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Congressional reset on FDA

Lawmakers focus PDUFA V hearing on barriers to drug development at FDA

Last week's House Energy & Commerce hearing on PDUFA reauthorization marks an inflection point in Congress' relationship with FDA that could, if it is sustained, lead the agency to start reversing six years of increasingly intense concentration on the safety side of the risk-benefit equation.

Committee members indicated they want to use PDUFA V to mitigate the effects of some of the drug safety provisions enacted in conjunction with PDUFA IV, to relax conflict of interest regulations that have hampered FDA's ability to recruit qualified advisory committee members, and to expand access to investigational drugs.

The hearing was the first drug regulation oversight hearing since the September 2004 withdrawal of Vioxx rofecoxib from Merck & Co. Inc. that didn't focus almost exclusively on drug safety, and one of the first to raise concerns about the competitiveness of the U.S. biopharma industry

The turnabout seems to be the result of the political focus on jobs and the economy, lobbying by individual companies and trade associations warning that the U.S. lead in biotechnology

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