Monday, December 11, 2023

Scott Gottlieb: FDA Anecdotes from Trump Administration

Dr. Scott Gottlieb was the 23rd FDA Commissioner, from May 2017 to April 2019.   He was the first keynote speaker at the Personalized Medicine Coalition's annual meeting on November 30, 2023.   His discussion recounted two anecotes about the FDA under President Trump.

CAR-T in the Oval Office

Gottlieb's tenure included the first CAR-T approval in August 2017.   He and then-Secretary Dr. Tom Price were debriefing the President on health policy issues a few weeks ahead of that.   Dr. Price gave Dr. Gottlieb the floor, and Gottlieb described the imminent approval and Trump listened closely and with enthusiasm.   ("He like wins.")   Leaving the Oval Office, Gottlieb grew concerned that the President might prematurely tweet the news, and asked Jared Kushner, passing by, to be sure and tell him not to do so.   As he was leaving, Gottlieb caught a glimpse of Trump making a motion "I know, I know."

A few weeks later, Gottlieb got a couriered envelope from the White House, hand-delivered to the FDA, which was a favorable Washington Post op ed. And a handwritten note from the President, "Great job!"


VALID and More: An Agile HHS

Gottlieb also discussed the recent FDA LDT regulatory proposal, which he felt was not well crafted.  Gottlieb talked about the several years of work between FDA and Hill to  craft and revise the VALID Act (currently stalled on the Hill.)   Gottlieb noted that in the early Trump years there may have been more degrees of flexibility and pivoting in negotiating things like that, with less tiers of burocracy (OMB, levels within HHS, etc) for every sign-off.   Gottlieb surmised that the layers of controls and gates and sign-offs are probably back in place now, making it harder to craft creative solutions (like VALID) into regulations or statutes.


Note 1
The video of Gottlieb's whole session is here:

Note 2
For 2024, Gottlieb is finishing a book on CAR-T and cellular therapies.

Note 3
See my long blog in August 2019 about the Trump adminsistration's roll-out of new kidney transplant initiatives (includes citation to Adam Boehler at CMMI and Abe Sutton in WH.)