Federal Health Minister Leona Aglukkaq has written her provincial and territorial counterparts to say Health Canada will not block the approval of generic forms of OxyContin.
However, new licensing rules imposed by her department are an attempt to prevent abuse of the powerful painkiller. Manufacturers and/or distributors of the drug will have to report spikes in sales and changes in distribution patterns, in addition to Health Canada's current requirements to report loss and theft.
Aglukkaq says she will not interfere with Health Canada's scientific review process for the drug.
"It should not be up to politicians to determine which drugs should be approved for medical use," she wrote. "While intentions may be noble in this instance, what stops future politicians from caving in to public pressure and allowing unproven, unsafe drugs on the market once political pressure starts to mount?
"A drug approval process based on politics is a recipe for disaster," she wrote.
Aglukkaq notes that there is no basis in the Food and Drug Act to withhold approval when a drug is considered safe for its recommended use. "The law does not permit approval to be withheld on the basis of misuse," she wrote.
Earlier this fall, provincial and territorial health ministers called on Health Canada to delay approvals for generic versions of OxyContin.
"Banning a generic version of one drug would do very little to solve the actual problem," Aglukkaq wrote.
New rules include enhanced reporting
A Health Canada news release Monday emphasized the new rules and conditions that will apply to future generic versions of OxyContin.
"The issue of prescription drug abuse is bigger than one specific pill, and I want to make sure that legitimate patients have access to drugs that Health Canada scientists determine are safe and effective when used as directed," the health minister says in the release.
In addition to imposing new reporting requirements on drug companies to track when sales spike or distribution patterns change, Health Canada says that when evidence of abuse is uncovered through its investigations, action can be taken, including the revocation of the company's licence to make the drug.
The police also could be called in, if warranted.
Aglukkaq called on the provinces and territories to bring forward any evidence they have of abuse of the drug, so that if warranted, Health Canada can use its powers to remove the ability of doctors, pharmacists and other health-care practitioners to provide the drug. The federal minister asked each province and territory to talk to its medical associations about their role in guarding against prescription drug abuse.
The minister's letter also left the door open to further federal intervention, should provincial and territorial actions be insufficient in an area like prescription and dispensing practices for potentially addictive drugs.
Decision due before next week
Aglukkaq was facing a Nov. 25 deadline to decide whether or not generic drug manufacturers should be allowed to produce copies of the opiate oxycodone. The patent on the original drug is set to expire, and several companies have indicated their interest in making their own generic versions.
Purdue Pharma, the company that made the original drug, pulled OxyContin in March over concerns that it was being abused by drug users who altered it to make it more potent. The company replaced the drug with a new formulation called OxyNeo.
The new drug, while not tamper proof, is more difficult for addicts to alter in search of a euphoric high.
Aglukkaq's letter acknowledges both sides of the controversy over OxyContin: the patients and doctors she says have made "heartfelt pleas" about its positive impact in treating chronic pain, but also the "heartbreaking stories of abuse and addiction" from individuals and families when it's misused.
Her letter called this a "defining moment for us as health ministers."
Aglukkaq letter on OxyContin (PDF)
Aglukkaq letter on OxyContin (Text)
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