Whom will the Trump administration nominate for the top FDA job? Acting Commissioner Ned Sharpless is one contender—and he reportedly scored endorsements from five former FDA chiefs, not to mention a laundry list of patient groups. But he’s not the only candidate.
Sharpless is among three frontrunners, the Wall Street Journal reported. Stephen Hahn, MD Anderson Cancer Center’s chief medical executive, and Alexa Boer Kimball, a dermatologist and president and CEO of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center, are top contenders as well.
Sharpless, formerly director of the National Cancer Institute, won the interim job on the recommendation of Scott Gottlieb, who abruptly stepped down in March. And apparently, Gottlieb thinks Sharpless has done a good job so far.
Commending Sharpless as “an outstanding physician and scientist who is committed to public health goals and the mission of FDA,” Gottlieb, in a tweet Wednesday, said he hopes to see him “permanently nominated” to the role.
That shouldn’t come as a surprise, as Sharpless basically took up Gottlieb’s mantle. In his first major speech at the FDA in April, Sharpless vowed to “maintain FDA’s current course of action in every area and proceed full speed ahead.”
Ned Sharpless is an outstanding physician and scientist who is deeply committed to public health goals and the mission of FDA and I hope to see him permanently nominated into that role. https://t.co/WSEydEdjzG— Scott Gottlieb, MD (@ScottGottliebMD) September 4, 2019
Four other former FDA commissioners have also thrown their weight behind Sharpless via a letter to President Donald Trump and Health and Human Services Secretary Alex Azar, according to the WSJ.
“He has gained the respect of the agency staff and a broad spectrum of the public in support of the FDA’s mission,” the commissioners said in the letter, as quoted by the newspaper. They are Robert Califf, Margaret Hamburg, Andrew von Eschenbach and Mark McClellan.
Dozens of patient and disease groups have also recommended Sharpless as the perfect 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,” Ellen Sigal, chair of Friends of Cancer Research said in a separate letter that was also signed by a few other cancer groups.
Under Gottlieb, the agency was widely viewed as having taken a more lenient attitude toward advancing drug candidates, culminating in a record-breaking 2018 in terms of new approvals. And Sharpless, vowing to take a similar path, was a welcome choice for the biopharma industry from the beginning.
Still, amid all the accolades, senior FDA officials have continued to jump ship during Sharpless’ short reign—though the trend began long before his tenure. The Center for Drug Evaluation and Research’s former director of the Office of Antimicrobial Products, Ed Cox, recently left for a regulatory affairs VP title at Regeneron. Kathleen Quinn, who was senior adviser to the commissioner, just became GlaxoSmithKline’s head of U.S. corporate communications.
The Federal Vacancies Reform Act only permits 210 days for how long “acting” agency heads can stay. That leaves Trump and Azar until first thing in November to decide on a formal recommendation.