White House Nominates MD Anderson’s Stephen Hahn as Next FDA Commissioner


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It’s now official. Stephen Hahn, chief medical executive of the University of Texas MD Anderson Cancer Center, will be nominated as the next commissioner of the U.S. Food and Drug Administration (FDA). Hahn had been the frontrunner for the top spot at the FDA.

Late Friday, President Donald Trump put forth Hahn’s name to take over the top spot of the nation’s regulatory agency as the permanent replacement for Commissioner Scott Gottlieb, who retired earlier this year. Hahn’s name was announced on Nov. 1, which was a deadline established by the Federal Vacancies Reform Act. Had Trump not named a new full-time commissioner, a new interim commissioner would have had to been named. The Federal Vacancies Reform Act states that a person may not serve in an acting or interim capacity for longer than 210 days.

Until Hahn, a radiation oncologist is confirmed by the Senate, Admiral Brett Giroir, assistant secretary for health in the Department of Health and Human Services, will helm the agency. Ned Sharpless, who has served as interim commissioner since Gottlieb’s retirement, will return to his role at the National Cancer Institute.

If Hahn is approved, which is likely in the Republican-led Senate, he will be stepping into new regulatory territory that includes the government’s response to e-cigarettes, its continued response to the opioid crisis and the use of real-world data in the approval process of new medicines. Hahn will also likely be looked at to continue the FDA’s recent stream of generics approvals as a means to lower the cost of prescription medicines, all while drug costs become a central issue of the 2020 election.

As a radiation oncologist, Hahn specializes in treating lung cancer and sarcoma and has authored 220 peer-reviewed original research articles, the White House said in its announcement. In his role as chief medical executive, Hahn has been responsible for the day-to-day operations of the famed cancer center that includes managing more than 21,000 employees and a $5.2 billion operating budget. MD Anderson is also involved with the largest number of clinical trials in the United States, the White House said. Hahn was promoted to that role two years after joining MD Anderson as division head, department chair and professor of Radiation Oncology. Prior to MD Anderson, Hahn served as head of the radiation oncology department at the University of Pennsylvania’s Perelman School of Medicine.

While Hahn is well-respected, his tenure as chief medical executive of MD Anderson was briefly entangled in accusations of racial-profiling earlier this year following the termination of some Chinese-born researchers who were accused of research espionage at the behest of China. During an MD Anderson town hall meeting following the terminations, which were part of a broader concern regarding intellectual property theft, Hahn attempted to reassure employees that racial profiling is something that the leadership at MD Anderson abhors and would not stoop to using.

Despite that problem, Hahn’s nomination has been hailed by many medical associations. The American Hospital Association said that Hahn’s decades of experience “on the front lines of delivering patient care, overseeing clinical research and operations, and quality and safety initiatives makes him a uniquely qualified nominee to lead the FDA.”

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