Massachusetts Democratic Sen. Edward Markey said on Monday he has placed a hold on the confirmation of Dr. Robert Califf, President Barack Obama’s nominee to head the Federal Drug Administration, until the agency agrees to overhaul its process for approving opioid painkillers.
Markey, who has made the issue of opioid addiction one of his legislative priorities, said he wants an FDA advisory committee to be in charge of reviewing future opioid approvals. He also asked the agency to rescind its approval of OxyContin for children.
“While people in every community across the country are dying every day from opioid overdoses, the FDA continues to operate as if safety just means the right dose, when it should include all the dangers of these painkillers,” he said in a statement. “Expert after expert has warned about the real world dangers of abuse of and dependence on these new supercharged opioid painkillers, but the FDA has willfully blinded itself to the warning signs.”
By Senate rules, Markey’s “hold” on the nomination can prevent the Senate from taking a confirmation vote for the time being.
“The FDA needs to commit to shift the way it approaches and evaluates addiction before I can support Dr. Califf’s nomination. Until it does, we will continue to see this tsunami of opioid overdoses engulf family after family,” he said.
Califf, a prominent Duke University cardiologist and drug trial researcher, was approved by a Senate panel earlier this month. Since his nomination last September, he has come under fire for his close ties to pharmaceutical companies, since he would be in the position of making multimillion-dollar decisions affecting his former clients.
Tragically, we have become the United States of Oxy. We are 5 percent of the world’s population but consume 80 percent of the world’s supply of oxycodone. We need to stop the over-prescription of pain medication that is fueling this crisis. Sen. Edward Markey, D-Mass.
The position has been vacant since Dr. Margaret Hamburg stepped down in February last year, and Califf is expected to ultimately be confirmed. The process has been under competing pressures to push through his confirmation and stop stalling the FDA’s work, and to allow lawmakers to voice concerns about his ties to drug companies and the direction of the agency.
Markey is not alone. Sen. Elizabeth Warren, D-Mass., and Vermont independent Sen. Bernie Sanders have also expressed doubts about Califf’s nomination.
Sanders voted against his confirmation earlier this month and said he was considering holding up Califf’s nomination.
Alaska Republican Sen. Lisa Murkowski has also said she might block Califf’s path to a full Senate vote over a clash about labeling genetically modified salmon. She said she was angry that the FDA had issued guidelines calling for voluntary, not mandatory, labeling of genetically modified foods after Califf promised to listen to her concerns.