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New drug safety bill in U.S. Senate

If passed, the new bill would strengthen monitoring for approved drugs, require companies to deposit clinical trial data into registry

Aaron J. Bouchie
Two U.S. Senators introduced last week (August 3) a bill intended to strengthen the Food and Drug Administration (FDA)'s ability to monitor drug safety for marketed products -- a hot topic since a series of high-profile recalls, including COX-2 inhibitors and Guidant?s pacemaker device. The bill would also build on ClinicalTrials.gov, the government's clinical trial registry that is housed by the National Library of Medicine, by requiring the registration of all late phase 2, phase 3, and phase 4 clinical trials -- even those that report negative results. Companies would also be required to deposit the data from such clinical trials, along with technical and lay summaries. Data from phase 2 trials would not need to be submitted if they contain commercially sensitive information.The Enhancing Drug Safety and Innovation Act of 2006 was introduced by Senators Mike Enzi (R-WY) and Edward Kennedy (D-MA).Greg Simon, president of the biomedical think...

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