Three of FDA’s former food safety chiefs have come together today to submit comments to a U.S. House of Representative’s oversight committee focused on chain of command problems at the agency.

The former Food and Drug Administration officials who submitted the comments to the U.S. House of Representatives Subcommittee on Health Care and Financial Services for the Committee on Oversight and Accountability are:

• Stephen Ostroff, M.D., Former FDA Deputy Commissioner for Foods and Veterinary Medicine and Acting Commissioner 2016-2018;
• Michael R. Taylor, Former FDA Deputy Commissioner for Foods and Veterinary Medicine 2010-2016;
• David Acheson, M.D., Former FDA Associate Commissioner for Foods 2007-2009.

While the comments submitted to the committee’s official record are made in the context of the 2022 infant formula crisis, which shed light on communication problems at the FDA, they focus on the overall problem of a lack of a clear chain of command for the agency’s foods program.

“The infant formula events are one sign that FDA has not accomplished the food safety transformation FSMA (the Food Safety Modernization Act of 2011) envisioned and is not organized for success on food safety, but there are many others,” the former FDA food safety leaders say in their comments. 

“The problems begin with the program’s low priority in the FDA commissioner’s office and include its fragmented organizational structure, insular culture, bureaucratic infighting, slow decision making, and failure to follow through on FSMA implementation.”

The comments repeatedly refer to the current FDA Commissioner Robert Califf and his apparent lack of willingness to effectively overhaul the food side of the FDA. The three former officials say Califf presides over an effective drug side of the agency, but they disagree with the commissioner’s handling of recommendations from an expert panel on how to make the food side of the agency work to ensure food safety.

“. . . they (the panel of experts) called for FDA to unify the program under a single leader with full line management authority to lead its essential culture change and program modernization,” the three former FDA deputy commissioners say in their comments.

“Inexplicably, FDA leadership has rejected this recommendation. . . Even more critically, the Deputy Commissioner for Human Foods (planned by Califf) does not even have authority over all of FDA’s human food components. That is because the large field-based units within FDA that manage food inspections, field laboratories, and import oversight – and consume some two-thirds of FDA’s food-related budget – remain organizationally separate, with no direct management accountability to the new deputy commissioner.”

The former FDA deputy commissioners say that Califf is focused on operations of the drug side of the agency — even though the FDA is responsible for more than 80 percent of the American food supply. They say the commissioner keeps pushing for an unrealistic option for the operation of the food side of the agency.

“The matrix management approach Dr. Califf touts from his private sector experience has been tried and failed at FDA, as we know from our personal experience and as exemplified by the lags in FDA’s action on infant formula,” according to the comments submitted to the committee hearing record.

“It is unclear why FDA leadership has rejected the recommendations of its stakeholders and independent experts who have deep experience and expertise on food matters.  One possibility is that, while the agency’s top leaders are highly expert in medical product oversight, they lack personal experience and expertise on food safety and what it will take to transform the Food Program’s culture and performance.

“Medical products certainly deserve all the attention they get at FDA, and for years that’s been the focus of FDA’s top leadership, which helps explain why food regulation has a lower priority within FDA and is chronically underfunded.  The focus of FDA leadership on medical products may also explain why the commissioner’s proposed reorganization of the Food Program is patterned after the model that works for drugs and other medical products but won’t work for food.”

The three former FDA deputy commissioners say quick action is required to ensure the safety of the country’s food supply and that Congress should step in if Commissioner Califf fails to take appropriate action.

“Ideally, the Commissioner would change course and replac the announced reorganization with one that truly unifies the Food Program and empowers the new deputy commissioner position.  Absent that, Congress must act by directing FDA to make these critical changes.  Or Congress could elevate and reset the Food Program by removing food from FDA altogether and creating a separate agency under a Commissioner for Food Safety and Nutrition,” the former deputy commissioners say. 

“With decisive action now, Americans can get the unified, efficient and forward-leaning food program they deserve and expect. With half steps, disunity and dysfunction that was so evident during the infant formula crisis will persist and history will surely repeat itself.”