Biden invokes Defense Production Act to alleviate baby formula shortage
President Biden has invoked the Defense Production Act to speed production of infant formula and has authorized flights to import supply from overseas.
President 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 to fulfill orders from formula manufacturers 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 diminished in recent weeks after a February recall by Abbott Nutrition exacerbated ongoing supply chain disruptions, leaving fewer options on store shelves and increasingly anxious parents struggling to find nutrition for their young 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 as a grandparent, I know just how stressful that is.”
The president’s 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, Biden directed the Departments of Health and Human Services and Agriculture to work with the Pentagon over the next week to identify overseas supplies that meet U.S. standards, so chartered Defense Department flights can swiftly fly them to the United States.
“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, Mich., factory, 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.
Abbott said it would take eight to 10 weeks for its formula to begin arriving in stores. The company didn’t set a timeline to restart manufacturing.
Low-income families are struggling to feed their infants amid the national shortage. A plant shutdown and supply chain issues are to blame.
“I’ve directed my team to do everything possible to ensure there’s enough safe baby formula and that it is quickly reaching families that need it the most,” Biden said in his statement, calling it “one of [his] top priorities.”
The White House actions come as the Democratic-led House approved two bills Wednesday addressing the baby formula shortage.
One bill passed by a vote of 414 to 9. It would allow the secretary of Agriculture 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.
“I want to say to the mom struggling that we hear you in Congress and you do not need to handle this on your own. We are working to find you a solution,” said the bill’s sponsor, Rep. Jahana Hayes (D-Conn.).
The other measure, a $28-million emergency spending bill to boost resources at the FDA, passed by a mostly party-line vote of 231 to 192, and it’s unclear whether the Senate will go along.
“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 (D-Conn.), 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 of them 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 infants’ bacterial infections. Samples of bacteria found at its plant did not match the strains collected from two babies by federal investigators.
But the FDA challenged that reasoning Monday, publicly addressing the company’s argument for the first time in a call with reporters. FDA staffers noted they were unable to collect bacterial strains from two of the four patients, limiting their chances of finding a match. “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,” said Susan Mayne, the FDA’s food director.
Fixing the violations at Abbott’s plant will take time, according to former FDA officials. The company will need to exhaustively clean the facility and equipment, retrain staff and repeatedly test and document that there is no contamination.
As part of the FDA’s new import policy, regulators said overseas companies would need to provide documentation of their factory’s inspections.
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