Institute of Medicine report urges major changes at Food and Drug Administration

Washington -- Restoring confidence in the nation's prescription drug monitoring system is the intention of a new Institute of Medicine report that provides a broad range of recommendations for changes at the Food and Drug Administration.

"The Future of Drug Safety: Promoting and Protecting the Health of the Public," was released Sept. 22 and advises expanding the FDA's authority to require postmarketing surveillance of approved drugs, ensuring better communication between the agency and the public on safety issues, strengthening agency leadership and boosting funding. Many of the recommendations would require legislation to put them into action.

The FDA's reputation as an effective drug safety watchdog already was under a cloud when, in 2004, it fell even more sharply after the painkiller Vioxx (rofecoxib) was withdrawn from the market. The agency took another hit that year when possible links were discovered between adolescent suicides and certain antidepressants. The IOM report was commissioned by the FDA and several other federal agencies to help resolve such situations, which often result in numerous phone calls to physicians' offices from patients concerned about the safety of their medications.

"If all the recommendations are adopted, it is possible we could see some real forward movement in a way that benefits the agency, the public and physicians who count on the FDA to do its job," said Susan Wood, PhD, who resigned from her post as director of the FDA's Office of Women's Health last year, citing concerns about agency integrity.

But improvements are only possible if the majority of the recommendations are adopted and acted upon. Curt Furberg, MD, PhD, professor of public health sciences at Wake Forest University School of Medicine in North Carolina, doubts that the FDA would take the necessary steps to transform itself. "Although it's great to have the report, how can we be sure actions will be taken?" he asked. "The problems at the FDA have existed for at least a decade, and they have done very little to fix them."

Dr. Furberg, who is on the FDA's Drug Safety and Risk Management Advisory Committee, co-wrote an article on the FDA and drug safety with other current and past panel members. It was scheduled to appear in the Oct. 9 Archives of Internal Medicine.

Dr. Furberg's piece identifies problems similar to those found by the IOM panel but goes a step beyond and asks Congress to help resolve them, recommending that a congressional committee keep tabs on FDA's efforts.

What's the problem?

The IOM report spells out several issues at the agency. "Legitimate questions have arisen about [the FDA's] Center for Drug Evaluation and Research's handling of drug safety," said the panel of physicians, epidemiologists and economists who drafted the report. "Are safety signals recognized and addressed in a timely fashion? Is the public informed about safety problems in a clear and timely manner?"

The panel found that a perception of crisis grips the agency and has compromised the FDA's credibility as well as that of the pharmaceutical industry. And, although there is general agreement on what needs improving, the FDA's "organizational culture" and lack of resources stand in the way of repair, the panelists said.

In reaction to these findings, Caroline Loew, PhD, senior vice president of scientific and regulatory affairs at the Pharmaceutical Research and Manufacturers of America, questioned whether the industry is seriously flawed. "After all, fewer than 3% of approved prescription drugs have been withdrawn from the American market for safety reasons over the last 20 years," she said.

As Dr. Wood read the report, though, she readily recognized the agency where she had worked. "Part of the culture of the FDA is not to acknowledge limitations," she said.

The agency has been without a permanent commissioner for the past few years, and by the end of September, Acting Commissioner Andrew von Eschenbach, MD, had not yet been confirmed by Congress.

Dr. von Eschenbach said the agency viewed the new report as an opportunity to address existing concerns but already had taken steps to improve the work environment and had developed new tools to communicate information to patients.

Steven Galson, MD, MPH, the FDA's director of the Center for Drug Evaluation and Research, pointed to a redesigned prescription drug label as an already complete agency initiative to address safety concerns.

The AMA favored much of the panel's advice, particularly its focus on postmarketing surveillance and the provision of the means to accomplish this goal. "Both pre- and postmarket study are necessary to understand the full risk/benefit ratio of prescription drugs," said Cecil B. Wilson, MD, chair of AMA Board of Trustees. "A greater emphasis on postmarket study will help physicians make wise prescribing decisions for their patients."

The AMA also supported the recommendation for a comprehensive clinical trial registry. But another postmarketing risk strategy -- restricting who could prescribe particular drugs -- raised concern. "This could have the unintended consequence of denying patients access to medically necessary drugs," Dr. Wilson said.