Food and Drug Administration officials dragged their feet on letting Abbott Nutrition reopen its Sturgis, Michigan, baby formula plant after it was closed to address safety and quality issues, top House Republicans said Thursday, citing information from industry insiders.
Abbott closed the facility in February after a formula recall and while the FDA conducted a multiweek inspection that discovered five strains of Cronobacter sakazakii and other safety concerns.
Those concerns were quickly addressed, Republican lawmakers say, yet the plant remained closed as America’s supply of baby formula dried up.
According to the Centers for Disease Control and Prevention, Cronobacter sakazakii is a germ found naturally in the environment that can live in dry foods, including powdered infant formula, powdered milk, herbal teas and starches.
None of the strains in the Abbott factory matched genotypes of bacteria found in two of four infants who were sickened after consuming powdered formula from the plant.
Abbott officials said they submitted a response to the problems the FDA cited in its inspection of the plant and sent a “corrective action plan” to the FDA on April 8.
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Six weeks later, the factory remains closed despite having produced most of America’s supply of Similac, the most popular infant formula, as well as the entire national supply of specialty formulas for infants with unique feeding needs.
“We have heard from folks in the industry that the FDA went silent for months and there was no engagement,” House Republican Conference Committee Chair Elise Stefanik, a New York Republican whose 9-month old baby is formula-fed, told The Washington Times.
“The plant addressed all the concerns from the FDA, even though they argue that it didn’t come from the facility,” she said.
Neither Abbott nor FDA officials have disclosed why the plant was not cleared to reopen after the company proposed the corrective action plan on April 8.
The agency was under intense pressure from Democrats in Congress to take action against the plant.
Rep. Rosa L. DeLauro, Connecticut Democrat and House Appropriations Committee chair, had begun calling a month earlier for the Health and Human Services Department inspector general to begin investigating the FDA for “acting too slowly.”
She wanted Abbott to pull infant formula from the shelves after the handful of infants became ill beginning last fall.
Ms. DeLauro requested the investigation into the FDA’s actions on March 4.
She said the FDA inspected the plant in September and discovered violations of safety protocols meant to prevent contamination of formula, four months before urging Abbott to recall formula and shut down the plant.
“The delay between the September inspection and the recall raises serious questions about the FDA’s ability to adequately regulate the infant formula industry,” Ms. DeLauro wrote to FDA Inspector General Christi Grimm.
“It seems evident that the FDA could have acted sooner to prevent additional illnesses and deaths after the initial inspection,” she said.
In testimony before Congress on Thursday, FDA Commissioner Robert M. Califf denied that the agency was getting in the way of efforts to get the plant back online quickly.
“From Day One, when we saw the problems with the Abbott plant, we knew that this was a critical plant for the supply chain and the team was meeting on a very regular basis, trying to figure out how to manage the situation, hoping to keep the plant open with better quality measures,” Mr. Califf told the House Appropriations Committee. “Then it became clear that was not going to work.”
The panel was meeting to examine the FDA’s fiscal 2023 budget request of $8.4 billion, a 25% increase over 2022 spending.
Mr. Califf did not explain in detail what happened to cause the delay in letting the plant reopen.
He told lawmakers that FDA officials “had a period of time” to work on a consent decree with the Department of Justice that would dictate the terms of the plant’s reopening, a step he described as “a complicated legal proceeding.”
On Monday, Attorney General Merrick Garland announced a “complaint and proposed consent decree to ensure safety of Abbott Laboratories’ infant formula.
The deal paves the way for Abbott to reopen the Sturgis plant, likely within two weeks.
After the plant is cleared to reopen, Abbott officials said, it would take an additional six to eight weeks to get formula back onto the shelves.
Republican aides told The Times their own investigators found the FDA had not moved quickly.
In fact, they said they have learned, FDA officials did not ramp up efforts to reopen the plant until the White House, responding to public outcry and political attacks over empty store shelves, got involved over the past two weeks.
“It was just the FDA culture,” a top Republican aide told The Times. “They do things slowly, and they don’t communicate between offices. And it took this to get up to the White House for action, because of all the public pressure.”
