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PharmExec – Administration Acts Fast to Smooth Transition to New FDA Commissioner

PharmExec – Administration Acts Fast to Smooth Transition to New FDA Commissioner

Health and Human Services (HHS) Secretary Alex Azar wasted little time in naming a new leader for FDA. Norman (Ned) Sharpless, director of the National Cancer Institute (NCI) at the National Institutes of Health (NIH), will become acting commissioner next month as Scott Gottlieb departs the agency. The appointment won praise on all sides, as Sharpless is a respected cancer researcher and well-acquainted with FDA operations and challenges.


Before becoming head of NCI in October 2017, he ran the Lineberger Comprehensive Cancer Center at the University of North Carolina. As a physician-scientist at that institute, he worked with industry on drug development programs and co-founded early-stage biotech companies involved with developing new cancer drugs and diagnostic blood tests.

Gottlieb praised the choice, as did the cancer research community and biopharmaceutical companies. Ellen Sigal, founder of Friends of Cancer Research, noted his expertise as an oncologist in treating leukemia, as well as research on the role the cell cycle plays in cancer and aging. She predicted that Sharpless will continue FDA policy “that best benefits patients.”


Sharpless will be supported in managing FDA by another oncologist, Amy Abernethy, FDA’s principal deputy commissioner, who directs cross-agency initiatives, including biomedical research and expanded use of real-world evidence. Her name was floated as a possible replacement for Gottlieb, along with several others. Although she has been at FDA only a few months, she will be a key aide to the acting commissioner.


In a message to FDA staff, Gottlieb welcomed Sharpless, saying his arrival would help make for a seamless transition and that he would advance policies to promote innovation. While Sharpless will work to advance many of the initiatives backed by Gottlieb, particularly the campaign to reduce teen use of e-cigarettes and excessive opioid use, as acting commissioner new initiatives will be put on hold pending the nomination and confirmation of a permanent commissioner for the agency, which may take some time.…