Oct. 14, 2019 — “I’d be lying if I said it didn’t have an impact.” That’s how former FDA Commissioner Scott Gottlieb responded when asked last week at the BioPharma Congress in Washington, D.C., whether it matters if the FDA is led by an acting or a permanent Commissioner, even as reports swirl in Washington that President Donald Trump will soon nominate someone other than acting FDA Commissioner Ned Sharpless for the permanent role.

“Dr. Gottlieb’s comments came just a few hours before BioPharma Congress attendees heard Dr. Sharpless give a witty and informative luncheon talk defending current FDA approaches to speeding drug development,” according to Jon Bigelow, executive director of the Coalition for Healthcare Communication. “Notably, Joe Grogan, director of the White House Domestic Policy Council, said at the conference that the administration intends to nominate someone soon, but twice dodged specific questions about whether Dr. Sharpless is in the running.”

Several news services are reporting that the President plans to nominate a permanent Commissioner before Nov. 1, and that the leading candidate is now Dr. Stephen Hahn, chief medical executive at the MD Anderson Cancer Clinic in Houston. Hahn is a respected oncology researcher, but he has no government experience. Any nomination, whether of Hahn, Sharpless, or someone else, would be subject to Senate confirmation.

Gottlieb noted that the FDA has previously operated under persons (he cited Dr. Les Crawford and Dr. Andrew von Eschenbach) who were “acting Commissioners” for long periods, and also noted that the FDA currently is guided by what he termed a “very professional leadership team.” However, he said that a large part of the job is to mediate disputes among federal agencies over control and scope, and that Capitol Hill relationships are very important. “Being Senate-confirmed inspires more confidence,” Gottlieb said.

Asked whether it makes sense to have one agency dealing with the different issues involved in regulating food and tobacco — and in the future potentially alcohol and cannabis — as well as drugs, Gottlieb advocated for retaining the current model of having the FDA as the one public health agency. He did note, however, that different parts of the agency portfolio prompt opposition from different directions and that “I probably testified on the Hill more than any other agency head who’s not under investigation.” He also said that when the next Commissioner is nominated, the confirmation process could be delayed by the concerns of various Senators on such issues as genetically-modified foods.