W

ASHINGTON — Dr. Scott Gottlieb has been preparing for this job his whole life.

He’s a physician and a conservative policy wonk. He’s been a federal regulator scrutinizing new drugs. He’s a writer. An investor. And a consultant: He’s made a lot of money advising biopharma executives on how to get through the bureaucratic thickets of the Food and Drug Administration.

As his confirmation hearing opens Wednesday for the post of FDA commissioner, that resume is both Gottlieb’s strongest asset and his deepest vulnerability.

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President Trump has made clear he wants to revamp the FDA to slash regulations and speed drug approvals. Gottlieb, 44, should be able to hit the ground running: He knows how new drugs are developed, tested, and reviewed. A cancer survivor, he also understands what such therapies can mean to desperate patients.

But if he wins confirmation, he’ll also soon be in a position to make or break the fortunes of many a biopharma executive he’s crossed paths with — or even worked for — in recent years. He’s promised to recuse himself when conflicts arise.

Still, Democrats are wary.

And CEOs are ecstatic.

“We’re very pleased he’s the nominee,” said David Bearss, chief executive of Tolero Pharmaceuticals.

Several years ago, when Bearss wanted to take his startup to the next level, he asked around for advice: “We were at a fork in the road. My friend said, ‘Talk to Scott Gottlieb.’’’

Gottlieb, he was told, was a former FDA official, now on Wall Street, who could help with both strategy and money. So Bearss flew Gottlieb to Lehi, Utah, where Tolero develops drugs for treating cancer and blood diseases.

That conversation turned out to be lucrative for them both.

Gottlieb helped Tolero raise about $22.5 million, invested some of his own money, and then joined the company’s board. Gottlieb was then in position to advise the startup on how to approach the FDA to start a conversation about Tolero’s products.

“He’s been incredibly helpful,” Bearss said. “You want to establish a relationship and have the FDA not think, ‘These are guys are trying to do something crazy.’’’ Gottlieb, he said, knows the agency well enough to be able to counsel startups on how to avoid such rookie mistakes.

“We’re very pleased he’s the nominee. … He’s been incredibly helpful.”

David Bearss, chief executive of Tolero Pharmaceuticals.

With Gottlieb’s guidance, Tolero Pharmaceuticals is now testing not just a leukemia drug, licensed from Sanofi, but also a companion diagnostic that is supposed to help identify the patients most likely to benefit from the medicine.

“It really worked out for us,” said Bearss.

It also worked out for Gottlieb, who reported a profit of between $100,000 and $1,000,000 in capital gains from the sale of Tolero stock on his disclosure form.

A muted rollout for a ‘fantastic’ nominee

The Trump administration named Gottlieb to head the FDA late on a Friday afternoon, with a bland press release that simply recapped the bare outlines of his resume. It didn’t include even a perfunctory quote of praise from the president — or, for that matter, from anyone in the administration.

It was a puzzlingly muted rollout, especially given that weeks before, President Trump had devoted a big chunk of his first speech to Congress to his plans to “slash the restraints” at FDA. He’d also publicly said that he planned to nominate “a fantastic person” to run the agency.

Behind the scenes, the process leading to Gottlieb’s selection was far more colorful than the announcement suggested.

Trump supporter Peter Thiel, an iconoclastic billionaire, had been pushing hard for a far more radical pick to head the FDA.

Thiel had Trump’s ear, and pitched him on two Silicon Valley libertarians who had publicly questioned the core mission of FDA. (One suggested the FDA need not ask for proof that a drug worked before releasing it onto the market. Another mused that the agency could perhaps be replaced with a consumer review site, a sort of Yelp for drugs.)

The Trump team seemed to toy with the idea of turning the agency on its head with such a pick.

But Gottlieb — a far more conventional choice — had powerful backers, too. An old colleague of his, Andrew Bremberg, had been named director of Trump’s Domestic Policy Council.

And Bremberg kept Gottlieb’s name front and center during the FDA search.

Before the White House announced his nomination, Gottlieb met with Trump. Neither Gottlieb nor Thiel would comment for this story.

The nomination drew quick praise from former FDA commissioners of both political parties, including Democratic appointee Dr. Margaret Hamburg and Republican appointee Dr. Mark McClellan.

“Scott has long been committed to finding better ways to advance science and improve health outcomes,” McClellan said. “He is deeply committed to getting these issues right.”

President Obama’s last commissioner, Dr. Robert Califf, praised the nomination, but also expressed some doubts. “It seems like the main question is, ‘Which Gottlieb are we going to get?'” Califf told Kaiser Health News.

A cancer diagnosis turns regulator into patient

Gottlieb grew up in East Brunswick, N.J., the son of a psychiatrist and a teacher.

He went to Wesleyan University, where he majored in economics and spent much of his time writing for the school newspaper, the Wesleyan Argus. He was known for his wide circle of sources and developed a love of writing that he has honed as a contributor to the Wall Street Journal editorial page, Forbes.com, and investment guides.

Even back in his college days, he was known as almost frenetically energetic, always throwing himself into new tasks.

Gottlieb attended Mt. Sinai School of Medicine, in a special program for students who hadn’t majored in the sciences. He did internships in medicine — but also at ABC News in Boston.

He was a resident at Mt. Sinai Hospital on 9/11, and wrote about that horrible day in the BMJ. The emergency room was not as busy as they’d expected, so he and his group went downtown to help victims they hoped were still being pulled from the rubble.

“Rescue crews coming in with injuries were solemn; some cried as we treated them,” he wrote. “They seemed ashamed to be there.”

