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Biden invokes the Defense Production Act to speed up baby formula manufacturing

Biden invokes the Defense Production Act to speed up baby formula manufacturing 2

President Biden invoked the Defense Production Act on Wednesday evening to boost baby formula production and issued a directive for planes to bring in supplies from overseas, after growing pressure from Congress. 

In addition to invoking the Cold War-era law to compel suppliers to direct resources to infant formula manufacturers before any other customer, Biden announced ‘Operation Fly Formula,’ which will direct Defense Department and U.S. Department of Agriculture (USDA) and Health and Human Services (HHS) resources to getting planes loaded with formula that meets FDA safety standards from other countries to bring it to American parents. The Defense Department will use its contracts with commercial airlines to transport the formula back to the U.S. 

Earlier Wednesday a bipartisan group in the House is brought forth a resolution imploring Biden to invoke the Defense Production Act.

Twenty members of the House, eighteen Democrats, two Republicans, and many who face competitive re-election races, co-sponsored the resolution, led by Rep. Josh Gottheimer, D-N.J.

Co-sponsors include Reps. Elissa Slotkin (D-Mich.), Mikie Sherrill (D-N.J.), Elaine Luria (D-Va.) and Chris Pappas (D-N.H.), and others. It has two Republican backers as well: Reps. Don Bacon (R-Neb.) and Maria Salazar (R-Fla.)

The resolution joins several other pieces of legislation, including one bill from a bipartisan group of senators led by Marco Rubio that would order Biden to invoke the DPA and approve the sale of European-produced baby formulas in the U.S. 

Critics have noted that the FDA has rigid labeling standards for containers that prohibit the sale of many European-made products, even if the content itself is deemed safe to consume. The agency also strictly enforces a 90-day waiting period before any new infant formula is allowed into interstate commerce. 

Biden wrote in a letter to HHS Sec. Xavier Becerra and USDA Sec. Tom Vilsack: 

‘Imports of baby formula will serve as a bridge to this ramped up production, therefore, I am requesting you take all appropriate measures available to get additional safe formula into the country immediately.

President Biden invoked the Defense Production Act on Wednesday evening to boost baby formula production and issued a directive for planes to bring in supplies from overseas, after growing pressure from Congress.

President Biden invoked the Defense Production Act on Wednesday evening to boost baby formula production and issued a directive for planes to bring in supplies from overseas, after growing pressure from Congress.

‘Specifically, I request that you work expeditiously to identify any and all avenues to speed the importation of safe infant formula into the United States and onto store shelves.’

On Monday, Sen. Kirsten Gillibrand had sent a letter to President Biden urging him to invoke the DPA.  

House Speaker Nancy Pelosi brushed past the idea on Sunday, claiming that it is not legally possible to invoke the DPA for baby formula.

While she said Congress should change the law, she focused on two other pieces of legislation– one the House plans to vote on Wednesday that would allow the Supplemental Nutrition Assistance Program for Women, Infants, and Children (WIC) to cover more brands of formula and another that would provide $28 million in emergency aid. 

Asked if Biden should invoke the DPA on Sunday, the speaker said: ‘I think so but as the law is now it is not possible to do that.’ 

‘[Appropriations chair Rosa DeLauro] feels quite certain that we have to change the law in order for the Defense Production Act to be called into play,’ she added. 

Twenty members of the House, eighteen Democrats, two Republicans, and many who face competitive re-election races, co-sponsored the resolution, led by Rep. Josh Gottheimer, D-N.J.

Twenty members of the House, eighteen Democrats, two Republicans, and many who face competitive re-election races, co-sponsored the resolution, led by Rep. Josh Gottheimer, D-N.J.

A nearly empty baby formula display shelf is seen at CVS pharmacy on May 17, 2022 in Falls Church, Virginia

A nearly empty baby formula display shelf is seen at CVS pharmacy on May 17, 2022 in Falls Church, Virginia

Outgoing White House press secretary Jen Psaki said the DPA was an option, but the White House was not yet sure it would be helpful. ‘You have to ensure that it would actually achieve what you’re trying to achieve,’ she said of using the act.

