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Statement on the authorization of generic OxyContin

2012-176
November 26, 2012

Under the Food and Drugs Act, a drug is authorized based on a demonstration of safety and effectiveness for its recommended use.

As a controlled substance, controlled release oxycodone was already subject to the tightest controls imposed by the Controlled Drugs and Substances Act (CDSA). On November 19, 2012, the Minister of Health announced even tougher new licencing conditions under the CDSA for dealers who manufacture and distribute products that contain the controlled release formulation of oxycodone to address the risk of diversion of these types of products. For example, dealers will be required to report spikes in sales and changes in distribution patterns, in addition to Health Canada's current requirements to report loss and theft.

The Minister also announced that any losses or theft of controlled release oxycodone must be reported to law enforcement authorities like the RCMP, and not just Health Canada.

Following the expiry of the patent held by Purdue Pharma for controlled release oxycodone (brandname: OxyContin), the first generic versions of these products for the Canadian market were authorized today by Health Canada. This decision was made based on a scientific review of evidence that determined these products demonstrate "bioequivalence" to OxyContin (meaning they will behave the same way in the body), which is considered safe and effective under the recommended conditions of use.

  1. Guidelines to the New Licence Conditions Regarding Controlled Release Formulations of Oxycodone Products

For all drug authorizations, the benefits of the medications must outweigh the risks for the intended patient group. These are generic products and Health Canada scientific reviewers had to be satisfied that each company's product was demonstrated to be bioequivalent to OxyContin, which is considered safe and effective under the recommended conditions of use. Generics can be expected to have the same pain relief effect as the name-brand original.

Further information about Health Canada's authorization decision is available here:

  1. Next link will take you to another Web site Notice of Compliance database (authorized drug listing)
  2. Email to request a copy of the Product Monographs

Opioid products containing oxycodone, including in controlled release formulation, have been on the market for many years, and their effectiveness in the group for which it is intended - patients with chronic or ongoing moderate to severe pain - has been well established. The labeling information for opioids makes the proper use of these products, and the associated risks, clear for physicians and patients. This includes the potential for abuse or dependence. As part of the regulatory process for licensing generic controlled release oxycodone products, Health Canada has asked manufacturers to submit risk management plans that outline their proposed strategies to monitor, respond to, and educate healthcare professionals and the public on known and potential risks. This will provide another mechanism to work towards the safe use of these medications.

The Minister in her November 19 announcement also strongly encouraged provinces and territories to use the tools at their disposal to fight prescription drug abuse, which include establishing training requirements, setting scopes of practice for physicians and other practitioners, and monitoring prescription practices. Similar controls, including a prescription monitoring program, have been applied by Health Canada in recent years to the Non-Insured Health Benefits program for First Nations and Inuit, which is administered by the federal government.

The actions under the CDSA took into consideration the issues raised recently by a number of stakeholders. Our responses to their concerns are available here:

  1. Letter to provincial and territorial Health Ministers regarding generic OxyContin
  2. News Release

Health Canada has also recently published the Notice of Decision for OxyNEO, the controlled release oxycodone product authorized in August of 2011. This ND explains that OxyNEO was approved on the basis of its similarity to OxyContin but not for differences in format to deter tampering. The Product Monograph for OxyNEO currently contains no claims that it is tamper-resistant, tamper-proof or harder to abuse than any other controlled release oxycodone product and states that there is no evidence that OxyNEO has a reduced abuse liability compared to other controlled release oxycodone formulations. There is no scientific evidence to date that would allow OxyNEO to claim that it is "tamper-resistant".

Notice of Decision on OxyNEO

As well, Health Canada convened a Scientific Advisory Panel on Opioid Analgesic Abuse (SAP-OAA) to act as a forum of input and a sounding board for management and scientists. Issues related to tamper resistance were considered at their meeting on March 29, 2011:

  1. Record of Proceedings of Health Canada's Scientific Advisory Panel on Opioid Analgesic Abuse

Further details on regulatory requirements and risk management are available here:

  1. It's Your Health on Opioid Pain Medications
  2. Next link will take you to another Web site Controlled Drugs and Substances Act

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