Opinion: Plenty of qualified people are ready to run the FDA. Time for Biden to choose one
As the Delta variant ramps up and the FDA prepares to fully approve Covid-19 vaccines and quickly review booster shots this fall, the agency desperately needs a permanent commissioner.
Although FDA officials have reassured the public that their jobs continue as expected, even without a permanent leader for more than 200 days now, there’s no question that having a Senate-confirmed head for FDA is extremely important during a once-in-a-century pandemic, and even more so to develop longer-term, agency-wide strategies to help prepare for the next pandemic.
The White House doesn’t seem to have the votes (or doesn’t want a Republican-led confirmation) to transition Janet Woodcock and her four decades of FDA experience from acting to permanent status. The opioid crisis and other decisions she made while leading CDER (e.g., Sarepta’s eteplirsen and Biogen’s aducanumab approvals) weigh on her nomination, with at least one Democratic senator, Joe Manchin of West Virginia, publicly calling on Biden not to nominate Woodcock.
But Woodcock can remain in her current, acting role until about mid-November, and it seems like the Biden administration has every intention to run out the clock on her tenure, even if she isn’t nominated for the permanent spot in the end.
Strangely, the administration has consistently bemoaned the lack of promising FDA commissioner candidates, even as the White House has had plenty of time to select and vet qualified candidates.
In what has become almost a weekly question for the White House, Jen Psaki confirms President Biden hasn't selected anyone, even privately, to nominate as FDA commissioner. The White House has had trouble finding a candidate they're confident can get confirmed by the Senate.
— Kaitlan Collins (@kaitlancollins) August 4, 2021
With this difficulty in identifying FDA commissioner candidates in mind, here are 10 qualified people who could serve the agency well in the top slot, and advance FDA’s role in creating the gold standard in medical product approvals (presented in no particular order):
The academics
- Eric Topol — He’s a well-respected cardiologist who understands the way FDA works, isn’t afraid to stand up to political meddling in scientific decisions, especially with regard to the pandemic, and is a well-rounded public health communicator.
- Joshua Sharfstein — His name was floated as an early contender for the FDA’s top job, but then Biden seemed to think he might not be a good selection. Perhaps his name resurfaces again? His academic colleagues all think highly of him, and he knows the agency well given his prior experience.
- Aaron Kesselheim — Although Kesselheim, a Harvard professor of medicine, recently resigned from the FDA adcomm that voted unanimously to reject Biogen’s new Alzheimer’s drug when it was approved, perhaps the Biden administration can bring him back into the fold at FDA. Again, he’s a well-respected physician, professor and frequent author of papers on various FDA policies. Certainly, the learning curve would be significantly less steep for someone like Dr. Kesselheim when compared with others.
- Caleb Alexander — Another academic leader with a strong understanding of the FDA, and who has served on multiple FDA adcomms, including the recent Biogen one. Alexander, a professor at Johns Hopkins, might provide a unique perspective to an agency that hasn’t seen an academic leader in the top spot since Duke’s Rob Califf led it.
- Carlos Del Rio — The Emory professor has been tracking and advising state and local governments on the ins and outs of the pandemic since it began. His clear communications have made him a well-respected source of information.
Former FDAers and industry leaders
- Ken Frazier — The former Merck CEO, who stepped down at the beginning of July, is a high-profile trailblazer who could offer a familiar face to the FDA, especially with his knowledge of the biopharma industry, its inner workings and his exceptional leadership skills.
- Michelle McMurry-Heath — As the head of industry group BIO, McMurry-Heath’s name has surfaced and re-surfaced again as a possible top contender for the FDA commissioner job. While she hasn’t commented on the prospect, her public opposition to certain Biden-backed initiatives, like the TRIPS waiver before the WTO and Medicare negotiations on drug prices, may not win over too many more Democrats than Woodcock.
- John Jenkins — A long-time FDA director in the Office of New Drugs, Jenkins knows the agency (more than 2 decades of experience) and understands how it works. He also served in a high-profile position for more than a decade, as well as on the other side, with his recent industry consulting work at Greenleaf Health.
- Scott Gottlieb — Clearly a favorite among FDA staff from his previous run as commissioner during the Trump administration. Gottlieb’s name comes up again, despite his role on Pfizer’s board and other lucrative positions, perhaps because of how consistently accurate he’s been in discussing the pandemic week in and week out on television and Twitter.
- Luciana Borio — A former acting chief scientist at FDA, she was vetted by Biden’s team for the top job early on, but has since taken on new roles at ARCH Venture Partners, so she may be out of the running.
