Thursday, October 21, 2021

Pick the Commish: Voters advance FDA vets, including Gottlieb, Sharfstein and Abernethy, to top-8 showdown

FiercePharma’s search for a voter-crowned FDA commissioner has narrowed to an Elite Eight squad of possible chiefs.

After the first round of voting, the men and women who remain in contention are almost all FDA veterans of one sort or another. Four of them previously led the agency, two served as deputy commissioner, and another held the chief scientist role.

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Only one—Laurie Glimcher, who is CEO of Dana-Farber Cancer Institute—doesn’t have previous FDA experience. Not that that stands in her way. Voters pointed out her strong scientific and management background in comments, with one person calling her “a rockstar academician and administrator.”

Another wrote, “Most appropriate background of all the candidates. Excellent track record in the job.”

Still, the common thread of FDA experience isn’t surprising considering the current state of the FDA and the generally agreed-upon need to right the ship—as well as the anticipated work on COVID-19 vaccines and treatments.

Many commenters mentioned the need for “experience” and “consistency” as important, along with the fact that those still in contention already know the processes at the agency. As one wrote, they “know where all the bodies are buried and would get up to speed in no time.”

But would they do it? Another common theme among voters across all the candidates were predictions that the former FDA chiefs wouldn’t take the job.

On Scott Gottlieb: “I don’t think Scott Gottlieb wants to do this job again and I don’t think Biden wants the Pfizer ties at the FDA,” one wrote. “He’s the absolute best choice on this list, but I’m not sure he’ll do it,” another said.

On Mark McClellan: “He won’t go back, but he is on the pulse of moving the agency forward. After COVID, FDA will benefit from thinking in new ways. McClellan is good for this.”

On Joshua Sharfstein: “Strong credentials, but may not want to leave JHU.”

On David Kessler: “Why would Kessler even want to do that job again?”

Another theme in the comments was personal experiences. Several people who have worked with or know some of the candidates came forward in the comments to shed a different light on the candidates.

About Amy Abernethy: “She was a few years ahead of me in training and a chief resident when I was an internal medicine resident and was fantastic. Always had the patient top of mind, great bedside manner, and phenomenally bright. I learned a lot from her as a student and resident.”

About Hamburg: “Peggy has been there, done that, (aka has job experience) and I know people that have worked under her and love her.”

The next round of voting opens now. Vote here through Sunday at midnight for the men and women you think are the best picks for FDA commissioner in President-elect Joe Biden’s administration. We’ll be back Monday with the list of four top vote-getters and new matchups.

Poll 1

David Kessler is one of three co-chairs of Biden’s COVID-19 task force and, according to various news reports, a leading candidate for the FDA job. Both a pediatrician and a lawyer, Kessler is a former FDA chief appointed by President George W. Bush in 1990 and reappointed by President Bill Clinton in 1992; he remains the agency’s longest-serving commissioner since 1965. He was known for standardizing nutrition labeling and regulating tobacco, as well as working to speed drug approval processes. Kessler was also in charge when Purdue’s opioid OxyContin was first approved in 1995, although he left before the 2001 labeling change allowing long-term use. He told 60 Minutes last year that “[t]he label change was a blank check—one the drug industry cashed in for billions and billions of dollars. Now, Big Pharma had a green light to push opioids to tens of millions of new pain patients nationwide.”


Margaret Ann “Peggy” Hamburg, FDA commissioner from 2009-2015 under President Obama, Hamburg was only the second woman to serve in the role. She’s currently foreign secretary for the National Academy of Medicine, and she’s also worked at HHS and the National Institutes of Health. If the administration is looking for someone with U.S. health agency knowledge and FDA chops, Hamburg is an obvious name to consider.

Poll 2

Joshua Sharfstein, a pediatrician by training, is a former principal deputy FDA commissioner who currently serves as the public health dean at the Johns Hopkins Bloomberg School. During President Obama’s first term, he first served as acting FDA chief and then as principal deputy under FDA Commissioner Peggy Hamburg. In September, Sharfstein wrote an article for Nature titled, “How the FDA should protect its integrity from politics.” He has previously been a critic of drug industry marketing practices; for instance, he advocated for stricter regulations on OTC cough and cold medicines as public health commissioner in Maryland and criticized the American Medical Association for its political donations. Now, Sharfstein is seen as a leading candidate for the top FDA job.


Laurie Glimcher currently serves as president and CEO of the Dana-Farber Cancer Institute, a job she chose even after being asked to consider interviewing for dean of Harvard Medical School. Glimicher is a renowned immunologist and refers to herself as a physician-scientist known for breaking glass ceilings and helping other women along the way. She’s also familiar to Biden because she was part of the advisory team that helped the then-vice president craft his cancer moonshot initiative in 2016.

Poll 3

Amy Abernethy, an oncologist and palliative medicine physician, has served as principal deputy director and second-in-command at the FDA since 2018. She also serves as the FDA’s acting chief information officer, a potentially key set of skills as data and technology take center stage in everyday life and health. She’s also familiar with the pharma industry, serving as chief medical officer of Flatiron Health before and after Roche’s acquisition of the cancer and real-world data software developer.


Luciana Borio, an infectious disease physician, is a member of Biden’s current COVID-19 task force, but there’s no reason she couldn’t make the jump to FDA commissioner. A former acting chief scientist and assistant commissioner for bioterrorism policy at the FDA, she helped develop and execute the agency’s public health responses to the H1N1 pandemic and Ebola and Zika outbreaks. During the COVID-19 pandemic, she and Gottlieb co-authored a series of straight-talking op-ed columns for the Wall Street Journal.

Poll 4

Mark McClellan, a practicing internist, led the FDA from 2002-2004 and served as administrator for the Centers for Medicare and Medicaid Services (CMS) from 2004-2006 under President George W. Bush. Currently director of the Duke-Margolis Center for Health Policy at Duke University, McClellan—and Scott Gottlieb, who worked for him at FDA—co-authored an American Enterprise Institute report in March proposing a framework for responding to the pandemic and safely reopening the U.S.


Scott Gottlieb, the former FDA commissioner, would be a tried-and-true pick, and stability wouldn’t be the worst thing for the U.S. drug industry right now. He garnered a plea from one Fierce Pharma reader, who wrote, “Bring back Scott Gottlieb, please.” The ex-commissioner has been outspoken during the pandemic, albeit quite politely, in noting administration missteps, but has also fiercely defended the integrity of the FDA. On the other hand, Gottlieb now serves on the Pfizer board and is considered pharma-friendly, while Biden may be looking to distance himself from the industry.

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