President Obama has made the most important healthcare decision of his administration. (No, not that.)
The nomination of Rob Califf to be the next Commissioner of the FDA signals the beginning of a new era at the agency that regulates more than a quarter of the US economy. Welcome to the era of entrepreneurial regulation.
Entrepreneurial Regulation means that the FDA can be both regulator of industry and its colleague in innovation. Expedited pathways are Entrepreneurial Regulation. Breakthrough Designation is Entrepreneurial Regulation. The Super Office of Pharmaceutical Quality is Entrepreneurial Regulation. More aggressive use of the Reagan/Udall Foundation is Entrepreneurial Regulation. Patient Focused Drug Development is Entrepreneurial Regulation.
It’s more than time for the FDA to take its place in the center of the healthcare ecosystem.
There are many issues facing the FDA and not just in drugs. Food safety, device reform, dietary supplement regulation. It's a long list. Califf knows the issues and the players -- most importantly those inside the agency. His nomination is both timely and savvy -- particularly with PDUFA reauthorization under way.
Califf’s nomination is an n-of-1 opportunity. When considering who could replace Peggy Hamburg, Rob Califf was the short list.
Put up your Dukes? In more ways than one.