FDA Follows Committee Recommendations Only 72 Percent of Time, Does Not Present Its Own Reviews 18 Percent of Time

WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) is not using its own advisory committees effectively when considering the approval of new drugs, according to a Public Citizen study, the results of which are published in a letter in the current edition of the Lancet medical journal. The study of drug advisory committee meetings found that the FDA overrules the findings of its own advisory panels 28 percent of the time, a figure higher than is generally assumed.

The FDA has 18 drug advisory committees that provide the agency with independent advice, but there have been virtually no quantitative examinations of how the committees function. In the present study, Public Citizen expanded upon its earlier study of financial conflict of interest in FDA drug advisory committee meetings published in April in The Journal of the American Medical Association. The nonprofit organization examined meetings between Jan. 1, 1997, and June 30, 2006, to determine how well the system is performing.

Public Citizen found that the FDA often allows drug companies to make an oral presentation without a countervailing FDA view. The agency fails to present its own interpretation of the company’s data 18 percent of the time, or at 49 of 275 drug advisory committee meetings for the period covered – which is inexcusable, according to Public Citizen.

The data also revealed that the FDA is holding drug advisory committee meetings less often than it did in the late 1990s. The study showed that only 24 percent, or 35 of 147, new molecular entities (NMEs) approved between 2000 and June 30, 2006, were preceded by advisory committee meetings. This represents a decrease from 1998 and 1999, when the FDA held meetings for 40 percent and 52 percent of approved NMEs, respectively.

“Advisory committees are a vital element of the nation’s drug safety net, but by failing to use these committees adequately, this resource is being squandered,” said Dr. Peter Lurie, deputy director of Public Citizen’s Health Research Group and an author of the letter. The other authors were Asa Tapley and Dr. Sidney M. Wolfe, director of the group. 

To read the letter in the Lancet, click here.

To read the press release for Public Citizen's study of financial conflicts of interest at the FDA, click here.