FDA faces test under new chief

The newly named acting commissioner of the Food and Drug Administration (FDA) is poised to take over at a crucial time for the agency, as outgoing Commissioner Scott Gottlieb leaves an ambitious legacy largely unfinished.

President Trump’s decision to tap Norman Sharpless as acting commissioner of the FDA is drawing praise from health advocates, who see it as an opportunity for the agency to continue its work uninterrupted.

{mosads}Gottlieb’s ambitious agenda on curbing youth vaping and tobacco use was thrown into uncertainty last week when he surprised politicians and advocates by his sudden decision to retire.

But the administration is preaching continuity and wants Sharpless, a respected cancer researcher, to continue Gottlieb’s efforts after he departs.

“We are going to be carrying forward Dr. Gottlieb’s vision,” Health and Human Services Secretary Alex Azar told House members at a hearing Tuesday, when he made the announcement about Sharpless. “His agenda is my agenda. My agenda is his agenda.”

Sharpless, currently the director of the National Cancer Institute (NCI), will take over as acting commissioner of the FDA when Gottlieb steps down next month.

Azar said the administration has already begun the process of finding a permanent replacement, and it’s possible Sharpless will be considered.

Sharpless is a close ally of Gottlieb, and he has praised the FDA’s recent actions to curb youth vaping.

In a statement issued Tuesday, Sharpless said, “It will be an honor to advance the FDA’s critical public health mission.”

Sharpless will be taking the helm at an agency dealing with a number of important issues on its docket.

{mosads}An analysis by investment firm Cowen and Company said FDA is currently viewed “as operating at peak efficiency during an unprecedented innovation period.” But the analysis cautioned that Sharpless is taking over “where all the risks are on the down side if the agency is unable to match very high bar metrics of success going forward.”

Sharpless has been the NCI’s director for less than two years, but as a presidential appointee, he has already been vetted by the administration.

However, NCI director is a position that doesn’t need Senate confirmation. If Sharpless were formally tapped to be full FDA commissioner, it would likely be months before a confirmation hearing could be scheduled.

The process could be further complicated by the politics of the upcoming 2020 election.

During his two-year tenure at the FDA, Gottlieb unveiled ambitious proposals that he said were aimed at curbing the youth vaping “epidemic” and reducing the harm and appeal of traditional cigarettes.

Gottlieb launched his main salvo on Wednesday, releasing a draft guidance that would drastically restrict the sales of e-cigarettes. The proposal would essentially end sales of e-cigarettes at gas stations and convenience stores.

Gottlieb has also called for banning menthol cigarettes, as well as cutting nicotine levels in all types of cigarettes to make them less addictive.

But none of the proposals has been implemented, and there’s some concern that an acting commissioner may not have the political capital to press ahead. Many of the most controversial proposals face stiff opposition from industry and some GOP members of Congress.

“It’s a challenge for a permanent FDA director. It’s an extraordinarily difficult challenge for an acting FDA director,” said Matthew Myers, president of the Campaign for Tobacco-Free Kids.

“We are deeply concerned that the exceptionally important promises that have been made will not get implemented,” Myers added. “Our hope is that the administration will quickly move to make him the permanent director and then provide him with the political support necessary to move these measures through the decisionmaking process.”

Other health advocates said having a confirmed commissioner is better for the agency but did not think Sharpless will be limited in his role as “acting” commissioner.

“He’ll be an effective leader in any capacity,” said Jeff Allen, president and CEO of the Friends of Cancer Research. “He obviously has the backing of the administration.

“The transition into a fully confirmed role conveys backing of the Congress, [but its absence] doesn’t do anything to diminish his role,” Allen added.

Still, Allen said he hopes the administration moves quickly to formally nominate Sharpless.

“I think the [tobacco] industry will try to knock down the doors of anyone they can think of to prevent their industry from receiving the scrutiny it deserves,” said Gregg Haifley, director of federal relations at the American Cancer Society Cancer Action Network.

“I don’t think a change in the commissioner’s office will change” that behavior, he added.