Drug Safety

Taking the wraps off drug safety data from clinical trials

Published in FDA Law Weekly, March 22nd, 2007

For years, pharmaceutical companies have sought to restrict public access to drug safety data collected in clinical trials on the basis that it is proprietary information, arguing that competitors could use that information in the development of their own products.

However, a number of recent cases of drugs found to have dangerous side effects after coming to market, such as the anti-inflammatory drug rofecoxib (Vioxx), have raised concerns about safety data being treated as confidential. A new analysis by researchers at the Harvard School of Public Health (HSPH) and Brigham and Women's Hospital (BWH) of laws and regulations governing public disclosure of clinical trial...

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Source: FDA Law Weekly (2007-03-22)

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