By Karla L. Palmer -
The National Association of Attorneys General (“NAAG”) today sent a letter to the U.S. Food and Drug Administration’s Margaret Hamburg urging the Agency to adopt standards requiring manufacturers and marketers of generic prescription opioids to develop tamper-resistant versions of such products. Signed by 48 state and territorial Attorneys Generals, the letter applauds FDA for “expeditiously proposing guidelines establishing clear standards for manufacturers who develop and market tamper- and abuse-resistant opioid products while considering incentives for undertaking the research and development necessary to bring such products to market.” (See our previous post on FDA's draft guidance on abuse-deterrent opioids.) It also encourages FDA to assure that generic versions of “such products are designed with similar [tamper-resistant] features.”
The letter warns that nonmedical users of opioid products are now shifting away from the new tamper-resistant formulations as well as to illegal drugs. It notes that there is “great concern” in the law enforcement community that many non-tamper-resistant generic products are available for abuse when only a few products have been formulated with tamper-resistant features. The Attorneys General referred specifically to a concern with the possibility that generic versions of extended-release opioid prescription drugs and other non-tamper-resistant products may reach the market.
The press release announcing the Attorneys General letter states that prescription drug abuse is a significant danger that is reaching “epidemic levels in many states. It specifically notes that “[o]pioids relieve pain and codeine, hydrocodone (e.g., Vicodin) and oxycodone (e.g., OxyContin, Percocet) fall into this medication class.”
In recent months, FDA has denied without comment several citizen petitions concerning generic versions of drug products approved with formulations intended to be abuse-deterrent. FDA's denial of one such petition concerning OxyContin has prompted a petition for reconsideration. In another case concerning oxymorphone (Opana), FDA is scheduled to rule in May on a petition concerning whether a non-abuse-deterrent formulation of the drug was removed from the market for reasons of safety or effectiveness.