When it talks, what should FDA say?

It's been a long time coming, but FDA is finally working to overhaul its safety communications. The agency posted a new plan for announcing safety problems to healthcare providers and the public, patterned on a 2006 report by the Institute of Medicine. The plan includes some 70 initiatives, including 14 the agency says it will accomplish over the next year.

"The FDA must communicate frequently and clearly about risks and benefits and inform patients and consumers about ways to minimize risk as they become increasingly involved in managing their health and well-being," said Commissioner Margaret Hamburg (photo), putting her own public-health spin on the communications plan.

One ex-HHS official told the Wall Street Journal that this is yet another attempt to improve FDA's interaction with the public--an interaction that is eternally subject to the balance between too much info and not enough, too soon and too late.

Some of the 14 first-in-line steps will have immediate effect--such as posting photos of products subject to Class I or high-priority Class II recalls--but some are steps toward deciding about further steps. For instance, designing surveys to determine how FDA communications now affect the public. Presumably the surveys will then be taken, and communications will be redesigned accordingly. No wonder it's going to be a five-year process to finish all 70 items on the list.

- see the FDA announcement
- get the story from the Wall Street Journal

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