The FDA still allows serious conflicts of interest in decision panel experts

Monday, September 17, 2007 by: David Gutierrez

NewsTarget) Earlier this year, the FDA announced a series of significant changes to its policy on conflict of interest in advisory panels. Up until now, there have been no rules barring experts with financial conflicts of interest from participating in the panels, which recommend to the agency which drugs, diagnostic tests and medical devices should be approved for use.

The FDA has come under increasing fire lately for its policies toward conflicts of interest. Because the FDA almost always accepts the recommendations of its advisory panels, critics have been particularly concerned that many of the "experts" that make up these panels have financial ties to the companies that make the products being reviewed.

Under the new rules, no one who has received $50,000 or more in financial benefits from a company in the previous 12 months -- including direct research grants, stocks and consulting fees -- may participate in a panel about any of that company's products. People who have received less than $50,000 in the past year may participate but not vote.

While welcoming the announcement as a step in the right direction, many critics claim that the new rules do not go far enough. R. Alta Charo, a bioethicist from the University of Wisconsin, noted that the FDA ignored the national Institute of Medicine's recommendation to cap the number of members with conflicts of interest on any given advisory panel.

Diana Zuckerman, president of the National Research Center for Women & Families, said that the new rules fail to take into account more subtle forms of influence.

"A drug rep who takes someone to a memorable restaurant twice a year to chat about their research is spending relatively little money but is building a relationship that is likely to be more influential than giving a $2,000 honorarium -- perhaps even more than a $50,000 grant...funded by several companies," she said.

Zuckerman also pointed out that simply being barred from voting does not prevent someone from influencing a panel's decision.

"The votes are often unanimous, because the group comes to a consensus -- almost always to approve a product," she said.

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