President Joe Biden on Wednesday invoked the Defense Production Act to speed production of infant formula and authorized flights to import supply from overseas, as he faces mounting political pressure over a domestic shortage caused by the safety-related closure of the country’s largest formula manufacturing plant.
The Defense Production Act order requires suppliers of formula manufacturers to fulfill orders from those companies before other customers, in an effort to eliminate production bottlenecks. Biden is also authorizing the Defense Department to use commercial aircraft to fly formula supplies that meet federal standards from overseas to the U.S., in what the White House is calling “Operation Fly Formula.”
Supplies of baby formula across the country have been severely curtailed in recent weeks after a February recall by Abbott Nutrition exacerbated ongoing supply chain disruptions among formula makers, leaving fewer options on store shelves and increasingly anxious parents struggling to find nutrition 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 begin shipping more formula into the U.S.
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 overseas supply of formula that meets U.S. standards over the next week, so that chartered Defense Department flights can swiftly fly it to the U.S.
“Imports of baby formula will serve as a bridge to this ramped-up production,” Biden wrote.
Regulators said Monday that they’d reached a deal 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 issues. The company must overhaul its safety protocols and procedures before resuming production.
After getting the FDA’s OK, Abbott said it will take eight to ten weeks before new products begin arriving in stores. The company didn’t set a timeline to restart manufacturing.
The White House actions come as the Democratic-led House is expected to approve two bills Wednesday addressing the baby formula shortage as lawmakers look to show progress on what has become a frightening development for many families.
One bill expected to have wide 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 goal is to give participants in an assistance program commonly known as WIC the ability to use vouchers to purchase formula from any producer rather than be limited to one brand that may be unavailable. The WIC program accounts for about half of infant formula sales in the U.S.
The other measure, a $28 million emergency spending bill to boost resources at the Food and Drug Administration, is expected to have less bipartisan support and it’s unclear whether the Senate will take it up.
“This is throwing more FDA staff at a problem that needs more production, not more FDA staff,” said Rep. Bill Huizenga, R-Mich.
Rep. Rosa DeLauro, the Democratic chair of the House Appropriations Committee, said the money would increase FDA staffing to boost inspections of domestic and international suppliers, prevent fraudulent products from getting onto store shelves and acquire better data on the marketplace.
Abbott’s voluntary recall was triggered by four illnesses reported in babies who had consumed powdered formula from its plant. All four infants were hospitalized with a rare type of bacterial infection and two died.
After a six-week inspection, FDA investigators published a list of problems in March, including lax safety and sanitary 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 has emphasized that its products have not been directly linked to the bacterial infections in children. Samples of the bacteria found at its plant did not match the strains collected from two babies by federal investigators.
But FDA officials pushed back on that reasoning Monday on a call with reporters — their first time publicly addressing the company’s argument. FDA staffers noted they were unable to collect bacterial strains from two of the four patients, limiting their chances of finding a match.
“Right from the get-go we were limited in our ability to determine with a causal link whether the product was linked to these four cases because we only had sequences on two,” FDA’s food director Susan Mayne said.
Fixing the violations uncovered at Abbott’s plant will take time, according to former FDA officials. Companies need to exhaustively clean the facility and equipment, retrain staff, repeatedly test and document there is no contamination.
As part of the FDA’s new import policy, regulators said companies would need to provide documentation of their factory’s inspections.