Generic controlled-release oxycodone

We wish to respond to Miller’s article in CMAJ.1 The US Food and Drug Administration (FDA) approved abuse-deterrent labelling for reformulated OxyContin in the United States. The new labelling indicates that the product has physical and chemical properties that are expected to make abuse via injection difficult and to reduce abuse via the intranasal route (snorting). In addition, the FDA determined that the original OxyContin was withdrawn from sale for reasons of safety or effectiveness and, accordingly, the agency will not accept or approve any abbreviated new drug applications (generics) that rely upon the approval of the original OxyContin.2

All available postmarketing assessments of the impact of reformulated OxyContin (OxyNEO in Canada) on abuse, as well as the FDA’s draft Guidance for Industry: Abuse-Deterrent Opioids — Evaluation and Labeling,3 were available to former federal health minister Leona Aglukkaq.

We are not in the market for a revival of the “cross-border controlled-release oxycodone shopping” that was observed near the Detroit–Windsor Tunnel between August 2010 and October 2011, at a time when the original OxyContin remained available in Canada and the reformulated OxyContin had been introduced in the US.4

The FDA has now provided the evidence-based guidance former minister Aglukkaq alluded to in her March 2013 letter to the Commissioner of the FDA. The health minister now needs to protect the health and safety of all our communities and take concrete action to reduce risk by removing generic controlled-release oxycodone from the Canadian market.