More Access to U.S. Drug Safety Data Urged

Harvard School of Public Health officials urged the U.S. Food and Drug Administration to allow more access to drug safety data from clinical trials.

FDA rules allow data to be kept secret and that, said the researchers, hinders discovery of dangerous side effects.

Pharmaceutical companies have sought to restrict public access to drug safety data collected during clinical trials on the basis it is proprietary information and might aid competitors in developing their own products.

But the Harvard researchers noted several recent cases in which drugs were found to have dangerous side effects after coming to market, thereby raising concerns about safety data being treated as confidential.

In an analysis by the Harvard School of Public Health, in collaboration with Brigham and Women’s Hospital, researchers determined allowing greater access to safety data would enable medical scientists to independently evaluate risks, resulting in more timely risk detection.

The review and a commentary appear in the March/April issue of the journal Health Affairs.