The Senate on Wednesday confirmed Dr. Robert Califf as FDA commissioner by an 89-4 vote. Senators Bill Nelson and Rob Portman voted for Califf, in a reverse of their vote against Califf in a procedural vote on Monday. BioPharma Dive has updated coverage here.
UPDATE: It's likely that the final vote on Califf's nomination will occur on Tuesday, and barring a surprising turn of events, he is likely to be easily confirmed.
Senate Majority Leader Mitch McConnell tweeted out his support of Califf's confirmation while simultaneously addressing critics who cited the opioid crisis as their reason for opposing him.
This post will be updated once the final confirmation vote takes place.
- The Senate on Monday voted 80-6 in favor of advancing Dr. Robert Califf's nomination for FDA Commissioner to a final vote. A procedural cloture vote was needed to override the legislative holds placed on Califf's nomination by three Democratic senators.
- Senators Edward Markey (D-MA) and Joe Manchin (D-WV) vocally opposed Califf's nomination, citing their concerns over the FDA's handling of the growing opioid overdose crisis and Califf's ties with the pharmaceutical industry. Manchin specifically cited the FDA's much-debated label expansion for OxyContin to some children, as well as the agency's controversial approval of Zogenix's painkiller Zohydro in 2014.
- Both senators, along with Democratic presidential candidate Sen. Bernie Sanders (I-VT), had continued their attempts to block a vote even after the FDA announced an overhaul of its opioid approval process.
- With this successful cloture vote, further debate on Califf's nomination will be limited to 30 hours, likely setting up a potential final vote on Tuesday.
Although the procedural vote on Monday passed easily, Califf's nomination has sparked notable opposition from a number of senators. At one point, five senators were attempting to block his nomination through a legislative "hold," a procedural tool requiring an initial vote to force an end to debate. Criticism centered on Califf's ties to the pharmaceutical industry, and growing concern over the FDA's role in approving addictive painkillers in the midst of a burgeoning opioid overdose epidemic in America.
Six senators voted against advancing the nomination: Manchin, Markey, Richard Blumenthal (D-CT), Kelly Ayotte (R-NH), Bill Nelson (D-FL), and Rob Portman (R-OH).
Sens. Markey and Manchin held an impassioned press conference Monday afternoon to press both Congress and President Barack Obama to more seriously consider the toll opioid addiction has taken throughout the country. Although they conceded Califf would likely win the nomination, both senators called for a new culture at the FDA and substantial changes in its approach to approving opioid painkillers.
Calling the FDA "grossly out of touch," Manchin said legal prescription drug abuse has become one of the top killers in West Virginia due, in part, to previous drug approvals by the FDA. "The Commissioner must be someone willing to lead in another direction. If Dr. Califf is confirmed, I do not feel confident that this change will happen," Manchin said.
He also called for President Obama to personally step in and rescind Califf's nomination. "I believe that this nomination is staff-driven, not President-driven. I think the President should step in and say we should rethink this....Give us someone who has the passion to change the culture at the FDA."
Markey and Manchin indicated this is just the beginning of their advocacy on the issue, pointing toward the future appropriations and legislative process.
At the beginning of February, the FDA announced a major overhaul to how it will handle opioid approvals. Among other reforms, the FDA will now convene advisory committees before approving any new drug applications for opioid painkillers which do not have abuse-deterrent properties. However, this did not go far enough for Markey and Manchin, who argued advisory committees should be held before any approval process.
The FDA also will change immediate-release opioid labeling to bring warnings for those products in line with the labeling for long-acting painkillers. "We are determined to help defeat this epidemic through a science-based and continuously evolving approach," Califf said in a statement at the time (in his capacity as a deputy commissioner).
Since 2000, the rate of drug overdose deaths involving opioids has increased by 200%. In 2014, 28,647 people died in the U.S. from opioid-related drug overdoses (including heroin). According to the CDC, this increase has been driven by a steady 15-year increase in overdose deaths from prescription opioid pain relievers, along with a "surge" in illicit opioid deaths.
In Markey's home state of Massachusetts, the number of drug overdose deaths increase by 18.8% from 2013 to 2014, a statistically significant increase. "We are now approaching losing a Vietnam Wall's worth of people every single year in our country," Markey said.