Sharpless to Succeed Gottlieb at FDA on Acting Basis

March 13, 2019 — The Trump administration wasted little time in appointing an acting FDA Commissioner: Dr. Norman (Ned) Sharpless – currently director of the National Cancer Institute – has been tapped to succeed Dr. Scott Gottlieb (who resigned March 5) on a temporary basis. Sharpless is a physician and former director of the Lineberger Comprehensive Cancer Center at the University of North Carolina, has industry experience from co-founding two biotech firms, and has had significant interaction with the FDA in his current position.

“This quick appointment ensures there is someone with relevant credentials who enjoys the administration’s confidence in this significant position at a key point in the budget cycle,” stated Jon Bigelow, executive director of the Coalition for Healthcare Communication. “The importance of that was shown in the release of the administration’s 2020 fiscal year budget earlier this week, which included higher FDA funding that reflects strong advocacy for the FDA by Dr. Gottlieb, as well as confidence in his initiatives.”

As part of major cuts in domestic programs to offset increased spending on defense and the border, the administration’s budget calls for roughly $5 billion less in spending by the National Institutes of Health, sharp cuts in payments to Medicare providers, and block grants with spending caps for Medicaid. The budget also calls, however, for $6.1 billion for the FDA, which the administration says is an increase of $643 million (and which the Alliance for a Stronger FDA calculates as a net increase of $362 million due to changes proposed in user fees). The increase includes more spending to counter the opioid epidemic and to advance digital health technologies, and comes on top of increased FDA funding in the 2019 budget and from earlier legislation (including PDUFA VI and the 21st Century Cures Act).

As always, the proposed budget will be subject to significant change during the legislative process, but it offers a window on the administration’s priorities for healthcare and other areas.

“It is notable that Dr. Sharpless was appointed on an acting basis, and is not relinquishing his role at the NCI,” Bigelow pointed out. “This may reduce his clout in the current battles over e-cigarette marketing, and may also suggest that it will be some time before a permanent Commissioner, whether Dr. Sharpless or anyone else, is nominated and can be confirmed by the Senate.”