The head of the National Cancer Institute, UNC alum Norman “Ned” Sharpless, has been tapped as the next head of the FDA.
The news follows a few different stories pointing to Sharpless as the likely next helmsman of the agency, where the popular commissioner Scott Gottlieb announced his surprise resignation less than 2 years after taking the post. And Gottlieb was quick to offer a thumb’s up.
Sharpless won’t encounter much, if any, opposition in the biopharma industry, but execs will be waiting to see if he can come close to matching Gottlieb’s zeal for speeding up agency reviews and hastening approvals at a time of record new drug OKs — including the initial launches for the first in a whole new generation of cell and gene therapies.
Sharpless has a solid resume that resonates well with industry execs. He graduated from UNC School of Medicine and did his residency at Mass General. Following a 2-year stint at Harvard Med he went back to UNC, where he became the Wellcome Professor of Cancer Research at UNC in 2012. He was tapped to run the NCI in 2017.
That all translates into instant respect in biopharma, but not necessarily enthusiasm.
Respect, though, will go a long way in setting the stage for Sharpless, particularly as earlier candidates pitched to President Donadl Trump includes at least one with an odd libertarian streak that didn’t sit well with drug developers devoted to maintaining a gold standard for new drug approvals — even if that standard has proven increasingly flexible.
