The FDA has been repeatedly criticized for expanding approvals for opioids in the face of an "epidemic" of abuse and overdoses. Today Dr. Robert Califf, President Obama's pick to head the agency, took that matter head-on, calling for a sweeping review of the agency's policies.
Califf, who is FDA's deputy commissioner for medical products and tobacco, set out an 8-point plan that he said would "focus on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief." That includes a re-examination of "the risk-benefit paradigm for opioids" to ensure that the agency considers their wider public health effects. The FDA said it would turn to outside experts for guidance on how to balance the needs for pain management with the perils of drug abuse.
"We are determined to help defeat this epidemic through a science-based and continuously evolving approach," Califf said in a statement. "This plan contains real measures this agency can take to make a difference in the lives of so many people who are struggling under the weight of this terrible crisis."
Lawmakers and public officials working to ward off opioid abuse in their communities have continued to lash out at the agency. The controversy was stirred again last year when the FDA approved Purdue's powerful painkiller, OxyContin, for children ages 11 to 16.
The issue has also been used as a roadblock to approval of Califf as commissioner of the FDA. Just last week, Sen. Edward Markey of Massachusetts put a hold on Califf's confirmation until the agency did some of the things it now says it will do. He said the agency needs to make abuse and dependence issues a factor in which painkillers are deemed "safe" and to automatically convene advisory committees for recommendations on future opioid-related decisions, the Washington Post reported. He also wants the FDA to rescind the approval of the use of OxyContin for children.
Antiaddiction advocates called for the resignation of former FDA Commissioner Margaret Hamburg in 2014 when the FDA approved opioid painkiller Zohydro because it did not include abuse-deterrent technology.