AMA calls on FDA for more physician-friendly drug data

Physicians want the agency to step up monitoring and make information readily available.

By Victoria Stagg Elliott, AMNews staff. July 11, 2005.

Chicago -- It seems lately that pharmaceutical trial data -- especially adverse events not noted in original studies but that emerged after drugs were approved -- have become all-too-frequent controversies in the news.

In response, the American Medical Association adopted several policies at its Annual Meeting in June in the hope of helping to bring about systemic changes to reduce the chance that such negative experiences will be repeated.

"We really think that we need access to the data and the postmarketing information that comes in as well," said AMA Trustee Rebecca J. Patchin, MD. "It needs to be more than just available. It needs to be accessible so that I can find what I need, and I don't need to spend a zillion hours looking for one small part of information."

According to a new AMA Council on Scientific Affairs report, the Association should urge the Food and Drug Administration to issue its final rule on modifying drug package inserts so that they provide the greatest amount of information in the most useful way. The CSA report also encourages the agency to work with medical societies in order to develop better ways to communicate risk.

Both of these recommendations have a clear endpoint in mind -- to avoid burying physicians in the increasing amount of available data that might not be in a form that is clinically relevant. Delegates also are optimistic that these steps will make it more likely that doctors have the information they need before it reaches the mass media.