FDA Needs a Major Overhaul, Watchdog Says

FDA Needs a Major Overhaul, Watchdog Says

REUTERS/Denis Balibouse

The Food and Drug Administration’s oversight of the U.S. food industry is severely lacking, with shortcomings so significant that the organization should consider a major restructuring, according to a new report from a watchdog group.

The scathing analysis was produced by the Reagan-Udall Foundation, an independent watchdog created by Congress 15 years ago to provide oversight and advice for the FDA. Last July, the foundation commissioned an independent panel to review the FDA’s Human Foods Program, following the FDA’s failure to maintain the supply of infant formula earlier in the year, and its analysis was released Tuesday.

Among the many problems identified in the report, the expert panel found that the FDA’s food program lacks both strong leadership and a clear sense of mission. “The lack of a clear overarching leader of the Human Foods Program has contributed to a culture of indecisiveness and inaction and created disincentives for collaboration,” the report’s authors said.

As a result, the FDA is slow to respond to threats to the food supply and avoids making tough decisions on enforcement. Taken together, the problems mean that the agency falls short in its primary mission of protecting public health, the report says.  

The panel recommends restructuring the food program to centralize leadership. It also says the program needs more funding from Congress in order to accomplish its mission.

In response to the report, Robert M. Califf, the FDA’s Commissioner of Food and Drugs, thanked the panel for its analysis and said it “will help to inform a new vision” for the program to be announced in January. “This new vision and structure will be built on the external evaluation being released today; the internal review of the agency’s infant formula supply chain response completed in September, which has already resulted in noticeable improvements in our operations across the Foods Program; and ongoing work that allows the agency to take advantage of emerging advances in food science, with a goal of designing a system that allows us to more quickly adapt to an ever-changing and evolving environment,” Califf wrote.