Rep. Andy Harris of Maryland, a senior Republican on the Appropriations Committee, told The Times that the FDA did not move quickly.
“What is clear is that the FDA did not act expeditiously in February when they came to an agreement with Abbott to close the plant,” Mr. Harris said.
He said the agency simply acted as if it didn’t understand supply chain issues and the downside of closing a factory.
“They did not work expeditiously on a plan to reopen the plant, even though it was predictable that, given other supply chain issues which of course surfaced last fall regarding infant formula in general, that if you close the largest plant while you already have supply chain interruptions, you will have a formula shortage,” he said.
The baby formula shortage has come to dominate the agendas of the White House and Democratic-led Congress this month, culminating in President Biden’s announcement Wednesday that he would take the unusual step of invoking the Defense Production Act.
That emergency production law will let U.S. military planes ship formula into the country from abroad and help provide the supplies needed to enable domestic factories to fill the empty formula shelves more quickly.
On Thursday evening, the Biden administration announced the first such shipment had been sourced.
Pentagon planes will fly 1.5 million bottles of formula produced by Nestle S.A. in Switzerland to Plainfield, Indiana, from where the product will be distributed within the U.S.
Democrats continue to hammer Abbott, blaming the company for the shortage by cutting safety protocols and putting tainted formula on store shelves that sickened infants.
Among the four babies who became ill, two died, but the deaths were not specifically attributed to the formula by federal health officials.
In Thursday’s hearing, Ms. DeLauro said the FDA was slow to respond to an October whistleblower report from a former factory employee who said the company failed to properly test the powdered formula and committed other safety violations.
“Whomever looked at that report, felt that there was no need to respond at all from October to February, until there was a recall,” Ms. DeLauro said, is guilty of “a dereliction of duty, in my view.”
Abbott officials have downplayed the whistleblower’s significance, saying the person is a former employee fired for “serious violations of Abbott’s food safety policies.”
The employee, Abbott officials said in a statement last month, “has made evolving, new and escalating allegations to multiple authorities.”
Abbott officials also say the government is falsely accusing them of sickening infants.
“Cronobacter sakazakii is naturally occurring and found nearly everywhere in the environment,” Abbott officials said in a separate statement this week. “Powdered infant formula manufacturers periodically detect it in their plants, and FDA … stated that, based on current technologies, it is not possible to produce a sterile powdered infant formula.”
Nevertheless, Abbott said, the company “has no tolerance for Cronobacter sakazakii in its production environment, and no Abbott product was distributed with Cronobacter sakazakii contamination.”
Ms. Stefanik, with Energy and Commerce Committee ranking member Cathy McMorris Rodgers of Washington and other Republican lawmakers, introduced legislation that would require more FDA transparency and would make it easier to import formula from abroad as well as increase competition to produce supplies domestically.
Just three formula companies produce 80% of the nation’s infant formula supply.
Abbott is the sole supplier of formula for the federal WIC program providing infant formula for low-income families. About half of all infant formula is purchased through WIC.
Republicans say their press conferences on the shortage sounded the alarm on the crisis and helped put pressure on the Democrats to take action.
Ms. Stefanik told The Times that Republicans want to know more about why the FDA has kept the Sturgis plant from reopening for so long and why it was not prepared to address the massive shortage that the closure was destined to cause.
“The FDA was not proactive in thinking about how we would address this significant closure to the supply chain, so shame on them,” Ms. Stefanik said. “I believe this is going to show incompetence at the FDA, incompetence from Joe Biden. They’re trying to brush this under the rug because I think it’s going to be a much bigger scandal than they want the public to realize.”
The House this week approved legislation providing the FDA with an additional $28 million in emergency spending, mostly for salaries for new inspectors. They also approved a bill allowing those enrolled in WIC to buy formula from other companies.
The Senate passed the same bill Thursday evening and sent it to Mr. Biden for his expected signature.
“Now, millions of parents will have an easier time finding the baby formula that they need,” Senate Majority Leader Chuck Schumer, New York Democrat, said after passage.
• Joseph Clark contributed to this report.
• Susan Ferrechio can be reached at firstname.lastname@example.org.
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