‘We never want to have this happen again,’ FDA official testifies about formula shortage


In a rare moment of bipartisan agreement, lawmakers Thursday heavily criticized the US Food and Drug Administration for its handling of infant formula shortages.

The hearing of the US House Oversight and Accountability Subcommittee on Health Care and Financial Services was one of several Congress has held recently to better understand the formula’s shortfall and figure out how to prevent more problems down the road.

repealed. Lisa McClain, R-Michigan, said the FDA has not been fully upfront with Congress and the public.

“Why Wasn’t The FDA Prepared For The Crisis?” she asked in her opening statement.

She said the agency failed to prioritize food safety. “The FDA has not taken the necessary action to prevent a similar crisis from happening again.”

repealed. Katie Porter, D-Calif., said she agreed with McClain that there could be another shortfall, “and it’s a deadly serious problem.”

“There’s a lot of blame to go around,” Porter said. “It’s clear from today’s witness selection that Republicans want to blame the FDA, and I’ll lay level with you, I think some of the blame is well placed. We already have two post-baby formulas in 2023.” There are recalls, and we’re still looking at where the FDA can make further improvements to internal processes, intervene sooner in issues, and conduct more oversight to prevent further contamination.

The three major manufacturers control more than 90% of the formula market in the US, and this consolidation is a “serious concern” that “contributed significantly to the shortage,” Dr. Susan Mayne, director of the FDA’s Center for Food Safety and Applied Nutrition, testified Thursday.

The shortage, which began in 2021, was compounded when Abbott Nutrition, the nation’s largest infant formula maker, recalled several products in mid-February 2022 after FDA inspectors found potentially dangerous bacteria at its plant in Sturgis, Michigan. Production had to be halted.

The plant inspection was linked to an outbreak of Cronobacter sakazakii, which sickened at least four infants and killed two, although investigations found a genetic link between samples of bacteria from the facility and bacteria found in the water and powder. Couldn’t find what mixed the formula. The babies had eaten.

Mayne testified that it was difficult to trace cases and determine how large an outbreak was of concern. The bacteria is a common pathogen in the environment “but about which we have limited information.”

The FDA has urged the US Centers for Disease Control and Prevention to make Cronobacter infection a notifiable disease — meaning providers would be required to report cases to local or state public health officials — so public health experts are more Will be able to determine the source quickly. any contamination.

In addition to bacteria, an FDA inspection of the Sturgis plant found unhygienic conditions and numerous violations of food safety regulations.

A whistleblower alerted the FDA to alleged safety lapses at the plant in February 2021, months before Abbott’s formula was recalled. The complaint suggested that the plant lacked proper cleaning practices and that workers falsified records and hid information from inspectors.

Like other FDA leaders who have been called before Congress, Maine testified that he was not immediately made aware of the complaint. He called it a “failure to scale up”.

“I wish I had been made aware of this particular whistleblower complaint, but just to reiterate, the complaint was acted upon,” Mayne said. However, she said, it was “less than ideal” how quickly the FDA inspection of the plant took place and how quickly the agency was able to act.

When the whistleblower complained, there was no process within the FDA to escalate it. The process has since changed so that if a complaint meets certain criteria involving a vulnerable population, hospitalization or death, leadership will be notified immediately. If a consumer complaint involves infant death or hospitalization, it is immediately escalated to the leadership.

To prevent future shortages, Maine testified, it won’t just be the FDA that needs to change. He added that the industry should do more to adopt advanced food safety measures to provide the “safest possible” infant formula.

The agency would also like better rules. There have already been two infant formula recalls in 2023, and in neither case the manufacturer was required to notify the FDA that it found contamination before the formula left the plant.

The FDA has asked formula makers to notify the agency about positive tests, but such reporting is only voluntary. If it were mandatory, the FDA could learn about problems in real time and take action.

“Our food safety specialists, our compliance specialists can work with manufacturers,” Mayne said. With this kind of collaboration, they can quickly identify which products to focus on to prevent shortages.

The FDA has taken recent steps to improve. In February, it announced that it was restructuring its food department to make it more accountable and that it was creating an Office of Vital Foods. Mayne said the FDA is also hiring specialized infant formula inspection staff.

That said, infant formula supplies are generally in good shape, but there are still some distribution issues.

The in-stock rate is near 90%, well above pre-recall levels. But some rural areas are having difficulty getting all the needed formula.

Mayne said formula makers are producing more than is being purchased week-to-week to increase supply. The Biden administration has also worked to bring formula from manufacturers abroad.

But another shortfall isn’t out of the question, especially if one of the country’s leading manufacturers is taken offline for any significant amount of time.

“We don’t want that again,” Mayne said.

Lawmakers Propose Significant Cut of Nearly 22% to FDA’s Budget for 2023. Mayne said consumers and industry would be “adversely affected” if the cuts were to go through.

“Broadly speaking, across the FDA, I can say it will be catastrophic,” she said, resulting in a loss of 32% of domestic inspections and 22% of foreign inspections. The cuts would also adversely affect its food programs, which get most of their funding from the budget, unlike drug-related divisions that receive money from user fees.

“We will be unable to do what I think American consumers expect us to do,” Mayne said.

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