It’s official: President Donald Trump has nominated Stephen Hahn as the next commissioner of the FDA.
He will take over from Ned Sharpless, who had been running the U.S. regulator on an interim basis since Scott Gottlieb, another Trump pick, left in the spring. Sharpless had been a front-runner, but Hahn in the past few weeks had overtaken him.
In fact, Sharpless is making the unusual move of going straight back to his former role at the National Cancer Institute (NCI).
Admiral Brett Giroir, an official at the Department of Health and Human Services (HHS), will be steering the ship in the interim. Sharpless’ last day is, in fact, today, as this was the deadline for his acting role, and he can’t serve for any longer.
HHS Secretary Alex Azar said: “Under Dr. Sharpless’s leadership for the past seven months, FDA has forged ahead in its essential work of protecting the public health. Dr. Sharpless’s willingness to step into the role of Acting Commissioner, and to lead the team at FDA with a steady hand, ensured that the agency did not miss a beat in advancing its vital mission.
“I look forward to having him back at NCI, where he can continue the important work he has led on administration priorities, such as pediatric cancer, rural cancer care, and precision medicine, and I want to thank Acting Director Lowy for advancing efforts in those areas over the past seven months.”
He added: “Admiral Giroir has been an indispensable leader for HHS on a number of public health priorities. 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.”
Hahn, who still needs to be confirmed by the Senate, has been chief medical executive at the University of Texas MD Anderson Cancer Center in Houston since 2018 and the Gilbert H. Fletcher Memorial Distinguished Chair and professor of radiation oncology at MD Anderson since 2015.
An oncologist and previously a senior investigator at the NCI, he is something of a Washington outsider, and Hahn’s background differs from those of his predecessors.
Gottlieb did a stint at the FDA before coming back to take the top job. And Margaret Hamburg and Robert Califf, who held leadership roles during the Obama years, each had public health policy experience from time spent at the HHS and FDA, respectively.
In contrast, Hahn has spent the vast majority of his career at academic medical centers, starting out at the University of Pennsylvania in the 1990s before arriving at MD Anderson to lead the radiation oncology division about five years ago.
Some prominent people had called for Trump to make more of a continuity pick by nominating Sharpless, with former FDA commissioners, including Gottlieb, having lobbied for him to get the position on a permanent basis, as did more than 50 groups involved in cancer and other areas affected by the agency. That lobbying has failed.
While a sizable slice of Hahn’s inbox upon arrival at the FDA is likely to focus on issues unrelated to biopharma—such as the agency’s handling of vaping, which is in the spotlight—drug regulation will still be a major issue.
The FDA has been undergoing something of a cultural shift in recent years, with a focus on speedy reviews but arguably at the expensive of a slower, more considered approach to drug approvals.
Some green lights, such as for Sarepta Therapeutics' Duchenne muscular dystrophy (DMD) therapy three years ago, saw internal and external wrangling at the regulator about whether the bar was being lowered. There are also whispers as to how political the FDA’s rejection of Sarepta’s second attempted DMD approval was, and as a backlash to its first.
A big test for Hahn is on the horizon: namely, Biogen’s once failed and canned Alzheimer’s disease drug aducanumab, now resurrected and set to spook more than a few FDA insiders.
Biogen, working some data magic/dredging operation, found that their drug may actually work in some Alzheimer’s patients, though skepticism is sky-high from some analysts and bio-Twitterati (though investors, not so much).
Biogen said it has spoken with the FDA, which appeared happy for it to attempt to file the drug. Anything could happen: a refuse to file notice, a demand for another phase 3 trial, a hostile AdComm, even a flat-out no. Whatever the decision and path, this will be a litmus test for Hahn.