Biden is looking beyond Woodcock or Sharfstein for FDA commissioner — report
Neither Janet Woodcock nor Joshua Sharfstein is likely to be nominated as the permanent FDA commissioner, Steve Usdin at BioCentury reports.
The White House is looking for alternatives to Woodcock, the acting chief and longtime CDER director, after opposition from several Democratic senators who are calling on others to block her nomination if her name is put forth, according to Usdin. Sharfstein, the former principal deputy FDA commissioner and current Johns Hopkins professor, is out of the running altogether.
As the vacancy at the helm of an agency tasked with overseeing the development and review of Covid-19 vaccines became more conspicuous by the day — prompting the New York Times to ask, “Who will be the next FDA chief?” — distinct camps had formed around the two leading candidates.
Woodcock earned plaudits early from patient advocacy organizations and biopharmaceutical companies, the same groups that have spoken out against Sharfstein for lack of experience.
But there was a particular group of activists who made their disdain for Woodcock clear: those fighting the opioid abuse epidemic. And they believe Woodcock should be held responsible for “one of the worst regulatory agency failures in U.S. history,” not only overseeing but defending “harmful opioid decisions.”
Senators from some of states worst hit by the opioid crisis were reported to be her fiercest opponents, including Senators Maggie Hassan from New Hampshire, Ed Markey from Massachusetts and Joe Manchin from West Virginia.
Less publicized, perhaps, was the harsh critique that some industry insiders reserved for Woodcock over what they perceived as the loosening of the FDA’s regulatory standards, manifested in her decision to overrule FDA staffers and approve Sarepta’s eteplirsen without clinical proof that their Duchenne muscular dystrophy drug works.
In a recent letter to Public Citizen, Woodcock shut down the watchdog’s proposal of a firewall between regulators and drug companies, arguing it would unnecessarily “reduce the efficiency of FDA’s review process and cause delays in drug development.”