PharmExec Blog

Safety Trumps Access to Pain Meds for FDA

By Jill Wechsler, Washington Correspondent.

The Food and Drug Administration has come down on the side of reducing abuse of opoid medications, over encouraging wider availability of low-cost painkiller meds. The agency decided to block generic versions of the original OxyContin formulation, which is fairly easy to manipulate by illegal users. The aim is to help halt the epidemic of prescription drug abuse raging across the country. FDA’s decision leaves the market open to Purdue Pharma’s newer version of the drug, which the agency determined has features that make it more difficult to abuse via injection or snorting.

Purdue had stopped shipping original OxyContin in 2010 when FDA approved its reformulated, safer product, and had waged a campaign to prevent generic versions of its original product, whose patent expired April 16, 2013. After much deliberation, FDA agreed with Purdue and declared on the same day that it would “not accept or approve any generic forms of the original OxyContin ER,” according to Douglas Throckmorton, deputy director of the Center for Drug Evaluation and Research. FDA also updated the labeling of “new” OxyContin to support its abuse deterrent features.

Generic drug makers and some physicians had argued that patients need access to less costly pain treatments. But the prospect of cheap, easily abused generic painkillers flooding the market aroused strong opposition from state and federal officials struggling to control illegal prescription-drug use. FDA may approve other oxycodone extended release products with abuse-resistant features, but Purdue’s new product has a patent until 2025.

FDA has asked Purdue to conduct postmarketing studies of reformulated OxyContin to evaluate further its impact on abuse. Meanwhile, the agency is working to finalize draft guidance issued in January that maps out approaches for manufacturers to develop drugs with abuse-deterrent characteristics. A number of generics firms were poised to launch new versions of old Oxy, eager to gain a bigger share of the $10 billion U.S. painkiller market. Some are likely to challenge FDA’s decisions and contest patents of the newer painkillers.

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