With a Resume That’s Both Asset and Liability, Scott Gottlieb Preps for FDA Confirmation Hearing


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. […]

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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