- The FDA closed the Abbott Nutrition plant in Sturgis, Mich., in February after four infants who drank formula produced there contracted bacterial infections, two of whom died.
- The FDA closed the facility in February — after four infants who drank formula produced there contracted bacterial infections, two of whom died.
- They also criticized the FDA for failing to promptly investigate a whistleblower complaint sent in October that accused the company of numerous safety violations at the plant.
U.S. lawmakers on Thursday grilled Food and Drug Administration Commissioner Dr. Robert Califf about a nationwide baby formula shortage that’s left parents across America scrambling to feed their children, calling the agency’s response a “dereliction of duty.”
“The shortage was caused in large part by the lack of action by the FDA and by corporate greed and consolidation,” said Rep. Rosa DeLauro, D-Conn., during a House Appropriations subcommittee hearing.
Califf is the first FDA official to testify before Congress on the shortage, which has sown fear and frustration among parents across the U.S. and prompted lawmakers from both parties to demand answers.
Lawmakers specifically pointed to the closure of an Abbott Nutrition plant in Sturgis, Michigan, a key infant formula factory that has been linked to the shortage. They also criticized the FDA for failing to promptly investigate a whistleblower complaint sent in October that accused the company of numerous safety violations at the facility, including falsifying records and failing to properly test baby formula before releasing it.
The FDA closed the plant in February — after four infants who drank formula produced there contracted bacterial infections, two of whom died.
The U.S. produces 98% of the baby formula American parents buy. Four manufacturers – Abbott, Mead Johnson Nutrition, Nestle USA and Perrigo – dominate the market. When one plant goes offline, the supply chain is easily disrupted.
DeLauro, chair of the subcommittee, condemned the FDA’s delayed response, noting that the agency only began inspecting the Abbott facility several months after the first case of bacterial infection was reported in September.
“We need to get to the bottom of FDA slow response, which contributed to product staying on the shelf 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 would be playing,” DeLaura said in her opening statement.
Califf said he reviewed the whistleblower complaint but sidestepped questions about whether the FDA should have intervened sooner.
“We have an ongoing investigation about the details of exactly wh at happened, you know, from point A to point B along the way,” Califf said. “Since it is ongoing, I can’t give extensive more details on that part of it.”
Califf acknowledged the frustrations of parents across the U.S. due to the shortage. But he said the issue existed even before the controversy with Abbott, noting that the Covid pandemic, the Russian invasion of Ukraine and labor supply issues have all impacted the infant formula supply chain.
Califf also assured lawmakers that the FDA “has been working tirelessly to address this issue this week.”
This includes ramping up domestic manufacturing, relaxing guidelines for foreign imports and reaching an agreement with Abbott to reopen the Michigan plant. He expects formula supply to improve “within days” but noted it would take weeks before it returns to normal.
Califf pointed to the need for more funding that could bolster the FDA’s regulatory capacities, citing a lack of staff, experts and resources .
He urged lawmakers to approve the FDA’s proposed $8.4 billion in funding for the next fiscal year, which would be $2.1 billion above the current level. Included is $76 million in new funding for food safety and nutrition, money that Califf said would address staffing issues.
“The entire food side of the FDA is understaffed in every category. That’s why in the budget we’ve asked for money to staff up and also to improve the authority for hiring and salaries, just like we have on the medical product side,” Califf said. “This is absolutely essential.”
But lawmakers said the baby formula shortage goes beyond funding and is driven by internal issues within the FDA.
“You have serious structural leadership issues,” DeLauro said. “Someone in this agency needs to have serious and relevant food credentials who understand it because otherwise, food safety will continue to be a second-class citizen at the FDA.”
Rep. Mark Pocan, D-Wis., also slammed Califf for stonewalling questions about the FDA’s response throughout the hearing.
“It’s not acceptable to say you just can’t comment on it,” said Pocan. “This is a problem I’ve seen over and over with the FDA: You guys aren’t good at communicating.”
The hearing comes one day after President Joe Biden invoked the Defense Production Act to boost the supply of baby formula, requiring suppliers to direct ingredients used in baby formula to key manufacturers. The president also launched a program that will use U.S. military aircraft to import formula from foreign manufacturers.
The hearing also comes hours after the House passed two bills aimed at combating the shortage. The main piece of legislation, sponsored by DeLauro, would provide $28 million in emergency funding to the FDA to bolster inspections of formula made at foreign plants and prevent future shortages.
— CNBC’s Spencer Kimball contributed to this article.
Source: Business - cnbc.com
