FDA Commissioner Nomination Expected Amid Leadership Changes

Texas oncologist Stephen Hahn, MD, is expected to receive the Trump administration’s nomination for the role of FDA Commissioner,¹ a move that had been anticipated by federal insiders.^2-3

The intent to nominate Hahn was announced Friday by sources that include US Secretary of Health and Human Services (HHS) Alex Azar.

I’m pleased that @POTUS has announced his intent to nominate Stephen Hahn to lead the @US_FDA. Stephen is a talented, experienced leader whose scientific accomplishments make him well prepared to lead FDA in its vital public health mission.

— Secretary Alex Azar (@SecAzar) November 1, 2019

Hahn is the chief medical executive for The University of Texas MD Anderson Cancer Center in Houston, as well as a professor in the center’s Department of Radiation Oncology—Division of Radiation Oncology.⁴

Confirmation by the Senate is required to appoint Hahn as the new FDA Commissioner.³

If appointed to the permanent position, Hahn would replace former FDA Commissioner Scott Gottlieb, MD, who left the agency in April. Acting Commissioner Norman “Ned” Sharpless, MD, fulfilled the role in the interim until his tenure expired on November 1, 2019.^1-2

The Federal Vacancies Reform Act requires that a person may not serve in an “acting” capacity for longer than 210 days. By law, Sharpless may no longer serve as Acting Commissioner of the FDA.¹

Admiral Brett Giroir, Assistant Secretary for Health, will serve as FDA’s new acting commissioner until a formal appointment is made for the permanent position. Sharpless is returning to his role as Director of the National Cancer Institute (NCI).¹

Sharpless was previously viewed as a strong contender for the permanent position, as he had garnered endorsements from numerous cancer organizations and other health care groups, as well as several previous commissioners.^2,5

At one point, Washington insiders also viewed Harvard dermatology professor Alexa Boer Kimball, MD, MPH, as a possible candidate. She is president and chief executive of the Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center, Boston, MA.⁶

Hahn became a frontrunner for the FDA Commissioner job after he reportedly met with President Trump at the White House in September.^2-3

Hahn was hired by MD Anderson in 2015, initially serving as department chair for the Department of Radiation Oncology, as well as division head of the cancer center in Houston.⁴ He has been the center’s chief medical executive since 2018.⁵

A graduate of the medical school at Temple University in Philadelphia, PA, Hahn spent nearly 2 decades with the University of Pennsylvania (UPenn) health system, serving in a variety of positions, prior to his arrival at MD Anderson. Among his UPenn roles, Hahn served nearly a decade as chairman of the Department of Radiation Oncology at the university’s School of Medicine in Philadelphia.⁴

Early in his career, Hahn was a medical and radiation oncologist with Redwood Regional Oncology in San Francisco, California. As a student and resident, he received training at hospitals in San Francisco, CA, that are affiliated with the University of California and the NCI, where he focused on medical oncology and radiation oncology.⁴

During his career, Hahn has specialized in treating lung cancer and sarcoma. His research has focused on the molecular causes of the tumor microenvironment and the evaluation of proton therapy for improving the efficiency of radiation therapy.⁵

Hahn and his wife have been married more than 30 years. They have 4 children: Chris, Rob, Emma, and Caroline.⁵

Gottlieb announced his resignation in March, citing a desire to spend more time with his wife and 3 young children.⁷ Since his departure from the FDA, Gottlieb has taken on public speaking roles. Among his speaking engagements is the upcoming keynote address at the 37th Annual Chemotherapy Foundation Symposium Innovative Cancer Therapy for Tomorrow^®, which will be hosted by Physicians Education Resource^® on November 7, 2019, in New York City.⁸

REFERENCES

• Secretary Azar Statement on FDA Leadership [news release]. Washington, DC; November 1, 2019: HHS website. https://www.hhs.gov/about/news/2019/11/01/secretary-azar-statement-on-fda-leadership.html. Accessed November 1, 2019.
• McGinley L. Trump set to nominate Texas cancer doctor to head FDA. Washington Post. https://www.washingtonpost.com/health/2019/10/24/trump-set-nominate-texas-cancer-doctor-head-fda/ Published October 24, 2019. Accessed October 31, 2019.
• Burton T. Trump to Nominate Texas Doctor to Lead FDA. Wall Street Journal. https://www.wsj.com/articles/trump-to-nominate-texas-doctor-to-lead-fda-11571845705 Published October 23, 2019. Accessed October 31, 2019.
• The University of Texas MD Anderson Cancer Center. Profiles: Stephen M. Hahn, MD, FASTRO. MD Anderson website. https://faculty.mdanderson.org/profiles/stephen_hahn.html Accessed October 31, 2019.
• Harvey L. Getting to know Stephen Hahn, M.D. MD Anderson website. https://www.mdanderson.org/publications/cancerwise/getting-to-know-stephen-hahn-MD-Anderson-Deputy-President-Chief-Operating-Officer-COO.h00-159149190.html?_ga=2.53477672.1668527119.1572529885-2085421574.1572529885 Updated 2018. Accessed October 31, 2019.
• McGinley L. Former agency heads, health groups push for FDA’s Sharpless to be permanent commissioner. Washington Post. https://www.washingtonpost.com/health/2019/09/04/former-agency-heads-health-groups-push-fdas-sharpless-be-permanent-commissioner/ Published September 4, 2019. Accessed October 31, 2019.
• Coppock K. FDA Commissioner Announces His Resignation From the Agency. Pharmacy Times. https://www.pharmacytimes.com/news/fda-commissioner-announces-his-resignation-from-the-agency- Published March 5, 2019. Accessed October 31, 2019.
• Scott Gottlieb to Serve as Keynote Speaker for the 37th Annual Chemotherapy Foundation Symposium. Pharmacy Times. https://www.pharmacytimes.com/news/scott-gottlieb-to-serve-as-keynote-speaker-for-the-37th-annual-chemotherapy-foundation-symposium- Published August 8, 2019. Accessed October 31, 2019.