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Biden administration launches an audit of the FDA’s actions on Abbott plant closure

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The Biden administration has launched an audit into the FDA’s actions around the February closure of Abbott Nutrition’s baby formula plant as the White House struggles to answer why President Joe Biden didn’t know about the shortage until April. 

The Department Health and Human Services’ Office of Inspector General announced the audit, which will also examine the Food and Drug Administration’s decision to recall baby formula.

The review will examine whether the FDA upheld its duty ‘to safeguard the nation’s food supply, including infant formula and ensure all ingredients are safe,’ the IG office said.

The Sturgis, Michigan, plant was shut down in February after contamination issues inside were linked to four infants being hospitalized with a rare bacterial infection. Two of the infants died.

But the closure also triggered a nation-wide shortage of baby formula, leading to empty grocery store shelves and frantic parents. 

The findings from the review are expected until 2023. 

But the announcement comes amid national outrage about the formula shortage and why the Biden administration wasn’t more prepared to counter it.

The White House has struggled to explain its response, its monitoring of the formula, and its overhandling of the job.

The administration has emphasized the safety issue aspect of baby formula, touted its recent work in importing formula from Europe and Australia, and even launched a website to brag about its ‘progress by the numbers.’ 

But what officials can’t say is when the shortage will end.

The Biden administration has launched an audit into the FDA’s actions around the February closure of Abbott Nutrition’s baby formula plant in Strugis, Michigan

White House has struggled to answer why President Joe Biden didn't know about the baby formula shortage until April

White House has struggled to answer why President Joe Biden didn’t know about the baby formula shortage until April

Questions about Abbott’s quality control and sanitation issues have been raised by the federal agency for months. 

TIMELINE SHOWS HOW AMERICA’S LARGEST BABY FORMULA PLANT CEASED PRODUCTION

Abbott Laboratories, the biggest baby formula supplier in the U.S., ceased production at its Michigan plant in February 2022 amid reports of fatal bacterial infections.

A timeline of events shows reveals the shut down was the plant had previously been under scrutiny by the U.S. Food and Drug Administration (FDA).

September 2021: The FDA conducted a four-day inspection of the Abbott Laboratories plant in Sturgis, Michigan.

The inspection report revealed the plant ‘did not maintain’ clean and sanitary conditions in at least one building that manufactured, processed, packaged or held baby formula.

FDA officials also observed poor hand washing among Abbott plant staff who ‘worked directly with infant formula.’

The FDA also noted an instance of improper equipment maintenance and temperature control. 

October 2021: A whistleblower sends the FDA a 34-page document outlining potential concerns with the Sturgis plant. 

The document, which was made public by Congresswoman Rosa DeLauro in April 2022, was written by a former plant employee. 

The employee accused the plant of lax cleaning practices, falsifying records, releasing untested infant formula, and hiding information during an FDA audit in 2019, among other issues. 

January – March 2022: The FDA conducted multiple inspections at the Sturgis plant over the course of three months in 2022. A ten-page inspection report revealed multiple violations at the facility.

The agency alleged the plant failed to ensure that all surfaces that contact infant formula were maintained to prevent cross-contamination.

The report states the facility ‘did not establish a system of process controls’ to ensure the baby formula ‘does not become adulterated due to the presence of microorganisms in the formula or the processing environment.’

Officials also alleged the plant failed to disclose in an investigation report whether a health hazard existed at the facility.

Additionally, the report stated plant workers were did not wear the ‘necessary protective material’ when working directly with infant formula.

February 17: U.S. health officials urgently warn parents against using three popular baby formulas manufactured at the Abbott plant in Michigan. Investigators claim the products were recently linked to bacterial contamination after an infant died and three others fell ill.

Abbott voluntarily recalled several major brands and shut down its Sturgis plant. 

The FDA also said it is investigating four reports of infants who were hospitalized after consuming the formula, including one who died.

February 28: Abbott Laboratories expanded its recall of Similac baby formulas after a second infant who was exposed to the powdered baby formula died.

April 15: Abbott releases a statement alleging it is working closely with the FDA to restart operations at the Sturgis plant. 

Week of April 24: The nationwide share of out-of-stock baby formula hit 40 percent. Texas, Tennessee, Missouri, Iowa, North Dakota and South Dakota, seemingly hardest hit by the shortages, reported out-of-stock rates of about 50 percent.

May 10: Abbott releases a statement to DailyMail.com claiming ‘thorough investigation’ by the FDA and Abbott revealed ‘infant formula produced at our Sturgis facility is not the likely source of infection in the reported cases and that there was not an outbreak caused by products from the facility’.

Abbott claims they are ‘working closely with the FDA to restart operations’ at the plant, with the spokesperson noting: ‘We continue to make progress on corrective actions and will be implementing additional actions as we work toward addressing items related to the recent recall’.

The FDA told DailyMail.com it was holding discussions with ‘Abbott and other manufacturers to increase production of different specialty and metabolic products’ but refused to say when the Sturgis plant could reopen.

