DEA Endorses Citizen Petition To Limit Approved Uses and Impose Maximum Day and Quantity Limits on Controlled Release Oxycodone-Hydrochloride

By Delia A. Stubbs –

As previously reported, Congress recently introduced the Stop Oxy Abuse Act that would restrict the labeled indications for use of any controlled release drug containing Oxycodone-Hydrochloride (HCl) to “severe-only” versus current labeling of “moderate-to-severe” pain.  The legislation is similar to a recent Citizen Petition filed by the Physicians for Responsible Opioid Prescribing (“PROP”) to FDA.  Id.  The PROP petition (Docket No. FDA-2012-P-0818), in addition to requesting that FDA restrict those drugs’ approved uses to “severe-only” pain, further requests that FDA impose day and quantity limits in their approved labeling.  Id.  Namely, it requests that FDA “add a maximum daily dose equivalent to 100 milligrams of morphine” and “add a maximum duration of 90-days for continuous daily” use.  Id.  Importantly, while the proposed legislation would apply to use by all patients the PROP petition would apply only to non-cancer patients.  Id.

In a rare move, DEA has endorsed the PROP petition.  On March 20, 2013, DEA filed a letter with the Division of Dockets Management at FDA.  See Letter from Joe Rannazzisi, Deputy Assistant Administrator, DEA to FDA (Mar. 20, 2013).  Therein, DEA explained that opioid analgesics have a long history of abuse, which has increased over the past decade, and that the primary source of the drug for abuse purposes is diverted pharmaceuticals.  Id.   DEA explained that it is concerned about the potential public health risks resulting from abuse of opioid drug products” and “additional regulatory measures are necessary for opioid formulations to adequately safeguard the American public.”  Id.  DEA also noted that the agency had “previously requested FDA to consider additional regulatory measures such as restrictions on prescribing, marketing practices, and clinical indications for these opioid products.”  Id. DEA did not provide any specific references to such prior action.  Id.

Of note, although the PROP petition was filed in July 2012, on January 17, 2013, FDA issued an interim response to the petition stating that “FDA has been unable to reach a decision on . . . [the] petition because  . . . [it] raises significant issues requiring extensive review and analysis by Agency officials.”  Therefore, DEA’s comment is likely intended to encourage FDA to take action, given its timing and DEA’s stated concerns about prescription drug abuse.