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12:00 AM
Jul 11, 2011
 |  BioCentury  |  Regulation

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 and medical devices is at risk, and advocacy by patient groups that think regulators are slowing the translation of science into therapies.

Republican regard for industry is being complemented by the reluctance of many Democrats to criticize a regulatory agency under a Democratic administration.

Rather than berate FDA with allegations that it is imperiling public health by allowing unsafe drugs onto the market, committee members criticized the agency for stifling innovation by creating unnecessary regulatory uncertainty.

Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, pushed back. She argued that scientific uncertainty, not regulatory uncertainty, is responsible for the crisis in pharmaceutical R&D.

Woodcock said FDA is developing strategies for speeding the development of targeted therapies, and expressed interest in working with Congress to streamline the entire drug development process.

Revisiting FDAAA

Energy & Commerce Chair Fred Upton (R-Mich.) said he wants to tweak the Food and Drug Administration Amendments Act of 2007 (FDAAA) that was enacted along with PDUFA IV.

"The committee will evaluate provisions of FDAAA,...

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