The U.S. Food and Drug Administration is in a precarious position, according to a subcommittee of its science board. Charged with assessing whether or not the existing science and technology at the FDA can truly keep the public safe, the subcommittee answered with a resounding "no."
The Science and Technology Subcommittee, comprising three board members and a bevy of external advisers with expertise in the agency's regulatory science, published a report in December based on a yearlong review of the FDA's capabilities. The report found that the agency doesn't have the science and technology to support its current and future regulatory needs, and concluded that the "FDA does not have the capacity to ensure the safety of food for the nation." In contrast to previous reviews of the agency that warned of impending crises if funding issues were not addressed, this report indicated that some of those crises —pet food recalls and E. coli outbreaks, for example—are now realities.
"FDA's inability to keep up with scientific advances means that American lives are at risk," the report states. Demands on the FDA have soared in recent years because of new scientific discoveries, the complexity of new products and claims submitted for pre-market review and approval, the emergence of challenging safety issues, and the globalization of the industry. But resources haven't kept up with the demands, according to the report. "This imbalance is imposing a significant risk to the integrity of the food, drug, cosmetic and device regulatory system, and hence the safety of the public," the subcommittee wrote.
"Consumers and industry are working together with FDA to improve the safety of America's food supply," said Caroline DeWaal, director of food safety at the Center for Science in the Public Interest. "It is frustrating that FDA does not have the scientific capacity and person-power to get the job done." CSPI is working with the Coalition for a Stronger FDA, a group of public health advocates, to urge the Bush administration to support a 2009 budget request that would include an effort to at least double the FDA's budget within five years.
In the past 20 years, Congress has passed 125 statutes heaping more responsibility on the FDA, while the agency lost $300 million to inflation and gained only a 9 percent increase in staffing, according to the report. Lack of funding has meant the eroding of the FDA's scientific organizational structure and work force, and left its Internet technology inadequate, the subcommittee reported.
To keep up with emerging science, the subcommittee recommended developing a new entity—dubbed the Incubator for Innovation in Regulatory and Information Science—that would recruit cross-disciplinary scientists as liaisons with "new science" groups across the agency. But the subcommittee was quick to point out that inadequate resources had doomed similarly necessary projects in the past, and stated that it would be vital for the IRIS to be adequately funded.
The report ended somewhat pessimistically, noting "a long history of excellent reviews of the FDA that have been followed by little or no action taken to achieve the recommendations." The subcommittee urged the FDA to develop a comprehensive plan and align it with the 2009 budget process in order to avoid jeopardizing the public's health.
Natural Foods Merchandiser volume XXIX/number 1/p. 9