It’s not as if FDA commissioners don’t have a tough enough job—balancing safety and speed, risks and benefits while trying to keep politics at bay. But President-elect Joe Biden's pick to head the drug agency faces a uniquely challenging tenure from day one.
Multiple COVID-19 vaccines, treatments, tests and technology approvals—and a backlog of delayed drugs to review and manufacturing plants to inspect—await the new chief. Compounding the hefty operational issues are wavering public trust and charges of politicization and inappropriate pressure for approvals under the Trump administration.
It’s no surprise, then, that media reports about emerging frontrunners have FDA leadership experience. Stability and familiarity may be some of the more important boxes to check right now.
While Biden will give the final nod to an FDA nominee, that person’s boss—aka the Secretary of HHS—will likely have some say in the decision, and Sunday, the president-elect nominated California Attorney General Xavier Becerra to fill that post.
No matter who gets the nod, though, reclaiming the agency's reputation will be key. Joshua Sharfstein, one of the leading candidates and a former FDA deputy chief under President Obama, summarized the importance in a recent opinion column about the FDA's role.
“With the number of U.S. deaths from COVID-19 approaching 200,000, the integrity of the country’s leading public-health regulatory agency is more than an abstraction; it is a matter of life and death,” he said. That death toll has now surpassed 280,000.
The Fierce Pharma bracket here comprises contenders tagged in news reports and on social media, plus suggestions from readers and editors. Some are more plausible than others, but the realm of possibilities in political nominations is broad indeed.
Names were chosen randomly for individual match-ups, and the top vote-getters will advance after each round. Vote for your favorite eight here and check back Thursday to see who’s moving on to the next round.
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.”
Eric Topol, current editor-in-chief of Medscape, is a cardiologist and founder and director of the Scripps Research Translational Institute. The physician-scientist is an outspoken science advocate on Twitter and played a role in pushing current FDA director Stephen Hahn to stay the course against outside political influence, writing an op-ed in late August advising him to “tell the truth or resign.” (Which, incidentally, led to the two corresponding and becoming friends.) Topol is no stranger to high-profile ethical decisions. When he was provost at the Cleveland Clinic College of Medicine in the early 2000s, he was one of the first physicians to point out potential cardiovascular problems with Cox-2 class painkillers, including Merck’s Vioxx. He told a jury in a Vioxx lawsuit in 2005 that Merck engaged in “scientific misconduct.” Days after the taped deposition was heard, Cleveland Clinic took away his chief academic officer title and removed him from its board in what it said was “administrative streamlining.”
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.
Susan Desmond-Hellman served as CEO of the Bill & Melinda Gates Foundation from 2014 until earlier this year. She led the University of California-San Francisco as chancellor for five years before leaving to join Gates, and before that, spent 14 years at Genentech, where she ended up as president of product development. She joined Pfizer’s board of directors this year. While Biden may want to steer away from a candidate with strong pharma ties, Desmond-Hellman's academic background and not-for-profit experience could balance out her industry résumé. But then again, in announcing her departure from Gates, she noted family and health issues as the reason. While she certainly has the prerequisites, she may not be eager to take a full-time, high-pressure role in D.C.
Tom Frieden, former head of the Centers for Disease Control and Prevention, was appointed by Obama in 2009 and left that role in 2017. A physician and public health expert, Frieden is currently the president and CEO of Resolve to Save Lives, an initiative aimed at preventing epidemics and cardiovascular disease. Before the CDC, he served as commissioner for public health in New York City; banning smoking in restaurants was one of his marquee achievements. Frieden’s current Resolve organization pivoted to COVID-19 pandemic support this year and Frieden has become an outspoken science communicator on social media. Like others, he has advocated strategies like mask wearing and strategic closures to control the coronavirus until vaccines are vetted and widely available.
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.
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.
Peter Lurie currently heads the food and health watchdog Center for Science in the Public Interest. Before that, however, he spent almost eight years at the FDA. He served as associate commissioner for public health strategy and analysis, where he helped to expand access to investigational drugs and work to curb prescription drug abuse.
Norman “Ned” Sharpless served as interim FDA chief after Gottlieb resigned and before current commissioner Stephen Hahn came to the fore. Sharpless, in fact, was widely seen as a favorite for the post before Trump picked Hahn instead. Gottlieb and a handful of other ex-FDA commissioners publicly endorsed Sharpless as permanent replacement. He returned to his role as director of the National Cancer Institute, a job he's held since 2017.
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.
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.
Stephen Hahn, the current FDA chief isn’t beyond the scope of reality, although he would more likely be an interim choice. He’s only held the role since last December, joining just months before the global pandemic began, and his record so far hasn't been flawless. Hahn stumbled in overseeing the rush to approve hydroxychloroquine without much evidence, for instance, and touched off an outcry by co-anchoring a press conference with Trump where he misrepresented the effectiveness of plasma treatments. Still, he did stand firm more recently, famously bucking White House pressure by publishing COVID-19 vaccine approval standards.
Robert Califf, FDA commissioner under President Obama from early 2016 through January 2017, is certainly a familiar face for Biden. A cardiologist, Califf currently heads up clinical policy and strategy for Verily and Google Health. He wrote an article for STAT last year that quoted a common saying at the FDA: “In God we trust, all others must bring data.”
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.
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.
Atul Gawande, a member of Biden’s coronavirus task force, Gawande is a well-known surgeon, writer and public health official. Also a professor at Harvard Medical School, he's founder and chair of Ariadne Labs and non-profit Lifebox, which works to reduce surgery deaths around the world. He's also a writer for the New Yorker and served as a senior advisor at HHS during the Clinton administration. He recently served as CEO of Haven Healthcare, the joint Amazon, Berkshire Hathaway and JPMorgan Chase employee healthcare initiative; though he stepped down from that role in May, he remains chairman.