Minister won't interfere with generic OxyContin approval
Letter says no basis to withhold approval, but new licensing rules will apply
Posted: Nov 19, 2012 10:28 AM ET
Last Updated: Nov 19, 2012 7:03 PM ET
Federal Health Minister Leona Aglukkaq has written her provincial and territorial counterparts to say she won't interfere in the regulatory approval process for a generic form of OxyContin.
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.
"We need to make the decisions on prescription drugs based on science," she told the media. "Scientists are there to provide that advice to us and we need to work with the system that we have in place."
"The prescription drug abuse problem across the country is much broader than this one product," Aglukkaq said.
Provinces wanted intervention
Earlier this fall, provincial and territorial health ministers called on Health Canada to delay approvals for generic versions of OxyContin.
Ontario Health Minister Deb Matthews wrote Aglukkaq last July asking her to use her ministerial authority to reject generic oxycodone, fearing even more abuse if a lower-cost form of the highly addictive drug became readily available.
"The claims that she's making, there are no basis for that," Aglukkaq told reporters. "We can do other things ... to mitigate the issue."
“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," Matthews said in a Monday afternoon statement. "National problems require a national solution.
"If the Government of Canada had truly wanted to do what was in the best interests of all Canadians, it could have stopped these drugs from being readily available," the Ontario health minister said. "The social costs of allowing generic OxyContin have been estimated at $500 million a year."
New rules include enhanced reporting
New rules and conditions will apply to future generic versions of OxyContin, Health Canada says, and more federal intervention is possible to help control the drug.
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 notified, if warranted. "The missing piece here is enforcement officers," Aglukkaq told reporters.
She 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.
She also said her department was sharing with provinces and territories examples of the anti-abuse measures it's taking for the health benefits programs under federal jurisdiction, such as tracking the number of actual prescriptions for the painkiller in places where abuse is rampant to help identify fraudulent dealers.
The minister's letter also left the door open to further federal intervention, should provincial and territorial actions be found insufficient to control prescription and dispensing practices for potentially addictive drugs.
Patent expires next week
The patent on the original drug is set to expire on Nov. 25. Several companies have indicated their interest in making their own generic versions of OxyContin.
A generic drug would require a scientific review by Health Canada before approval.The patent for OxyContin expires Nov. 25, raising the possibility of cheaper generic versions. (Canadian Press)
"We'll wait for that decision to come through," Aglukkaq said Monday, distancing herself from that process.
"It is [Aglukkaq's] call in terms of a licence," said Liberal MP Carolyn Bennett, who is also a medical doctor and thinks a generic form of the drug would be a bad idea. "She can delay [the approval.]
"They've not fixed the problem and now they're going to make it worse," Bennett said, adding Northern Ontario reserves she's visited are battling addiction rates as high as 80 per cent.
"The health minister is three years too late in terms of addressing anything with Oxy," said Northern Ontario NDP MP Charlie Angus. "The real threat is the lack of monitoring, the lack of resources.
"We're not seeing anything new here," he says, in terms of the impact on reserves in his riding.
"It doesn't matter whether we're talking about real oxy or generic Oxy," Angus said. "They've completely left the [First Nations] communities high and dry. They're on their own."
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."with files from Julie Van Dusen
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