NCI’s Ned Sharpless to head FDA in wake of Gottlieb’s surprise exit last week

By PharmaCompass

2019-03-14

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After the US Food and Drug Administration (FDA) commissioner Scott Gottlieb’s sudden resignation last week, the US Department of Health and Human Services announced Norman (Ned) Sharpless, current director of the National Cancer Institute (NCI) at the National Institutes of Health, as the acting FDA commissioner when Gottlieb steps down next month.

“Dr Sharpless’ deep scientific background and expertise will make him a strong leader for FDA,” Alex Azar, Secretary, Department of Health and Human Services (HHS), said in a statement. “There will be no let-up in the agency’s focus, from ongoing efforts on drug approvals and combating the opioid crisis to modernizing food safety and addressing the rapid rise in youth use of e-cigarettes.”

In a tweet posted Tuesday, Gottlieb expressed his delight and confidence in Sharpless who he regarded as “a friend to FDA, a great public health champion, a dedicated physician”, and said he “will be warmly welcomed into his new role.” Gottlieb said FDA will “benefit greatly from his leadership.”

Apart from his predecessor setting high expectations for him as the FDA chief, Sharpless will also face an eager biopharma industry that would want to know if he can match Gottlieb’s zeal for speeding up agency reviews and hastening approvals. Under Gottlieb, the industry saw record new drug approvals, including launches of a whole new generation of cell and gene therapies.

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