Advisors to the US Food and Drug Administration recommend approval for the vast majority of new medical products that come before them, a new analysis suggests. The National Research Center for Women & Families looked at the voting patterns and panel discussions from a random sample of nearly one third of the advisory committees used by the FDA’s Center for Drug Evaluation and Research and its Center for Devices and Radiological Health. The researchers found that, between 1998 and 2005, these committees gave the green light to 76% of the drugs and 82% of the medical devices they assessed.
Moreover, a number of panel members “recommended approval for every product they considered year after year,” the NRC said. For example, 98% of the votes cast by members of the FDA’s advisory committee for arthritis drugs over the study period were in favour of approval. Like Merck & Co’s now defunct Vioxx (rofecoxib), almost all of these products were recommended unanimously, the NRC noted.
It pointed to previous studies revealing that most advisory committees included at least one member with a financial tie to the company whose product was 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,” commented NRC president Dr Diana Zuckerman.
On the rare occasions when an advisory committee gave a negative verdict, the FDA often went ahead and approved the product anyway, the think-tank added, saying this was especially true of medical devices. Transcripts suggested panel members felt under peer and other pressure to wave through new products even if they had serious misgivings about safety and efficacy.
FDA officials “almost never” responded to these concerns, “which is likely to be interpreted as acquiescence,” the NRC observed. It also accused the agency of frequently ignoring the post-marketing studies and other approval conditions recommended by committee members as safeguards for new products.
The FDA is under intense political pressure to tighten up drug approval systems, including its screening of advisory committee members for potential conflicts of interest. The agency announced its own plans to improve the transparency of committee procedures in late July, parrying criticism of its policies on conflict-of-interest waivers. While the FDA pledged more openness in granting waivers, however, it insisted on the need to draw on the best scientific expertise, even if that involved conflicts of interest. By Peter Mansell