- National Cancer Institute Director Ned Sharpless will serve as acting commissioner of FDA effective early April, HHS Secretary Alex Azar announced Tuesday.
- The temporary replacement comes one week after FDA Commissioner Scott Gottlieb said he would resign effective in one month.
- Sharpless, who according to the NCI website co-founded the tech companies G1 Therapeutics and HealthSpan Diagnostics, was sworn in as head of NCI Oct. 17, 2017.
Most observers did not expect Gottlieb's departure to greatly impact the agency's efforts in the medtech sphere and Sharpless appears to be a conventional figure.
During his tenure, Gottlieb left much medtech decision making to Center for Devices and Radiological Health Director Jeff Shuren, who has served at FDA for over 20 years in various roles. He'll provide a source of continuity on the agency's medical device oversight efforts and initiatives, experts told MedTech Dive last week.
As acting FDA commissioner, Sharpless will lead the agency during the ongoing search for a permanent successor to Gottlieb and through any subsequent nomination proceedings, a process that could take some time.
I'm delighted by the announcement from @SecAzar that @NCIDirector 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.— Scott Gottlieb, M.D. (@SGottliebFDA) March 12, 2019
The 15th director of the NCI, Sharpless is an oncologist and an academic who has been an author on more than 150 publications listed on PubMed.
HealthSpan Diagnostics, now known as Sapere Bio, was founded in 2013 by Sharpless and Natalia Mitin. The company is building on research conducted by Sharpless' lab at the Lineberger Cancer Center at the University of North Carolina, Chapel Hill.
The company is developing blood tests to be given to patients before heart procedures to "stratify patients by risk of devastating adverse events."
Sapere Bio says it is conducting a multi-center clinical validation trial for AKI-Sapere, a blood test aiming to identify patients at risk of acute kidney injury after cardiac revascularization procedures. A company spokesperson told MedTech Dive Sharpless divested from the company before joining NCI and is "not involved in any other capacity."
Mike Carome, director of Public Citizen's Health Research Group, noted Sharpless has "trivial amounts of industry payments prior to coming to NCI" in the Open Payments Database.
"He certainly has many qualifications to be FDA commissioner. He's a physician, he has extensive medical training, an academic and research background, he should be capable of leading FDA," Carome told MedTech Dive. "He seems much less entangled with regulated industries than Gottlieb, and before him Califf."
(1/3) Change is good, but bittersweet. It is difficult for me to say goodbye to @theNCI family as I head to @FDA to serve as acting commissioner. Rest assured that our shared goals for patients and the public’s health will translate into my new duties.— Dr. Ned Sharpless (@NCIDirector) March 12, 2019