Sen. Mitt Romney issued a letter to the FDA and U.S. Department of Agriculture (USDA) urging leaders to address the formula shortage and work to prevent future threats to infant health.

May 11: Lawmakers on Capitol Hill announce plans to hold a hearing in two weeks on infant formula shortages.

Abbott announced it would take up to ten weeks for the company to get baby formula to retailers once the Sturgis plant reopens.

Abbott also said: ‘After a thorough review of all available data, there is no evidence to link our formulas to these infant illnesses.’

May 12: White House Press Secretary Jen Psaki defends the government’s closure of the Abbott plant.

President Joe Biden met with executives from infant formula manufactures and retailers to address the shortage.

May 13: Biden addresses the formula crisis during a press briefing, saying: ‘We’re going to be, in a matter of weeks or less, getting significantly more formula on shelves.’ 

The FDA announced it was working to streamline a process that will get more products to consumers – while also meeting safety, quality and labeling standards 

May 16: Abbott and the FDA reach agreement to reopen baby formula facility in Michigan.

However, the FDA has yet to disclose a timeframe for allowing the plant to resume production. 

The FDA also implemented new measures, in effect for 180 days, to increase imports of baby formula produced overseas.

May 18: Biden invoked the Defense Production Act to boost baby formula production and issued a directive for planes to bring in supplies from overseas, after growing pressure from Congress. 

In September 2021, the FDA conducted a four-day inspection of the Abbott Laboratories plant in Sturgis, Michigan. 

The inspection report revealed the plant ‘did not maintain’ clean and sanitary conditions in at least one building that manufactured, processed, packaged or held baby formula.

In October, a whistleblower sends the FDA a 34-page document outlining potential concerns with the Sturgis plant.

The employee accused the plant of lax cleaning practices, falsifying records, releasing untested infant formula, and hiding information during an FDA audit in 2019, among other issues. 

But the report was in limbo at the FDA for months. Officials told Congress they didn’t receive that report last fall “due to an isolated failure in FDA’s mailroom, likely due to COVID-19 staffing issues.”

In the first three months of 2022, the FDA conducted multiple inspects of the Michigan plant. 

The formual recall and plant closure happened in February. 

And multiple baby formula manufacturers on Wednesday told President Joe Biden they knew the shutting down of the Abbott plant would lead to shortages and that they warned the FDA about it.

Their comments are raising questions about why Biden and his administration didn’t act faster to get more formula produced and onto store shelves. The closure resulted in a bare grocery store shelves, a major hike in formula prices and frantic parents worried about feeding their children.

Biden defended his administration’s response, saying they ‘kicked everything into gear’ when they knew how bad the problem was. 

‘I don’t think anyone anticipated the impact of one facility,’ the president said, referring to the closure of Abbott’s Michigan plant, which is a major producer of infant formula.

‘Once we learned of the extent of it, and how broad it was, we’ve kicked everything in the gear. And I think we’re on the way to be able to completely solve the problem,’ he said in response to reporters’ questions.

But when asked why the administration didn’t act sooner, given the executives’ warnings, Biden said he didn’t know about it.

‘They did, but I didn’t,’ he said. He revealed he first learned of the issue in April.

White House press secretary Karine Jean-Pierre didn’t answer repeated questions on when the president received notification on the shortage and why he said he learned about the crisis in April but the manufacturers said they knew from the start of the Abbott plant shutdown.

‘I just don’t have that, the timeframe to share,’ she said during her Wednesday press briefing.

‘The president has multiple issues crises at the moment,’ she noted. ‘So that’s number one to remember. But the most important thing is that as a White House, working with the inter agencies, we have been working on this since day one, since the recall. And this is his White House,’ she said.

She struggled to explain the White House timeline on handling the crisis, on when the president was told about it, who decided to tell the president and what she meant when she said there was a ‘whole of government’ response from the start.

Instead she repeated talking points and reitierated all the forumla being produced and imported now that the shortage is front page headlines.  

In a sitdown with formula manufacturers to talk about how they were amping up their production and distribution, multiple executives told Biden they saw the shortages coming in February – and issued the appropriate warnings. 

Robert Cleveland, an executive at Reckitt, told Biden that his company anticipated the impact the Abbott formula recall in February would have and they reached out retailers immediately. 

‘We knew from the very beginning this would be a very serious event,’ he said during the zoo meeting. ‘We were aware of the general impact that this would have.’

He said they advised retailers like Target and Walmart to order more formula and to push everything in inventory onto the shelves. 

And Murray Kessler, CEO of Perrigo Company, which manufacturers generic brands of formula, said they knew there would be a ‘shortage.’

‘The very first thing we did when we heard about the Abbott recall was we could foresee that this was going to create a tremendous shortage,’ Kessler said.

He said they warned the Food and Drug Administration. 

‘We began communication with the FDA immediately, we began collaborating closely with the FDA, our retail customers and other stakeholders to identify and prioritize what was most critical,’ he said.

No representatives from Abbott were at the meeting even though the plant’s closure and its affect on the infant formula market was a main topic of conversation.  

