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S&P Global Market Intelligence – Former US FDA chiefs, health groups back Sharpless as permanent commissioner

S&P Global Market Intelligence – Former US FDA chiefs, health groups back Sharpless as permanent commissioner

Ned Sharpless, acting commissioner of the U.S. Food and Drug Administration, has won the support of five previous agency chiefs — Republican and Democratic appointees — and nearly 60 healthcare organizations to remain in the job permanently.


Under a 1998 law, Sharpless can only remain as commissioner in a temporary capacity until Nov. 1 — 210 days from the time he took the helm at the FDA. After that, President Donald Trump must submit a nomination to the U.S. Senate or appoint another acting commissioner.


In addition to Sharpless, who has said he wants to stay on permanently, some other names have been circulating around Washington as possible contenders for the top FDA job, including Brett Giroir, assistant secretary for health at the U.S. Department of Health and Human Services.


In a Sept. 3 letter to Trump and HHS Secretary Alex Azar, former FDA Commissioners Robert Califf, Margaret Hamburg, Andrew von Eschenbach and Mark McClellan urged the administration to keep Sharpless permanently in the role.


“During his time in the acting commissioner role, he has shown the ability to execute the critical and complex work of the agency,” the four former chiefs wrote in their letter. “He has gained the respect of the agency staff and a broad spectrum of the public in support of the FDA’s mission.”


They insisted Sharpless, who previously led the U.S. National Cancer Institute before taking over at the FDA in the acting role, had the expertise to enable new activities in key areas like cancer treatment and prevention and precision medicine.


Having a presidentially appointed, Senate-confirmed commissioner would not only provide more secure governance for the FDA “at a time when there is so much to do, but will also create needed momentum and support for the thousands of public servants who serve to protect and promote the health of the American public,” they said.


Scott Gottlieb, who served less than two years as Trump’s first FDA commissioner and left the agency on April 5 to return to his former job as a venture capitalist, did not sign the letter but said in a Twitter post that he hoped to see Sharpless nominated as the permanent leader.


“Ned Sharpless is an outstanding physician and scientist who is deeply committed to public health goals and the mission of FDA,” Gottlieb tweeted.


“It’s important to note the spectrum of political backgrounds of the four of us who signed the letter, and it’s significant that Scott agreed, although it would not have been appropriate for him to sign the letter,” Califf told S&P Global Market Intelligence in an email.


Califf and Hamburg served under President Barack Obama, while von Eschenbach and McClellan were nominated by President George W. Bush.


The healthcare groups, which included a number of cancer organizations, told Trump and Azar they had “sincere confidence” that Sharpless was the best person to be nominated and confirmed as the permanent FDA commissioner.


“During his brief time at FDA he has continued to navigate and direct the agency in a manner that best benefits patients and is effectively executing the critical work of the agency,” the groups wrote in their Sept. 3 letter. “His presence has been a calming force, which has gained him the respect of the agency staff and those that support its mission.”


They insisted Sharpless’ nomination would be supported by the patient advocacy community, as well as leading scientific and research institutions across the U.S.


“The support from the community shows just how important the FDA is to the lives of patients and just how much the community trusts and supports Dr. Sharpless to lead that agency,” Ellen Sigal, chair of Friends of Cancer Research, told S&P Global Market Intelligence.


But Sharpless has come under some criticism.


Democratic Senate Whip Dick Durbin of Illinois said he did not have confidence in Sharpless and criticized him for not doing enough to stem the use of e-cigarettes in the U.S., particularly in young Americans.


“Do not repeat the mistakes of Commissioner Gottlieb by underestimating the danger these products present to our nation’s children,” Durbin told Sharpless in a May 29 letter. “As acting FDA commissioner, you must not be a spectator to this epidemic.” He sent a follow-up letter in July.


In a June 19 letter to Azar, Durbin told the HHS secretary that the senator’s May 14 meeting with Sharpless was “one of the most disappointing and alarming” he had ever had in public service.


Durbin called on Azar to “intervene and force FDA’s hand” in taking stronger actions in regulating e-cigarettes.…