Chattanooga Times Free Press

Biden picks ex-FDA chief to again lead agency

- BY MATTHEW PERRONE AND ZEKE MILLER

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 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, 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 researcher at Duke University, where he helped design studies for many of the world’s biggest drugmakers.

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 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 30-plus years at the agency.

The White House faced a legal deadline of mid-November to nominate a permanent commission­er or name another acting commission­er.

 ?? AP PHOTO/ANDREW HARNIK ?? Dr. Robert Califf speaks at a news conference in Washington on May 5, 2016. President Joe Biden chose Califf on Friday to again lead the Food and Drug Administra­tion.
AP PHOTO/ANDREW HARNIK Dr. Robert Califf speaks at a news conference in Washington on May 5, 2016. President Joe Biden chose Califf on Friday to again lead the Food and Drug Administra­tion.

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