Biden invokes Defense Production Act over shortage of formulas

WASHINGTON (AP) — President Joe Biden on Wednesday invoked the Defense Production Act to speed up production of infant formula and authorized flights to import supplies from overseas, as he faces pressure growing policy in the face of a domestic shortage caused by the country’s security-related shutdown. largest formula manufacturing facility.

The Defense Production Act ordinance requires formula manufacturers’ suppliers to fulfill orders from these companies ahead of other customers, in an effort to eliminate production bottlenecks. Biden also authorizes the Department of Defense to use commercial aircraft to transport federally-compliant formula supplies from overseas to the United States, in what the White House calls “Operation Fly Formula.”

The supply of formula milk across the country has been severely reduced in recent weeks after a February recall by Abbott Nutrition exacerbated ongoing supply chain disruptions among formula manufacturers, leaving fewer options on store shelves and increasingly anxious parents struggling to find food for their children.

The announcement comes two days after the Food and Drug Administration said it was streamlining its review process to make it easier for foreign manufacturers to start shipping more preparations to the United States.

In a letter Wednesday to the Department of Health and Human Services and the Department of Agriculture, Biden directed the agencies to work with the Pentagon to identify the overseas supply of U.S.-standard formula during next week, so Department of Defense charter flights can quickly fly to the United States

“Imports of infant formula will serve as a bridge to this accelerated production,” Biden wrote.

Regulators said Monday they had reached an agreement to allow Abbott Nutrition to restart its Sturgis, Michigan plant, the nation’s largest formula plant, which has been closed since February due to contamination concerns. The company should revise its safety protocols and procedures before resuming production.

After getting clearance from the FDA, Abbott said it would take eight to 10 weeks before new products start hitting stores. The company has not set a timetable for restarting manufacturing.

Abbott’s voluntary recall was triggered by four reported illnesses in babies who had consumed formula from its factory. All four infants were hospitalized with a rare type of bacterial infection and two died.

After a six-week inspection, FDA investigators released a list of issues in March, including lax safety and health standards and a history of bacterial contamination in several parts of the plant. Under Monday’s agreement, Abbott must regularly consult with an outside safety expert to restart and maintain production.

Chicago-based Abbott stressed that its products were not directly linked to bacterial infections in children. Bacteria samples found at his factory did not match strains taken from two babies by federal investigators.

But FDA officials pushed back on that reasoning Monday during a call with reporters — the first time they’ve publicly addressed the company’s argument. FDA staff members noted that they were unable to collect bacterial strains from two of the four patients, limiting their chances of finding a match.

“From the outset, we were limited in our ability to causally determine if the product was related to these four cases because we only had sequences out of two,” said FDA food director Susan Mayne.

Fixing violations found at Abbott’s plant will take time, according to former FDA officials. Companies must thoroughly clean the facility and equipment, retrain personnel, test repeatedly, and document that there is no contamination.

Under the FDA’s new import policy, regulators said companies would have to provide documentation of their factory inspections.

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