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Pharmaceuticals / Regulatory Affairs

Sharpless: Meet the New Boss (Same as the Old Boss)

May 9, 2019

Acting FDA Commissioner Ned Sharpless had his coming-out party last week at the Food and Drug Law Institute’s annual conference in Washington, D.C., where he reassured participants that, although there may be a new belle, the ball will go on as planned.

“I don’t anticipate major departures from my predecessor,” Sharpless told a packed audience for his keynote address. “I don’t want to disrupt these strong processes.”

Sharpless, who had been serving as director of the National Cancer Institute, acknowledged that it’s a tough act to follow former Commissioner Scott Gottlieb, who was lauded up and down Pennsylvania Avenue. But he also made clear that he’s not just putting in an appearance.

He said he spoke to five former commissioners—including Gottlieb—and their advice was consistent: listen to the FDA center directors.

Sharpless spoke with feeling about FDA investigators and enforcement officers, whom he said are needed to crack down on “charlatans” among illicit pharmacies, stem cell clinics and dietary supplement makers who are “peddling false hope.”

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