APPROPRIATIONS BILL CONTAINING DRUG SAFETY, IMPORTATION AMENDMENTS PASSES IN HOUSE

The House has bucked both the White House and the FDA in passing two controversial measures, one related to conflict of interest waivers and the other concerned with drug importation.

The House approved the fiscal 2007 Agriculture, Rural Development, FDA and Related Agencies Appropriations bill by a vote of 378-46, moving the provisions curbing the agency's ability to grant conflict-of-interest waivers and easing drug importation one step closer to becoming law. These two proposals have recently come under fire from the administration: The FDA has gone on record opposing the conflict-of-interest provision, and the White House issued a statement opposing the importation proposal.

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 members of these boards 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 this proposal are slim, a congressional source says. The Senate addressed the conflict of interest issue last year and is unlikely to agree to additional changes, Jenny Manley, the Senate Appropriations spokeswoman said. 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 drug or device companies. (http://www.fdanews.com/did/5_103/)