FDAnews Drug Daily Bulletin

DRUG SAFETY AMENDMENT DEFEATED ON HOUSE FLOOR

May 25, 2006
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A controversial amendment to a House appropriations bill giving the FDA new authority to require postmarket studies was stripped from the legislation, while another divisive provision eliminating conflict-of-interest waivers for advisory boards lives on.

Rep. Rosa DeLauro's (D-Conn.) provision giving the agency authority to require postmarket studies was stricken as improperly legislating through the appropriations process, a move that is prohibited under House rules. The amendment, which was added to the fiscal 2007 Agriculture, Rural Development, FDA and Related Agencies Appropriations bill, was meant to address growing concerns over the agency's drug review program. It was removed from the bill when the presiding officer of the House ruled in favor of a point of order raised against it.

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. Incidents like Merck's withdrawl of Vioxx make such additional authority necessary, DeLauro said in a statement following the point of order. She also pointed out that both the Government Accountability Office and many consumer groups have advocated for the FDA to have this authority.

However, another proposal that the FDA itself has opposed is moving forward. Rep. Maurice Hinchey's (D-N.Y.) amendment prohibiting the FDA from granting waivers allowing doctors or scientists with conflicts of interest to serve on FDA advisory panels had not been stricken from the appropriations bill as of press time and will apparently not face opposition from the White House.

While the FDA has argued that such a proposal would undermine the effectiveness of the agency's advisory committee system, the White House did not oppose the amendment in its May 23 Statement of Administration Policy (http://www.whitehouse.gov/omb/legislative/sap/109-2/hr5384sap-h.pdf) (SAP) on the bill. The SAP is a document in which the administration gives its view on pending legislation, including provisions it will oppose. (http://www.fdanews.com/did/5_102/)