Former FDA official says agency dysfunction led to baby formula crisis

WASHINGTON - The nation remains one outbreak, tornado, flood or cyberattack away from ending up where it was last February when the shuttering of a baby formula plant sparked a nationwide shortage, the Food and Drug Administration’s former top food safety official told lawmakers Tuesday.

Frank Yiannas, the agency’s deputy commissioner for food policy until his resignation this year, testified before a subcommittee of the House Oversight Committee that the agency was slow to act when concerns about sanitation arose at the Abbott Nutrition formula plant in Sturgis, Mich., setting off a chain reaction that dramatically reduced the U.S. supply of formula. The agency also failed to monitor the food supply chain, despite glaring deficiencies exposed by the coronavirus pandemic, he said in written testimony.

“Even as COVID-19 created the biggest challenge to the food system in a hundred years, there was internal debate at the agency on whether there was really a role for the FDA in monitoring food supply chains,” he said in his prepared remarks.

Yiannas said that the FDA’s structure and culture exacerbated delays and that the agency had no data system in place to monitor key food supply chains. While Abbott is responsible for the safety and testing of its own powdered formula, he said, the sickened children and months-long shortage “was all a preventable tragedy” had FDA acted more urgently.

“I believe that the literature of the future will also conclude that this incident is a sad example of how FDA’s siloed organizational structure and culture impeded rapid critical problem identification, communication and response,” Yiannas said.

The testimony comes during a period of upheaval at an agency that came under fire from consumers and lawmakers last year over its handling of the formula crisis. Despite a whistleblower complaint about conditions at the Abbott plant, the FDA was slow to inspect the facility and did not clear it to reopen for months, contributing to a nationwide shortage. At least two babies died and others were sickened after consuming formula made at the plant, though Abbott has said the bacterial contamination didn’t occur at the factory. The FDA was unable to conclusively link the outbreak to the factory.

In a statement Tuesday, Abbott Nutrition complained that “some continue to imply that our product caused the four investigations investigated by the FDA (and Centers for Disease Control and Prevention) that led to the February 2022 recall,” despite the probes’ results. The company said it has stepped up efforts to manufacture and import formula and plans to open a new U.S. plant.

The FDA has long been accused of giving short shrift to its role of overseeing the nation’s food supply in favor of its drug approval side, and this year it announced a plan to reorganize. Yiannas resigned in February, citing shortcomings in the FDA’s ability to handle foodborne illness crises.

His was among several recent departures of top officials at the FDA. Susan Mayne, the FDA’s long-standing director of the Center for Food Safety and Applied Nutrition, announced Monday that she would retire effective May 31, saying it was “necessary that FDA look critically at the broader foods program structure, to reduce redundant operations, increase efficiencies and make optimal utilization of our field resources.”

In September, the agency released a 10-page internal analysis of its own performance during the formula crisis, giving itself largely high marks. Its author, a 32-year veteran of the agency, retired three months later. There is no permanent director of the FDA’s Office of Food Additive Safety, and there were rotating acting directors at the FDA’s Office of Dietary Supplement Programs for a year until a permanent director was named in spring 2022. As Yiannas said Tuesday, there has been a “rotating sea” of leaders at the agency.

Rep. Lisa C. McClain (R-Mich.), who chairs the subcommittee on health care and financial services, presided over Tuesday’s hearing.

“We owe it to parents, caregivers and infants to get to the bottom of what happened and prevent it from happening again. We owe it to the families of the babies that died as a result of contaminated formula,” she said.

On Wednesday, FDA Commissioner Robert M. Califf is scheduled to testify before the House Appropriations Committee on the Biden administration’s 2024 budget. He will probably be questioned about the agency’s planned reorganization, including his proposal to appoint a deputy commissioner of human foods.

Yiannas and members of Congress and the food industry have called for the appointment of a new deputy commissioner with authority over inspections of food-manufacturing facilities. That center accounts for nearly 70 percent of the FDA’s food-related budget and represents the “boots on the ground” part of the agency.

Califf has said he opposes giving a new deputy authority over inspections, saying in a letter to the Consumer Brands Association, a food industry group, that he does not want that person saddled with day-to-day oversight of inspections and criminal investigations. Califf criticized “the tenor of some of the public criticism of FDA’s foods program,” which he said has made recruiting for the position difficult.

Roberta Wagner, vice president of regulatory and technical affairs for the Consumer Brands Association and a former FDA official, disagreed that the rhetoric has discouraged strong applicants. She cited an outside report commissioned by the FDA itself that says the agency seems to be in a state of “constant turmoil” with “little motivation” and that recommends giving the deputy real authority, particularly over the inspection arm of the agency.

Brian Ronholm, director of food policy for Consumer Reports, said Califf’s current plan doesn’t appear to give the deputy commissioner sufficient power to fix problems with the agency’s food oversight.

“I would equate it to giving someone a new car but saying to them, ‘By the way, other people will also have the keys to the car, and, oh, they also think they own it,’” he said.

Food safety recalls have spiked recently. Last year broke records, with 416.9 million units recalled, according to Sedgwick’s State of the Nation Recall Index report. Of that number, 14.9 million units were of infant formula in three recall events.

Peter Lurie, executive director of the Center for Science in the Public Interest, testified at Tuesday’s hearing that much of the FDA’s response to the formula crisis was appropriate and that the commissioner’s reorganization plan addresses most of the critical issues facing the FDA.

Because the inspection division also oversees cases involving the pharmaceutical, tobacco and medical device side of the agency, Lurie said in an interview, it isn’t logical to “want solutions for a foods program problem that end up creating problems for the rest of the agency.”

McClain and Rep. James Comer (R-Ky.), chairman of the House Committee on Oversight and Accountability, have asked Califf to provide documents and communications related to the FDA’s handling of the formula crisis. Their request includes communications between the agency and the White House, as well as all documents and communications related to the decision not to reassign or terminate the employment of agency workers in connection with the infant formula shortage.