA continued during the height of the omicron surge.
Califf said he couldn’t disagree with Underwood that ensuring infant formula was safe should have been part of that classification.
When asked what the FDA would change going forward to ensure infant formula facilities would be inspected in a safe and timely manner during public health emergencies, Califf said “that no matter what, we will be on top of this issue until we’re back to normal.”
Califf then pressed for more funding and more staff, saying that as the FDA looks for additional infant formula manufacturers they’re “going to need people who can actually evaluate 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 U.S. House voted mostly along party lines Wednesday night to pass a $28 million bill to bolster the FDA’s funding to address the current shortage of infant formula and prevent another shortfall from happening in the future.
The legislation doesn’t currently have a path forward in the U.S. Senate amid Republican opposition.
The FDA has broad responsibilities to ensure that most food and pharmaceuticals sold throughout the country are safe. The list of products the agency must keep track of includes food (except meat from livestock, poultry and some egg products), vaccines, medical devices, veterinary drugs, cosmetics, dietary supplements and tobacco products.
DeLauro challenged Califf’’s assertion that more funding is key.
“I’ve worked to increase resources to the FDA, but your problems are structural,” DeLauro said. “You have serious structural leadership issues.”
FDA leadership needs to ensure that someone at the agency has relevant food credentials, “because otherwise food safety will continue to be a second-class citizen at the” agency, DeLauro added.
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