Former agency heads, health groups push for FDA’s Sharpless to be permanent commissioner
Source:

Laurie McGinley, The Washington Post

September 4, 2019

The jockeying over who will be the next Food and Drug Administration commissioner intensified Tuesday when former agency heads and dozens of health groups urged the White House to nominate acting FDA chief Norman “Ned” Sharpless to become the agency’s permanent commissioner.

Supporters of Sharpless sent two letters — one from four former FDA commissioners and the other from more than 50 cancer and other groups — to President Trump and Health and Human Services Secretary Alex Azar. The letters had the same message: The FDA needs a permanent commissioner, and Sharpless should be nominated and confirmed to lead the agency.

The maneuvering underscored the importance of the FDA job, which is often overlooked in the hyper-political atmosphere in Washington. Headquartered in Silver Spring, Md., the agency regulates a huge slice of products consumed by Americans, from lettuce to e-cigarettes to cancer medications.

Sharpless, a North Carolina cancer researcher who was appointed by Trump to be head of the National Cancer Institute, was tapped as acting FDA commissioner in March, when Scott Gottlieb announced he was leaving the agency. As the acting head, Sharpless can serve only until early November, under federal rules.

The Department of Health and Human Services declined to comment on the letters or on Sharpless’s prospects.

Earlier this summer, indications were that Sharpless and two other candidates were in the running for the FDA job. One reportedly was Alexa Boer Kimball, a Harvard dermatology professor and president and chief executive of the Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center. The other was a doctor at M.D. Anderson Cancer Center whose name wasn’t disclosed.

More recently, concern has risen among some health groups and scientists that Azar may be supporting Brett Giroir, assistant HHS secretary for health, for the FDA job, at least in an acting capacity. Giroir has implemented several controversial administration policies, including antiabortion initiatives and new restrictions on federal funding for fetal-tissue research.

Though Sharpless is well liked by the research community, he faces some challenges. Records show that he donated to Barack Obama’s 2008 and 2012 presidential campaigns and to other Democrats. And some Democrats — notably Sen. Richard J. Durbin (D-Ill.) — have repeatedly criticized Sharpless for not moving aggressively enough to stem youth vaping.

The two letters sent Tuesday insisted that Sharpless is the best person for the job.

“We need to have a strong leader like Ned who has treated patients, run clinical trials and advanced science with every position he has held,” said Ellen Sigal, chair of the nonprofit Friends of Cancer Research. Other groups that signed the letter from patient and disease groups included the American Cancer Society Cancer Action Network, the National Brain Tumor Society and the Leukemia and Lymphoma Society.

Mark McClellan, an FDA commissioner during the George W. Bush administration, was one of four previous agency heads to sign a letter supporting Sharpless. He said a permanent commissioner would enable the agency “to take new directions” on such issues as the youth vaping epidemic, reducing smokers’ dependence on nicotine and drug pricing.

The other former FDA chiefs who endorsed Sharpless were Robert Califf and Margaret Hamburg, who served during the Obama administration, and Andrew von Eschenbach, who led the agency during the George W. Bush administration.

Gottlieb, who preceded Sharpless, said he “fully supports” his nomination and confirmation, but he didn’t sign the letter to avoid any debate about post-employment restrictions that limit his contact with federal health officials.

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