FDAnews Drug Daily Bulletin

EFFORT TO IMPROVE DRUG REVIEWS MOVES TO HOUSE FLOOR

May 12, 2006
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Efforts to strengthen the FDA's drug reviews passed a major legislative hurdle as lawmakers in the House Appropriations Committee agreed to amendments banning conflict-of-interest waivers for agency advisory boards and giving the agency the authority to mandate post-market studies.

The committee approved by voice vote Rep. Maurice Hinchey's (D-N.Y.) amendment to the fiscal year 2007 Agriculture, Rural Development, FDA, and Related Agencies Appropriations bill prohibiting the FDA from granting waivers allowing doctors or scientists with conflicts of interest to serve on FDA advisory panels. The committee also approved Rep. Rosa DeLauro's (D-Conn.) amendment on postmarket studies. The bill also includes an amendment by Rep. Anne Northup (R-Ky.) easing drug importation. Congressional staff said the full House of Representatives could vote on the bill as early as next week.

These amendments come as the FDA has been under pressure to make changes to its drug review program, including its tendency to grant conflict-of-interest waivers to advisory board members. The agency has faced growing criticism for its handling of Vioxx and other drugs, with critics arguing that the FDA review process is too slow and incomplete to catch potential problems.

Hinchey and DeLauro tried to implement similar changes last year, only to have these fail during conference committee negotiations with the Senate. But recent ethics scandals may improve the chances this time around, Hinchey spokesman Jeff Lieberson said.

"Members are more sensitive to the culture of corruption," potentially leading to more support in the Senate. Specifically, controversies concerning former House Majority Leader Rep. Tom Delay's (R-Texas) dealings with disgraced lobbyist Jack Abramoff have changed lawmakers' view toward such issues, he said. Hinchey's office is currently developing its strategy for obtaining support in the Senate. (http://www.fdanews.com/did/5_93/)