Ottawa won't intervene in generic OxyContin decision
Canada’s health minister says she cannot delay or block the approval of generic OxyContin on the premise that some could misuse and become addicted to it.
In a letter to her provincial counterparts, Health Minister Leona Aglukkaq said that there’s nothing in the Food and Drugs Act that indicates she could withhold the approval ofgeneric Oxy if the formula is considered “safe and effective” when taken as recommended.
Her remarks bear significant weight in the debate over whether Health Canada should allow drug companies to manufacture alternative versions of the powerful time-release painkiller.
Last September, Aglukkaq’s provincial counterparts had asked her to intervene and delay the approval of a generic form of OxyContinto allow for more research on the discontinued drug.
Reaffirming a position she’s held throughout the generic Oxy debate, Aglukkaq said politicians should not weigh in on decisions that should be made by medical experts.
“While intentions may be noble in this circumstance, what stops future politicians from caving into public pressure and allowing unproven, unsafe drugs on the market once political pressure starts to mount?,” Aglukkaq said in her letter.
OxyContin was developed by Purdue Pharma Canada to alleviate chronic pain by releasing a dose of oxycodone into the body over several hours. The drug, however, became popular among addicts who crushed the tablets into a fine powder that could be injected or snorted.
The original drug was discontinued early this year and replaced with a drug called OxyNEO.OxyNEO tablets are said to be tougher to crush and extract oxycodone from, but as Aglukkaq notes, the drug cannot bill itself as being “harder to abuse” or “tamper-proof.”
Meanwhile, Purdue Pharma’s patent on the original OxyContin formula expires on Nov. 25.
Ontario Health Minister Deb Matthews was among the provincial health ministers championing calls to block the production of generic forms of OxyContin. In her view, the emergence of an Oxy alternative would be “tragic,” leading to widespread abuse all over again.
Responding to concerns about the potential emergence of Oxy generics, Aglukkaq said banning alternative versions of the powerful painkillerdoes not solve the overarching issue of prescription drug abuse in Canada.
There nearly 100 drugs in Canada in the same class of drugs as OxyContin, she said. If generic Oxy is allowed to hit the market, it will be available by prescription only and up to provinces, territories and medical professionals to regulate use of the drug.
“If the country is ‘flooded’ with prescription drugs, it can only be in part because some medical professionals are making it possible,” Aglukkaq said in her letter.
She announced that Ottawa would be introducing new licensing rules to “clamp down” on the misuse of prescription drugs. Manufacturers of time-release oxycodone drugs are now subject to new rules under Health Canada,requiring them to report any sharp increases in sales or changes in distribution.
Previous requirements, which still stand, just required companies to report loss and theft.
The idea that prescription drug abuse represents a failure at the regulatory level has been disputed by many, including the Ontario Pharmacists’ Association, which advocated Monday for the deferral of Health Canada’s generic Oxy decision.
“While the drug-approval process is designed to ensure that a product is safe and effective, it cannot protect patients against any product's eventual misuse and alteration, or illicit potential,” the association said in a statement.
Though Aglukkaq has asked provinces and territories to consider what they can do to combat prescription drug abuse, she has also said that she will consider more federal oversight.
But additional oversight, she warned, could make it more difficult for patients with chronic pain to access pain-relieving drugs.
“I want to make sure that whatever we do to crack down on prescriptiondrug abuse does not have unintended negative consequences on those who need this medicine to maintain a reasonable quality of life,” said Aglukkaq.