With a resume that’s both asset and liability, Scott Gottlieb preps for FDA confirmation hearing

Sheila Kaplan, STAT News

April 5, 2017

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.

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. […]

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. […]

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. […]

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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