- MD Anderson Cancer Center executive Stephen Hahn is President Donald Trump's choice to become the next FDA commissioner. The intended nomination, announced Friday, keeps a cancer expert in the agency's lead position more permanently, with acting commissioner Ned Sharpless set to pass the torch.
- Hahn, 59, previously chaired the radiation oncology department at the University of Pennsylvania School of Medicine. He then served at The University of Texas MD Anderson Cancer Center as radiation oncology division head, deputy president and chief operating officer, and, since last June, chief medical executive.
- HHS Secretary Alex Azar announced Sharpless will return to his previous role as director of the National Cancer Institute, which he left this spring to replace former FDA Commissioner Scott Gottlieb. Azar said FDA commissioner responsibilities will be delegated to HHS Assistant Secretary for Health Brett Giroir until Hahn is confirmed by the Senate.
Friday's appointment puts a radiation oncology expert in FDA's top seat. Hahn's professional specialties include treating lung cancer and sarcoma (cancers found in bones and soft tissues), with proton therapy one of his main research areas.
“Dr. Hahn’s distinguished career as a health care provider and researcher gives him a unique perspective on the importance of patient access to the latest medical advances," Scott Whitaker, CEO of trade association AdvaMed, said in a statement Friday, praising Hahn's "extensive management experience."
Hahn sat on the board of the American Society for Radiation Oncology (ASTRO) from 2014 to 2018.
"With a background in radiation oncology and medical oncology, he is uniquely positioned to advance the crucial work of the FDA," Ronald Ennis, who chairs ASTRO's government relations council, said in a statement from the organization Friday.
The sentiments echoed those in a a Sept. 6 statement put out by ASTRO amid reports of Hahn's candidacy.
"Dr. Hahn’s experience using some of the most sophisticated medical devices in health care gives him insight and expertise to drive progress for the benefit of patients and consumers," said Paul Harari, chair of the board at ASTRO.
The nomination confirms months of media reports pointing to Hahn as Trump's pick, beating out Sharpless and Harvard dermatology professor Alexa Boer Kimball, both of whom were reportedly on the short list of potential candidates, according to The Wall Street Journal.
Sharpless was appointed as interim commissioner following Gottlieb's resignation. Under a federal vacancies law, acting officers are limited to 210-day tenures, making Nov. 1 the last day the Trump administration could keep Sharpless at the helm without naming a next-in-line.
Azar said he hopes for an "expeditious confirmation" process, but in the interim is transferring responsibilities to Giroir.
"As Assistant Secretary for Health, whose authorities include overseeing the U.S. Public Health Service, he will be able to assume the delegable duties of the Commissioner at this time and ensure the FDA’s work continues to move forward," Azar said.
Obama-era FDA Commissioner Robert Califf, who had voiced support for Sharpless to be given the role officially, told BioPharma Dive in September upon reports of Hahn's selection that replacing Sharpless would be "disruptive to the agency" and its functions.
"I don't know Dr. Hahn, but his reputation is good and he appears to be a good leader and administrator," Califf said in an email to BioPharma Dive. "However, it takes a while to get to know how the FDA works."
As was the case with the Gottlieb to Sharpless transition, CDRH will maintain leadership continuity under Jeff Shuren during the Sharpless to Hahn transition. January 2020 will mark Shuren's decade as center director.
This story has been updated with additional information and comments from HHS, AdvaMed and ASTRO.