The FDA has been criticized for moving too slowly to investigate a whistleblower complaint last year at the Abbott facility, which was inspected and shuttered only this year after two infants were sickened and two infants died after consuming contaminated formula. Abbott has said there isn’t clear evidence the contamination came from the factory.
“Why did the FDA not spring into action?,” Rep. Rosa L. DeLauro (D-Conn.) said. “How may illnesses and deaths were due to the FDA’s slow response? This makes me question which side FDA is on, on the side of Abbott or the American public?”
The factory’s closure has led to a shortage that has left parents of infants and medically fragile children scrambling to find alternatives. This week, two children were treated at a Tennessee hospital because their parents could not find food for them.
The FDA and Abbott agreed on a path this week to reopening the plant. But Abbott has said once it gets the all-clear from the FDA to reopen, production can begin within two weeks and its products can be back on the shelves six to eight weeks after that.
Califf offered assurances that grocery stores’ stocks of formula will improve even before Abbott products are fully restocked, as other companies step up production domestically.
“It will gradually get better,” he said. “The big problem we have right now is distribution, and we’ll have to pay special attention to rural areas. It will be a few weeks until we’re back to normal supply.”
Rep. Andy Harris (R-Md.) said the FDA’s problems are broader than the formula issue, pointing to a recent Politico investigation that highlighted flaws in the agency’s oversight of food safety. But he rejected suggestions that the agency needs more funding. “Many of the problems facing your agency can be solved by strong leadership, not more money,” he said.
The House hearing, which was scheduled previously to discuss FDA’s funding request and touched on a range of issues including the coronavirus vaccine, comes a day after President Biden invoked the Defense Production Act to address the shortage of baby formula, tapping a Korean War-era law to ramp up domestic manufacturing. The Biden administration also loosened rules governing imported formula to allow foreign providers to help fill the gap.
DeLauro expressed concerns about the FDA’s looser guidance for foreign infant formula manufacturers, expressing concern that in the name of increasing domestic supplies of formula, unsafe formula would be introduced from abroad.
“We will not let infant formula into the U.S. that is not safe,” Califf said.
On Wednesday, Califf announced a restructuring at the agency, tapping Principal Deputy Commissioner Janet Woodcock to oversee the Center for Food Safety and Applied Nutrition and the Office of Regulatory Affairs, which together conduct the inspections and oversight of food manufacturers.
“My goal is to ensure that these programs acquire the resources, tools and staffing necessary to meet the challenges the FDA faces in these areas now and in the coming years,” Califf wrote.
Rep. David G. Valadao (D-Calif.) suggested that the FDA would need a more dramatic overhaul than the appointment of Woodcock, who has been at the agency for decades.
“This is just the start of a change, we will have a major fortification on the food side,” Califf said, defending his choice of Woodcock. “And Dr. Woodcock knows every nook and cranny of the organization.”
The FDA has requested a budget increase of $158 million above 2022 levels to support both food safety and medical product safety. The additional funding, according to Califf, would be focused on technology modernization and additional inspectional activities.