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January 16, 2020 - FDA

2020 Under Dr. Stephen Hahn, FDA’s New Commissioner

Last month, Dr. Stephen Hahn was officially sworn in as the new commissioner of the U.S. Food and Drug Administration (FDA). The Senate confirmed him by a 73-17 vote. Hahn became the fourth leader of FDA in 2019 and the first confirmed nominee since former Commissioner Dr. Scott Gottlieb resigned unexpectedly in April and was followed by two temporary acting commissioners. Under a permanent commissioner, we will likely see more consistent and future-oriented policy agendas and programs, but the 2020 presidential election may threaten Hahn’s extended tenure as commissioner—a position nominated by the president with no fixed term. Hahn will most likely be compared to Dr. Gottlieb, the well liked and effective communicator. 

Hahn’s specific strategies and goals for the agency are not yet clear, but his experience as a researcher, practitioner, and administrator will give him valuable insight to take on the issues currently facing FDA. With a specialization in radiation oncology, he was most recently the Chief Medical Executive at the University of Texas M.D. Anderson Cancer Center, which has over 20,000 employees, runs on an annual budget of over $5 billion, and currently ranks as the top cancer center in the United States. Hahn earned respect as a skilled leader after becoming Chief Operating Officer of M.D. Anderson in 2017. At the time, the medical center was suffering major financial losses, but it became profitable merely months after Hahn stepped into the role. Before that, he was a professor, research director, and chief of the Radiation Oncology Department at the University of Pennsylvania Perelman School of Medicine. Hahn has also treated patients as a clinician. Despite his familiarity with running a large healthcare organization, he has never worked in government and his regulatory philosophy is largely unknown. He also has no notable ties to large pharmaceutical companies—a concern raised during Gottlieb’s confirmation process in 2017.

Already on Hahn’s future agenda is teen vaping, which has garnered extensive media and government scrutiny due to a rising number of vaping-related illnesses and deaths. Although e‑cigarette products have been targeted by proposed state and federal legislation, they also fall under FDA’s regulatory authority. During his confirmation hearing before the Senate Health, Education, Labor and Pensions (HELP) Committee, Hahn was questioned extensively about his position on a potential ban of flavored tobacco products. The Trump administration proposed the ban on flavored e‑cigarettes earlier this year, but retreated from implementing it before finally settling on a compromise position of banning some but not all flavored e-cigarette cartridges. Despite calling teen tobacco use an “urgent crisis in this country” and saying that “aggressive action needs to be taken to protect our children,” Hahn was similarly noncommittal to the ban. The cancer doctor’s refusal to take a clear stance on the issue led some committee members to question whether Hahn will remain objective against pressure from President Trump and industry lobbyists.

In addition to e‑cigarette use, the HELP Committee expressed concerns about generic drug approval and availability, FDA’s framework for assessing cannabidiol‑based medical products, and ongoing management of the opioid crisis. Hahn’s approach to those issues remains to be seen, but he has promised to use “science and data” to guide his decisions as the next FDA Commissioner. Gottlieb, still a prominent voice in the industry, has continued to criticize the current CBD supplement and beverage industry, outside FDA. We will continue to monitor and report on Commissioner Hahn’s impacts on the regulatory landscape alongside other novel FDA regulation and compliance issues, and expect 2020 to be an exciting year as we all get to know him and understand his approach and priorities.