Facing tough scrutiny from both Democrats and Republicans, FDA Commissioner Robert Califf ton Thursday told lawmakers the agency has made “significant progress” in working to reopen the closed Abbott baby formula plant that triggered the nationwide shortage, but conceded it will be weeks before the supply gets back to normal.
“I’m pleased to say today we’ve already made significant progress, and I think we are on track to get it open within the next week to two weeks, most likely at the outerbound two weeks,” Califf, testifying virtually, told a House Appropriations subcommittee.
FDA regulators ordered the facility shut down in February after contamination issues at the factory had been linked to four infants being hospitalized with a rare but serious bacterial infection, two of whom ultimately died.
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But even when Abbot, the nation’s largest infant formula manufacturer, does restart operations at its Sturgis, Michigan, facility, it will still take time to ramp up production — six to eight weeks before the product is back on shelves.
Califf was pressed on how soon parents will be able to find the food for their children that they’re desperately seeking.
“It will gradually get better,” he responded, adding, “the big problem we have right now is distribution.”
“The worst problems are in the rural areas because they’re not the major areas that are purchasing these goods and we’re going to have to pay very special attention to that,” Califf said. “So, within days it will get better, but it will be a few weeks before we’re back to normal.”
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Califf’s appearance came just hours after President Joe Biden announced new steps to ramp up the federal response to the crisis, a problem that had been brewing for months.
On Wednesday evening, Biden invoked the Defense Production Act to help expedite domestic manufacturing and allow military aircraft to fly formula into the U.S. from overseas.
House Appropriations Committee chair Rosa DeLauro D-Conn., underscored what she said was the need to “get to the bottom of FDA’s slow response,” which she said contributed to the product going missing on the shelves “and in the homes of families the country over, potentially putting babies at risk and forcing parents to play a game of Russian roulette that they did not know they were playing.”
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“Why did the FDA not spring into action?” DeLauro said, pointing to the time it took for the agency to make the recall of several of Abbott’s brands, following reports of contamination at their plant and allegations of ongoing quality control concerns.
“It makes me question which side the FDA is on,” DeLauro said. “Are they on the side of Abbott, and industry, or on the side of the American consumer, in this case babies and their moms and dads?”
In his opening remarks, Califf recognized American families’ anxieties at the shortage.
“We know many parents and caregivers are feeling frustrated,” Califf said. “This crisis has shown us the impact of having a single manufacturer cease production for a brief period, and unless we strengthen the resilience of our supply chain, we could be one natural disaster or quality mishap or cyber attack from being here again. I hope I can work with this committee to ensure we have the tools and resources we need moving forward.”
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On how much more formula will realistically be imported, given FDA’s announced easing of import restrictions, Califf said his agency is “pulling a bunch of levers just to save time.”
“I do want to point out that right now in the last week we have had more infant formula bought, between 11 and 19 percent, than what was bought in the months before the closure of the plant,” Califf said.
He underscored one of the salient points of the nationwide shortage — that so few manufacturers hold such heavy influence over the baby formula market — with four companies holding responsibility for roughly 90% of the nation’s supply.
This crisis now “exemplifies the problem that we face when we have a concentrated industry where taking out one plant has such an enormous impact. This creates a situation where we have a delicate balance. If conditions are unsafe, how do we get the plant back up and operating without interrupting the supply?” Califf said. “We had to really wrestle this to the ground with Abbott.”
“This crisis has shown us the impact of having a single manufacturer or ceased production for a brief period and unless we strengthen the resilience of our supply chain, we could be one natural disaster quality mishap or cyber attack from being here again,” he said.
Califf lamented what he described as insufficient technology, manpower and funding for his agency to adequately carry out their duties in a fast-paced and high stakes environment, urging the committee fund technology and experts “at least as good as the companies we regulate.”
“The technology and data systems that we have are not of the quality we need for us to fully facilitate innovation and the rapidly moving industry we regulate in order to protect the public from well-meaning or potentially harmful products,” he said.