FDAnews Drug Daily Bulletin

ELIMINATING CONFLICT-OF-INTEREST WAIVERS WILL THREATEN SYSTEM, SAYS FDA

May 18, 2006
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The FDA opposes lawmakers' efforts to limit the agency's ability to grant conflict-of-interest waivers for advisory committee members, arguing that such a move would undermine its ability to have the necessary expert advice needed to make drug policy, an agency official says.

Legislative proposals to limit advisory committee membership where financial and other conflicts of interest exist threaten the FDA's advisory committee system, Steven Galson, director of CDER, said. "The system is really under threat now" due to legislation that contains "extreme views" on how to define conflict of interest, he said at the Chemical Heritage Foundation's recent centennial conference in Philadelphia.

Lawmakers and activists have criticized the agency's advisory committee policies, arguing that too many members of these boards have financial ties to industry, potentially clouding their judgment.

One proposed legislative remedy is Rep. Maurice Hinchey's (D-N.Y.) amendment to the fiscal year 2007 Agriculture, Rural Development, FDA and Related Agencies Appropriations bill. The amendment would prohibit the FDA from granting waivers allowing doctors or scientists with conflicts of interest to serve on FDA advisory panels.

The amendment was included in the version of the bill that is currently pending on the House floor. The House is expected to consider the bill by the end of this week. If passed, the bill then would go the Senate.

But the solution is not as simple as Hinchey suggests, according to Galson. Because the agency's work is so important, there will always be controversy surrounding its decisions. Given such an environment, there will always be advisory committee recommendations that people criticize, he added. (http://www.fdanews.com/did/5_97/)