President Trump on Friday announced that he intends to nominate Stephen Hahn, CMO of MD Anderson Cancer Center in Houston, to serve as FDA commissioner—and Brett Giroir, assistant secretary for health at HHS, has replaced Ned Sharpless as FDA's acting commissioner until Hahn is confirmed.

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Acting commissioner shake-up

Sharpless, who had been serving as the director of the National Cancer Institute (NCI), took over as FDA's acting commissioner in April, after former FDA Commissioner Scott Gottlieb resigned. Sharpless' term as acting FDA commissioner expired Friday, and the Trump administration under federal regulations could extend his term only if Trump nominated a permanent commissioner, Inside Health Policy reports.

However, individuals who spoke on the condition of anonymity told the Washington Post that Trump could not nominate Hahn on Friday because paperwork regarding the nomination was not completed. As such, the administration shifted Giroir to serve as FDA's acting commissioner until a permanent replacement is confirmed, and Sharpless returned to his post at NCI, the individuals said.

According to Inside Health Policy, HHS Secretary Alex Azar on Friday sent out an official announcement that Grior would take over as FDA's acting commissioner, and added that the administration hopes lawmakers will quickly confirm Hahn. "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," Azar said in the announcement.

Giroir has been serving as HHS' assistant secretary for health since February 2018, and reportedly had been on a short list for consideration as Gottlieb's permanent replacement. However, Giroir over the past year has been criticized by Democratic lawmakers over his involvement in HHS' "controversial" restrictions on fetal tissue research, Inside Health Policy reports. According to Inside Health Policy, Sen. Patty Murray (D-Wash.)—chair of the Senate Health, Education, Labor, and Pensions Committee, which will oversee the confirmation process for the FDA commissioner nominee—was among those who raised concerns about Giroir.

Murray in a statement issued Friday said she is "alarmed that … Giroir will step in as acting commissioner given his track record of letting ideology drive decisions at the expense of women and families—so [she] will hold him accountable while he serves in this role."

About Hahn

Hahn has served as MD Anderson Cancer Center's CMO since May 2018. According to the Post, Hahn is a radiation and medical oncologist who oversees clinical care in his current role at MD Anderson. Hahn also has served as the center's COO, and has been lauded for helping to restore the center's financial health, the Post reports. According to a White House release, Hahn also has served as a Gilbert H. Fletcher Memorial Distinguished Chair and professor of radiation oncology at MD Anderson since January 2015.

Hahn from 1989 to 1996 worked at NCI as a senior investigator. He then took a position at the University of Pennsylvania, where he worked from 1996 to 2014. Hahn served as the university's chair of radiation oncology from 2005 to 2014. Hahn then began working as the head of MD Anderson's radiation oncology division.

According to the Post, Hahn throughout his career has conducted various clinical trials, including studies involving proton therapy treatment for prostate cancer and combining radiation with immunotherapy. The White House release noted that Hahn "has authored 220 peer-reviewed original research articles." Hahn also holds five patents, STAT news reports.

Hahn has been involved with some "controvers[ial]" moments throughout his career, according to STAT News. For instance, while working at the University of Pennsylvania in 2009, Hahn appeared before the House Veterans' Affairs Committee "to deliver an in-person apology … after a doctor under his supervision implanted small radioactive 'seeds' used in some cancer treatments at the incorrect dose or in the incorrect organ in dozens of veterans," according to STAT News. In addition, Hahn "helped to extinguish concerns surrounding the recent dismissal of a small group of Chinese researchers" at MD Anderson, "assuring staff there the dismissals were driven by an ongoing federal investigation into foreign influence into research and were not racially driven," and has overseen care at MD Anderson as "[r]egulators this year … found [the center] had violated federal guidelines so severely that the regulatory failures 'substantially limit [the] hospital's capacity to render adequate care,'" STAT News reports.

Although Hahn does not have much experience working in government agencies, some of his colleagues said they think he would be a good fit for the FDA post.

Karen Bird—executive director of the Alliance of Dedicated Cancer Centers, of which MD Anderson is a member—said, "People who don't work at academic medical centers underestimate how complicated they are to navigate, because there are so many interested that are not all aligned in any given day or year." She added that Hahn is a "great politician with a small 'p'," who is able to manage "many stakeholders" and implement changes in intricate environments.

The Alliance for a Stronger FDA also praised Hahn. Steven Grossman, the group's deputy executive director, said, "Hahn's success in academic medicine is being undervalued as a credential for being FDA commissioner." Grossman explained, "Being chosen to lead and then being promoted in that environment requires sustained political acumen and extraordinary interpersonal skills."

Grossman said Hahn's experience makes him a particularly well-suited candidate to lead FDA. "Unlike most organizations—where the leader stands at the top of a largely hierarchical structure—in an academic health center the leader is required to constantly engage and satisfy multiple co-equal fiefdoms who have competing demands. The resemblance to dealing with HHS, [the White House Office of Management and Budget], the House, and the Senate is unmistakable."

Further, Thomas Feeley—a senior fellow at Harvard Business School and professor emeritus at MD Anderson who had worked with Hahn—said he does not "think [Hahn] is a political person," but he is "pro-patient [and] pro-consumer." As such, Feeley said he does not believe Hahn would "let politics get in the way of doing the right thing."

According to Politico, Hahn "has accepted relatively little money from the drug and medical device industries" when compared with some former FDA commissioners. Medicare's Open Payments database shows Hahn received about $1,000 in travel and lodging fees from the radiation oncology device company Varian Medical Systems in 2017, Politico reports.

According to STAT News, it is not clear when the Senate could begin considering Hahn's nomination (Cohrs/Wang, Inside Health Policy, 11/1 [subscription required]; McGinley, Washington Post, 11/1; Karlin-Smith, Politico, 11/1; Facher, STAT News, 11/1).