David Brooks, in a recent New York Times op-ed, invented a resonant phrase, “the redistribution of respect.” And that’s applicable on both macro and micro levels. When it comes to the FDA, it can mean a significant magnification and integration of the patient voice, a focus on facilitating innovation, and working with industry to drive enhanced competitiveness.
Over the last decade the agency that regulates nearly a third of the US economy has been lending a more regular and critical ear to the real-life experiences of patients and caregivers and trying (although not always with equal enthusiasm across centers and divisions) to address the many thorny issues relative to clinical trial design, endpoints and biomarkers, safety and efficacy and Phase IV studies. But the status quo is a harsh commandant.
What will the Trump FDA look like? Well, for starters, it will look a lot like it currently does. The FDA has only a handful of political appointees (including the Commissioner) and none reside in any of its regulatory review centers. But, with a new sheriff in town we can expect – and should embrace -- more targeted, regular, and collegial friction. And that’s a good thing. Meaningful change, respectful change can help to grease the skids of 21st century regulatory change. A little creative destruction can go a long way.
What will the Trump FDA look like? Well, it’s not even early days yet, but when I attend JP Morgan early next year, one of my messages will be, “Ladies and Gentlemen – fasten your seatbelts and start your engines.”
Over the last decade the agency that regulates nearly a third of the US economy has been lending a more regular and critical ear to the real-life experiences of patients and caregivers and trying (although not always with equal enthusiasm across centers and divisions) to address the many thorny issues relative to clinical trial design, endpoints and biomarkers, safety and efficacy and Phase IV studies. But the status quo is a harsh commandant.
What will the Trump FDA look like? Well, for starters, it will look a lot like it currently does. The FDA has only a handful of political appointees (including the Commissioner) and none reside in any of its regulatory review centers. But, with a new sheriff in town we can expect – and should embrace -- more targeted, regular, and collegial friction. And that’s a good thing. Meaningful change, respectful change can help to grease the skids of 21st century regulatory change. A little creative destruction can go a long way.
What will the Trump FDA look like? Well, it’s not even early days yet, but when I attend JP Morgan early next year, one of my messages will be, “Ladies and Gentlemen – fasten your seatbelts and start your engines.”
