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NCI head Sharpless named as interim FDA chief

The search for a permanent replacement is still ongoing

The head of the National Cancer Institute (NCI, Ned Sharpless, is the Trump administration’s pick to serve as acting FDA commissioner after Scott Gottlieb departs next month.


Ned Sharpless, interim FDA chief

The temporary appointment was announced by Health and Human Services Secretary Alex Azar yesterday at a hearing of the House Energy and Commerce health subcommittee, a week after Gottlieb announced his surprise resignation.

The search for a permanent replacement is ongoing, with industry hoping that the new incumbent will continue Gottlieb’s approach, which walked the line between striving to accelerate access to new therapies such as cell and gene therapies, whilst encouraging greater competition to products at the other end of their lifespan from generics and biosimilars.

Azar said in a statement that as acting commissioner Sharpless “will be carrying forward Dr Gottlieb’s vision”.

“Sharpless’ deep scientific background and expertise will make him a strong leader for FDA,” said Azar 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 modernising food safety and addressing the rapid rise in youth use of e-cigarettes.”

Gottlieb tweeted his support of the pick, describing Sharpless as “a friend to FDA, a great public health champion, a dedicated physician, [who] will be warmly welcomed into his new role.” And it seems ties with the regulator are already strong, as the NCI head plays on a weekly basketball team with some of the agency’s medical review staff.

Sharpless has headed up the NCI since October 2017, and previously led the University of North Carolina's Lineberger Comprehensive Cancer Centre, and has also shown his willingness to pursue reforms with efforts to revamp the clinical trial recruitment process and deploy ‘big data’ to interpret trial results. He will be replaced at the NCI by deputy director Douglas Lowy in the interim, who previously served as director.

The acting commissioner has industry experience as well, having co-founded two early-stage biotechs, one of which – G1 Therapeutics – was listed on the Nasdaq in 2017. He is no longer a shareholder in those companies however having divested his stakes when named as NCI director.

The big question now is whether Sharpless will only serve as a caretaker or will be put forward as a candidate for the permanent position. As a potential candidate Sharpless has already gone through the vetting process and divested any financial holdings that could be deemed as conflicts of interest.

A permanent successor must be nominated by President Trump and confirmed by the Senate, however, and Sharpless isn’t the only name linked to the FDA’s top job. Others mentioned in dispatches include FDA principal deputy commissioner Amy Abernethy, US assistant secretary for health Brett Giroir, and former FDA commissioner Mark McClellan.

According to Politico, Gottlieb has recommended that Sharpless be officially named for the position going forward, with the current commissioner’s high standing with the administration will no doubt count for much.

Sharpless said in a statement that he is “grateful for the confidence the President and Secretary Azar have shown by asking me to assume the role of acting commissioner of the FDA,” adding: “It will be an honour to advance the FDA’s critical public health mission and build on its progress toward the priorities laid out by President Trump, Secretary Azar, and commissioner Gottlieb alongside the leadership and staff of the agency.”

Article by
Phil Taylor

13th March 2019

From: PME



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