Former FDA official reveals how the agency caused the infant formula crisis

Former FDA official reveals how the agency caused the infant formula crisis

The FDA “dropped the ball” on the nation’s infant formula crisis – closing a crucial factory on top of product recalls and not warning parents of the ramifications, experts told the Post on Friday.

Desperate moms and dads have been scouring stores across the country for formula milk since mega-maker Abbott issued a safety recall in February for products made at its Sturgis, Michigan plant due to issues contamination.

The Food and Drug Administration later closed the plant after federal inspectors found that Abbott failed to maintain sanitary conditions and procedures there, causing a cascade of crippling effects on the supply chain.

“Somebody, whether it’s Abbott or the FDA, should have realized, ‘We’re shutting down production at one of the few factories that’s making formula and what the repercussions are of that,'” William Marler said. a lawyer specializing in food – security cases, at La Poste.

“This is where the FDA and Abbott dropped the ball. … They could have recalled the product without shutting down the facility. They do reminders all the time without shutting down the facility.

Manhattan mum Amy Daly, 38, of the Upper West Side, lamented on Friday that she was forced to take her 11-month-old baby Alice off infant formula early when the shortage hit.

Former FDA associate commissioner Peter Pitts criticized the agency for failing to warn parents of the impending shortage of infant formula.
Paul Hennessy/SOPA Images/LightRocket via Getty Images

“People are desperate. … It’s a real crisis. Moms are in need,” she said.

“The administration should have known the shortage was coming and did something to prevent it — or at least gave moms more warning,” Daly said, standing in a playground about a block away. a Duane Reade with his shelves of baby formula now completely naked.

On Friday, President Biden, who has been hammered by criticism over his handling of the crisis, claimed that only “better mind readers” could have been more effective than his administration and the FDA in dealing with the dire situation.

Former FDA Associate Commissioner Peter Pitts
Former FDA associate commissioner Peter Pitts pointed out that the agency was aware of the baby shortage as early as February.
Public interest medical center.

His offhand comment came the day after the White House announced that it would finally start clearing the way for infant formula imports from overseas, several months after the plant closed.

“Some products come from overseas, but US red tape prevents much-needed supply,” Wall Street Journal opinion writer James Freeman said Friday.

“Every time this issue pops up in the news cycle, all the Biden team and their allies on Capitol Hill do is call for further investigation of the cases.

“Now the President wants the Federal Trade Commission to seek evidence of price gouging and House Democrats want testimony from formula makers. How about investigating the FDA and letting the people who can make baby formula feed starving newborns? »

Peter Pitts — former associate commissioner of the FDA and current director of the Center for Medicine in the Public Interest — told the Post that the agency “knew this shortage situation was coming.

“They should have educated parents, give them advance warning, let them know how to prepare,” he said. “The result is that one day the parents go to the store and the shelves are empty – and they panic.

“The White House doesn’t care about that,” Pitts added bluntly.

Outgoing White House press secretary Jen Psaki was no more helpful than her boss when asked on Friday how long shortages are expected to be a problem.

“Really important question, but difficult for us to make an assessment,” she said.

She even claimed during a Thursday briefing that the FDA made the right choices all along because “there were babies who died taking this formula.”

Jen Psaki holds her final briefing as White House Press Secretary at the White House in Washington, DC, United States, May 13, 2022.
White House press secretary Jen Psaki argued that the Biden administration had seen no warning signs of a formula shortage.
EPA / Oliver Contreras / SWIMMING POOL

Abbott strongly denied that any of his factory’s products killed infants, let alone made them sick.

FDA Commissioner Dr. Robert Califf said in a tweet on Friday that the government’s efforts to help other companies ramp up production and increase imports from overseas should ease the shortage in “a few weeks”.

But the head of the Perrigo company, which makes Walmart and Amazon-branded baby formula, told Reuters on Friday he expects the shortage to last for the “rest of the year”.

Nearly empty shelves of baby formula with signs warning customers that they are limited to 8 cans per customer at a major Sydney supermarket on November 12, 2015 in Sydney, Australia.
Parents became desperate to find available infant formula supplies during the shortage.
Christopher Pearce/Getty Images

Abbott has insisted it will be able to resume manufacturing at its closed plant “within two weeks” of FDA approval to restart operations.

Since closing, Abbott said it has shipped millions of cans to the United States from its FDA-registered facility in Ireland and is prioritizing infant formula production at its plant in Columbus, Ohio.

Various industry experts have said the formula disaster could have been avoided had the government had clear leadership and a “dedicated food agency”.

Jen Psaki holds her final briefing as White House Press Secretary at the White House in Washington, DC, United States, May 13, 2022.
White House press secretary Jen Psaki bids farewell after her final briefing on May 13, 2022.
EPA / Oliver Contreras / SWIMMING POOL
formula milk shortage
“People are desperate. … It’s a real crisis. Moms are in need,” New York mom Amy Daly told The Post.
Kevin C. Downs for the New York Post

“The whole situation could have been handled with a sense of urgency when you look at the population ingesting this product,” said Mitzi Baum, chief executive of nonprofit STOP Food Borne Illness.

Baum added that the delay is a reflection of “system dysfunction”, which does not protect public health.

“The majority of FDA funding goes to drugs and devices, and the food portion of the agency is severely underfunded and lacks clear leadership,” Baum said.

Food and Drug Administration (FDA) Commissioner Robert Califf testifies during a hearing of the Senate Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies on Capitol Hill, Nov. April 28, 2022 in Washington, DC.
FDA Commissioner Dr. Robert Califf promised the infant formula shortage would improve “in a matter of weeks.”
Kevin Dietsch/Getty Images

Hal King, managing partner at Active Food Safety LLC, a food industry consulting firm, added, “I don’t blame the FDA, I blame the government.

“We need a dedicated food agency,” King said.

“The FDA’s communication to the public and the company’s communication to the public has been too slow to let people know there is food in the system that is making people sick.

“Taking things off the shelves is fine, but it doesn’t tell people what products they might have in their homes. This process is broken.

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