David J. Phillip/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 mounting political pressure amid a domestic shortage caused by the closure for safety reasons of the country’s largest infant formula manufacturing plant.
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.
“I know parents across the country are worried about finding enough formula to feed their babies,” Biden said in a video statement released by the White House. “As a parent and grandparent, I know how stressful it is.”
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.
“I have asked my team to do everything possible to ensure that there is enough safe formula and that it quickly reaches the families who need it most,” Biden said in the statement, calling it “one of my top priorities”.
The White House actions come as the Democratic-led House is expected to approve two bills on Wednesday addressing formula shortages as lawmakers seek to show progress on what has become a frightening development for many families. .
A bill that is expected to have broad bipartisan support would give the Secretary of the Department of Agriculture the ability to issue a narrow set of waivers in the event of a supply disruption. The aim is to give participants in an aid program commonly referred to as WIC the ability to use vouchers to purchase infant formula from any producer rather than being limited to one brand which may not be available. . The WIC program accounts for about half of U.S. infant formula sales
The other measure, a $28 million emergency spending bill to boost Food and Drug Administration resources, is expected to have less bipartisan support and it’s unclear whether the Senate will vote for it. will adopt.
“It sends more FDA staff to an issue that needs more production, not more FDA staff,” said Rep. Bill Huizenga, R-Mich.
Rep. Rosa DeLauro, Democratic chair of the House Appropriations Committee, said the money would increase FDA staff to strengthen inspections of domestic and international suppliers, keep fraudulent products off store shelves and acquire better market data.
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 security 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.