In a highly unusual move for a federal agency, the U.S. Drug Enforcement Agency has publicly urged the Food and Drug Administration to change the labeling requirements for opioid painkillers.
In a March 20 letter to the FDA, the DEA expressed support for a citizen petition filed last summer by Physicians for Responsible Opioid Prescribing (PROP), which calls for major changes in the way opioids are prescribed to help end a wave of prescription drug abuse and deaths.
“The DEA is concerned about the potential public health risks resulting from the abuse of opioid drug products. Additional regulatory measures are necessary for opioid formulations to adequately safeguard the American public,” wrote Joseph Rannazzisi, deputy assistant administrator of the DEA’s Office of Diversion Control.
Typically, interagency letters of this magnitude would be addressed to FDA commissioner Margaret Hamburg. Rannazzisi’s letter was addressed to “Whom It May Concern” at the FDA’s Dockets Management Branch.
Rannazzisi’s letter expressed concern about continuing reports of opioid diversion, drug-related emergency room admissions, and the slow pace of FDA action to address prescription drug abuse.
“DEA previously requested FDA to consider additional regulatory measures such as restrictions on prescribing, marketing practices and clinical indications for these opioid products,” Rannazzisi wrote. “The DEA hopes that FDA will implement suitable measures, such as labeling revisions, to help mitigate the adverse impact on the public health resulting from abuse of these products.”
The FDA currently approves most opioid analgesics for “moderate to severe pain.” The PROP petition would eliminate the word “moderate” and would restrict opioid prescriptions to no more than 90 days for non-cancer pain. Doctors would still be able to prescribe opioids “off-label” after 90 days, although critics contend many physicians would be unwilling to do that.
“It’s unusual for a federal agency to weigh in supporting an advocacy group’s citizens petition. Typically federal agencies advocate with each other behind the scenes, not publicly, so I think it’s highly significant,” PROP co-founder Dr. Andrew Kolodny told National Pain Report.
“And I think it suggests there is tremendous frustration with FDA’s repeated failures on this issue, frustration at DEA and elsewhere in government and among the public. I think that’s why you’re seeing this. I was very pleasantly surprised.”
The FDA is also coming under pressure from Congress to take stronger measures against prescription drug abuse. Two recent bills introduced on Capitol Hill would make it harder to obtain Vicodin and other hydrocodone painkillers, and would require generic opioid painkillers coming on the market to have tamper resistant features.
“You’ve got Congress and DEA both reacting to the same problem which is that you’ve got an epidemic getting worse and you’ve got the Food and Drug Administration failing to properly enforce existing laws,” Kolodny said.