Nov. 1, 2019 – In a statement issued by the White House, President Donald J. Trump today nominated Stephen Hahn, M.D., to be Commissioner of the Food and Drug Administration (FDA). Hahn is a radiation oncologist, experienced clinical trial investigator, and coauthor of more than 200 papers. He previously served as Chair of Radiation Oncology at the University of Pennsylvania, and currently is Chief Medical Executive at MD Anderson Cancer Center.

Notably, Dr. Ned Sharpless, who has been Acting Commissioner since Dr. Scott Gottlieb’s departure in April and was endorsed for the permanent role by the five most recent commissioners, was not nominated to continue in the position on a permanent basis. Sharpless will now return to his position as director of the National Cancer Institute and Assistant Secretary of Health and Human Services Admiral Brett Giroir, M.D. – another person who reportedly was considered for the nomination – will serve as Acting Commissioner until Hahn’s confirmation is completed.

Although Hahn has no experience in government and his positions on many of the FDA’s current initiatives are not yet clear, at UPenn and at MD Anderson he dealt with controversies (e.g., concerning improper radiation therapy for prostate cancer, and alleged racial bias in clinical trials) that arose or continued during his watch; his own work was not questioned, and defenders say these experiences honed management and political skills that will serve him well at the FDA.

Hahn is not considered to be a disruptive choice for the Commissioner position and is likely to take a middle-of-the-road approach to the job. His nomination now goes to the Senate where he is certain to be grilled about his positions on drug pricing, opioid promotion, and vaping.

“Unless the confirmation process reveals any ethical issues or off-the-wall opinions, we hope Dr. Hahn will be confirmed promptly,” said Coalition for Healthcare Communication Executive Director Jon Bigelow. “Since Dr. Gottlieb’s departure, several high-ranking officials have left the FDA, and as Dr. Gottlieb put it recently during the BioPharma Congress, recruitment and retention of top talent ‘is an unrecognized challenge for the FDA.’”

It is worth noting that the last prolonged period without a permanent Commissioner, during the middle of the George W. Bush administration, was a period of drift for the FDA. “Having a Senate-confirmed leader is important when defending the agency in upcoming budget battles and turf wars, and when maintaining momentum on important initiatives, including modernizing approaches to clinical trials and improving processes for approving new molecular entities, generics, and biosimilars,” according to Bigelow.