Posted by gardenergirl on July 22, 2007, at 2:13:37
Bill on Drug Safety, FDA Funding Clears U.S. House
By Lisa Richwine
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WASHINGTON (Reuters) Jul 12 - The U.S. House of Representatives voted on Wednesday to give the Food and Drug Administration more power over drugmakers as part of an effort to better protect the public from dangerous medicines.
The measure must be merged with a competing version that passed the Senate in May before it can go to President George W. Bush to sign into law.
The FDA could require post-approval studies of new prescription drugs or order additional warnings under the legislation, which passed the House in a 403-16 vote.
Companies that fail to follow FDA directives could face fines as high as $50 million. Running a false or misleading advertisement to consumers could draw fines of $250,000.
...
The new authority for the FDA was among provisions meant to improve the government's drug safety oversight, increase transparency of company clinical trials and raise the fees that manufacturers pay to help speed reviews of medicines and medical devices.
Lawmakers crafted the legislation in response to complaints about the FDA's handling of serious side effects seen after drugs hit the market. The agency was criticized as slow to act on signs of problems with Merck & Co. Inc.'s arthritis pill Vioxx, which the company withdrew in 2004, and other medicines.
...
The drug industry has generally supported the bill. Pharmaceutical companies strongly favor extending the fees they pay the FDA because they help cut product review times.
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http://www.medscape.com/viewarticle/559672?src=mp
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poster:gardenergirl
thread:771087
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