FDA Commissioner Robert Califf expects shortage to end within two months

Shelves normally for infant formula lie nearly empty at a store in downtown Washington, DC on May 22, 2022.

Samuel Corum | AFP | Getty Images

Food and Drug Administration Commissioner Dr. Robert Califf told lawmakers on Thursday that it will be until July before store shelves across the country are once again stocked with infant formula.

“It’s going to be a gradual improvement until about two months or so until the shelves are full again,” Califf said in testimony before the Senate Health, Education, Labor Committee. and pensions.

Abbott plans to resume production at its Sturgis, Michigan plant on June 4, and it will begin shipping its specialty EleCare formula on June 20. The company previously said it would take six to eight weeks for its formula to hit stores. once production has restarted.

The FDA has eased import restrictions to allow foreign manufacturers to send formula to the United States, and the Department of Defense is airlifting the equivalent of 1.5 million bottles of formula from the United States. ‘Europe.

Abbott closed the plant and recalled several infant formulas in February after FDA inspectors found Cronobacter bacteria in the facility. The plant’s closure and recall triggered a nationwide baby formula shortage, forcing some parents to drive for hours to find food for their infants.

Four manufacturers – Abbott, Mead Johnson Nutrition, Nestlé USA and Perrigo – control 90% of the domestic infant formula market in the United States. Abbot alone holds 40% of the US infant formula market. The Michigan plant is responsible for 40% of the company’s US production.

Infant formula has become increasingly scarce over the past year as the Covid pandemic disrupted supply chains and families stocked up on infant formula. However, one-time shortages in some parts of the country turned into a national crisis about a month ago as parents resumed stocking up on formula in response to Abbott’s recall, Califf said.

“We knew shutting down plant operations would create supply issues, but we had no choice given the unsanitary conditions,” Califf told lawmakers.

FDA inspectors found shocking conditions inside the plant, including bacteria growing from multiple sites, standing water, roof leaks and inadequate sanitation, he said. declared.

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Four infants who consumed plant-based formula fell ill with Cronobacter infections, two of whom died. However, the FDA and the Centers for Disease Control and Prevention have not found a link between childhood illnesses and the bacteria found in the plant, Califf said.

Still, the plant cannot reopen until Abbott takes hundreds of steps to meet the requirements of a federal consent decree to comply with U.S. food safety standards.

“You can’t just crack open a plant with bacteria growing in it,” Califf said.

“Would you go to a nearby kitchen if there was bacteria growing everywhere, standing water and people walking around with mud on their feet?” he asked lawmakers.

The senators criticized the FDA for taking too long to physically inspect the plant after receiving reports of contamination at the facility. The FDA first received a report in September that an infant who had consumed formula from the Michigan plant had become ill with a Cronobacter infection.

A whistleblower sent a complaint to the FDA in October about lax practices and regulatory violations at the plant. However, the FDA did not inspect the plant until late January.

Califf acknowledged that the FDA responded too slowly to the whistleblower’s complaint and took too long to conduct an inspection. Although the FDA received the whistleblower’s complaint in October, it was not escalated up the agency’s hierarchy until February.

“The [are] systemic issues at the FDA and in our interactions with industry and our authorities that need to be corrected,” Califf told lawmakers.

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