“Cozy Deal” (New York Times, April, 29, 2012) argues,
“The best approach would be for the government to fully finance the F.D.A. That is unlikely to happen. So before it ratifies any new deal on user fees, Congress must ensure that patient safety is the first priority.”
Sure, but unlike the Gray Lady we must all live in the real world. User fees are the cost of predictability -- not just for innovators who wants to know if and when they can commence marking new products but also for patients and physicians who want to know if and when these new treatments will be available. Predictability is also an issue of how. And this rests on the ability of the FDA to create and communicate a thoughtful and patient-centered model of risk/benefit analysis. Thankfully this is a central part of the current reauthorization debate.