“I’m sorry to see him go.”

That was the sentiment among many in healthcare after Dr. Scott Gottlieb stepped down as commissioner of the Food and Drug Administration in April, as expressed by healthcare lawyer Michael Gaba. Gottlieb was widely regarded as a patient advocate and one of the most activist commissioners of the FDA, tackling issues from teen vaping to the lengthy drug-approval process.

Although Gottlieb has moved on, health policy experts believe the FDA will stick to the course he set during his two-year tenure — and most regard less uncertainty as good for the pharma business.

“What bothers the industry the most is when you have transition at important agencies,” says Chad Landmon, chair of the FDA practice at Axinn, Veltrop & Harkrider. “Getting that candidate that’s out of left field, that’s unexpected and might bring in different things, isn’t good, but there’s a fair amount of certainty here.”

That certainty comes from the appointment of Dr. Ned Sharpless as acting FDA commissioner. His appointment, along with assurances from Health and Human Services Secretary Alex Azar that Gottlieb’s agenda will continue, means little will likely change. Unless the administration nominates a left-field candidate for the FDA, the pharma industry can expect smooth sailing from the agency through the 2020 election.

Gottlieb’s enduring legacy

Hallmarks of the FDA the past two years have included streamlining the drug-approval process and addressing drug prices through increased generic and biosimilar competition. Outside of pharma, Gottlieb made e-cigarettes a major focus, cracking down on teen use and threatening more than once to pull the product from the market completely.

Gottlieb also pulled the FDA into the drug-price debate, an arena the agency had not been part of before.

“It’ll be good for pharma, and ultimately for patients and payers, too, particularly on drug-pricing issues and ways to make drug approval more efficient,” says James Boiani, an attorney in the healthcare and life sciences practice at Epstein Becker Green. “There’s an understanding of the FDA’s role in the process and how it can impact pricing. Drugs coming to market more quickly will continue to be a focus at FDA because of the administration’s focus on drug pricing.”

On many of these issues, the agency is already “past a tipping point” of action, says Landmon, meaning it would be difficult to slow its momentum.

While some note that tobacco companies are capitalizing on the transition between Gottlieb and Sharpless to lobby against the regulations placed on e-cigarettes, experts say the pharma industry is not planning to do the same.

The FDA’s changes to drug approval have largely been good for pharma, especially companies that make generics and biosimilars. Even the branded drug manufacturers that have pushed for faster review times are seeing the benefits of Gottlieb’s FDA.

Boiani says pharma’s laundry list for the next FDA chief could include continuing to speed up the drug development and approval process, along with more movement on approving combination products of drugs and devices.

“It’s certainly a good thing for generic pharma companies,” says Landmon. “Gottlieb has done a lot of good things on the branded side, as well, like trying to be more transparent and speed up approval on that end. The agency is overall being more communicative with the companies.”

One thing that could leave with Gottlieb is his communication strategy and very public-facing persona. He was a regular, and sometimes funny, Twitter user and often made statements and press appearances to push the FDA’s efforts. That visibility was good for building support for the FDA’s agenda from Congress, the Trump administration, the drug industry and the public, Landmon explains. The next commissioner would be wise to take a leaf out of Gottlieb’s book, but Landmon says it’s unlikely that whoever ends up in the role will be as visible.

“Almost regardless of who ultimately takes over, I don’t think anyone will be as out there and public as Gottlieb has been,” he adds.

The next commish

The driving force behind many of Gottlieb’s efforts has been his identity as a patient advocate. Speeding up drug approval gets innovative medicine to patients sooner; increasing generic competition lowers the price of medicine for patients.

That’s why the appointment of Sharpless, former head of the National Cancer Institute (NCI) and previously a medical researcher, indicates the FDA will keep on that path.

Gaba, vice chair of the FDA practice group at Polsinelli, notes that the other senior leaders at the FDA, including the deputy commissioners and center directors, are set to stay in place, keeping the agency on course.

“[Sharpless] is going to continue down the path that Dr. Gottlieb has blazed; they’re all in sync on that,” says Gaba. “If that is true, we would see the acting commissioner continue to press on these issues and continue to be a patient advocate. [Sharpless] himself has already demonstrated that capacity as a patient advocate as leader of the NCI.”

Many in the industry believe Sharpless is a leading pick to permanently take over the commissioner role, but the Trump administration has yet to float potential candidates.

Several factors play into choosing and confirming the next FDA head: proximity to the 2020 election, avoiding political headaches and President Donald Trump’s history of out-of-the-blue appointments.

Considering how drawn out Trump’s previous confirmation hearings have been, there is the chance that if someone were nominated for the FDA, the Senate may not take up the vote for several months. For instance, Gottlieb’s nomination in 2017 took three months to confirm.

But Sharpless has fewer of the industry ties that barbed many who opposed Gottlieb’s nomination two years ago. Gottlieb’s connections to investment banks, e-cigarette companies and pharma, including consulting for companies like GlaxoSmithKline, Daiichi Sankyo and Tolero Pharmaceuticals, irked many Democrats.

Sharpless’s background could be easier to confirm than Gottlieb’s. After completing his medical training, Sharpless went on to academia, where he was a professor and eventually led the cancer research center at the University of North Carolina.

Others in Washington are aware of the timing and potential benefits of leaving Sharpless as acting commissioner until the 2020 election, but Gaba notes that Trump doesn’t always follow the advised path.

“The administration would be wise to leave Sharpless where he is, as he is,” Gaba says. “Azar is an old political hand; he understands the dynamics here. I like to think he would counsel the president to leave this one as is. Although, President Trump has distinguished himself by not taking counsel.”

While the presidential election is a year and a half away, campaigning is picking up and primaries will begin next February. As the Trump administration begins to focus on re-election, choosing an FDA commissioner may be put on the back burner and Sharpless may remain in the acting role for some time.

“FDA tends to be a hot-button area politically, so I think this administration would be wise to not draw more attention to the commissioner position when they’ve got someone who appears to be capable and able to lead FDA through the end of this term,” Gaba says. “Why create another political firestorm around somebody?”