CSPI: FDA Failing to Find Advisers Without Conflicts of Interest

The Food and Drug Administration's latest report on the make-up of its advisory panels reveals that little has changed in the 15 months since Congress required the agency to document its efforts to find scientists without ties to industry, the Center for Science in the Public Interest's Integrity in Science Watch reported today.

In a report sent to Capitol Hill on Jan. 31, FDA Commissioner Andrew von Eschenbach reported that 24 percent of advisers to the agency’s seven centers and offices received conflict-of-interest waivers between November 2005 and January 2007. The Center for Drug Evaluation and Research (CDER) had the worst performance, with 146 of 417 advisers, or 35 percent, requiring waivers because they owned stock in, consulted for, or served on the speakers' bureaus of firms with products up for approval or their competitors.

The agency's ability to identify advisers without conflicts of interest has not budged since Congress acted. Although the agency says it reviewed the resumés of 724 candidates to fill the 175 open slots on its committees, its ratio of waivers per meeting was nearly identical over the period. For instance, CDER granted 42 waivers for the 8 meetings in the first quarter of last year compared to 30 waivers for 6 meetings in the fourth quarter.

The advisory committee that met last November to discuss Pfizer's application to use the painkiller Celebrex for juvenile arthritis was typical. While just 2 of the 8 permanent members required waivers, 4 of the 8 temporary specialists appointed to the committee for their expertise had conflicts.

When questioned about the agency's failure to reduce its reliance on outside advisers with ties to industry, acting deputy commissioner Randall Lutter said that "it is very difficult to get the quality of the expertise we want without going to people who have some sort of relationship with industry related to product development."

But as a Lancet (subscription required) editorial  noted in 2005 shortly before Congress passed its law, "it is hard to believe that in a country with 125 medical schools – not to mention the pool of international experts – the FDA cannot find experts who do not have financial ties with companies whose products are under review." A New York Times editorial has pointed out that "unless the FDA makes a more aggressive effort to find unbiased experts or medical researchers start severing their ties with industry, a whiff of bias may taint the verdicts of many advisory panels."

Lutter said that FDA plans to issue a guidance document aimed at reducing its reliance on conflicted advisers "very soon." Former deputy commissioner Scott Gottlieb promised the new guidance last July at a meeting sponsored by CSPI.