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Congress Moves Closer to Drug-Safety Bill


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"A huge difference is the issue of biogenerics, and whether they can be made available," Nissen said. Biogenerics -- generic forms of pricey biotech drugs -- are currently not covered by FDA regulations. "That is in the Senate bill but not in the House bill. It remains to be seen what happens in the conference committee," he said.

Nissen noted that whatever bill comes out of Congress has to be signed by President George Bush. He believes that the president will probably sign the bill, since the pharmaceutical industry is supporting it.

One item noticeably absent from the House bill: any provision that would allow U.S. consumers to buy cheaper drugs from abroad. The White House has said in the past that it would veto any bill containing such a clause.

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Learn more about the Prescription Drug User Fee Act at the U.S. Food and Drug Administration.

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Copyright © 2007 ScoutNews, LLC. All rights reserved.
Last updated 7/13/2007

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SOURCES: Steven E. Nissen, M.D., chairman, department of cardiovascular medicine, Cleveland Clinic, Ohio; Sidney M. Wolfe, M.D., director, Health Research Group, Public Citizen, Washington, D.C.; news release, July 11, 2007, Pharmaceutical Research and Manufacturers of America; Associated Press


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