- Stephen Hahn, an oncologist and top official at the MD Anderson Cancer Center in Texas, is President Donald Trump’s choice to lead the Food and Drug Administration next, the White House announced on Friday.
- Hahn, who emerged in September as the frontrunner for the job, will replace acting commissioner Ned Sharpless, pending confirmation by the Senate. Sharpless has run the agency since early April, after Scott Gottlieb unexpectedly stepped down.
- As Hahn goes through confirmation, Brett Giroir, an assistant secretary of health, will assume FDA leadership on a temporary basis. Sharpless' term expires Friday.
In selecting Hahn, Trump chose a candidate whose resume differs notably from past FDA commissioners.
Unlike his predecessors Gottlieb, Robert Califf and Margaret Hamburg, Hahn hasn’t previously served in top health policy positions.
Rather, Hahn’s risen through the ranks at The University of Texas’ MD Anderson, where he currently serves as chief medical executive, a senior position that oversees the hundreds of clinical trials run at the hospital.
Hahn’s specialty is radiation oncology, a branch of cancer medicine that uses radiation to shrink or eradicate tumors. Prior to joining MD Anderson as department chair in 2015, Hahn worked in a similar role at the University of Pennsylvania School of Medicine.
If confirmed as FDA head, Hahn will play a central role in forming the government's response to public health crises, most notably an epidemic of opioid overdoses and addiction as well as rising concern over the dangers of e-cigarettes.
He'll be the nation's top drugs regulator at a time when both the White House and lawmakers in Congress are seeking to curtail pharmaceutical pricing. The FDA does not have authority over how drugs are priced, but under Gottlieb became more vocal on the issue and related market dysfunction.
The FDA is also grappling with questions over how it should balance historical standards of safety and efficacy with a desire to speed drugs to patients in need.
Some clues to Hahn's views can be found in some of the more than 200 studies and articles on which he’s listed as an author. In one from 2008, published in the Journal of Clinical Oncology, Hahn and three co-authors from the University of Pennsylvania argue forcefully in favor of conducting randomized controlled trials of proton therapy, a type of radiation technology.
Another, from 2011, discusses the need for comparative effectiveness research in radiation therapy.
While reports have indicated for months that Hahn was Trump’s choice, the White House waited until the last possible day to announce the nomination. Under federal rules, Sharpless could not serve as acting commissioner longer than 210 days, a clock that ran out on Friday.
Sharpless, who will return to his former role as director of the National Cancer Institute, was also in consideration for the top FDA role. He received the support of four former FDA commissioners, who wrote a letter to Trump recommending Sharpless.