Whistleblower report on baby formula didn’t reach top FDA food safety official

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When a whistleblower sent a 34-page report to the Food and Drug Administration in October alleging a host of unsanitary conditions at an Abbott infant formula factory, the top official in charge of food safety didn’t see it.

In fact, Frank Yiannas, the FDA’s deputy commissioner for food policy and response, didn’t learn about the complaint until four months later, according to Yiannas and others knowledgeable about the case.

By that time, one infant had already died and two others were hospitalized after consuming formula from the plant — all while other top FDA officials less-versed in food safety had elected not to send new inspectors to the plant in Sturgis, Mich. As another infant death was linked to Abbott-produced formula, the plant closed down and a recall was issued, sparking a critical national shortage of baby formula.

FDA commissioner testifies to Congress on baby formula crisis: Follow the hearing here

“It wasn’t sent to me and it wasn’t shared with me internally. How does this happen?” Yiannas, who previously ran the food safety program for Walmart, the nation’s largest grocer, told The Washington Post. “There were early signals and in any safety profession you want to take those seriously to stop the domino effect. That didn’t happen.”

The national fallout over the Abbott case has exposed a fractured structure at an agency that has long prioritized drugs and medicine over food safety, experts say — a problem exemplified by its handling of the whistleblower complaint and other warning signs of problems at the plant.

On May 22, experts explained how a special military operation is helping to relieve the U.S. baby formula shortage. (Video: Blair Guild/The Washington Post)

Neither of FDA’s food policy divisions have to report to Yiannas and neither do the agency’s food safety inspectors. Instead, they report directly to FDA Commissioner Robert M. Califf, a physician who was appointed to the top post on Feb. 17, the day Abbott recalled many of its powdered products. Before Califf was appointed, food safety problems were reported directly to Principal Deputy Commissioner Janet Woodcock, another physician who was acting commissioner when the whistleblower complaint arrived.

“The essential thing is that you’ve got three major operating components that are reporting only to the [FDA] commissioner, who, by tradition and current reality is a physician who is focused on medical products and doesn’t have the bandwidth or the inclination to spend time providing the leadership that’s needed for the food program to be successful,” said Michael R. Taylor, who was deputy commissioner for foods and veterinary medicine during the Obama administration.

On Wednesday, two House committees will hold separate hearings to investigate the agency’s actions in the Abbott case as well as whether there are deeper structural problems in the agency.

“Why didn’t we act more quickly on the complaints and the whistleblower report? Who knew what when?” Yiannas said. “Those are going to be some of the tough questions that will have to be answered.”

Yiannas spoke to The Post after…

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