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.
On Monday, the Senate voted overwhelmingly in favor of advancing Dr. Robert Califf's nomination for FDA Commissioner to a final vote, likely to take place later today. However, six senators voted against moving the nomination forward: Kelly Ayotte (R-NH), Richard Blumenthal (D-CT), Joe Manchin (D-WV), Ed Markey (D-MA), Bill Nelson (D-FL), and Rob Portman (R-OH).
Despite Califf's pedigreed background at Duke University and as deputy commissioner at the FDA, the senators expressed concern over the FDA's—and by extension Califf's—role in the growing level of opioid addiction and overdose in the U.S.
Califf has also been criticized, most notably by Senator Sanders, for his long ties to the pharmaceutical industry during his time at Duke University School of Medicine. He oversaw major clinical trials at Duke, including one for Johnson & Johnson's Xarelto, and received substantial remuneration from pharma companies. However, Califf has said he donated all consulting fees to nonprofits.
(Note:Senator Nelson did not get back to BioPharma Dive by press time with a statement on the Senator's position on opioids. The other five have been public in their concern over opioid overdoses)
A growing crisis
Overall, 47,055 Americans died from drug overdose deaths in 2014, exceeding the number killed in car accidents. Sixty-one percent (28,647) of those deaths were due to overdose from opioids, including heroin, according to data from the Centers for Disease Control and Prevention.
The home states of each of the six senators has been hit hard by the crisis, with many of them seeing sharp increases in the number of overdose deaths from 2013 to 2014. Senator Portman's home state of Ohio had 2,744 drug overdose deaths, the second highest total in the U.S. Florida was fourth, and West Virginia tenth.
Smaller states like New Hampshire and Connecticut have smaller death totals but fare worse when looking at age-adjusted rates of death. New Hampshire had the third highest age-adjusted rate at 26.2 deaths per 100,000 people. (West Virginia was first in this category).
From 2013 to 2014, the number of deaths in Massachusetts and Ohio respectively increased by 18.8% and 18.3%, a statistically significant change. New Hampshire saw deaths skyrocket 73.5%, albeit from a lower baseline.
In the chart below from the CDC, states colored a darker red indicate higher age-adjusted rates of drug overdose deaths in 2014. Massachusetts, New Hampshire, Ohio, West Virginia all rank highly.
Before Monday's vote, Sens. Markey and Manchin held an impassioned press conference calling on the FDA to further change its approach to approving opioid painkillers. Manchin specifically cited the FDA's much-debated label expansion for OxyContin to some children last year, as well as the agency's controversial approval of Zogenix's painkiller Zohydro in 2014.
The FDA did announce an overhaul to its approval process in the beginning of February, but that did not go far enough for Markey and Manchin.
Senator Ayotte took to Twitter on Tuesday to push the FDA to prioritize the issue and express her concerns over the agency's reforms plans.
The heroin & prescription opioid abuse epidemic is devastating NH, and the home states of many of my colleagues— Kelly Ayotte (@KellyAyotte) February 23, 2016
Senator Portman also cited his concerns over the FDA's approach in his cloture vote to block Califf's nomination. Portman has sponsored a bill to address the heroin epidemic in Ohio, the Comprehensive Addiction and Recovery Act.
Nearly 500,000 people have died from drug overdoses in the decade and a half from 2000 to 2014, with the highest number of deaths coming in 2014, according to a recent report from the CDC. In that report, the agency cited two concurrent trends. There has been a steady increase in the number of overdose deaths involving prescription opioid painkillers and, more recently, a "surge" in the number of overdose deaths from illicit opioids like heroin and fentanyl.
BioPharma Dive will update this article when the final vote to confirm Robert Califf takes place, likely later in the day on Tuesday.