Biden settles on ex-FDA official Califf to again lead regulatory agency
WASHINGTON — President Joe Biden on Friday chose Dr. Robert Califf, a former Food and Drug Administration commissioner and prominent medical researcher, 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 decided on Califf.
A cardiologist and clinical trial specialist, Califf, 70, ws FDA commissioner for the last 11 months of President Barack Obama’s second term. Califf faced some concerns over his drug industry connections in 2016, but he was ultimately confirmed by an overwhelming 89-4 Senate vote.
Since leaving government, he has worked as a policy adviser to tech giant Google, in addition to his ongoing work as a researcher at Duke University, where he helped design studies for many of the world’s biggest drugmakers.
“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.
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.
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.
“We feel he’s a qualified person who has the exact experience for this moment,” press secretary Jen Psaki said Friday.
The powerful pharmaceutical and medical device lobbying groups issued strong statements of support Friday, as did a number of physician and patient groups.
Califf has worked as a consultant for major drugmakers including Eli Lilly and Merck & Co., and he sits on the board of two smaller biotech companies.
Federal ethics rules do not require government officials to sell all their investments, but they must recuse themselves from matters that could affect those investments.
FDA watchers said Califf had several key advantages over other candidates vetted for the job, several of whom would have faced more scrutiny in the Senate.
His first tasks would include easing burnout and boosting morale among the FDA’s 18,000 employees.