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Baby formula plant may be open within a week, FDA commissioner says

On Capitol Hill, Robert M. Califf defended his agency’s response to a baby formula shortage

(Erik S Lesser/EPA-EFE/Shutterstock)

Congress on Thursday passed a measure aimed at helping low-income mothers more easily get baby formula, as lawmakers intensified their scrutiny of failures at the Food and Drug Administration, failures that led to a nationwide shortage of a critical food source for infants and medically fragile children.

The bill, which President Biden is expected to sign, passed unanimously in the Senate and with bipartisan support in the House. It would allow mothers in the Women, Infants and Children program — who buy half the formula in the United States — a broader choice of formulas during supply-chain crises that threaten baby food and formula.

The votes came on a day when FDA Commissioner Robert M. Califf was grilled by members of a House appropriations subcommittee about failures at his agency that contributed to the shortage. The members criticized the FDA for moving too slowly to investigate a whistleblower complaint last year at a baby formula plant in Sturgis, Mich., that makes much of the U.S. supply of powdered formula. The plant was inspected and shuttered only this year after two infants were sickened and two infants died after consuming contaminated formula. Abbott Nutrition, which operates the plant, 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 the FDA is on, on the side of Abbott or the American public?”

Califf told lawmakers his agency is still investigating. He said FDA officials had been working “tirelessly” to increase supplies of baby formula nationally and he expects the Abbott plant to be operating again in one or two weeks.

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Califf said the FDA would prioritize restarting production of Abbott’s EleCare formula, a special product for infants and children who have multiple food allergies, which has been in short supply nationally.

This week, two children were treated at a Tennessee hospital because their parents could not find the specialized formula they need, the hospital said.

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.”

The crisis has put a spotlight on long-running problems at the FDA.

The Food Safety Modernization Act, which was signed into law by President Barack Obama in 2011, infused the FDA with more money to conduct inspections. But the number of inspections has plummeted since then because of limited financial resources and trouble retaining staff, according to some observers. The problem has been exacerbated during the pandemic, said Scott Faber, a food safety expert. “No one who was working on Food Safety Modernization Act ever imagined that inspections would go down, not up.”

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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 told Califf.

The House hearing, which was scheduled previously to discuss the FDA’s funding request and touched on a range of issues including coronavirus vaccines, comes a day after 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. Department of Defense commercial aircraft will also be used to retrieve formula from overseas manufacturers, bypassing traditional cargo routes.

DeLauro expressed concerns about the FDA’s looser guidance for foreign infant formula manufacturers, worried 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.

The Biden administration announced another initiative on Wednesday, launching Operation Fly Formula, which will require that ingredient and packaging producers prioritize fulfilling the requirements of their formula manufacturing customers before any others, so that oils, fat blends, labels, cans and other materials are swiftly made available to baby formula producers. Administration officials also said there would be a crackdown on price gouging or unfair sales practices.

Biden invokes Defense Production Act to boost baby formula supply

On Wednesday, Califf announced a restructuring at the agency, tapping Principal Deputy Commissioner Janet Woodcock to oversee changes at 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 (R-Calif.) suggested 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.”

Brian Ronholm, director of food policy for Consumer Reports, called the appointment of Woodcock, a physician who has held various posts at the agency since 1986, “a disappointing move,” saying that, while she has medical expertise, she has no background in food policy and that “food gets lost in the shuffle.”

“There’s a running joke that the F in the FDA is silent,” Ronholm said. “It’s clear that public confidence in the FDA is eroding.”

A number of food industry groups, he said, are calling on the agency to appoint a deputy food commissioner.

Faber said the FDA’s failure to address the problem’s at Abbott’s Michigan facility is “symptomatic of a bigger failure within the food program,” and that “no one is more frustrated with the FDA than the food industry.”

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 $24 million to optimize inspections. Califf said that due to covid-19, the ability to inspect food manufacturing facilities was disrupted and that this money is needed “to bring our program back on track and to improve its operational readiness [and to] ensure the agency can modernize and execute our inspectional programs effectively.”