OxyContin Generic Approval Proceeds in Canada
OTTAWA - Canada's federal government allowed the approval process to proceed Monday for the generic form of the highly-addictive painkiller OxyContin, a move that set off a quick outcry from the country's provinces and aboriginal communities.
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.
Aglukkaq rejected those warnings. She told a news conference that federal laws don't allow regulators to ban a drug just because some people abuse it, and said the provinces already have several ways to prevent oxycodone and other opiates from being abused. If provincial authorities have proof that doctors and pharmacists are enabling abuse, the federal government will take action, she added.
While national figures are hard to come by, Matthews said OxyContin has led to a five-fold increase in oxycodone-related deaths. She said the social costs of allowing generic oxycodone would be about $500 million a year in Ontario alone.
OxyContin is trafficked on the black market across rural Canada. In some northern Ontario tribal reservations, more than half the adult population is addicted to prescription drugs.
Alvin Fiddler, deputy grand chief of the Nishnawbe Aski Nation, called the decision another unwelcome blow to aboriginal communities that are already suffering.
"With OxyContin clones on the market, it just means more drugs flow to the north," said Fiddler, whose group represents some 49 First Nation communities in northern Ontario.
"While we appreciate the minister's distinction between science and politics, NAN First Nations are experiencing extreme levels of addiction and require extreme solutions."
Aglukkaq, the federal health minister, said banning a single drug won't solve the problem of prescription drug abuse, she warned.
"Banning a generic version of one drug would do little to solve the actual problem," Aglukkaq said her letter. "There are almost 100 authorized drugs in Canada that are in the very same class of drugs as OxyContin.
"Banning all these drugs because they have the potential to be addictive would help dry up the drug supply for addicts, but would lead to pain and suffering for patients who desperately need them."
Opposition Liberals accused the minister of abandoning her responsibility to prevent prescription drug abuse.
"It's a serious epidemic," said Liberal aboriginal affairs critic Carolyn Bennett. "Why will she not listen to the health ministers of this country?"
Aglukkaq says Ottawa will tighten licensing rules so that distributors of oxycodone have to keep better track of where the drug goes. Starting in 2013, they will need to report spikes in sales and changes in distribution patterns, in addition to previous responsibilities to report losses and theft.
And if the provinces eventually find that they still can't sufficiently control oxycodone, Aglukkaq says she would be open to new regulations to further restrict prescribing and dispensing of the drug.
David Juurlink, the head of clinical pharmacology at the University of Toronto, said he'd like to see federal action on the drug as soon as possible. If Ottawa sees legal barriers to banning oxy, it should at least consider changing the law, he said.
Canada's doctors should be warned against prescribing high doses of oxycodone over a long period of time, Juurlink said, because OxyContin is among the easiest medications to abuse and is "actually very dangerous."