Under fire from both Democrats and Republicans, FDA Commissioner Robert Califf testified before Congress on Thursday that the agency has made “substantial progress” in reopening the Abbott baby formula plant that caused the statewide shortage, but that it will be weeks before supplies are restored.
Califf told a House Appropriations subcommittee, “I’m delighted to tell that we’ve already made substantial progress, and I believe we’re on pace to open it within the next week to two weeks, most likely at the outerbound two weeks.”
After contamination issues at the factory were connected to four infants being hospitalised with a rare but serious bacterial infection, FDA officials ordered the facility shut down in February.
Even if Abbot, the nation’s largest infant formula manufacturer, restarts operations at its Sturgis, Michigan, facility, it will take six to eight weeks to build up production and get the product back on stores.
When asked how fast parents will be able to find the nourishment their children need, Califf said it depends on the situation.
“It will get better,” he said, adding, “right now the primary challenge we have is distribution.”
“The hardest challenges are in rural areas since they aren’t the major purchasers of these things, and we’ll have to pay very close attention to that,” Califf added. “So it’ll get better in a few days, but it’ll be a few weeks before we’re back to normal.”
Californiaf’s appearance occurred only hours after President Joe Biden announced fresh initiatives to strengthen the federal response to the issue, which had been building for months.
Biden used the Defense Production Act on Wednesday evening to assist speed up domestic manufacturing and allow military planes to fly formula in from overseas.
House Appropriations Committee Chair Rosa DeLauro, D-Conn., emphasised the need to “get to the bottom of FDA’s slow response,” which she claimed contributed to the product disappearing from shelves “and in the homes of families across the country, potentially putting babies at risk and forcing parents to play a game of Russian roulette they didn’t realise they were playing.”
“How come the FDA didn’t act sooner?” DeLauro cited the time it took the FDA to issue a recall for multiple Abbott brands after reports of contamination at their plant and charges of persistent quality control issues.
DeLauro added, “It makes me wonder which side the FDA is on.” “Are they on Abbott’s and industry’s side, or are they on the side of the American consumer, in this case babies and their parents?”
Califf acknowledged American families’ concerns about the shortage in his opening remarks.
“We understand that many parents and caregivers are frustrated,” said Califf. “This crisis has demonstrated the consequences of having a single manufacturer stop production for a short amount of time, and unless we increase the resilience of our supply chain, we may be here again in a natural disaster, a quality incident, or a cyber assault. I want to be able to collaborate with this committee in order to ensure that we have the tools and resources we require moving forward.”
Given the FDA’s promised loosening of import limitations, Califf said his agency is “pulling a bunch of levers merely to save time” on how much more formula will truly be imported.
“I do want to stress out that in the last week, we have had between 11 and 19 percent more infant formula purchased than in the months leading up to the plant’s closure,” Califf said.
He emphasised one of the key aspects of the statewide shortage: that only a few manufacturers wield such power over the baby formula business, with four companies accounting for about 90% of the country’s supply.
This situation “exemplifies the problem we face when we have a concentrated industry where the loss of a single plant has such a massive impact.” As a result, we find ourselves in a fragile balance. How do we get the facility back up and running without disrupting the supply if the conditions are unsafe?” According to Califf. “With Abbott, we had to really wrestle this to the ground.”
“This crisis has demonstrated the consequences of having a single manufacturer or temporarily halting production,” he added. “Unless we increase the resilience of our supply chain, we might be one natural disaster, quality error, or cyber attack away from being here again.”
Califf bemoaned his agency’s lack of technology, staff, and budget for carrying out its obligations in a fast-paced, high-stakes environment, imploring the committee to invest technology and specialists “at least as excellent as the corporations we supervise.”
“We don’t have the technology and data infrastructure we need to fully facilitate innovation and the swiftly moving industry we govern in order to safeguard the public from well-intentioned but potentially hazardous products,” he said.