The FDA's many initiatives on risk management are confusing to the industry—and the problem is, in many ways, of the agency's own making. We need better risk management management.
Alas, the excesses of the post-Vioxx inquisition have inured many to any kind of safety warnings. And when important safety warnings become ambient noise, we're facing a dangerous public health situation.
Despite the best intentions, FDA-mandated initiatives such as REMS and early safety signal communications have resulted in negative unintended consequences: tabloid media reporting, patients scared into non-compliance, industry communications being increasingly “lawyered-up,” and ever-more defensive medical practices that add costs to our already over-burdened healthcare system. At a certain point, prescribers just stop listening. Not good.
Honestly, what is the real level of understanding physicians have about the products they prescribe— especially since they are spending less and less time with pharmacy-field staff. We don't know.
Isn't it time for sales reps to “detail the label” to their physician audience? That would be a real public health service—and a positive marketing strategy.
Relative to PDUFA V reauthorization, it's going to be a tough slog for FDA to request new things when it still has much to deliver on from PDUF IV. And that certainly includes many risk management issues.
Rather than a laser beam focus on REMS, perhaps what is required is a broader focus on the appropriate spirit of risk management.
Perspective. It's a wonderful thing.
Peter Pitts is partner/director of global health at Porter Novelli and a former FDA associate commissioner