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Saturday, November 26, 2022

Biden invokes Defense Production Act to make up for lack of formula

WASHINGTON ( Associated Press) – President Joe Biden invoked the Defense Production Act on Wednesday to accelerate production of infant formula and authorized flights to import supplies from overseas as they face a domestic shortage caused by the nation’s security-related shutdowns. Facing increasing political pressure. Largest formula manufacturing plant.

The Defense Production Act mandates that suppliers of formula manufacturers fulfill orders from those companies before other customers in an effort to eliminate production bottlenecks. Biden is authorizing the Defense Department to use commercial aircraft that meet federal standards in the US from overseas, in what the White House is calling the “Operation Fly Formula.”

The supply of baby formula across the country has been severely cut in recent weeks after being recalled by Abbott Nutrition in February, due to ongoing supply chain disruptions among formula makers, leaving fewer options on store shelves and increasingly Concerned parents are struggling to find nutrition for their children.

“I know parents across the country are concerned 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 announced it was streamlining its review process to make it easier for foreign manufacturers to start shipping more formula to the US.

In a letter to the Department of Health and Human Services and the Department of Agriculture on Wednesday, Biden directed agencies to work with the Pentagon to identify overseas supplies of formula that meet US standards next week, to help Chartered Defense To make the flights of the department faster. fly it to usa

“The import of baby formula will serve as a bridge to this ramped-up production,” Biden wrote.

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

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After getting the OK from the FDA, Abbott said it would take eight to ten weeks for the new products to arrive in stores. The company did not set any deadline for the resumption of manufacturing.

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“I have directed our team to do everything possible to ensure that there is enough safe infant formula and that it is quickly reaching the families who need it most,” Biden said in the statement.

The White House action comes as the Democratic-led House approved two bills on Wednesday that address a lack of baby formula as lawmakers have become a fraught development for many families.

A bill with broad bipartisan support was passed by 414-9 votes. This would give the Secretary of Agriculture the ability to issue a narrow set of exemptions in the event of a supply disruption. The goal is to give participants in a support program commonly known as WIC, the ability to use vouchers to purchase formula from any manufacturer, rather than limiting it to a single brand that may be unavailable. The WIC program accounts for nearly half of infant formula sales in the US

“I want to tell the struggling mother that we hear you in Congress and you don’t need to handle this on your own. We’re working to find you a solution,” said Bill’s sponsor representative Jahanna Hess, D-Conn.

The other measure, a $28 million emergency spending bill to boost resources in the Food and Drug Administration, was passed by a mostly party-line vote of 231–192, and it is unclear whether the Senate will go along.

“The bill continues the Democrats’ strategy of throwing money at the same bureaucrats who created the crisis and who didn’t prioritize solving it,” said Rep. Andy Harris, R-MD.

Rosa Delaro, 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 going on store shelves and get better data on the market.

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“It’s essential that we make sure the federal government has the resources necessary to get baby formula back on the shelves,” said House Speaker Nancy Pelosi, D-Cal..

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

After six weeks of oversight, FDA investigators published a list of problems in March, including lax safety and hygiene 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 specialist to restart and maintain production.

Chicago-based Abbott stresses that its products have not been directly linked to bacterial infections in children. The bacterial samples found in its plant did not match the strains collected by federal investigators from two children.

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

“From the beginning we were limited in our ability to determine with a causal link whether a product was linked to these four cases because we only had two sequences,” said FDA food director Susan Mayne.

According to former FDA officials, it will take time to fix the breaches uncovered at Abbott’s plant. Companies are required to thoroughly sanitize the facility and equipment, re-train employees, repeatedly test and document that there is no contamination.

As part of the FDA’s new import policy, regulators said companies would be required to provide documentation of their factory inspections.

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