President Joe Biden’s failure to name someone to lead the Food and Drug Administration, more than 10 months after the election, has flummoxed public health experts who say it’s baffling for the agency to be without a permanent leader during a national health crisis.
The pandemic has taxed the FDA, an 18,000-person agency whose chiefs have traditionally received bipartisan backing during the Senate confirmation process. Many leaders in public health, industry and consumer groups agree that Biden’s foot-dragging on finding a new director has demoralized the staff and sent the wrong message about the agency’s importance, even as the toll of COVID-19 mounts, with an average of 130,000 new cases and 1,500 deaths daily, according to the Centers for Disease Control and Prevention.
It’s a tough job in normal times, observers say, and at the moment may be the worst top job in Washington. At the heart of the tension is finding a nominee who balances the agency’s dual responsibilities of protecting public health while also working with the drug, medical device and other industries to approve products and treatments for market. Meanwhile, the agency has been mired in controversies related to drug approvals and COVID-19 vaccines, and discord over decisions has spilled into public view.
FDA commissioner is a “particularly rough job in wartime,” said Steven Grossman, executive director of the Alliance for a Stronger FDA, an outside organization consisting of industry, research and other groups, which pushes for Congress to increase agency funding. “It is a much more difficult post to fill than it appears to the eye.”
Dr. Janet Woodcock, an agency veteran of three decades, has for months led as acting commissioner. She commands broad respect. But her perceived closeness to the drug industry, particularly with respect to the agency’s role in the opioid crisis, led some Senate Democrats to come out against her official assumption of the role. Biden would need all Democrats on board or some Republican senators to back his choice to get the votes for confirmation.
In December, Biden announced other top health appointees who would helm his pandemic response, including Health and Human Services Secretary Xavier Becerra, Surgeon General Vivek Murthy and CDC Director Rochelle Walensky. HHS oversees the FDA — as it does the office of the Surgeon General, the CDC and the National Institutes of Health.
But still no sign of an FDA nomination. Biden officials reportedly considered multiple potential candidates throughout the spring, including Woodcock; former top FDA official and Maryland health secretary Joshua Sharfstein; former FDA official Michelle McMurry-Heath; and Scripps Research Translational Institute director Dr. Eric Topol (who confirmed to KHN he wasn’t interested). Then the process seemed to deadlock.
“People are just flabbergasted,” said Dr. John Whyte, chief medical officer of WedMD and former FDA official. “We don’t even have rumors of viable candidates.”
Many of the agency’s other critical responsibilities require sustained leadership even as the FDA urgently vets COVID-19 treatments, tests and vaccines, according to people in public health, the health care industry and consumer groups. The FDA oversees much of the nation’s food supply and the regulation of tobacco products, and reviews everything from stents and catheters to cancer drugs.
Long-term decisions on tobacco regulation can’t wait, said Matthew Myers, president of the Campaign for Tobacco-Free Kids, which has pushed the FDA to move quickly to implement a ban on menthol cigarettes — something it announced in April — and decide which e-cigarettes can stay on the market. This month the agency punted on whether it would ban the sale of e-cigarettes from several major companies, including Juul, the largest maker of such products.