Senator Markey: I Will Continue to Hold Califf Nomination to Head FDA Until Opioid Approval Process Reformed
Medical, public health, law enforcement and other experts have all pointed to increasing overprescription of opioid painkillers as primary driver of epidemic
Washington (February 2, 2016) – Senator Edward J. Markey (D-Mass.) today spoke on the U.S. Senate floor to call for immediate reforms to the Food and Drug Administration’s (FDA) process for approving opioid painkillers before be can consider removing his hold on the Obama administration nominee, Dr. Robert Califf, to head the agency. Last week, Senator Markey placed a hold on Dr. Califf’s nomination, calling on the FDA to commit to three steps: convene advisory committees for any future opioid-approval questions; consider addiction, abuse and dependence as part of its determinations of which opioids are ‘safe’; and rescind the approval of OxyContin for kids and convene an advisory panel to provide direction as it reconsiders that decision.
“A tsunami of opioid addiction is swallowing families as quickly as Big Pharma wants Americans to swallow its pills,”said Senator Markey. “Despite a raging prescription drug and heroin epidemic, the agency responsible for the safety of all prescription drugs in the United States is dismissing expert advice from doctors and other public health professionals by not convening advisory panels or overruling expert panel recommendations. The FDA must commit to shift the way it approaches and evaluates opioid addiction before I can consider supporting Dr. Califf’s nomination.
“We can no longer act like an ostrich, putting our heads in the sand as this crisis is devastating millions of people across the country,” continued Senator Markey. “Fighting this epidemic will be my number one priority in Congress this year, and I call on all of my colleagues to join me in this effort.”
Nationally, the prescription drug and heroin overdose crisis led to 27,000 deaths, including more than 1,300 in Massachusetts, in 2014.