Scott Gottlieb, MD, Commissioner of the United States Food and Drug Administration (FDA), announced his resignation from his post on March 5, 2019. In his resignation letter, Gottlieb noted that there was nothing prompting his resignation other than his young family and his wish to be around them more.
In the time since the announcement, much hubbub has surrounded who the replacement will be. That discussion partly ended on Tuesday when National Cancer Institute (NCI) Director Norman “Ned” Sharpless was called upon to serve as acting FDA commissioner following Gottlieb’s departure. The announcement was confirmed during Health and Human Services (HHS) Secretary Alex Azar’s opening statement before the House Energy and Commerce Health Subcommittee on the FY 2020 HHS Budget.
According to those familiar with the situation, Gottlieb has allegedly recommended that Sharpless be given the permanent position.
Who Is Ned Sharpless?
Sharpless is an oncology doctor by training and he was appointed to his current Director role in June 2017. Following his appointment to lead NCI, part of NIH, he focused on modernizing research, diversifying clinical trials, and improving outreach to underserved populations.
At NCI, Sharpless also focused on developing and retaining a workforce, especially younger researchers. He has made efforts at deciphering the “basic science” behind how cancer works and to use that data to better understand the disease.
Before his role at NCI, Sharpless directed the Lineberger Comprehensive Care Center at his alma mater, University of North Carolina. There, he focused on how the cell cycle plays a role in cancer development.
Sharpless is also familiar with the biotechnology industry and the drug-development process. He co-founded two biotech companies: G1 Therapeutics, a developer of cancer drugs that raised $108.6 million in a 2017 initial public offering, and HealthSpan Diagnostics, a developer of blood tests.
Sharpless has been an enthusiastic supporter of Gottlieb’s push to increase tobacco and e-cigarette regulations.
What Next?
Sharpless has previously expressed an interest in using artificial intelligence, including to improve treatments, while also recognizing that the technology is limited. “It’s early days for the National Cancer Institute in this area,” he said last year, “and most of the regulatory issues are really for the FDA to tackle.”
Azar said in a statement that Sharpless’ “deep scientific background and expertise” will make him a strong leader for FDA. He added, “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.”
Gottlieb seems to be pleased with the decision to appoint Sharpless as acting commissioner, tweeting, “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.”
The Trump Administration has not given any hints as to when it will appoint a permanent successor, nor who that person may be. FDA principal deputy administrator Amy Abernethy and HHS Assistant Secretary for Health Brett Giroir have emerged as other possibilities to serve in the permanent role.