Are FDA Changes Really a Step in the Right Direction?
August 12 2006
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The U.S. FDA has announced plans to make its conflict of interest rules more stringent. This announcement comes in the wake of criticism that many of its advisory board members have undisclosed financial ties to the drug industry.
Advisory committees guide the FDA on issues of drug safety and effectiveness, and their recommendations carry considerable weight. A recent study found that 28 percent of committee members have industry ties.
Currently, the FDA can waive its own conflict of interest rules for these committees. Congress is considering legislation that would prevent the FDA from doing so.
The FDA, however, has argued that it is difficult to find qualified panel members without industry connections, and has proposed instead enacting rules that would help identify when committee members have a conflict of interest, and address when conflict of interest waivers should be granted.
Critics of this move contend that these reforms would not stop many researchers with financial conflicts from serving on the panels.