PR View by Peter Pitts

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The other day a senior FDA official asked me what the agency should do to combat the negative media coverage. My response: “Do something, because nothing isn't working.” Actually, that was a bit harsh. The FDA makes a difference, mostly with rule-making and infrastructure. But neither the mainstream media nor many elected officials seem to notice.

Take, for example, the new physician labeling rule and the choice of Paul Seligman as CDER's new associate center director for safety policy and communication. Not sexy, but superb examples of forward movement.

Can more be done to aggressively battle a bloodthirsty media and bandwagon pols? Don't get me started…

Actually, do get me started.

First, respond aggressively. Rather than playing government-speak non-responsive rope-a-dope, the FDA must call it like they see it. Point out the inconsistencies in the arguments of “advocates” and “concerned” politicians and segue into a more productive conversation about making things better.

Second, drive the agenda. FDA is doing progressive, innovative and urgent things (can you say “Critical Path?”) but who knows about it? He who tooteth not his own horn, that horn shall go untooted.

Third, feed the beast. FDA must keep the media busy, lest idle hands do the devil's work. During my tenure at the FDA, reporters (believe it or not) complained that the agency was so active that they weren't able to take any time off. Today the media and media-hungry pols drive the agenda. That's deleterious to the public health.

Time for the agency to stop playing defense—especially in advance of the forthcoming hardscrabble PDUFA reauthorization.

Peter J. Pitts is director of the Center for Medicine in the Public Interest, SVP for global health affairs at Manning Selvage & Lee, and a former associate commissioner at the FDA

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