F.D.A. Chief Details ‘Shocking’ Conditions at Baby Formula Plant

The Abbott Nutrition plant in Michigan that was shut down in February, sparking a widespread baby formula shortage crisis, had a leaking roof, water pooled on the floor and cracks in key production equipment that allowed bacteria to get in and persist, Dr. Robert Califf, the head of the Food and Drug Administration, told a House panel on Wednesday.

He detailed “egregiously unsanitary” conditions in the Sturgis, Mich., plant to lawmakers during a hearing, but he also acknowledged that his agency’s response was too slow in addressing problems at the plant.

“Frankly, the inspection results were shocking,” Dr. Califf told members of the House Energy and Commerce Subcommittee on Oversight and Investigations. “We had no confidence in integrity of the quality program at the facility,” noting the agency worked with Justice Department officials to dictate steps the company needed to take to turn the facility around.

That effort is expected to result in the plant reopening on June 4, Jonathon Hamilton, an Abbott spokesman, said, with some formula expected to begin rolling out June 20. Officials hope new shipments will reach store shelves within six to eight weeks, although resumption of full production at the plant will take longer.

Abbott has replaced the leaking roof at the plant as well as the floor, Dr. Califf said.

House panel members sharply questioned the commissioner and other agency officials at the hearing. They also demanded answers from an Abbott executive about the plant’s troubled history as well as to how the company would correct glaring deficiencies and ease shortages that have agonized families across the country.

Christopher Calamari, an Abbott Nutrition senior vice president, offered little explanation for conditions at the Michigan factory but said he was “deeply, deeply sorry” about the shortages. He said the company was coordinating 50 flights a week from its formula plant in Ireland to a dozen U.S. airports to increase supplies.

“We are committed to ensuring that this never happens again,” Mr. Calamari said.

Representative Gary Palmer, a Republican of Alabama, pressed Mr. Calamari for specifics about why the company did not fix problems at the plant before the F.D.A. forced its hand.

“We prioritize safety and compliance in our plants,” Mr. Calamari said. “And we’re committed to doing so and getting better coming out of this event.”

Mr. Palmer replied that he was not satisfied with that response.

Committee members pushed back against F.D.A. and Biden administration assertions that it was difficult to recognize in real time the extent of the contamination and the resulting nationwide breakdown in the supply chain. The Abbott plant had produced one-fourth of the nation’s infant formula, including tailored formulas for people with specialized nutritional needs.

“There was a life-and-death crisis in front of the F.D.A., but they failed to see the severity of the situations,” said Representative Cathy McMorris Rodgers, a Republican of Washington. “We must solve the immediate issue and also ensure that we are taking action so this situation never happens again.”

The agency had discovered a battery of problems at the plant last fall. At the same time, reports began emerging of babies who had been hospitalized with a rare bacteria. Cronobacter sakazakii, which can be deadly to infants, was found in four babies who had consumed formula from the plant, according to the Centers for Disease Control and Prevention.

Testimony during the hearing made it clear that the F.D.A. took months to try to match the bacteria that sickened the first baby to bacteria that was later found throughout the plant.

Cronobacter strains related to two of the babies did not match samples of the bacteria later found at the plant, although Dr. Califf said the agency considered those results “inconclusive” given shortcomings with genome sequencing.

The illnesses set the recall in motion this year. The plant shutdown began Feb. 17 and exacerbated shortages that had been intermittent during the height of the pandemic. Empty shelves have left parents struggling, driving hundreds of miles to find baby formula and, at times, improvising to feed hungry infants.

Dr. Califf also acknowledged several ways that the F.D.A. had erred in addressing this problem: Its follow-up inspection in January should have started sooner, he said, adding that the agency took too long to circulate a whistleblower report that arrived in October but did not reach top officials until February.

“It was too slow, and there were decisions that were suboptimal along the way,” Dr. Califf said.

He told lawmakers that the agency did not receive an immediate notice when a formula plant found the deadly Cronobacter bacteria. Nor does the agency have access to the supply chain information that each of the three main U.S. baby formula manufacturers have in-house.

