Why the Biden administration might not want to be content with just an acting FDA commissioner
Another month has passed without President Joe Biden nominating anyone to fill the permanent FDA commissioner position, and experts are continuing to raise concerns about what it means for the agency to not have a Senate-approved leader during a once-in-a-lifetime pandemic.
The push to fill the top spot at the FDA once seemed like a two-person race between acting commissioner Janet Woodcock, an industry and FDA insider favorite who has ruffled some feathers among Senate Democrats, and former principal deputy commissioner of FDA Josh Sharfstein, who’s now a vice dean and professor at Johns Hopkins.
Sharfstein declined to comment on whether he’s still interested or up for the job, and the Biden administration seems intent to just let Woodcock serve as acting commissioner for the foreseeable future.
A former FDA official told Endpoints News that he’s heard from people in the administration that they’re in no rush to nominate a permanent commissioner because they’re comfortable keeping Woodcock, a 35-year veteran of FDA, in the acting role.
Other former FDA officials and commissioners are pushing the Biden administration to nominate someone quickly for the role.
“A strong, confirmed Commissioner is a vital advocate and champion for the Agency, who can speak with the authority and presidential support that come from the confirmation process. Without confirmed leadership, it is more challenging for FDA to set long-term policy priorities, and to speak with a strong and independent voice,” Lowell Schiller, FDA’s former principal associate commissioner for policy, and chief legal and regulatory officer at Aetion, told Endpoints News. “That independent voice is critical at all times, and especially so during a global pandemic.”
Another former FDA official expressed surprise in mid-February that a nomination hadn’t been made yet, but the official said that the agency was in a good place with Woodcock, and that there were proactive campaigns inside the FDA to name her as the permanent commissioner. The official also said that Sharfstein, at the time, was pushing hard for the permanent role (Sharfstein again declined to comment on this point).
Six former FDA commissioners endorsed Woodcock in a letter to Biden last month, urging the administration to secure the agency’s leadership with a formal nomination. That leadership team has since taken a hit with the announced departure later this month of Amy Abernethy, FDA’s principal deputy commissioner and acting chief information officer.
But this lack of permanent leadership (soon to be in the top 2 spots at the agency) may not hold up more routine FDA operations, like the drafting of new guidance.
“Especially with an acting commissioner as experienced at the Agency as Dr. Woodcock is, I don’t think that having an acting commissioner should, as a practical matter, hold up things like routine guidance documents [one new guidance has been released since Biden took office], and we’ve seen the agency take some interesting steps, like announcing the April advisory committee meeting to review six oncology indications granted accelerated approval,” Patricia Zettler, former FDA lawyer and associate professor of law at the Ohio State University, told Endpoints News via email. “That said, it might mean the Agency is less able or less willing to begin or announce new, broad initiatives.”
Industry group PhRMA also agrees on the need for urgency.
“For the Agency to continue providing critical science-based regulatory oversight of our nation’s medicine supply, we believe it is vital for a qualified permanent commissioner be named in a timely manner,” Andrew Powaleny, senior director of public affairs at PhRMA, told Endpoints News via email.
Moving forward, Biden will be required by law to nominate someone for the permanent slot by about mid-August, as according to the Federal Vacancies Reform Act, acting officials can only serve for 210 days and Woodcock took over as acting commissioner on Jan. 20 (although there is some wiggle room on that deadline).