FDA: The more things change, the more they stay the same – Opinion

Fifteen years ago, the Science Board of the US Food and Drug Administration (FDA) released a report in which they concluded that the agency’s scientific base had eroded, its scientific organizational structure was weak, its scientific workforce lacked sufficient capacity and capability, and its information technology (IT) structure was inadequate.

Today, the Reagan-Udall Foundation for the FDA released an Expert Panel report on the agency’s Human Food Program capabilities, in which they concluded that the program is underfunded and understaffed, IT resources are inadequate, no single individual is in overall charge of the program, and the agency is risk-averse.

Problems with organizational structure, funding, staffing and information technology. It would appear that not much has changed in fifteen years.

Expert Panel findings

In a fifty-one page report, the panel presented a damning list of deficiencies, the most glaring of which is the absence of a Deputy Commissioner of Foods, a position that was eliminated in 2019 during the Trump Administration.

Without a Deputy Commissioner, responsibility for fulfilling the FDA’s food safety and nutrition mandates is spread among the Center for Food Safety and Nutrition (CFSAN), the Center for Food Policy and Response (CFPR), and the Office of Regulatory Affairs (ORA). The Center for Veterinary Medicine (CVM) is responsible for the Animal Food Program, which includes both animal feed and companion animal food.

All four of these Centers report directly to the office of the FDA Commissioner, diluting the overall clout of the Food component of the FDA.

This lack of cohesive leadership and coordination was part of the reason for the FDA’s slow response to the Abbott Nutrition infant formula contamination crisis.

Many of the panels other findings are an inevitable consequence of the current organizational structure. Among these are:

• Lack of a clear vision and mission
• Absence of an ultimate decision-maker
• A culture of indecisiveness and inaction
• Overlapping roles and competing priorities among the various Centers
• Over-reliance on consensus for decision-making
• Aversion to regulatory risk-taking, resulting in reluctance to take enforcement action, including the use of mandatory recall authority
• Funding has barely kept pace with inflation, and has fallen behind the increase in the size of the food industry
• Critical staff have left the agency due to pay disparity with the private sector

Room at the top

The Expert Panel report does more than simply list deficiencies. It recommends a number of substantive improvements to the FDA’s organizational structure, hiring and personnel practices, budget and appropriation strategies, and information sharing.

The panel also recommends that the animal feed and companion animal food portions of the Center for Veterinary Medicine (CVM) be integrated with the Human Food Program.

But implementing the panel’s recommendations will require a strong leader–one with the courage and the clout to fight the Food Program’s battles within the FDA, with Congress, and with the food industry.

In January 2019, upon the retirement of Dr. Stephen Ostroff from the FDA, the position of Deputy Commissioner for Food disappeared from the agency’s organizational structure. Instead, the Trump Administration created a Center for Food Policy and Response (CFPR), and named Dr. Frank Yiannas as its first Deputy Commissioner.

Since then, responsibility for the Human Food Program has been parceled out among the CFPR, the CFSAN and the ORA, leading to “…overlapping roles and competing priorities that result in what is perceived as constant turmoil.”

I have long been an advocate of a single, independent Human and Animal Food Safety Agency that would take over all federal responsibility for regulating the safety of the US food supply, including most of the activities now carried out by the US Department of Agriculture’s Food Safety and Inspection Service (FSIS).

The single-agency approach has been adopted by many countries around the developed world, including Canada, the United Kingdom, a number of EU Member countries, Australia, and New Zealand.

This consolidation would, with a single stroke, eliminate significant overlap and duplication of enforcement activities, simplify the communications between regulators and the regulated (ie., food industry), and free the USDA to focus on its mandate to promote and support the agricultural industry without simultaneously trying to enforce food safety standards.

But I am, above all, a realist. I know that an independent Food Safety Agency is not even a twinkle in the Biden Administration’s eye.

In the absence of an independent agency, what the FDA needs desperately is a steady hand at the helm of the Food Program. Someone who has the authority to make tough decisions, advocate for the resources needed to ensure the safety of the food supply, and defend the Food Program against internal erosion and external pressures.

If FDA Commissioner Califf does nothing else in response to the Expert Panel report, he must act with dispatch to consolidate all of the disparate elements of the Human and Animal Food programs into a single entity headed by a Deputy Commissioner reporting directly to the Office of the Commissioner.

The gory details

If you wish to read the full report, you can download the pdf file here.