The report of an anonymous whistleblower who said he worked in the Sturgis plant came up repeatedly during the hearing. The whistleblower alleged that safety staff there “celebrated” the F.D.A. overlooking problems after a 2019 inspection and did not destroy enough product when it found Cronobacter in finished products. That top agency officials did not see those claims until February “is stunning to me,” Mr. Palmer said.

Details in the report suggested there was “corruption” at the plant, Representative Kim Schrier, Democrat of Washington, charged. Dr. Califf said he could neither confirm nor deny whether there might be criminal proceedings in the future.

Mr. Calamari emphasized that the whistleblower’s claims had not been proven. “That’s an open investigation,” he said. “And it’s ongoing.”

The report’s allegations resonated with panel members of both parties, including Representative Larry Bucshon, Republican of Indiana, who described himself as a “private-sector guy.”

“It seems like that facility’s culture is a problem,” Mr. Bucshon said. “It seems to me that the company needs to do better with oversight.”

Mr. Calamari contended that Abbott had invested tens of millions of dollars toward quality and maintenance, and he praised the dedication of employees at the 700,000-square-foot facility, which he visited last week.

“I saw the team members there,” he said. “They are empowered to speak up and they are passionate about what they make and they make those products as it was for their own family.”

Several panel members called for stricter agency oversight of food safety and more frequent inspections of troubled plants.

Last week, the Justice Department announced a consent decree with Abbott on the conditions required to reopen the Sturgis plant, and the company could face heavy fines if it does not comply. In a complaint supporting the decree, officials described contamination with Cronobacter bacteria in finished baby powdered formula lots as long ago as 2019 and 2020.

Abbott officials “have been unwilling or unable to implement sustainable corrective actions to ensure the safety and quality of food manufactured for infants,” the complaint concluded.

Cronobacter sakazakii bacteria thrive in dry conditions, like powdered foodmaking. Only one state, Minnesota, requires doctors or labs to report cases of food-borne illness from the bacteria to public health authorities, who, in turn, are supposed to alert the C.D.C., The New York Times has reported.

Senator Tammy Duckworth, Democrat of Illinois, urged the C.D.C. to change the protocols. “Our nation’s inadequate reporting system results in critical data gaps that undermine our ability to understand the true scope of Cronobacter infections in infants,” according to the letter she sent on Wednesday.

At the subcommittee hearing, Dr. Califf agreed that reporting should be required of cases involving the bacteria.

Last week, President Biden invoked the Defense Production Act to increase formula production and authorized the use of aircraft to speed shipment of infant formula to the United States from overseas. The first military plane carrying 500,000 bottles of formula arrived in Indianapolis from Europe on Sunday.

During the hearing, Xavier Becerra, the secretary of Health and Human Services, tweeted that 60 tons of baby formula had “just arrived on U.S. soil.” He posted a photo of the first lady, Jill Biden, in front of the FedEx plane delivering an overseas shipment on Wednesday.

The F.D.A. said last week that it set up a streamlined process for foreign baby formula manufacturers to send their products to the United States. On Tuesday, it announced that it approved one company’s application to send two million cans.

Mr. Biden has also signed legislation into law broadening the types of formula that can be purchased using benefits from the federal food aid program for women and babies, which cleared both chambers of Congress with few objections. A House-passed emergency $28 million measure to boost staffing for the agency, however, has stalled as some senators question whether the money will adequately address the shortage.

“We don’t want anybody to be short of baby formula or anything,” said Senator Richard Shelby of Alabama, the top Republican on the Senate Committee on Appropriations. “Let’s see if we need it — the answer is not always money. The answer is good government and market forces.”

It is unclear what other legislative steps Congress will take. But as pleas from desperate parents searching for formula flooded Capitol Hill, lawmakers hastily scheduled hearings to interrogate both Dr. Califf and top industry executives over the failures that led to the shortage.

Two more hearings are scheduled for this week, with House Appropriations subcommittees summoning a panel of experts on Wednesday and Dr. Califf set to appear before the Senate’s Health, Education, Labor and Pensions Committee on Thursday.

Emily Cochrane contributed to this report.



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