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FDA food safety officer resigns, citing flaws in agency’s crisis response

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Less than two months after an outside group made damning indictment of the structure and culture of the Food and Drug Administration and recommended major restructuring, the agency’s top food safety officer resigned, citing shortcomings in the FDA’s ability to address foodborne illness crises, including the recent baby formula shortage.

Frank Yiannas, the deputy commissioner for the office of food policy and response, will leave his post next month, he wrote to FDA Commissioner Robert M. Califf on Wednesday.

“The decentralized structure of the food program that you and I inherited significantly hampered the FDA’s ability to operate as an integrated food team and protect the public,” Yiannas wrote in the letter obtained by The Washington Post.

He also recommended that Califf restructure the agency to include “a fully empowered and experienced Deputy Food Commissioner, with direct oversight of the centers and offices responsible for human and animal food.”

Yiannas confirmed his resignation but declined to comment.

A damning report urges major changes at the FDA, which may include breaking up the agency

He was at the center of the agency’s flawed response to the baby food crisis, in which allegedly contaminated powdered formula was blamed for sickening four children and killing at least two.

When a whistleblower sent a report to the FDA in October about alleged problems at an Abbott infant formula plant, Yiannas, the top official in charge of food safety, didn’t see it.

Yiannas told The Washington Post at the time that he didn’t learn about the complaint until four months later.

By then, one baby had already died and two others were hospitalized after consuming formula from the plant — while other top FDA officials less versed in food safety had opted not to send new inspectors to the Sturgis, Michigan, plant. to send. infant deaths were associated with Abbott-produced infant formula, the factory was closed and a recall was issued, leading to a critical national shortage of infant formula.

“It was not sent to me and it was not shared with me internally. How did this happen?” Yiannas, previously implemented the food safety program for Walmart, the nation’s largest grocer, The Post told The Post. “There were early signals and in any security profession you want to take them seriously to stop the domino effect. That did not happen.”

Whistleblower report on baby food failed to reach FDA’s top food safety officer

A federal investigation failed to prove that the children became ill from bacteria brought into the factory. Abbott officials have said the bacteria did not come from the factory.

The FDA is expected to announce more changes within the agency’s food safety division in the coming days.

The FDA has long been criticized for making short shrift of its food program. Last year, the agency came under fire from members of Congress and others for failing to fix a formula shortage that left many parents rushing to feed their babies. According to a December US Census Pulse survey, more than 50 percent of parents in Mississippi, Kansas, West Virginia, Nebraska and Arizona said they still had trouble finding formula.

The response to the formula crisis has been hampered by flaws in leadership structure and poor communication within an agency that appeared to be in a state of “constant turmoil,” according to a report for the FDA from the Reagan-Udall Foundation, which asked the agency to review its assess operation.

The report recommended several options for establishing the agency, which is housed within the Department of Health and Human Services and is responsible for overseeing aspects of the national food system, as well as tobacco products and pharmaceutical drugs.

The task force’s most sweeping suggestion was to create separate food and drug administrations within HHS, which would require congressional approval. Less ambitious suggestions included separating the food and drug poor, but keeping them within one agency, and creating a new position of deputy commissioner with authority to oversee food.

Justice Department opens investigation into Abbott over baby food

On Friday, the Justice Department opened a criminal investigation into the Abbott Laboratories factory, at the heart of the baby food shortage. The facility closed more than four months after FDA inspectors discovered Cronobacter sakazakii, a potentially deadly bacteria for newborns and immunocompromised infants, at the plant along with a spate of safety violations, according to inspection data. The closure came four months after the whistleblower filed the report with the FDA.

FDA critics said the agency’s failure to ensure baby food safety hinted at bigger failures. Experts say the formula doesn’t go through the same kinds of rigorous testing that pharmaceutical products do.

“Before a drug hits the market, it goes through several rounds of FDA testing,” said Stacey Lee, a professor of health law at Johns Hopkins University. “Baby foods, which reach the most vulnerable people, do not undergo any sort of FDA testing before being released to the market, and they rely solely on manufacturers after the product has been made available to the public and compliant. … I think what this says about the drug side versus the food side speaks for itself.

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