Dr Ned SharplessNed Sharpless, MD
Ned Sharpless, MD, the director of the National Cancer Institute, has been named to the position of acting FDA Commissioner, effective next month once the current commissioner’s resignation is final.1

The announcement was made by the Trump administration just a week after the current commissioner, Scott Gottlieb, MD, announced his plans to resign in early April. Sharpless has been the head of the National Institutes of Health’s (NIH) cancer center since October 2017. He also works as the chief of the aging biology and cancer sections of the National Institute on Aging’s Laboratory of Genetics and Genomics.

“Dr. Sharpless’ deep scientific background and expertise will make him a strong leader for FDA,” Alex M. Azar, the secretary of Health and Human Services, said in a statement. “There will be no let-up in the agency’s focus, from ongoing efforts on drug approvals and combating the opioid crisis to modernizing food safety and addressing the rapid rise in youth use of e-cigarettes.”

Azar made the announcement of Sharpless’ naming at a hearing before the House Energy and Commerce Committee’s health subcommittee. “We are going to be carrying forward Dr. Gottlieb’s vision. His agenda is my agenda. My agenda is his agenda,” he said.2

Gottlieb also noted his approval of the decision, writing on his Twitter account that he is “delighted by the announcement from [Secretary Azar] that [Ned Sharpless] will serve as acting commissioner of FDA. Ned is a friend to FDA, a great public health champion, a dedicated physician, and will be warmly welcomed into his new role. FDA will benefit greatly from his leadership.”
 
Prior to his work at the National Cancer Institute, Sharpless was the director of the University of North Carolina’s Lineberger Comprehensive Cancer Center, a position he held since 2014. He attended medical school at the University of North Carolina and completed his residency at Massachusetts General Hospital. Notably, he is one of the founders of G1 Therapeutics, a biotechnology company which develops treatments for cancer.

Despite some talk that Sharpless would be the possible successor to Gottlieb, Azar noted that this appointment is a temporary one and that the search for a permanent commissioner is ongoing. That successor must then be nominated by President Donald Trump and confirmed by the Senate.

Although, it has been reported that Sharpless has been seen a favorite for the long-term position. STAT News reported that Gottlieb informed FDA staff in a memo that Sharpless is “well acquainted with the agency” and “he plays on a weekly basketball team with some of our medical review staff.” Sharpless told STAT in a 2018 interview, shortly after being named the head of the National Cancer Institute that something that made him appealing to the White House was that in addition to having research and center director  experience, he is familiar with the commercialization of products, including taking one through to a phase 2 trial.3

Under Gottlieb, the FDA has revamped its stance on cigarette and tobacco product use, especially among the youth. Sharpless echoed his support of this work in a statement and said that “it will be an honor to advance the F.D.A.’s critical public health mission.”

Although, it remains uncertain if he, as an acting commissioner, will continue on the more combative points the FDA has made in relation to tobacco, including long-term proposals to reduce nicotine levels in traditional cigarettes, the tightening of regulations on all e-cigarettes and other smoking alternatives, and the pursuit of a ban on menthol cigarettes. Several of these restrictions are facing extensive opposition from Congress and the tobacco industry.
REFERENCES
1. Kaplan S. National Cancer Chief, Ned Sharpless, Named F.DA.’s Acting Commissioner. NY Times website. nytimes.com/2019/03/12/health/fda-ned-sharpless.html. Published March 12, 2019. Accessed March 13, 2019.
2. McGinely L, Goldstein A. Nation’s cancer chief appointed acting FDA commissioner. Washington Post website. washingtonpost.com/health/2019/03/12/nations-cancer-chief-appointed-acting-fda-commissioner. Published March 12, 2019. Accessed March 13, 2019.
3. Facher L. Ned Sharpless, director of the National Cancer Institute, to be named acting FDA commissioner. STAT News website. statnews.com/2019/03/12/ned-sharpless-director-of-the-national-cancer-institute-to-be-named-acting-fda-commissioner. Published March 12, 2019. Accessed March 13, 2019.