OTTAWA – The federal government is refusing to interfere in the drug approval process to halt the highly addictive generic form of OxyContin, saying the provinces have the wherewithal to do a lot more.
Health Minister Leona Aglukkaq wrote her provincial counterparts on Monday to reject their plea to delay or deny approval of the knock-off opioid painkiller – a move that immediately provoked an outcry from Ontario, as well as some health experts.
Federal laws don’t allow regulators to simply ban a drug just because some people abuse the medication, Aglukkaq told a news conference.
“The law does not permit approval to be withheld on the basis of misuse,” she said, asking the public to also consider the needs of patients with chronic pain.
Her refusal to get involved in the process opens the door for generic oxycodone to win approval in Canada after the patent for the brand-name OxyContin expires on Nov. 25.
That’s despite a unanimous request from provincial health ministers to at least delay approval until regulators can examine how oxycodone is abused, and repeated demands from Ontario to completely ban the drug.
“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.
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.
Small communities and First Nations in particular have been wrestling for the past few years with widespread addictions related to oxy, which is trafficked on a secondary market. In some northern Ontario reserves, 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.”
Last year, the drug’s producer, Purdue Pharma, replaced OxyContin with a different version called OxyNeo, which some say is harder to crush and snort or inject.
Ottawa should not allow the easily-abused format back in, Matthews said.
“National problems require a national solution. Provincial and territorial health ministers unanimously asked for federal help, but have once again been told that it’s a provincial problem.”
Matthews had asked that federal regulators take into account broader public health and safety issues as they decide whether to approve the generic painkiller.
But the provinces already have several ways to prevent oxycodone and other opiates from being abused, Aglukkaq said.
Provinces have jurisdiction over doctors, pharmacists and the prescription system, she said. And if provincial authorities bring forward proof that doctors and pharmacists are enabling abuse, Health Canada can take action under the Controlled Drugs and Substances Act, she added.
In her letter and remarks, Aglukkaq zeroed in on claims from Matthews that “streets would be flooded” with the generic form of the drug if it is approved.
“With respect, that could only occur if the provinces and territories, and the medical professions they regulate, let it happen,” she said.
Plus, banning just one 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.”
Federal opposition critics accused the minister of abandoning responsibility for prescription drug abuse.
“It’s a serious epidemic (in some First Nations). Why will she not listen to the health ministers of this country?” said Liberal aboriginal affairs critic Carolyn Bennett. “She needs to figure out a way.”
Indeed, 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, then Aglukkaq says she would be open to new regulations to further restrict prescribing and dispensing of the drug.
Ottawa could set up a regime that could place extra controls on who can prescribe or dispense potentially addictive drugs. It already has a similar arrangement for methadone.
David Juurlink, the head of clinical pharmacology at the University of Toronto, said he’d like to see federal action as soon as possible. If Ottawa sees legal barriers to banning oxy, it should at least consider changing the law, Juurlink said.
Plus, he sees a need to “de-educate” doctors across the country so that they realize that the “commonplace” practice of prescribing high doses of oxycodone over a long period of time is fraught with risk.
There are other ways to deal with pain, he said. And while there may well be 100 other products that contain opioids, OxyContin is among the easiest to abuse.
“It’s actually very dangerous.”