Trump Nominates Hahn to be FDA Commissioner

Regulatory NewsRegulatory News
| 01 November 2019 | By Zachary Brennan 

Photo courtesy of MD Anderson Cancer Center.

President Donald Trump on Friday nominated Stephen Hahn, chief medical executive of the MD Anderson Cancer Center in Houston, to be the next US Food and Drug Administration (FDA) commissioner.

If confirmed by the Senate, a process that could take several months, Hahn will take the reins of FDA from Acting Commissioner Ned Sharpless, who moved over to FDA following a stint as head of the National Cancer Institute (NCI). Sharpless will return to direct NCI, while Brett Giroir, assistant secretary for health at the US Department of Health and Human Services (HHS), will serve as acting FDA commissioner while Hahn's confirmation process occurs. 

Hahn, also a former NCI alum in the early 1990s, previously served as chair of the Radiation Oncology Department the University of Pennsylvania’s Perelman School of Medicine from 2005 to 2014. The American Society for Radiation Oncology and several other groups expressed their support for Hahn's nomination on Friday.

"I have known Dr. Hahn for many years and have served with him in numerous capacities. He possesses the qualities needed to successfully lead the FDA…intelligence, medical and scientific expertise, an engaging style and a clear sense of how to get to the right answer, particularly in complicated situations," said Theodore DeWeese, director of radiation oncology and molecular radiation sciences at Johns Hopkins University School of Medicine. 

Hahn, a Republican donor, has received limited funding from the biopharma or medical device industries, although according to the Texas Tribune, Hahn’s role at MD Anderson makes him the 24th highest paid government worker in the state, with a salary of $933,600, so he will be taking a large pay cut to come to FDA.

But his opinions on matters related to the regulation of pharmaceuticals and medical devices is less well known. And it’s unclear if he will continue on with what Gottlieb started, as Sharpless did, or if he’ll try to forge his own path on contentious issues such as the regulation of stem cell clinics, the use of real-world evidence, the use of surrogate biomarkers and approvals of new types of therapeutics.

He does seem interested in allowing for the further use of real-world data and evidence. At an FDA-AACR-ASTRO workshop in 2018 he discussed using "big data and analytics to accelerate research," adding: "It's no surprise" that Roche paid $1.9 billion for electronic health records company Flatiron Health. Hahn also argued in the Journal of Clinical Oncology for reference pricing for proton therapy. The Trump administration has proposed other types of reference pricing to try to bring down the cost of pharmaceuticals.

On the lighter side, Hahn has said that if he wasn’t a doctor, he’d run a vineyard and winery, and that his first job was serving ice cream at Friendly’s.


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