Monday, November 19, 2012

Minister of Health's Response to Concerns Regarding Expiry of OxyContin Patent

Monday, November 19, 2012

In a letter to her provincial counterparts, Health Minister Leona Aglukkaq has indicated that Health Canada has no plans to withhold approval of generic versions of OxyContin based on misuse. In particular, Ms. Aglukkaq noted that “[t]here is no basis in the Food and Drugs Act for the Minister of Health to withhold approval of a drug where the drug is otherwise considered safe and effective for its recommend use. The law does not permit approval to be withheld on the basis of misuse.” 

The Minister went on to express her concern with respect to how the media has presented this story, noting that in “recent media reports, in which Minister Matthews for Ontario has said that she envisions that “streets would be flooded” with generic versions of OxyContin if it would be made available”. Ms Aglukkaq rightfully noted, as a prescription drug, if generic versions of OxyContin flood the streets, it is because “some medical professionals are making it possible. 

Her letter goes on to detail “concrete action to clamp down on prescription drug abuse”. A copy of her letter can be found at: 

In my opinion, some of the most interesting comments in the letter relate to OxyNeo. Ms. Aglukkaq notes “it’s important to remember that OxyNeo is, to date, not authorized to make claims that it is “tamper-proof”, tamper-resistant” or “harder to abuse.” Health Canada had a panel of experts evaluate the evidence of describing drugs in this fashion, and found that there was insufficient proof to back up these claims. As noted in the prior blog, OxyNeo is a patented medicine. One of the patents listed on the Patent Register, Canadian Patent No 2,661,573, is entitled “Tamper Resistant Oral Pharmaceutical Dosage Forms Comprising An Opioid Analgesic”. It is unclear from Ms. Aglukkaq’s comments if she is speaking about OxyNeo in particular or to this type of drug in general. If Ms. Aglukkaq is speaking about OxyNeo in particular, one has to wonder if she has inadvertently suggested that the patents that cover OxyNeo specifically do not fulfill their promised utility. It would be interesting to hear Purdue Pharma’s response to her comments regarding OxyNeo.