President Trump Nominates Oncologist Stephen Hahn to Head FDA

Stephen M. Hahn, MD, FASTRO

President Donald Trump is nominating Stephen M. Hahn, MD, FASTRO, as the next commissioner of the FDA. Hahn, who is currently serving as the University of Texas MD Anderson Cancer Center’s chief medical executive, was reportedly the preferred choice of Department of Health and Human Services (HHS) Secretary Alex Azar, according to Politico.¹

If confirmed by the Senate, the noted radiation oncologist will serve as the successor to Scott Gottlieb, MD, who resigned from the role in March 2019. Unlike Gottlieb, who has a resume packed with government experience and a notable history of working on health policy issues for Washington interest groups, this will be Hahn’s first venture into public service in over 2 decades.

In the early 1990s, Hahn was part of the Public Health Service, where he served as the chief of the National Cancer Institute (NCI)’s prostate cancer clinic for the duration of 2 years: 1994 and 1995. Hahn has been a member of the American Association for Cancer Research (AACR) since 1999, where he has served as an inaugural member of the AACR Radiation Science and Medicine Working Group Steering Committee and the AACR Radiation Oncology Task Force. Hahn also served as the chairman of the Radiation Oncology Department at the University of Pennsylvania Medical School for 9 years. In 2015, he joined the MD Anderson Cancer Center team, where he ascended to the role of chief medical executive just 3 years later. Additionally, Hahn is the author of over 200 peer-reviewed journal articles and publications.

“The unprecedented research opportunities that exist today, coupled with our rapidly improving ability to translate these scientific advances into improved treatments for patients, require an experienced and visionary leader at the FDA,” said Elaine R. Mardis, PhD, AACR President and coexecutive director of the Institute for Genomic Medicine at Nationwide Children's Hospital in a press release.² “Dr Hahn’s impressive qualifications make him ideally positioned to succeed at the FDA.”

Acting Commissioner Ned Sharpless, MD, who was appointed to the position in April 2019 shortly after Gottlieb’s departure, is expected to remain in the position throughout the confirmation hearings, according to the media outlet BioSpace.³ If the nomination passes through the Senate, Sharpless is expected to return to his role at the NCI.

To meet the terms of the Federal Vacancies Reform Act, which call for a new interim commissioner or a permanent replacement for Gottlieb by today, November 1, 2019, the Trump administration has temporarily named the current HHS Assistant Secretary of Health Brett P. Giroir, MD, as the interim FDA chief until Hahn is appointed into his position.

As commissioner, Hahn will oversee a bureaucracy with a $5.4 billion budget that regulates products that comprise about 20 cents of every dollar spent by consumers in the United States, according to Politico. The scope of the agency’s portfolio goes beyond Hahn’s experience in drugs and medical devices, to that of animal health, food, and notably, tobacco policy. Specifically, Hahn will be tasked with combatting the public health crisis with electronic vaping products. He will also be an instrumental player in the Trump administration’s plans to regulate e-cigarettes.

The e-cigarette debate has grown exponentially in the past couple of years, and the nature of the topic could potentially slow down the confirmatory process necessary to install Hahn in the role, according to former FDA commissioner, Mark McClellan, MD, PhD, who served during the George W. Bush Administration.

For example, the confirmatory process for Robert M. Califf, MD, MACC, former President Barack Obama’s second choice to head the regulatory agency, was delayed due to concerns regarding the FDA’s work with opioids at the time.

“In the past, there have been holds put on, not for any personal reasons but because there are so many issues that FDA deals with that members have strong feelings about,” said McClellan saying in a past interview. Although Hahn does not have prior experience with tobacco policy, those who have worked with him in the past predict he will fill those knowledge gaps to adequately address the issue.

In fact, Karen Bird, executive director, Alliance of Dedicated Cancer Centers, whose membership includes MD Anderson, commented that Hahn’s academic experience has equipped him for the task of running a large regulatory agency like the FDA.

“People who don’t work at academic medical centers underestimate how complicated they are to navigate, because there are so many interested that they are not aligned in any given day or year,” said Bird. Hahn is “a great politician with a small ‘p,’” who will be capable of managing “many stakeholders” and facilitate change in difficult settings.

AACR President-Elect Antoni Ribas, MD, PhD, professor of medicine at the David Geffen School of Medicine at the University of California Los Angeles, also spoke to Hahn's capabilities. "For several years, I served with Dr Hahn on a NCI study section, and I always found him to be an extremely thoughtful and science-oriented grant reviewer," Ribas said. “He has always put the interests of patients first, by embracing the importance of regulatory science to truly inform and improve the way new cancer medicines are evaluated for safety and efficacy.”

References

1. Karlin-Smith S. Trump to pick Texas cancer doctor to head FDA. Politico. politico.com/news/2019/11/01/trump-fda-nominee-stephen-hahn-063800. Accessed November 1, 2019.
2. American Association for Cancer Research. AACR applauds nomination of Stephen M. Hahn, Md, as FDA comissioner. aacr.org/Newsroom/Pages/News-Release-Detail.aspx?ItemID=1355. Accessed November 1, 2019.
3. Keown A. Stephen Hahn is front-runner to take over the FDA, reports say. BioSpace. biospace.com/article/md-anderson-s-stephen-hahn-could-be-the-next-fda-commissioner/. Accessed November 1, 2019.