FDA Advisory Committee: Does Approval Mean Safety?

The National Research Center for Women & Families releases a report that examines the voting patterns of FDA advisory committee members on medical devices and drugs.

August 28, 2006

Washington, D.C. – Whether it is a prescription medication, a medical device, a vaccine, or another type of medical product, consumers assume that a product is safe and effective if it has been approved by the U.S. Food and Drug Administration (FDA).

“Unfortunately, our new study indicates there is every reason to doubt that assumption,” said Dr. Diana Zuckerman, president of the National Research Center (NRC) for Women & Families, which released its report, FDA Advisory Committee: Does Approval Mean Safety? “From our analyses of the FDA advisory committee voting patterns and committee discussions, our study shows advisory committee members usually recommending approval, even if they have strong concerns about the products’ safety and effectiveness. And, on those rare occasions that the advisory committee opposes approval, the FDA frequently approves the product anyway. That is especially likely for medical devices.”

The report provides the first objective analysis of the key role of the FDA advisory committees as part of the FDA approval process. The purpose of the report is to better understand the strengths and weaknesses of the advisory committee process for the FDA’s two largest centers, the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH). The study analyzed the voting patterns and committee discussions of all new medical products reviewed from 1998 through 2005 for a random sample of almost one-third of the drug and medical device advisory committees.

The results indicate that advisory committees recommended approval for 76% of new drugs and 82% of new medical devices. Some committees are more discriminating than others. Many panel members and some committee members recommended approval for every product they considered year after year. For example, 98% of the votes by members of the advisory committee reviewing arthritis drugs over the eight years of the study recommended approval; almost all, like Vioxx®, were recommended unanimously. The committee reviewing medical devices for vision correction and eye diseases unanimously recommended approval for every medical device they considered for the last six years of the study. About 96% of these drugs and devices were subsequently approved by the FDA.

The overwhelming pattern of unanimous approval recommendations sheds light on previous studies indicating that most committees have at least one member with a financial tie to the company whose product is under review. “Our study indicates that even one committee member with a financial conflict of interest could easily influence the votes of the entire committee, and thus the FDA decision to approve the product,” said Zuckerman.

The study also found that committee members often explicitly questioned whether the products were safe or effective, but described peer pressure and other pressures to approve them despite their concerns. FDA transcripts indicate that FDA officials almost never respond to those comments or concerns, which is likely to be interpreted as acquiescence.

The FDA subsequently approves virtually every product recommended for approval, apparently unconcerned about the doubts expressed, and often ignoring the post-market study requirements and other “conditions of approval” that committee members recommend as safeguards.

“It is not possible to know what the rate of approval ‘should’ be, but the study results are worrisome. The percentage of approval recommendations is very high, the percentage of unanimous approvals is very high, and advisory committee members are regularly admitting that they vote for approval despite serious misgivings about safety or effectiveness,” Zuckerman notes.

Congresswoman Rosa L. DeLauro, Ranking Member of the House Appropriations Subcommittee with jurisdiction and oversight responsibilities for the FDA and its budget, said, “This is an important study that helps us understand the kinds of changes needed to strengthen the FDA approval process. When experts serve on FDA’s outside advisory committees, they should be valued for providing independent expertise based on scientific scrutiny. Consumers are harmed if those advisors are pressured, directly or indirectly, to recommend approval when they are uncertain if a product is truly safe or effective. And when the advisory panels oppose approval, the FDA should take those warnings seriously.”

NRC for Women & Families is a Washington, DC -based nonprofit, nonpartisan think tank founded in 1999. The Center focuses on health information and health policy issues affecting women, children, and families. NRC provides information that can be used to improve the lives of adults and children by gathering and synthesizing research information and explaining its implications to consumers, the media, policy makers and opinion leaders.

For a copy of the executive summary click here. For a PDF copy of the 50-page report, click here.