Issues at baby formula plant went back ‘years’: former FDA head

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Issues at baby formula plant went back 'years': former FDA head

​​The former head of the Food and Drug Administration on Sunday said problems at the shuttered Michigan plant that produced baby formula date “back many years” and acknowledged that “more aggressive action” should have been taken​ to routinely inspect the facility​.

“These were persistent problems that appear to have been handled poorly, certainly by the company,” Scott Gottlieb said on CBS News’ “Face the Nation.” “FDA didn’t exert all the oversight that they could have of that facility. There were known problems with that facility going back many years or findings on previous inspections.”

“The agency had a 34-page whistleblower report in hand, making pretty serious allegations that there was data falsification and data falsification information withheld from inspectors. So these should have prompted more aggressive action earlier,” ​he added. 

Abbott Nutrition, the largest producer of baby formula in the country, recalled several brands of powdered baby formula in February after four babies were hospitalized with bacterial infections after consuming products from its Sturgis, Mich., plant and closed the facility amid a federal investigation. Two of the babies died.

Once the FDA gives Abbott the OK to begin production again after clearing the hygiene violations, it could take nearly two months before any new product reaches store shelves, an Abbott spokeswoman told The Post on Saturday.

Milk lab technicians Welney Huang processes breast milk at the University of California Health Milk Bank, Friday, May 13, 2022, in San Diego.
Four babies were hospitalized with bacterial infections after ingesting powdered baby formula made from Abbott Nutrition’s Michigan plant.
AP/Gregory Bull

House Speaker Nancy Pelosi on Sunday said the chamber will take action this week to cut some of the red tape to help ease the shortage that has ​desperate ​parents across the country fretting about how they will feed their children.

Pelosi, asked on CNN’s “State of the Union,” whether she would support the president using emergency measures to increase the supply answered: “Yes, I think so.”

But the California Democrat said the way the Emergency Authorization Act is written makes that impossible.

This week, Pelosi said, the House will take up two pieces of legislation to increase the supply. 

The shelves at the Walgreens on 3rd Ave and 65th St., NYC, remain empty of baby formula as the nation falls into another empty shelf crisis.
The House of Representatives will take action this week to ease baby formula shortages, House Speaker Nancy Pelosi said.
Matthew McDermott

She said Rep. Bobby Scott, the chairman of the House Education and Labor Committee, will work to lessen the regulations around the purchase of formula through the Women, Infants and Children program.

WIC buys about 50% of the formula supply, Pelosi said.

At the same time, Rep. Rosa DeLauro, the chair of the House Appropriations Committee, will look into purchasing formula from overseas producers. 

“But she has been working on this to have some funding so that we can immediately purchase, overseas — there are four countries, Chile, Mexico, Ireland and the Netherlands, that have supply that might be available to us,” Pelosi said on ABC News’ “This Week.”

Dr. Scott Gottlieb, the former head of the Food and Drug Administration, appears on Face the Nation.
“FDA didn’t exert all the oversight that they could have of that facility,” Gottlieb said.
CBS

Gottlieb, who served as FDA chief from May 2017 until April 2019, said production of baby formula in the hands of four companies is a recipe for disaster.

“And so when you do have a shutdown, when the market’s that concentrated, it creates these distributed shortages that we’re seeing right now that are very hard to resolve. They’re going to eventually need to get that facility reopened. The timeline for that is very unclear right now,” Gottlieb told CBS’ Margaret Brennan. 

Amid the criticism from Republicans that the Biden White House was too slow in responding to the closure of the Abbott plant, Transportation Secretary Pete Buttigieg said Sunday that the burden is on the company to maintain supply. 

The Abbott manufacturing facility in Sturgis, Michigan, on May 13, 2022.
Abbott could stock shelves with product approximately two months after the FDA gives the OK to begin production again after clearing the hygiene violations, a spokeswoman said.
JEFF KOWALSKY/AFP via Getty Images

“A plant shutting down because a company can’t assure that it is physically safe from contamination is the responsibility of the company,” he said on CBS. “The responsibility of the regulator is to ensure, as they take steps to get it ready, that it will in fact be safe when it comes back online.”

The problem is that the four companies that produce formula control the market.​

“​Again, we’ve got four companies making about 90% of the formula in this country which we should probably take a look at​,” Buttigieg said. ​

He noted that Congress will take legislative action this week and said the shortage has the attention of the “highest levels” of the administration, as well as “direct involvement by the president.” 

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