A box of Nestle Alfamino Junior baby formula waits at Ramstein Air Base, Germany, on Saturday, May 21, 2022, before being flown to the United States.

A box of Nestle Alfamino Junior baby formula waits at Ramstein Air Base, Germany, on Saturday, May 21, 2022, before being flown to the United States. (Phillip Walter Wellman/Stars and Stripes)

An outside firm asked to examine problems at the Food and Drug Administration in the wake of an infant formula crisis this year offered a scathing indictment of the agency's structure and culture and recommended major restructuring, including possibly breaking up the agency so that oversight of the food system gets more attention.

The FDA has long been criticized for giving its food program short shrift, and it came under fire from members of Congress and others for failing to head off a formula shortage that left many parents scrambling to feed their infants. The response to the formula crisis was hampered by flaws in the leadership structure, and poor communication within an agency that seemed to be in a state of "constant turmoil," according to the report from the Reagan-Udall Foundation, which was hired by the FDA to assess its operations.

The report recommends several options for fixing the agency, which is housed within the Department of Health and Human Services and is responsible for overseeing aspects of the nation's food system, as well as tobacco products and pharmaceutical drugs.

In a statement, FDA Commissioner Robert M. Califf said he will review the report and make decisions about the future of the agency with input from experts inside and outside the FDA. Some of the changes suggested in the report would require approval from Congress.

The report comes in the wake of heavy criticism of the agency's handling of a formula shortage earlier this year. Critics said the agency failed to act quickly enough on complaints about sanitation at a large Abbott Nutrition manufacturing facility in Michigan — and then didn't foresee the shortage triggered when the plant was shuttered to fix deficiencies identified by the FDA.

At least four babies fell ill from a bacterial infection after drinking powdered formula manufactured there. Two of the babies died. FDA investigators were not able to identify the source of the bacteria, and the company said it did not originate at the factory. But the company recalled 5 million units of powdered formula, and the five-month closure dramatically squeezed formula supplies, leaving many parents scrambling to feed their babies and medically fragile children.

Legislators and food safety experts asserted that agency leadership has allowed long-standing structural flaws to fester.

But food safety experts have long complained that its food oversight arm has been chronically understaffed and underfunded. Those problems, critics say, have been exacerbated by poor communication between its centers. More broadly, experts say, the agency has prioritized the drug and medicine side, frequently drawing leaders with medical backgrounds and not food industry knowledge.

"This report exceeds expectations because it represents a formal acknowledgment of all the issues in the foods program that have taken place over many years," said Brian Ronholm, director of food policy for Consumer Reports. "That's actually a very significant step."

That bias toward the medical side, experts say, led to a series of miscommunications and failures. A whistleblower report from a former employee alleging safety failures at the Abbott plant took four months to reach the top food safety official. The former employee subsequently dropped a federal OSHA complaint, Abbott chief executive Robert Ford said in a call with investors this fall. Additionally, the coronavirus pandemic meant many food manufacturing facilities went without on-site inspections for most of a year.

In response to criticisms earlier this year in congressional hearings, FCaliff, a physician himself who was appointed to the top post in February, acknowledged that the response to the formula crisis took too long and that "some decisions in retrospect were not optimal."

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