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FDA Should Release Safety Data, Health Affairs Commentary States
FDA should release more detailed information about clinical trial data so that it can be used by independent researchers for further safety study, according to a commentary published on Tuesday in Health Affairs, Dow Jones reports. The authors, Aaron Kesselheim of Brigham & Women's Hospital and Michelle Mello of Harvard School of Public Health, dispute the belief that releasing more detailed safety data would jeopardize corporate secrets, and in the commentary they recommend "placing a heavier burden of proof on companies to show competitive harm if data are released." Currently, FDA releases a summary of safety issues associated with clinical trials of approved drugs but withholds the raw data over concerns that more detailed information "could enable competitors to more easily copy ... drugs or create similar versions," Dow Jones reports (Brickates Kennedy, Dow Jones, 3/6). Kesselheim and Mello write, "Balanced against the need to protect companies' investments in drug development, however, is the risk that withholding this information can frustrate evaluation of drug safety." Kesselheim said, "What we envision is a way that the FDA would more routinely release full safety data about drugs that it approves, so that independent analysts can look at the data and help physicians in their prescription decision making" (Henderson, Boston Globe, 3/7). Kesselheim and Mello believe that FDA can make changes to its publishing policy without congressional action but say that Congress should step in if the agency fails to make changes (Dow Jones, 3/6).
An abstract of the commentary is available online.
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
FDA ar trebui sã lansare de date de siguranþã, de sãnãtate Afaceri comentariu membre - FDA Should Release Safety Data, Health Affairs Commentary States - articole medicale engleza - startsanatate
