Experts say FDA, Biden “dropped the ball” on infant formula crisis


The US Food and Drug Administration “dropped the ball” on Baby milk crisis in the country Shutting down an important plant above product recalls and then not warning parents about the fallout, experts told The Post on Friday.

Desperate parents were trawling through stores across the country Looking for baby formula Manufacturer giant Abbott issued a safety order in February for products made at its plant in Sturgis, Michigan, due to contamination concerns.

The Food and Drug Administration later closed the plant after federal inspectors found that Abbott had failed to maintain sanitary conditions and procedures there — leading to a series of disruptive effects on the supply chain.

“Someone, whether it’s Abbott or the FDA, should have realized, ‘We’re stopping production at one of the few plants that produce infant formula and what are the implications,'” said William Marler, an attorney who specializes in food. For The Post.

“This is where the FDA and Abbott dropped the ball. … They could have recalled the product without closing the facility. They do the recall all the time without closing the facility.”

Manhattan mom Amy Daly, 38, of the Upper West Side, lamented Friday that she was forced to take 11-month-old Alice out of infant formula early when the shortage occurred.

A semi-empty infant formula display shelf is seen at a Target store in Orlando.
Former Commissioner of the Food and Drug Administration Peter Bates has criticized the agency for not warning parents about the upcoming shortage of infant formula.
Paul Hennessy/SOPA Images/LightRocket via Getty Images

“People are desperate. … It is a real crisis. Mothers are in need,” she said.

“Management should have known the shortage was coming and did something to prevent it — or at least give moms more warning,” Daly said, standing in a playground a block away from Duane Reade with shelves of baby formula, nude.

On Friday, President Biden who was Critics criticize him for his handling of the crisisHe claimed that only “the best mind readers” It could have been more effective than managing it And the Food and Drug Administration in addressing the dire situation.

Former Commissioner of the Food and Drug Administration Peter Bates
Former Commissioner of the Food and Drug Administration Peter Bates confirmed that the agency was aware of the children’s shortage as early as February.
Center for Medicine in the Public Interest.

His uneasy comment came the day after the White House announced that it would finally begin paving the way for formula imports from abroad — several months after the plant was closed.

“Some products are coming in from abroad, but American red tape prevents much of the needed supply,” Wall Street Journal opinion writer James Freeman said in an article on Friday.

“Every time this issue surfaces in the news cycle, every Biden team and his allies on Capitol Hill are calling for further investigation into the business.

“Now the president wants the FTC to look for evidence of price gouging and House Democrats want certification from formula manufacturers. How about investigating the Food and Drug Administration and letting people who are able to get newborns to feed formula hungry babies?”

Peter Bates — a former associate commissioner of the Food and Drug Administration and current head of the Center for Medicine in the Public Interest — told The Post that the agency “knew that this shortage was going to happen.

“They should have educated parents, be forewarned, and told how to prepare,” he said. “The result is that one day parents go to the store and the shelves are empty – and they panic.

“The White House doesn’t deal with it,” Bates added frankly.

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

“A really important question, but it’s hard for us to make an assessment,” she said.

She even claimed during a Thursday briefing that the FDA took the right steps all along because “there were children who died from taking this formula.”

Jane Psaki conducts her final briefing as the White House Press Secretary at the White House in Washington, DC, USA, on May 13, 2022.
White House press secretary Jen Psaki has argued that the Biden administration sees no warning signs of a shortage of infant formula.
EPA / Oliver Contreras / Swimming Pool

Abbott vehemently denied that any of its factory products had killed children, let alone sickened them.

Food and Drug Administration Commissioner Dr. Robert Califf claimed in a tweet Friday that government efforts to help other companies ramp up production and increase imports from abroad should ease shortages within “weeks.”

But the president of Perrigo, which makes commercial baby formulas from Walmart and Amazon, told Reuters on Friday he expects the “balance of the year” shortfall to continue.

Nearly empty shelves of infant formula with signs warning customers it is limited to 8 cans per customer at the Great Sydney Supermarket on November 12, 2015 in Sydney, Australia.
Parents have become desperate to find any available supplies of infant formula during the shortage.
Christopher Pearce / Getty Images

Abbott insisted it would be able to start manufacturing again at its closed plant “within two weeks” of the US Food and Drug Administration giving approval to resume operations.

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

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

Jane Psaki conducts her final briefing as the White House Press Secretary at the White House in Washington, DC, USA, on May 13, 2022.
White House Press Secretary Jen Psaki waves goodbye after her last briefing on May 13, 2022.
EPA / Oliver Contreras / Swimming Pool
lack of infant formula
“People are desperate. … It’s a real crisis. Moms need,” New York City mom Amy Daly told The Post.
Kevin C. Downs for The New York Post

“The whole situation could have been done with a sense of urgency when you look at the population that eats this product,” said Mitzi Bohm, CEO of the nonprofit STOP Food Borne Illness.

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

“Most 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 Senate Subcommittee on Agriculture, Rural Development, Food and Drug hearing on Capitol Hill, April 28, 2022 in Washington, DC.
Food and Drug Administration Commissioner Dr. Robert Califf promised that the shortage of infant formula would improve “within weeks.”
Kevin Deitch/Getty Images

Hal King, managing partner at Active Food Safety LLC, a consulting firm for the food industry, added, “I don’t blame the Food and Drug Administration, 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 very slow in letting people know that there is a food in the system that is making people sick.

“Pulling things off the shelves is fine, but that doesn’t tell people what products might be available in their home. This process is disruptive.”

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