Obama's FDA chief nominee rolls toward confirmation after Senate vote

FDA's Robert Califf

Robert Califf, President Barack Obama's pick to lead the FDA, cleared a procedural Senate vote on the way to a final confirmation hearing, likely to take place this week.

The Senate voted 80-6 on Monday to make Califf's confirmation filibuster-proof, counteracting a group of senators who promised to block his nomination. With the move, Califf's final approval could be up for a vote as soon as Tuesday.

The move came over objections from a group of senators, including Edward Markey and Joe Manchin, who criticized the FDA for its handling of opioid pain drugs, and Democratic presidential candidate Bernie Sanders, who took issue with Califf's ties to the pharma industry.

Califf has walked the line between academia and industry throughout his career, serving as the founding director of the Duke Clinical Research Institute, an university-owned CRO that employs more than 1,000 people and has an annual budget of more than $100 million, according to the school. That role put Califf in business with all of the world's largest drugmakers, handling studies on behalf of pharma and suggesting a coziness with the industry that has alarmed senators including Sanders and Republican Lisa Murkowski.

Califf, who is currently deputy FDA commissioner for medical products and tobacco, has moved to address senators' concerns about how the agency regulates opioids, this month putting out an 8-point plan that calls for re-examining how the FDA regulates painkillers. Califf is calling for the agency to re-examine how it weighs risks versus benefits for oft-abused drugs, bringing in outside experts to shed light on the possible dangers of approving increasingly powerful analgesics.

Senate Majority Leader Mitch McConnell, a Kentucky Republican, came out in support of Califf's plan after a meeting in which the nominee "acknowledged that a cultural shift will be needed within the FDA if the potential for addiction and abuse of prescription opioids is to be taken more seriously," McConnell said in a statement.

"I believe Dr. Califf understands the dire nature of the opioid epidemic and, accordingly, I believe he is today the right person to lead the FDA in a new direction," McConnell said.

Califf, a cardiologist by training, has been up for the top job at the FDA since 2014, when ex-director Margaret Hamburg named him deputy. Obama made his nomination official in September.

- read the vote tally
- here's McConnel's statement