Taking the wraps off drug safety data from clinical trials

Boston, MA -- 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 data submitted to the Food and Drug Administration (FDA) suggests changes should be made to the way the FDA implements its policy regarding the confidentiality of those data. Allowing greater access to safety data would enable researchers to independently evaluate risks, resulting in more timely risk detection. The review and commentary appears in the March/April 2007 issue of Health Affairs.

"The Vioxx case and other drug safety cases have demonstrated the value of making these data available to researchers," said co-author Aaron Kesselheim, M.D., Department of Pharmacoepidemiology at BWH and an attorney.

Currently, pharmaceutical manufacturers submit clinical trial data, which establish the safety and efficacy of their products, to the FDA as part of the drug application process. However, after the agency approves a New Drug Application (NDA), it does not release a full report of the safety and efficacy data. Rather, it releases a summary of the clinical data section of the NDA (called the Summary Basis of Approval), and FDA regulations allow the drug manufacturer to draft the Summary. The process reflects an understanding by the FDA that safety and efficacy information should be protected, so that competing manufacturers can't use those data to develop generic

Contact: Todd Datz
Harvard School of Public Health

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