10/24/2013

A study from Germany found that seldom-released regulatory reports do a better job than publicly available documents of detailing drugs' efficacy and side effects. Lead author Beate Wieseler said the FDA and the European Medicines Agency could begin publishing these reports on their websites, but a representative of the FDA said the agency is legally bound not to release a fair amount of that data. Drugmakers are at ease sharing clinical data with certified researchers on the condition that information is used appropriately and patient privacy is protected, said Jeff Francer, the vice president and assistant general counsel for the Pharmaceutical Research and Manufacturers of America.

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