FDA pledges better communication on drug safety: AMNews interviews Andrew von Eschenbach, MD

The commissioner outlines ways in which physicians can expect to see change.

By Susan J. Landers, AMNews staff. April 7, 2008.

Washington -- Muscle provided by Congress last fall was intended to allow the Food and Drug Administration to police drugs already on the market. Findings from this effort could enhance physicians' understanding of a medication's potential for harm or their ability to identify patients at risk for adverse events.

Now the issue is how to get word of these findings to physicians quickly. Current methods, such as the FDA's "Dear Doctor" letters, don't always reach physicians. Figuring out which new communication approaches and technologies will work is one of the challenges the agency faces.

The FDA Amendments Act of 2007 provided more funds to monitor drugs through their life cycles as well as authority to require warnings or studies when risks are first suspected.

In the lead-up to this change, the agency's reputation as drug safety watchdog took major hits when drugs such as the pain reliever Vioxx and the diabetes drug Avandia were pulled from the market.

FDA Commissioner Andrew von Eschenbach, MD, has vowed to improve the agency's record.

AMNews: Should doctors be looking for more messages from the FDA?

Dr. von Eschenbach: We feel strongly communications need to be timely. It is something we have to look at from both sides of the equation.

We have to be careful about saturation and overload. We don't want to be Chicken Little, but we want doctors and care providers to know what we know as early as we know it and then participate in it. But we want to put it in context. We'll tell you when it is something that demands your attention and immediate action, and we'll tell you when it is something we are concerned about but are still gathering information on. And we hope you will help us with that. It will take a little time to get there.