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

Ex FDA official reveals how agency caused baby formula crisis


The FDA failed parents by not warning them there would be baby-formula shortages as soon as it shuttered the main US manufacturer, one of the agency’s top former officials told The Post on Friday.

“They knew that this shortage situation was going to happen,” ex-Associate Commissioner Peter Pitts said of the now-nationwide crisis.

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

Desperate parents 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 had failed to maintain sanitary conditions and procedures there — sparking a cascade of crippling effects on the supply chain.

Some frantic parents have been reduced to rationing their current paltry supplies, while others have driven for hours in search of formula, fueled by specially formed Facebook groups designed to help with their search.

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

“This is a situation that began in February. … The FDA really should have made it a bigger deal,” said Pitts, who now heads the Center for Medicine in the Public Interest.

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

The Biden administration has come under intense scrutiny for the debacle, with the White House only announcing Thursday it would finally start clearing the way for imports of formula from overseas — even though it claims it was on top of the issue from the start.

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.

The administration hasn’t disclosed when President Biden was first briefed on the pending shortages.

On Friday, Biden dismissed critics from both sides of the aisles by claiming only “mind readers’’ could have done a better job at handling the crisis.

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

“Really important question, but hard for us to make an assessment,’’ she said, adding that the administration is still weighing whether to enact the emergency Defense Production Act to increase supplies.

Psaki was later asked what, if anything, the administration regretted in its handling of the debacle — and again danced around answering the question.

“Hindsight is always 20:20,” she said.

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 “weeks.

“We believe these and other ongoing efforts will help dramatically improve the supply in the U.S. in a matter of weeks,” he wrote.

“Our data indicates that in stock rates in retail stores are stabilizing but we continue to work around the clock to further increase availability.”

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

He added that the federal agency would announce plans next week on how manufacturers and suppliers abroad could import their products into the US, as well as creating flexibility for domestic companies.

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.”

The company’s two manufacturing plants in Ohio and Vermont are toiling at 115 percent capacity to churn out the off-brand versions of Similac Pro Sensitive and Pro Advance and Enfamil Gentle Ease and Infant, according to Perrigo CEO Murray Kessler.

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

“We have stepped up and are killing ourselves to do everything we can,” said Kessler, whose company also makes other brands such as Bobbi.

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.

“We know that the recall has worsened the industry-wide infant formula shortage, and we have been working to get as much product into the hands of parents as we can,” the company said in a statement.

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

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.

“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.

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

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.

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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