When asked about invoking the DPA on Monday, the White House’s new press secretary Karine Jean-Pierre said: ‘We’re leaving no stone unturned and every option is on the table, as we have been saying for the past several days.’

Biden most recently used the 1950 Defense Production Act to ramp up production of critical minerals. The act allows the federal government to compel certain industries to ramp up production in times of national emergency. 

The act was used to ramp up production of large capacity batteries, electric vehicles and the energy sector, both to reduce reliance on China amid increasing tensions and to address rising oil prices amid the Russian invasion of Ukraine. Russia is a major supplier of such minerals. 

Trump used the DPA at the height of the pandemic to crack down on hoarding of PPE, limit exports of medical goods and to increase production of tools to fight Covid-19 like ventilators. Biden has also used it to speed up vaccinations and testing. 

An Abbott Nutrition manufacturing plan in Sturgis, Michigan shuttered in February after four infants who drank its formula were hospitalized with a rare bacteria infection. Two babies died after consuming the product, and the Food and Drug Administration (FDA) announced an investigation into potential contamination. 

Abbott has acknowledged that is recall has worsened the formula shortage, but insisted that ‘after a thorough review of all available data, there is no evidence to link our formulas to these infant illnesses.’ 

The shortage began in November, when the out-of-stock rate for formula was about 11 percent for the country. On average 40 percent of the nation's baby formula is currently out of stock. Shortages are above 50 percent in some areas and the issue is hitting children with allergies and health conditions more severely

The shortage began in November, when the out-of-stock rate for formula was about 11 percent for the country. On average 40 percent of the nation’s baby formula is currently out of stock. Shortages are above 50 percent in some areas and the issue is hitting children with allergies and health conditions more severely

The shortage began in November, when the out-of-stock rate for formula was about 11 percent for the country.  

On average 40 percent of the nation’s baby formula is currently out of stock. Shortages are above 50 percent in some areas and the issue is hitting children with allergies and health conditions more severely.

President Biden’s home state of Delaware is second hardest-hit by the shortage– formula was 54.4 percent out of stock there, according to Datasembly, a grocery and retail pricing data firm. 

Biden on Friday suggested it would have taken a ‘mind reader’ to predict the baby formula shortage.

‘If we’d been better mind readers, I guess we could have,’ Biden said when asked if his administration should have acted sooner.

‘We’re going to be in a matter of weeks – or less – getting significantly where more formula is on shelves,’ he said.

Abbott reached an agreement with the FDA this week that could see its products restocked in about two months, after it reopens its Sturgis plant. 

Abbott said its tentative timeline to reopen the plant was in about two weeks, and products to be restocked in about six to eight weeks.  

FDA commissioner Dr. Robert Califf said he thought the timeline was doable, but refused to commit to when parents could see relief. 

‘We believe those timeframes are reasonable,’ adding that the FDA expected supply to normalize ‘in the next couple of months.’ 

TIMELINE SHOWS HOW AMERICA’S LARGEST BABY FORMULA PLANT CEASED PRODUCTION

Abbott Laboratories, the biggest baby formula supplier in the U.S., ceased production at its Michigan plant in February 2022 amid reports of fatal bacterial infections.

A timeline of events shows reveals the shut down was the plant had previously been under scrutiny by the U.S. Food and Drug Administration (FDA).

September 2021: The FDA conducted a four-day inspection of the Abbott Laboratories plant in Sturgis, Michigan.

The inspection report revealed the plant ‘did not maintain’ clean and sanitary conditions in at least one building that manufactured, processed, packaged or held baby formula.

FDA officials also observed poor hand washing among Abbott plant staff who ‘worked directly with infant formula.’

