President nominates MD Anderson Cancer Center’s Dr. Stephen Hahn to lead FDA

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November 04, 2019

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President Donald Trump intends to nominate Dr. Stephen Hahn, a radiation oncologist and the chief medical executive at MD Anderson Cancer Center in Houston, to be FDA commissioner, according to a tweet posted on Nov. 1 by HHS Secretary Alex Azar. If confirmed by the Senate, Hahn will replace another oncologist, Dr. Norman Sharpless, who has been acting commissioner since Dr. Scott Gottlieb stepped down from the commissioner’s post in April.

Hahn has extensive experience as a radiation oncologist. He has held leadership roles in radiation oncology at MD Anderson Cancer Center and at the University of Pennsylvania’s Perelman School of Medicine, with a focus on treating lung cancer and sarcoma, according to a biography on MD Anderson’s website. Much of his research work has been dedicated to measuring and comparing the effects of various radiation treatments on cancers.

In a letter of support, the American Society for Radiation Oncology pointed to Hahn’s experience as excellent training for the FDA role. “A culture of safety is woven into the fabric of radiation oncology, making Dr. Hahn expertly suited to further FDA’s mission of protecting the public health,” the association wrote. “At the same time, Dr. Hahn’s experience using some of the most sophisticated medical devices in health care gives him insight and expertise to drive progress for the benefit of patients and consumers.”

President Trump also has asked Dr. Brett Giroir, HHS assistant secretary for health, to take on some of the responsibilities of the FDA commissioner as the confirmation process proceeds, according to a statement from HHS. Sharpless will return to the National Cancer Institute as director of the institution.

HRI impact analysis

If he is confirmed, Hahn will take over the FDA as it undertakes an ambitious regulatory agenda in 2020 and implements the 21st Century Cures Act. He would also inherit the ongoing controversy over how to regulate e-cigarettes.

Hahn’s experience in radiation oncology, including conducting clinical trials, would complement the life sciences industry’s focus on oncology as an area of growth. Worldwide, spending on therapeutic and support care for cancer is expected to reach $200 billion by 2022, or roughly 14 percent of total global medical expenditure.

It remains unclear whether Hahn would continue Gottlieb’s agenda of emphasizing efficiency in regulatory reviews of pharmaceutical products and medical devices and strong approvals of generic drugs. It is also unclear whether Hahn would be as garrulous a communicator as Gottlieb, who was a frequent tweeter and public speaker as FDA commissioner. Gottlieb also was known for communicating with stakeholders, and emphasizing that in the agency.

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