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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 plans to tell lawmakers Tuesday.
Frank Yiannas, the agency’s deputy commissioner for food policy until his resignation earlier this year, will tell 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., sparking 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 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. .
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“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 has been accused of giving short shrift to its role overseeing of the nation’s food supply in favor of its drug approval side. 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 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.”
There is currently no permanent director of the FDA’s Office of Food Additive Safety, and there were a series of rotating acting directors at the FDA’s Office of Dietary Supplement Programs for a year until a permanent director was named last spring.
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Rep. Lisa C. McClain (R-Mich.), who chairs the subcommittee on health care and financial services, will preside over Tuesday’s hearing.
On Wednesday, FDA Commissioner Robert M. Califf is scheduled to testify before the House Appropriations Committee on the Biden administration’s 2024 budget. Experts say the commissioner is likely to be questioned about the agency’s planned reorganization, including his proposal to appoint a deputy commissioner of human foods.
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Yiannas, members of Congress and members of the food industry have urged the commissioner to give the new deputy commissioner direct management authority over the Center for Food Safety and Applied Nutrition, the Center for Veterinary Medicine and the Office of Regulatory Affairs, which conducts food safety inspections and accounts for nearly 70 percent of the FDA’s food-related budget.
They say Califf’s proposal falls short of creating a position with that level of authority. But Califf has pushed back, saying in a letter to the Consumer Brands Association that, while he intends to appoint a deputy commissioner for human foods, he does not want that person saddled with day-to-day operational oversight of inspections and criminal investigations. Furthermore, Califf said that “the tenor of some of the public criticism of FDA’s foods program is dissuasive” and has made recruiting a strong, talented leader more difficult.
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Food safety recalls have spiked recently. Last year broke records, with 416.9 million units recalled in the food industry, 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, who is slated to speak at Tuesday’s hearing, said the agency has done a number of things right.
Because the inspection division also oversees cases involving the pharmaceutical, tobacco and medical device side of the agency, he said, 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.
Source link: https://www.washingtonpost.com/business/2023/03/28/fda-formula-yiannis/