After a stint in medical practice and as a health care analyst, Gottlieb moved to Washington, where he worked at conservative think tanks. In 2003, McClellan hired him at the FDA. He wrote speeches for McClellan, worked on policy issues, and then went with his mentor to the Centers for Medicare and Medicaid Services. In 2005, he returned to FDA as deputy commissioner for medical and scientific affairs. His signature accomplishment: helping to launch President George W. Bush’s emergency plan to deliver HIV medication to Africa and around the world.

He also got married, to Allyson Nemeroff, who had worked in newspaper publishing. The couple has three young daughters.

It was while he was working at the FDA that Gottlieb was diagnosed with Hodgkin lymphoma. The experience gave him a rare perspective for a regulator: He learned what it was like to be a patient searching for the best treatment. In his case, he was able to go to the National Cancer Institute for advice and to schedule a quick surgery.

Shelley Fuld Nasso, CEO of the National Center for Cancer Survivorship, said Gottlieb doesn’t like to talk about the experience.

“He knows his treatment was much easier than what some people have to endure, “ Nasso said, “but I found that physicians who have a cancer experience really understand the human side of things.”

Gottlieb has been an adviser to Nasso’s group, and to other patient advocacy organizations, over the years; he also has continued to work in medicine, in private practice.

He’s better known, however, as a consultant to the drug industry.

Financial disclosure reports show that Gottlieb has helped launch at least 12  biomedical companies through his work as a managing director in the investment bank T.R. Winston & Co. and his role as a venture partner at New Enterprise Associates.

He also has been a board member, adviser, or speaker for a number of big pharma companies, among them: GlaxoSmithKline, Bristol-Myers Squibb, Daiichi Sankyo, Molecular Insight, and Vertex Pharmaceuticals.

And records show that pharmaceutical companies paid Gottlieb more than $400,000 between 2013 and 2015.

“When so much of a nominee’s career has been spent helping companies get their products approved, that creates the kind of … conflicts of interest that can’t be recused away.”

Diana Zuckerman, president of the National Center for Health Research

Despite his promises of recusal, Gottlieb’s close ties to industry worry consumer advocates — a concern echoed by some Democratic senators.

“It is essential that the FDA commissioner be very knowledgeable about how the FDA works,” said Diana Zuckerman, president of the National Center for Health Research, an advocacy group.

“But when so much of a nominee’s career has been spent helping companies get their products approved, that creates the kind of perspective and conflicts of interest that can’t be recused away,” Zuckerman said. “It’s an integral part of who that person is.”

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Senate Democrats, who held tense meetings with Gottlieb in the past week, plan to grill him about his potential conflicts at the confirmation hearing.

“I am deeply concerned about Mr. Gottlieb’s extensive ties to the pharmaceutical and biomedical industries and asked him to address conflicts of interest that might arise during his tenure at FDA,” said Washington Senator Patty Murray, the ranking Democrat on the Health, Education, Labor, and Pensions Committee.

No plans for radical reform

What would Gottlieb do at the FDA?

Comb through his hundreds of speeches, articles, and pages upon pages of congressional testimony, and you find a man who believes patients are often best served by a free-market approach — but who doesn’t seem to have radical overhaul in mind.

In short, he appears to believe the FDA does its job pretty well.

His agenda includes speeding up approval of complex generic drugs to try to drive down prices; giving companies incentives to develop drugs for pediatric diseases; and making sure FDA has more flexibility to hurry the review process for breakthrough medical devices. He’s also likely to focus on food safety, as well as the safety of the blood supply.

One issue that worries Gottlieb’s critics is his desire to use more “real-world” results as evidence when weighing whether to approve new drugs and devices. There’s no precise definition of the phrase, but it’s often used to refer to information gleaned outside of rigorous clinical trials, such as information from patients’ electronic records.

The FDA is also in the midst of a long review of lab-developed tests, a booming industry. These diagnostic tests are designed, made, and used within a single laboratory, sometimes in a hospital. As personalized medicine has become more common, so have these tests. But the FDA believes there is not currently enough oversight to make sure they are accurate.

“Nobody knows exactly how it’s going to play out. And Scott probably doesn’t know, either.”

Joshua Sharfstein, a former FDA deputy commissioner

The agency has stated its intention to regulate them, and there have been congressional hearings on the issue. Gottlieb, however, has written that to do so would slow progress — a point also made by the industry. In November, bowing to industry pressure, the Obama administration said it would delay implementation of its regulatory proposal.

Another area that will be closely watched if Gottlieb is confirmed is implementation of the Obama-era regulations on e-cigarettes. Gottlieb has invested in Kure, a company that makes e-cigarettes, and he has written that imposing restrictions might make it hard for some people to use them as a tool to quit smoking traditional cigarettes.

Despite Democrats’ concerns, Gottlieb is expected to be confirmed easily.

The question then becomes: Can he play to all the strands of his resume and satisfy patients, doctors, industry executives — and his new boss in the White House? Observers say they’ll be watching closely.

“I view his various connections to be something that will have to play out over time,” said Joshua Sharfstein, a former FDA deputy commissioner under Obama and now a professor at the Johns Hopkins Bloomberg School of Public Health.

“Nobody knows exactly how it’s going to play out,” said Sharfstein, who speaks to Gottlieb from time to time. “And Scott probably doesn’t know, either.”

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  • It’s about time we get a FDA Commissioner who actually cares about protecting public health, and keeping Americans alive.

    In sharp contrast to Robert Califf’s support for FDA’s cigarette protecting Deeming Regulation that is set to ban the sale of all lifesaving vapor products in the US on August 8, 2018, Gottlieb knows that vapor products are far less harmful than cigarette smoking, have helped millions of smokers quit smoking, and pose very little (if any) risk for creating daily dependence for nonsmokers.

  • The FDA doesn’t keep Americans safe. They were repeatedly warmed about NECC and did NOTHING. 74 patients were then murdered and 771 sickened by NECC and the FDA sat on the sidelines with knowledge about this murderous company.

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