³Ô¹Ï²»´òìÈ

The Food and Drug Administration has been without a permanent leader for 10 months in large part because of the Senate confirmation process. Key Democrats have voiced public complaints about nearly every potential agency leader, including longtime agency veteran and acting commissioner Janet Woodcock. Robert Califf isn’t going to have any easier of a time if he gets the nod. (Florko, 10/14)

Dr. Califf, a cardiologist who teaches at the Duke University School of Medicine, served only briefly as F.D.A. commissioner, at the end of President Barack Obama’s second term. He was the agency’s deputy commissioner for medical products and tobacco before leading it from February 2016 to January 2017.He was confirmed by the Senate as commissioner in February 2016 in a vote of 89 to 4, after some lawmakers opposed his nomination over what they said was the agency’s poor record on prescription painkillers. His nomination faced its fiercest pushback from Democrats. (Weiland, 10/14)

Califf previously worked closely with Biden on the Cancer Moonshot initiative launched by the Obama administration. Califf also has a long history with North Carolina, noted Alston & Bird attorney Marc Scheineson, who previously served as FDA associate commissioner for legislative affairs under former FDA Commissioner David Kessler. "Califf should have an inside track for a lot of different reasons," Scheineson said. "Sen. Richard Burr (R-N.C.) can help smooth a confirmation ... to have North Carolina's senator as the ranking member on the committee that confirms him is very important." But consumer advocacy group Public Citizen slammed Califf as a "recycled FDA Commissioner pick" with close ties to the pharmaceutical industry. (Lim, Cancryn and Owermohle, 10/14)

Califf, a cardiologist, had such strong bipartisan support that when President Donald Trump took office in early 2017, many pharmaceutical and medical device industry officials expressed hope he would continue on as the FDA’s leader. Sens. Joe Manchin III, D-W.Va., and Edward J. Markey, D-Mass., both opposed Califf’s confirmation in 2016 and argued that Califf was unlikely to make changes at the agency to reduce access to opioid painkillers. (Cohen and Kopp, 10/14)