Scathing report urges major changes at FDA, including possibly breaking up agency

An outside group that was 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 accused of giving its food program short shrift, and it came under fire from members of Congress and others for not heading 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 for the FDA, which the agency asked 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.

The task force’s first, most sweeping suggestion was to create separate food and drug administrations within HHS, which would require approval from Congress. The task force acknowledged this was “thinking big” and would be a longer-term solution to remedying problems but said the benefit would be elevating the visibility of each side and separating their budgets.

Other, less ambitious options included separating the food and drug arms but keeping them within a single agency, as well as creating a new deputy commissioner position with authority for overseeing food.

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.

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 did not 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 squeezed formula supplies. This left many parents without reliable sources of food for their babies and medically fragile children.

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

Food safety experts have long complained that the agency’s 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 without 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.”

A bias toward the medical side, experts say, led to miscommunications and failures. A whistleblower report from a former employee alleging safety risks at the Abbott plant took four months to reach the top food safety official. The former employee subsequently dropped a federal Occupational Safety and Health Administration 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, Califf, a physician 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.” Califf announced the review of the agency organization during a May hearing, and the Reagan-Udall review launched on Sept. 8.

Organizations representing consumers, the food industry and state food regulators are pushing to restructure the FDA. In April, the groups sent a letter to Califf, calling on him to unify the FDA food program under a deputy commissioner for foods, with accountability to the agency commissioner and direct authority over the agency’s food safety centers.

The Reagan-Udall task force suggested the agency establish a new structure with clear leaders and roles, that it develop a culture in which decision-making is rooted in scientific evidence and that it commit to better transparency, timeliness and predictability in decision-making.

“What’s clear is that the agency’s cultural and structural failures are contributing to communication, organizational and risk management failures that are making our food less safe,” said Scott Faber, a food safety expert with the Environmental Working Group. “Any of the structural reform options proposed by this task force would make the current system better, provided the Congress follows through on the needed resources.”

The Reagan-Udall Foundation is an independent nonprofit group created by Congress to help modernize industries and sectors covered by the FDA. It is funded by the FDA and large corporations that have business with the agency, including drugmakers Eli Lilly and Pfizer as well as Nestlé USA, which makes baby formula.