FDAnews Device Daily Bulletin

DEVICE REVIEW AMENDMENT PASSES HOUSE, FACES OBSTACLES IN SENATE

June 8, 2006
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While the House bucked the FDA by passing a medical device policy measure, the Senate seems less likely to agree to the provision regarding conflict-of-interest on device advisory boards.

The House approved the fiscal 2007 Agriculture, Rural Development, FDA and Related Agencies Appropriations bill by a vote of 378-46 May 23, moving the provision curbing the agency's ability to grant conflict-of-interest waivers one step closer to becoming law. The proposal had recently come under fire from the FDA, which has gone on record opposing the conflict-of-interest provision.

Rep. Maurice Hinchey's (D-N.Y.) amendment would prohibit the FDA from granting waivers allowing doctors or scientists with conflicts of interest to serve on FDA advisory panels. Lawmakers and activists have criticized the agency's advisory committee policies, arguing that too many board members have financial ties to industry, potentially clouding their judgment.

The amendment was included in the final House version of the bill even as the FDA argued that limiting waivers would undermine the advisory board process. But the chances of the Senate agreeing with the proposal are slim, a congressional source said.

The Senate addressed the conflict-of-interest issue last year and is unlikely to agree to additional changes, said Jenny Manley, the Senate Appropriations Committee spokeswoman. Last year, the Senate approved language requiring more transparency by requiring public notice 15 days before the panel's work begins regarding which advisory committee members have financial ties to device companies. ()a href="http://www.fdanews.com/ddl/33_23/" target=_blank>