Less than two months after an outside group delivered a scathing indictment of the FDA’s structure and culture and recommended a major restructuring, the agency’s chief food safety officer has resigned, citing shortcomings in the FDA’s ability to handle foodborne disease crises, including in children. the talk. lack of formula.
Stepping down from his post next month, Frank Yanas, deputy commissioner for the Office of Food Policy and Response, also wrote to FDA Commissioner Robert M. Calif on Wednesday.
“The decentralized structure of the Food Program that you and I have inherited significantly weakens the FDA’s ability to function as an integrated team for food and public protection,” Yanas wrote in the letter, which was obtained by The Washington Post.
He also recommended that Califf restructure the agency to include a “fully empowered and experienced Deputy Commissioner for Food, with direct oversight of those centers and offices responsible for human and animal foods.”
Yanas confirmed his resignation but declined to comment.
A scathing report urges major changes at the Food and Drug Administration, including a possible breakup of the agency
He has been at the center of the agency’s flawed response to the baby food crisis, as an allegedly tainted powder formulation has been blamed for making four babies sick and killing at least two.
When a whistleblower sent a report to the Food and Drug Administration in October alleging problems at the Abbott Infant Factory, Janas, the top food safety official, didn’t see it.
Yanas told The Washington Post at the time that he did not find out about the complaint until four months later.
By then, one infant had already died, and two more had been hospitalized after consuming formula from the plant—all while top FDA officials, less knowledgeable about food safety, chose not to send new inspectors to the plant in Sturgis, Michigan. Infant deaths were linked to the milk produced by Abbott, factory closures and chest recalls, which led to an acute shortage of infant formula.
“It wasn’t sent to me, it wasn’t shared with me internally. How does this happen?” Yiannas who before Managed the food safety program for Walmart, the nation’s largest grocer, he told The Post. “There were early signs, and in any security profession you want to take it seriously to stop the domino effect. It just didn’t happen.”
The infant formula whistleblower report did not reach the Food and Drug Administration’s food safety officer
A federal investigation did not prove that the children became ill from bacteria introduced at the plant. Abbott officials 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 giving its diet program short notice. Last year, the agency came under fire from members of Congress and others for not overcoming a formula shortage that left many parents scrambling to feed their babies. According to a December U.S. 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 was hampered by flaws in the leadership structure and poor communication within an agency that appeared to be in “constant turmoil,” according to an FDA report from the Reagan Udall Foundation, which asked to assess its operations.
The report recommended several options for reforming the agency, which is based within the Department of Health and Human Services and responsible for overseeing aspects of the country’s diet, as well as tobacco products and pharmaceutical drugs.
The task force’s most sweeping proposal was to create separate departments of food and drug within HHS, which would require congressional approval. Less ambitious proposals included separating the Food and Drug Corps but keeping them within a single agency, as well as creating a new Deputy Commissioner position with authority to oversee food.
The Justice Department opens an investigation into Abbott’s infant formula
On Friday, the Department of Justice opened a criminal investigation into the Abbott Laboratories plant at the heart of the infant formula shortage. The facility has been closed for more than four months after FDA inspectors discovered Cronobacter sakazakii, a bacterium potentially fatal to newborns and immunocompromised children, at the plant, along with a series of safety violations, according to inspection records. The closure came four months after the whistleblower submitted the report to the Food and Drug Administration.
Critics of the FDA said the agency’s failure to ensure the safety of infant formula was an indication of larger failings. Experts say the formula does not undergo the same types of rigorous testing as the drugs.
“Before a drug enters the market, it goes through several rounds of testing from the Food and Drug Administration,” said Stacy Lee, a professor of health law at Johns Hopkins University. “Infant formula, which goes into the most vulnerable populations, does not undergo any kind of FDA testing before it is marketed, and they rely exclusively on manufacturers after the product is available to the public in compliance with regulations. … I think what that says about The medication aspect versus the food aspect speaks for itself.”