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Saturday, May 28, 2022

Former top FDA official reveals how agency failed parents in baby-formula crisis

The FDA failed by not warning parents that there would be a shortage of baby-formula as soon as the main US manufacturer was shut down, one of the agency’s top former executives told the Post on Friday.

“They knew this was going to be a state of scarcity,” former associate commissioner Peter Pitts said of the now nationwide crisis.

“They should have educated parents, giving them advanced warnings, telling them how to prepare. The result is that one day the parents walk into the store and the shelves are empty – and they panic.”

Ever since mega-manufacturer Abbott issued a safety recall in February over contamination concerns for products made at its plant in Sturgis, Michigan, desperate parents have been looking for baby formula in stores nationwide.

The Food and Drug Administration later closed the plant when federal inspectors found that Abbott 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 gulping down their current modest supply, while others drive for hours in search of formula, created by Facebook groups specially designed to help them in their quest. has gone.

Former FDA associate commissioner Peter Pitts rebuked the agency for not warning parents about impending infant formula shortages.
Paul Hennessy / SOPA Images / LightRocket via Getty Images

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

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

The Biden administration has come under intense scrutiny for the debacle, with the White House only announcing Thursday that it will eventually begin clearing the way for imports of formula from overseas – even though it claims it has been doing this from the start. was on top of the issue.

Former FDA Associate Commissioner Peter Pitts
Peter Pitts, former associate commissioner of the FDA, stressed that the agency was aware of the baby shortage as early as February.
Medical center in public interest.

The administration did not disclose when President Biden was first told about the pending deficiencies.

On Friday, Biden slammed critics from both sides of the aisle, claiming that only “mind readers” could have done a better job handling the crisis.

Outgoing White House press secretary Jen Psaki was no help at her last press briefing on Friday when asked how long the shortages were expected to be an issue.

“A really important question, but it’s hard for us to make an assessment,” she said, adding that the administration is still weighing whether to invoke the Emergency Defense Production Act to increase supplies.

Saki was later asked whether, if anything, the administration expressed regret in dealing with the debacle – and danced again to answer the question.

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

FDA Commissioner Dr Robert Califf claimed 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 within “weeks”.

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

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

Jen Psaki holds her final briefing as White House press secretary at the White House on May 13, 2022 in Washington, DC, USA.
White House press secretary Jen Psaki argued that the Biden administration saw no warning signs of a shortage of baby formula.
EPA/Oliver Contreras/Pool

He said the federal agency will announce plans next week for how manufacturers and suppliers abroad can import their products into the US, as well as create flexibility for domestic companies.

But the head of Wal-Mart and Amazon’s brand baby formula maker Perrigo told Reuters on Friday he expects the shortfall to remain “the balance of the year.”

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

Shelves nearly empty of children's formula with signs warning customers at a large Sydney supermarket on November 12, 2015 in Sydney, Australia.
Parents have become desperate to find any available infant formula supplies during times of shortage.
Christopher Pearce / Getty Images

“We’ve stepped up and are beating ourselves up to do everything we can,” said Kessler, whose company also makes other brands like Bobby’s.

Abbott insisted it would be able to resume manufacturing at its closed plant “within two weeks” after the FDA approved it to resume operations.

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

Jen Psaki holds her final briefing as White House press secretary at the White House on May 13, 2022 in Washington, DC, USA.
White House Press Secretary Jen Psaki says goodbye after her final 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 a clear leadership and a “dedicated food agency”.

“When you look at the population that swallowed this product, the whole situation could have been handled with urgency,” said Mitzi Baum, chief executive of the nonprofit STOP Food Born Illness.

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

Baum said the delay is a reflection of “system dysfunction” not protecting public health.

“Most of the FDA’s funding goes toward drugs and devices and the agency’s food share is severely underfunded and there is a lack of clear leadership,” Baum said.

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

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

“The FDA’s communication to the public and the company’s communication to the public was very slow in letting people know that there was food in the system that is making people sick.

“Pulling stuff off shelves is nice, but it doesn’t tell people about the products they might have in their homes. That process is broken. ,

World Nation News Deskhttps://www.worldnationnews.com
World Nation News is a digital news portal website. Which provides important and latest breaking news updates to our audience in an effective and efficient ways, like world’s top stories, entertainment, sports, technology and much more news.
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