The FDA also noted an instance of improper equipment maintenance and temperature control. 

October 2021: A whistleblower sends the FDA a 34-page document outlining potential concerns with the Sturgis plant. 

The document, which was made public by Congresswoman Rosa DeLauro in April 2022, was written by a former plant employee. 

The employee accused the plant of lax cleaning practices, falsifying records, releasing untested infant formula, and hiding information during an FDA audit in 2019, among other issues. 

January – March 2022: The FDA conducted multiple inspections at the Sturgis plant over the course of three months in 2022. A ten-page inspection report revealed multiple violations at the facility.

The agency alleged the plant failed to ensure that all surfaces that contact infant formula were maintained to prevent cross-contamination.

The report states the facility ‘did not establish a system of process controls’ to ensure the baby formula ‘does not become adulterated due to the presence of microorganisms in the formula or the processing environment.’

Officials also alleged the plant failed to disclose in an investigation report whether a health hazard existed at the facility.

Additionally, the report stated plant workers were did not wear the ‘necessary protective material’ when working directly with infant formula.

February 17: U.S. health officials urgently warn parents against using three popular baby formulas manufactured at the Abbott plant in Michigan. Investigators claim the products were recently linked to bacterial contamination after an infant died and three others fell ill.

Abbott voluntarily recalled several major brands and shut down its Sturgis plant. 

The FDA also said it is investigating four reports of infants who were hospitalized after consuming the formula, including one who died.

February 28: Abbott Laboratories expanded its recall of Similac baby formulas after a second infant who was exposed to the powdered baby formula died.

April 15: Abbott releases a statement alleging it is working closely with the FDA to restart operations at the Sturgis plant. 

Week of April 24: The nationwide share of out-of-stock baby formula hit 40 percent. Texas, Tennessee, Missouri, Iowa, North Dakota and South Dakota, seemingly hardest hit by the shortages, reported out-of-stock rates of about 50 percent.

May 10: Abbott releases a statement to DailyMail.com claiming ‘thorough investigation’ by the FDA and Abbott revealed ‘infant formula produced at our Sturgis facility is not the likely source of infection in the reported cases and that there was not an outbreak caused by products from the facility’.

Abbott claims they are ‘working closely with the FDA to restart operations’ at the plant, with the spokesperson noting: ‘We continue to make progress on corrective actions and will be implementing additional actions as we work toward addressing items related to the recent recall’.

The FDA told DailyMail.com it was holding discussions with ‘Abbott and other manufacturers to increase production of different specialty and metabolic products’ but refused to say when the Sturgis plant could reopen.

Sen. Mitt Romney issued a letter to the FDA and U.S. Department of Agriculture (USDA) urging leaders to address the formula shortage and work to prevent future threats to infant health.

May 11: Lawmakers on Capitol Hill announce plans to hold a hearing in two weeks on infant formula shortages.

Abbott announced it would take up to ten weeks for the company to get baby formula to retailers once the Sturgis plant reopens.

Abbott also said: ‘After a thorough review of all available data, there is no evidence to link our formulas to these infant illnesses.’

May 12: White House Press Secretary Jen Psaki defends the government’s closure of the Abbott plant.

President Joe Biden met with executives from infant formula manufactures and retailers to address the shortage.

May 13: Biden addresses the formula crisis during a press briefing, saying: ‘We’re going to be, in a matter of weeks or less, getting significantly more formula on shelves.’ 

The FDA announced it was working to streamline a process that will get more products to consumers – while also meeting safety, quality and labeling standards 

May 16: Abbott and the FDA reach agreement to reopen baby formula facility in Michigan.

However, the FDA has yet to disclose a timeframe for allowing the plant to resume production. 

The FDA also implemented new measures, in effect for 180 days, to increase imports of baby formula produced overseas.

May 18: Biden invoked the Defense Production Act to boost baby formula production and issued a directive for planes to bring in supplies from overseas, after growing pressure from Congress.  

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