FDA chief Califf to appear at House hearing on formula shortage

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Food and Drug Administration Commissioner Robert M. Califf told lawmakers Thursday that his agency is working “tirelessly” to increase the supply of infant formula nationwide and that he expects that an Abbott Nutrition factory in Michigan that makes much of the country’s formula is up and running again in two weeks.

But Califf, speaking before a House Appropriations subcommittee, called the food supply fragile and urged Congress to authorize more funds for increased staffing and inspections to avert further food crises. the supply chain. “We could be a natural disaster or a cyberattack to be here again,” he said.

The FDA has been criticized for moving too slowly to investigate a whistleblower complaint last year at the Abbott facility, which was only inspected and closed this year after two infants fell ill and two infants have died after consuming contaminated infant formula. Abbott said there was no clear evidence the contamination came from the factory.

“Why didn’t the FDA intervene?” said Rep. Rosa L. DeLauro (D-Conn.). “How can illnesses and deaths be due to the slow response from the FDA? This makes me wonder which side is the FDA on, Abbott’s side or the American public’s side? »

The plant’s closure led to a shortage that left parents of medically fragile infants and children scrambling to find alternatives. This week, two children were treated at a hospital in Tennessee because their parents couldn’t get them food.

The FDA and Abbott agreed on a path this week to reopen the plant. But Abbott said once it gets the green light from the FDA to reopen, production can begin within two weeks and its products can be back on shelves six to eight weeks after that.

Califf said baby formula stocks at grocery stores will improve even before Abbott products are fully restocked, as other companies ramp up production nationwide.

“It’s going to get better little by little,” he said. “The big problem we have at the moment is distribution, and we will have to pay particular attention to rural areas. It will be a few weeks before we return to normal supply. »

Rep. Andy Harris (R-Md.) said the FDA’s problems are broader than the formula problem, pointing to a recent Politico investigation that exposed flaws in the FDA’s oversight of food safety. ‘agency. But he dismissed suggestions that the agency needed more funding. “A lot of the problems your agency faces can be solved by strong leadership, not more money,” he said.

An infant formula factory is still months away from putting the product on the shelves

The House hearing, which was previously scheduled to discuss the FDA’s funding request and touched on a range of issues, including the coronavirus vaccine, comes a day after President Biden invoked the production law defense force to address baby formula shortages, exploiting a Korean War-era law to expedite domestic manufacturing. The Biden administration has also relaxed rules governing imported formulas to allow foreign suppliers to help fill the void.

DeLauro has expressed concerns about the FDA’s looser guidelines for foreign infant formula makers, fearing that in the name of increasing domestic infant formula supply, unsafe formula will be introduced from overseas .

“We will not let infant formula into the United States that is unsafe,” Califf said.

On Wednesday, Califf announced a restructuring of the agency, bringing in Senior Deputy Commissioner Janet Woodcock to oversee the Center for Food Safety and Applied Nutrition and the Office of Regulatory Affairs, which together conduct food inspections and oversight. food manufacturers.

“My goal is to ensure that these programs acquire the resources, tools, and personnel necessary to meet the challenges the FDA faces in these areas now and in the years to come,” Califf wrote.

Representative David G. Valadao (D-California) suggested the FDA needs a more sweeping overhaul than appointing Woodcock, who has worked at the agency for decades.

“This is just the start of a shift, we’ll have a major fortification on the food side,” Califf said, defending his pick 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 focus on technology upgrades and additional inspection activities.

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