FDA under more pressure to regulate painkillers

“The DEA has now lent its voice to those of pain and addiction specialists, primary care physicians and public health officials in calling upon the FDA to do its job and properly regulate the safety and efficacy claims that opioid manufacturers are making,” said Dr. Andrew Kolodny, president of the Physicians for Responsible Opioid Prescribing, in a statement.

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Kolodny and other doctors, researchers and public health officials sent a petition to the FDA asking for tougher regulations on the medications, which can be highly addictive. Specifically, the groups asked the agency to only allow the drugs for severe pain in non-cancer patients. Currently, the drug’s label allows it to be prescribed for “moderate to severe” pain. The petitioners also asked to place limits on dosage.

“Drugmakers prefer a non-specific FDA-approved label because it allows them to encourage use of opioids for an indefinite period of time and for a wide range of common problems,” wrote Public Citizen, a public advocacy group, in a statement about the petition. “The proposed label changes would have serious implications for drugmakers because federal law prohibits ‘off-label’ advertising.”

On March 20, DEA echoed that request, telling FDA that it hopes the agency 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 DEA is concerned about the potential public health risks resulting from abuse of opioid drug products. Additional regulatory measures are necessary for opioid formulations to adequately safeguard the American public,” it said, noting the more than 15,000 opioid painkiller overdose-related deaths in 2009.

“It is clear that people who are knowledgeable about the overuse of opioids — including the experts at the DEA — agree that labeling restrictions such as those proposed in our petition are an important way of reducing the misprescribing of these drugs," said Dr. Sidney Wolfe, the director of Public Citizen’s Health Research Group, who was part of the 2012 petition to FDA.