A “little bit” turns out to be seven days: President Joe Biden’s pick for the FDA leader is reportedly Robert Califf, M.D., who helmed the post when Biden was vice president in the last year of Barack Obama’s presidency.
It’s been nine months of mystery atop the agency as Janet Woodcock, M.D., has filled the interim post, but now there might be clarity in the coming days.
And Califf is one of the high-profile scientific leaders who pushed the 46th president to select somebody to oversee the 18,000-employee agency (PDF). Califf and five other former commissioners sent a letter to the White House urging Biden to prioritize the decision, not explicitly endorsing any candidate, including Woodcock, who they described as “a highly effective advocate” for the agency’s mission.
That was in April.
The Washington Post reports the veteran FDA leader could return to steer the agency. It is a pivotal time, with COVID-19 vaccine boosters in the limelight, controversy around Biogen’s Aduhelm embroiling the regulator’s public standing and multiple leaders departing, most notably in the vaccine unit.
Biden has come under increasing pressure to nominate somebody to fill the permanent post. “We’ll be talking about that in a little bit,” he told reporters last week after National Institutes of Health Director Francis Collins, M.D., Ph.D., said he’d retire soon.
If confirmed, Califf would fill a post he held from February 2016 to the conclusion of Obama’s second term in the White House. Prior to that, Califf was deputy commissioner for medical products and tobacco for 12 months. Califf was a professor of cardiology and medicine at Duke University and a member of the Duke Clinical Research Institute, where he was the founding director.
Now, he serves as head of clinical policy and strategy for Google's Verily and Google Health.
During his nomination hearings in November 2015, Califf came under some congressional scrutiny for his ties to the pharmaceutical industry, taking investments from the Big Pharma world for the Duke institute. Democratic Sens. Elizabeth Warren and Bernie Sanders both were skeptical at the time.
In his one-year stint at the top, Califf called for increased actions on opioids. The agency's criminal office was examined by the House Energy and Commerce Committee for "management concerns" and "possible morale concerns with the field offices" during his tenure, as well.
Many names have been thrown into the speculation hat throughout Biden’s first year. Take Aaron Kesselheim, M.D., for one, but the Harvard Medical School professor resigned from the FDA’s advisory committee over its approval of Alzheimer’s disease drug Aduhelm. Former Merck CEO Ken Frazier is another. And Califf isn’t the only former FDA commissioner to be considered: Scott Gottlieb, M.D., has been mentioned as well.