Letter says no basis to withhold approval, but new licensing rules will apply
Health Canada is adding new licensing rules to 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 the department’s current requirements to report loss and theft.
“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?"
"It's a recipe for disaster for politicians to get involved in approving drugs," the minister told reporters at a press conference in Ottawa on Monday morning. "If we start with OxyContin, what's next?"
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 based on its scientific review. "The law does not permit approval to be withheld on the basis of misuse," she wrote.
Health Minister Leona Aglukkaq rejected a plea from Canada’s provinces, which unanimously requested a delay of approval until regulators could examine the abuse of oxycodone. Ontario asked for a complete ban on the drug, which has caused widespread addictions in Canada’s rural and tribal communities.
Her refusal to get involved in the process opens the way for generic oxycodone to win approval in Canada after the patent for the brand-name OxyContin expires on Nov. 25.
“I am profoundly disappointed in minister Aglukkaq’s decision to ignore the threat to public safety posed by generic OxyContin and to allow it to enter the Canadian market,” Ontario Health Minister Deb Matthews said in a statement.
Matthews had warned that the “streets would be flooded” with the generic form of the drug if it is approved.
Anyway, I'm not sure prohibition is the right answer in this case, or any case. But I'm not sure the government should approve the generic drug without planning for its harm to public safety. A middle position is probably best.
For more on Leona Aglukkaq, see Aglukkaq Blames Activists for Food Insecurity and Inuk Minister Cuts Aboriginal Services.