Stephen Hahn, MD, chief medical executive of The University of Texas MD Anderson Cancer Center, was named today by President Donald Trump as his nominee to run the FDA.

If confirmed by the U.S. Senate, Hahn would be permanent successor to Scott Gottlieb, MD, who submitted his resignation in March after less than two years in the position.  Gottlieb left the agency in April and has rejoined venture capital firm New Enterprise Associates, where he is now Special Partner on NEA’s healthcare investment team.

Since Gottlieb’s departure, the FDA has been helmed by acting commissioner Norman E. (Ned) Sharpless, MD. Sharpless will return to his pre-FDA role as director of the NIH’s National Cancer Institute (NCI), U.S. Department of Health and Human Services Secretary Alex M. Azar II announced.

“Dr. Sharpless’s willingness to step into the role of Acting Commissioner, and to lead the team at FDA with a steady hand, ensured that the agency did not miss a beat in advancing its vital mission,” Azar stated. “With Dr. Sharpless at the helm, the FDA has executed on its core responsibilities while also making progress on key priorities, such as lowering the price of prescription drugs and tackling the growing epidemic of youth use of tobacco products.”

Azar also noted that under the Federal Vacancies Reform Act, a person may not serve in an “Acting” capacity for longer than 210 days. Sharpless’s 210-day tenure was to end today at 5 p.m.

Hahn has been Chief Medical Executive MD Anderson since May 2018 and Gilbert H. Fletcher Memorial Distinguished Chair and Professor of Radiation Oncology at MD Anderson since January 2015. Hahn is a radiation oncologist who has specialized in treating lung cancer and sarcoma, and has authored 220 peer-reviewed original research articles.

From 1996-2014, Hahn worked at the University of Pennsylvania, where he was Henry K. Pancoast Professor and chaired the Department of Radiation Oncology from 2005-2014.

Earlier, he was a senior investigator at NCI from 1989-1996. He completed his residency in radiation oncology at NCI, his fellowship in medical oncology at NCI, and his residency in internal medicine at the University of California, San Francisco Hospitals.

A board-certified physician in both medical oncology and radiation oncology, Hahn received his medical degree from Temple University in 1984 and his B.A. in Biology from Rice University four years earlier.

New Acting Commissioner

Pending Hahn’s confirmation, the acting FDA commissioner will be ADM Brett P. Giroir, MD, Assistant Secretary for Health. Giroir is a physician who also holds the position of Senior Advisor to the Secretary for Opioid Policy, coordinating HHS’s efforts to fight the nation’s epidemic of opioid abuse. At HHS, Giroir also led a review of all HHS research involving human fetal tissue from elective abortions—a review that led to Trump administration policies that included ending the use of human fetal tissue from elective abortion in intramural NIH research.

U.S. Senate Committee on Health, Education, Labor and Pensions (HELP) Chairman Lamar Alexander (R-TN) responded to Hahn’s forthcoming nomination with a statement that said in part: “I look forward to meeting with Dr. Hahn and scheduling a hearing to consider his nomination.”

“Having the right person lead the FDA is critical to virtually every American,” Alexander added. “The FDA is responsible for ensuring drugs and medical devices that patients rely on are safe and effective, protecting the nation’s food supply, regulating tobacco products, and implementing 21st Century Cures and new federal laws to help combat the opioid crisis.”

The committee’s ranking member, Sen. Patty Murray (D-WA) told Bloomberg Government she wanted Hahn to address how the FDA plans to address the growing number of deaths from a respiratory illness linked to e-cigarette use. Yesterday, CDC reported 1,888 confirmed cases of the illness, and 37 resulting deaths, up from 1,604 cases and 34 deaths the previous week.

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