Biden, instead, met with leaders of baby formula manufacturers ByHeart, Bubs Australia, Reckitt, Perrigo Co. and Gerber at the White House on Wednesday.

Heath and Human Services Secretary Xavier Becerra and Surgeon General Vivek Murthy were also present. 

Last month, Biden shrugged off questions that his administration should have acted sooner. ‘If we’d been better mind readers, I guess we could have,’ he said.

The administration didn’t invoke the Defense Production Act and its Operation Fly Formula until May. 

Jean-Pierre described the president as ‘frustrated.’ 

‘The president is frustrated himself about the situation,’ she said. ‘And he’s frustrated on behalf of the American families.’

She couldn’t say when the White House was informed of the shortage and spent nearly 30 minutes of her daily press briefing defending the administration’s response. 

‘I don’t have the timeline on that. All I can tell you as a whole of government approach, we have been working on this since the recall on February,’ she said.

She said Abbott wasn’t invited to the meeting as they were working to get their Michigan plant back online after the FDA shut it due to contaminated formula. 

The administration has emphasized the safety aspect of the issue. 

Jean-Pierre also said that ‘yes,’ the president was ‘satisified’ with the FDA response on the shortage. 

Multiple baby formula manufacturers told President Joe Biden they knew the shutting down of the Abbott plant in February would lead to shortages

Multiple baby formula manufacturers told President Joe Biden they knew the shutting down of the Abbott plant in February would lead to shortages

President Biden met with leaders of baby formula manufacturers ByHeart, Bubs Australia, Reckitt, Perrigo Co. and Gerber

President Biden met with leaders of baby formula manufacturers ByHeart, Bubs Australia, Reckitt, Perrigo Co. and Gerber

Biden with Murray Kessler, CEO of Perrigo Company

Biden with Robert Cleveland, an executive at Reckitt

Murray Kessler, CEO of Perrigo Company (left) and Robert Cleveland, an executive at Reckitt (right) both told President Biden they foresaw the formula shortage

The news of the executives’ warnings came as the baby formula shortage is getting worse around the United States, particularly in the South and among the poor.

Minorities and lower-income families have been hit hardest by the crisis, which was sparked when Abbott Nutrition had to close its Michigan plant over safety concerns.

New data shows that nationally 23% of powdered baby formula was out of stock in the week ended May 22, compared with 21% during the previous week, the Wall Street Journal reported, citing figures from the market-research firm IRI. 

Before the recall of the Abbott formula, 11% of powdered baby formula was out of stock because of covid pandemic-related supply-chain shortages and inflation. Before the pandemic, the normal out-of-stock range for powdered formula was 5% to 7%, according to IRI.

Kansas, Georgia, Texas, Montana and Tennessee are among the states experiencing the worst of the shortage.

Additonally, families that rely on funds from the Special Supplemental Nutrition Program for Women, Infants and Children, or WIC, have also been hit hard.

The administration has not been able to say exactly when more formula will be available.

But the White House did announce a third shipment from Operation Fly Formula – this time bringing in Kendamil infant formula from the UK to the U.S. The shipments start June 9 and will contain 3.2 million 8-ounce bottle equivalents of Kendamil Classic Stage 1 and 540,000 8-ounce bottle equivalents of Kendamil Organic. 

United Airlines has agreed to transport Kendamil formula free of charge. The formula will be on Target shelves ‘within weeks’ of its arrival into the United States. 

The administration also announced a fourth flight – this time with formula from Australia. 

The 380,000 pounds of Bubs Australia infant formula, approximately 4.6 million 8-ounce bottles, will arrive in Pennsylvania and California on June 9 and June 11 respectively.

White House press secretary Karine Jean-Pierre didn't answer repeated questions on why Biden wasn't warned right away

White House press secretary Karine Jean-Pierre didn’t answer repeated questions on why Biden wasn’t warned right away

The pressure is on President Joe Biden as the baby formula shortage is getting worse around the United States: New data shows that nationally 23% of powdered baby formula was out of stock

The pressure is on President Joe Biden as the baby formula shortage is getting worse around the United States: New data shows that nationally 23% of powdered baby formula was out of stock

Baby formula arrives from Europe as part of Operation Fly Formula

Baby formula arrives from Europe as part of Operation Fly Formula

Abbott officials have said they expect to restart the plant on June 4 and begin shipping new formula to stores about three weeks later. 

Nearly 98% of baby formula is manufactured domestically. Four companies account for roughly 90% of the market: Abbott, Reckitt, Nestle and Perrigo. 

The Biden administration announced last week it is bringing in enough baby formula from Australia to fill 27.5 million full-size, 8-ounce bottles.

‘Bubs Australia plans to provide at least 1.25 million cans of several varieties of its infant formula,’ the FDA said. 

Some of the product is already in stock and more is being manufactured, the agency noted.

Already, two shipments of formula have come in from Europe under Biden’s Operation Fly Formula. They brought in total 1.5 million, 8-ounce bottles of formula.

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