Right on deadline, Trump taps Stephen Hahn as new FDA commish. Now what?
Stephen Hahn’s nomination as the new commissioner of the FDA was delivered right on schedule Friday, with the clock ticking down on the November 1 deadline President Donald Trump faced in finding a permanent replacement for Scott Gottlieb. The pending news had become the worst kept secret in Washington. But the full meaning of the move is still undetermined.
The Chief Medical Executive at MD Anderson had a rep for steering straight into confrontation, when the future of the institution was at stake. More problematic, perhaps, will be his role in dismissing Chinese researchers at a time the Trump administration has been bearing down on the Asian giant. Just how Hahn will manage drug development, which is my primary arena of interest, is going to take some time to figure out.
Interim chief Ned Sharpless was the clear institutional favorite for getting the job full time after a stint at the NCI. Patient groups loved him and the industry deeply respected his expertise, even if he never generated the kind of enthusiasm Scott Gottlieb achieved at the agency’s helm as the first commissioner with real celebrity status.
As the process to confirm Dr. Hahn begins, I will return to @theNCI to resume my role as @NCIDirector. I am confident Dr. Hahn will provide strong leadership for the FDA. https://t.co/3vcsyj7Pf4
— Dr. Ned Sharpless (@FDACommissioner) November 1, 2019
Hahn’s nomination, though, won’t trigger any obvious backlash in biopharma. As a respected executive at MD Anderson with a track record in research and a career in oncology that extended back through a stint at the prestigious University of Pennsylvania’s Perelman School of Medicine, he’ll be expected to maintain the gold standard in drug development.
Margaret Foti, chief executive officer of AACR, set the tone with a prepared comment for the occasion:
Dr. Hahn, who is board certified in both radiation and medical oncology, is esteemed for the breadth and depth of his scientific knowledge and expertise, and he has consistently advocated for a drug review process at the FDA that is both science-directed and patient-focused.
The question is whether he’ll keep pushing the envelope on greater regulatory flexibility that has helped revolutionize cancer drug development and changed the dynamics of R&D.
That’s something no one seems to know much about. But they’ll get a chance to hear much more once the Senate picks up the nomination.