The Federal Health Minister of Canada, Leona Aglukkaq, wrote in an official letter addressed to her provincial and territorial subsidiaries to announce that the department will not be interfering in the regulatory approval process of a generic form of OxyContin.
Health Canada has approved to add a new licensing rule which will attempt to prevent the abuse of powerful painkiller. The manufacturers and/or distributors of the drug are now to specifically account and report the spikes in sales or changes in distribution patterns, along with the department’s current requirements of reporting loss and theft.
Aglukkaq wrote in her letter that “It should not be up to politicians to determine which drugs should be approved for medical use.” It was added that “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?” She stated that “a drug approval process based on politics is a recipe for disaster.”
Aglukkaq pointed out that there is no source in the Food and Drug Act which allows withholding the approval of a drug that is considered safe for its recommended use based on its scientific review. She mentioned that “the law does not permit approval to be withheld on the basis of misuse.” Earlier this fall, the provincial and territorial health ministers requested Health Canada for delaying the approvals of generic versions of OxyContin. Aglukkaq now claims that “banning a generic version of one drug would do very little to solve the actual problem.”
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