By a narrow vote of 50-46, the Senate has confirmed Robert Califf to run the FDA.
- Califf, who previously served as the FDA commissioner from February 2016 to January 2017, takes over interim chief Janet Woodcock's job.
- He takes over as the agency faces a decision on whether to clear Pfizer Inc (NYSE:PFE)/BioNTech SE's (NASDAQ:BNTX) COVID-19 vaccine for kids ages six months to 4 years.
- He also comes to the FDA, during which it has been the target criticism for its approval of Biogen Inc's (NASDAQ:BIIB) controversial Alzheimer's drug Aduhelm.
- Related: Robert Califf's Speedy Confirmation Vote As FDA Head Likely Delayed: See Why?
- In securing votes to gain the nomination, Califf agreed to review the accelerated approval process, through which Aduhelm was endorsed.
- His nomination by President Joe Biden was opposed by five of Biden's fellow Democrats.
- Vermont Senator Bernie Sanders said Califf's work with pharmaceutical companies made him unfit to regulate the industry impartially. West Virginia Senator Joe Manchin criticized how the agency handled the opioid crisis under Califf's leadership.
- "Dr. Califf was there five years ago. He's coming back. Nothing's changed; 400,000 people have died (from opioids) since he was there," Manchin said before the vote.
