Former FDA chief Califf tapped again
WASHINGTON – President Joe Biden on Friday chose Dr. Robert Califf, a former Food and Drug Administration commissioner, to again lead the powerful regulatory agency.
Califf’s nomination comes after months of concern that the agency near the center of the government’s COVID-19 response has lacked a permanent leader. More than a half-dozen names were floated for the job before the White House settled on Califf.
A cardiologist and clinical trial specialist, Califf, 70, served as FDA commissioner for the last 11 months of President Barack Obama’s second term. Before that, he spent one year as the agency’s No. 2 official after more than 35 years as a prominent researcher at Duke University, where he helped design studies for many of the world’s biggest drugmakers.
Since leaving government, he has worked as a policy adviser to tech giant Google, in addition to his ongoing academic work at Duke.
“As the FDA considers many consequential decisions around vaccine approvals and more, it is mission critical that we have a steady, independent hand to guide the FDA,” Biden said in a statement announcing his decision.
If confirmed by the Senate, Califf
would oversee decisions on COVID-19 vaccines along with a raft of other knotty issues, including the regulation of electronic cigarettes and effectiveness standards for prescription drugs. He would be the first FDA commissioner since the 1940s to return for a second stint leading the agency.
“Rob is a relatively safe choice because he is known in Washington and is widely respected,” said Wayne Pines, a former FDA associate commissioner who has helped several commissioners through the confirmation process. “He will have broad support from FDA stakeholders.”
The FDA regulates the vaccines, drugs and tests used to combat COVID-19. That’s on top of its normal duties regulating a swath of consumer goods and medicines, including prescription drugs, medical devices, tobacco products, cosmetics and most foods.
Dr. Janet Woodcock, the agency’s longtime drug director, has been serving as acting commissioner since January. For months she was expected to be tapped for the permanent post, but her nomination ran into pushback from key Democratic lawmakers, including Sen. Joe Manchin of West Virginia, over the handling of opioid prescription painkillers during her 30plus years at the agency.
The White House faced a legal deadline of mid-november to nominate a permanent commissioner or name another acting commissioner.
Califf arrived at the FDA in 2015 determined to modernize how the agency reviewed drug and device study data. But his brief time as commissioner was dominated by unrelated pharmaceutical controversies, including surging opioid addiction and overdoses.
He was among the first FDA officials to publicly acknowledge missteps in the agency’s oversight of painkillers like Oxycontin, which is widely blamed for sparking the ongoing opioid epidemic, now driven by heroin and fentanyl.