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Scott Gottlieb On Tap to Lead FDA, and Biopharma Exhales

Xconomy National — 

[Updated 3/12/17 with more comments, see below] The Trump administration has nominated Scott Gottlieb to be the new commissioner of the FDA, a selection that had the life sciences industry breathing a sigh of relief Friday afternoon.

The 44-year-old Gottlieb is a physician, a venture partner at New Enterprise Associates, and was also the deputy commissioner of medical and scientific affairs at the FDA between 2005 and 2007, during George W. Bush’s administration. Gottlieb is also a resident fellow at the American Enterprise Institute, a conservative think tank. His nomination will have to be confirmed by the Senate before it’s official.

Gottlieb’s selection eases some fears in the life sciences world of drastic FDA upheaval. Trump has been very vocal about rolling back regulations at the agency. At a meeting with pharmaceutical executives in Washington, DC, last month, Trump said he wanted to slash FDA rules by 75 to 80 percent—“at a level no one has seen before”—while still promising “tremendous protection for the people.” And at a speech in front of Congress on Feb. 28, he had choice words for the drug industry and approval process, calling it “slow and burdensome.”

That’s even though the FDA is considered a relatively speedy agency compared to other health regulators around the world and is faster than it used to be, thanks in part to a bevy of regulations that have helped speed the review of drugs and incorporate patient feedback. Though there were just 22 new medicines approved in 2016—the lowest since 2010—that came right after two straight years of near-record highs, including 45 new drug approvals in 2015. In addition, the 21st Century Cures Act, a wide-ranging law that aims to speed the review of new drugs and devices, was just passed last year.

Trump’s bluster and penchant for picking Cabinet members who have previously opposed the agencies they now run—combined with some of the other names floated for the FDA’s top job—had many in the life sciences industry, including groups that advocate for patients, on edge. One rumored candidate, hedge fund manager Jim O’Neill, for instance, said at a conference years ago that the FDA should only review whether drugs are safe, leaving it to the market to decide whether they actually work.

Such talk scared industry experts who fear lowering the drug approval bar. At the recent BIO CEO & Investor Conference in New York, Deerfield Management partner Jonathan Leff noted that it would become “exceedingly difficult to invest” in biotech with a lower efficacy bar. “It becomes the Wild West, where snake oil competes with science-driven therapies,” he said.

Of the prospective choices named in reports, Gottlieb was clearly the industry favorite. In a recent survey, biotech analyst Salim Syed of Mizuho Securities polled 53 drug companies on who they’d prefer, and 72 percent of them chose Gottlieb. As one unnamed survey member responded, Gottlieb was the “least likely to rail for the obliteration of the current efficacy, safety, risk-benefit model that is a foundation for advancement of new treatments in the United States.”

No surprise, then, that the mood was bright on Friday as reports began to circulate of Gottlieb’s nomination. “I think he’s a very good choice, [and] experienced as the deputy FDA commissioner,” said Eric Topol, a practicing cardiologist, genomic researcher, chief academic officer of Scripps Health, and the head of the Scripps Translational Science Institute. “I have been expecting [his nomination].”

Atlas Venture partner Bruce Booth, who helps form startup biotech companies, called Gottlieb’s appointment a “clear positive for the biotech and pharma industry.”

“He knows the details of the drug R&D process and will help facilitate the approval of innovative new medicines,” Booth said.

[Updated with comments from Dunsire] Deborah Dunsire, the CEO of XTuit Pharmaceuticals and longtime head of Millennium Pharmaceuticals, also endorsed the selection, noting Gottlieb’s experience both at the FDA and within the “innovation economy” enable him to engage people from a variety of points of view.

“I feel certain he will bring ideas forward that continue to support innovation but also challenge us to do better as an industry,” Dunsire said. “He is a good thinker and has the bandwidth to think about regulatory policy design and the multiple impact areas for changes, in order to move American health care forward.”

Still, over the years, Gottlieb has publicly denounced the agency on a number of occasions through op-eds criticizing the speed of drug approvals, its rules governing generic drugs, off-label drug promotion, and more. That will be something to watch going forward as he begins to shape the future of the agency.