Ex-FDA official reveals how agency caused baby-formula crisis

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The FDA “dropped the ball’’ on the country’s baby-formula  crisis   —   shutting down a crucial plant on top of  product recalls and then not warning parents of the ramifications, experts told The Post on Friday.

Desperate moms and dads have been trawling stores across the country in search of baby formula ever since mega-manufacturer Abbott issued a safety recall in February for products made at its plant in Sturgis, Mich., over contamination concerns.

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

“Somebody, whether it be Abbott or the FDA, should have realized, ‘We’re stopping production at one of a handful of plants that produces baby formula and what are the repercussions,’ ’’ said William Marler, a lawyer specializing in food-safety cases, to The Post.

“That’s where the FDA and Abbott dropped the ball. … They could have recalled the product without shutting the facility. They do recalls all the time without shutting the facility down.”

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

A nearly empty baby formula display shelf is seen at a Target store in Orlando.
Former FDA associate commissioner Peter Pitts blasted the agency for not warning parents about the incoming baby formula shortage.
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 done something to prevent it — or at least given moms more warning,’’ said Daly, standing in a playground about a block down from a Duane Reade with its baby-formula shelves now completely bare.

On Friday, President Biden, who has been hammered by critics on his handling of the crisis,  claimed that only “better mind-readers’’ could have been more effective than his administration and the FDA in addressing the dire situation.

Former FDA Associate Commissioner Peter Pitts
Former FDA associate commissioner Peter Pitts emphasized the agency was aware of the baby shortage as early as February.
Center for Medicine in the Public Interest.

His flippant comment came the day after the White House   announced it would finally start clearing the way for imports of formula from overseas — several months after the plant’s shutdown.

“Some product is coming from overseas, but U.S. red tape prevents much needed supply,’’ said Wall Street Journal opinion writer James Freeman in a piece Friday.

“Each time this issue pops up in the news cycle, all Team Biden and its allies on Capitol Hill do is call for more investigation of business.

“Now the president wants the Federal Trade Commission to search for evidence of price-gouging and House Democrats want testimony from formula manufacturers. How about investigating the FDA and letting people who are able to make baby formula feed hungry newborns?”

Peter Pitts —  a former associate commissioner with the FDA and current head of  the Center for Medicine in the Public Interest —  told The Post that the agency  “knew that this shortage situation was going to happen.

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

“The White House isn’t handling it,” Pitts added bluntly.

Outgoing White House Press secretary Jen Psaki wasn’t any more help than her boss  when asked Friday how long the shortages were expected to be an issue.

“Really important question, but hard for us to make an assessment,’’ she said.

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

Jen Psaki conducts her final briefing as White House Press Secretary at the White House in Washington, DC, USA, on 13 May 2022.
White House press secretary Jen Psaki argued the Biden administration did not see any warning signs of a baby formula shortage.
EPA/Oliver Contreras/POOL

Abbott has strongly denied any of its plant’s products killed infants, much less sickened them.

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

But the head of the Perrigo Company, which makes Walmart’s and Amazon’s brand baby formulas, told Reuters on Friday that he expects the shortage to last the “balance of the year.”

Shelves almost empty of baby formula with signs warning customers that they are limited to 8 cans per customers at a large Sydney supermarket on November 12, 2015 in Sydney, Australia.
Parents have grown desperate to find any available baby formula supplies during the shortage.
Christopher Pearce/Getty Images

Abbott insisted that it will be able to start manufacturing again at its shuttered plant “within two weeks” of the FDA granting it approval to restart operations.

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

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

Jen Psaki conducts her final briefing as White House Press Secretary at the White House in Washington, DC, USA, on 13 May 2022.
White House press secretary Jen Psaki waves goodbye after her last briefing on May 13, 2022.
EPA/Oliver Contreras/POOL
baby formula shortage
“People are desperate. … It’s a real crisis. Moms are in need,” NYC 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 ingests this product,” said Mitzi Baum, chief executive of the non-profit STOP Food Borne Illness.

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

“The majority of the FDA’s funding goes towards drugs and devices and the food part of the agency is severely underfunded and lacking clear leadership,” Baum said.

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

Hal King, managing partner at Active Food Safety LLC, an advisory firm to the food industry, 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 was too slow in letting people know there was food in the system that’s making people sick.

“Pulling stuff off of shelves is good, but that doesn’t tell people about products that they might have in their homes. That process is broken.”



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2022-05-13 22:39:00

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