OxyContin, a prescription opioid narcotic pain reliever (containing the medicinal ingredient oxycodone hydrochloride), is indicated for the treatment of moderate-to-severe pain when around-the-clock analgesia is needed for at least several days.  Unfortunately, because OxyContin can produce euphoria and is widely available, a U.S. survey found that over half a million people in the U.S. used it non-medically for the first time in 2008.  Moreover, because OxyContin is provided as a controlled-release compound for extended dosing, each tablet contains a relatively large amount of oxycodone.  Abusers that have broken and crushed the tablets to be snorted, or dissolved and injected, have therefore been able to get a higher dose with a faster onset to increase the feeling of euphoria.  This has led to a significant number of drug addicts in Canada and elsewhere, and an increase in pharmacy break-ins in some areas.  It was for this reason that Health Canada, like the FDA, approved a new formulation of OxyContin called OxyNeo.  The reformulated tablets are harder to cut, break or crush, and contain polyethylene oxide, a non-ionic hydrophilic polymer that forms a viscous gel upon contact with water that cannot be snorted or injected.  It was hoped that this would decrease the level of oxycodone abuse.  There is no evidence, however, that allows the maker of OxyNeo to claim that the reformulated tablets are “tamper-resistant” or “harder to abuse”, and, of course, the reformulated tablets can still be abused by regular oral ingestion.

Complicating the matter now is the fact that Canadian patent no. 2,098,738 (“Controlled release oxycodone compositions”) expires on November 25, 2012.  This was the only patent blocking generic versions of OxyContin from coming to market.  As a result, numerous individuals have flooded various provincial and territory Health Ministers across Canada with stories of how OxyContin abuse and addiction has destroyed the lives of families and certain communities across Canada (with the intent to stop generic OxyContin from coming to market).  The Minister of Health for Ontario has even stated that she fears the “streets would be flooded” with generic OxyContin if it was made available.  Of course, the innovator pharmaceutical manufacturer has also suggested that allowing a generic version would be unwise, even if this would mean that it would retain its effective monopoly over oxycodone. On the other side of the argument are doctors, patients and generic manufacturers who implore that OxyContin has been invaluable in treating chronic pain, and that it is time that a cheaper alternative be available to the public.

Given the arguments raised, the federal Minister of Health for Canada has been under significant pressure to determine the best course of action.  And today, the Honourable Leona Aglukkaq informed everyone of her thoughts on the matter:

There 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 recommended use. The law does not permit approval to be withheld on the basis of misuse.

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During our recent Health Ministers Meeting, the request was made for me to delay approvals of generic versions of OxyContin.  At that time, I committed to relay any research you had related to this request on to Health Canada scientists for their consideration. Shortly after our meeting, my officials held a teleconference with your officials to review any research.

I want to be crystal clear: I do not believe that politicians should pick and choose which drugs get approved.   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?

A drug approval process based on politics is a recipe for disaster.

Health Canada will continue its scientific review process of generic versions of OxyContin based on whether the benefits outweigh the risks when used as prescribed and, as always, this will be completed without political interference.

In closing, I want to remind us all of the most important factor in every decision we make as Health Ministers: patients.

As I mentioned earlier, I have heard compelling accounts from doctors and the patients they care for: people who have lost limbs, people who have survived horrific automobile accidents, people who have been shot; people suffering from chronic pain due to cancer; these are the patients who have used drugs like OxyContin properly to improve their quality of life.

These legitimate patients cannot be forgotten.  Indeed, patients like these should motivate us to do the harder work of shutting down prescription drug abuse in Canada.

I want to make sure that whatever we do to crack down on prescription drug abuse does not have unintended negative consequences on those who need this medicine to maintain a reasonable quality of life.

Given that it is likely that Health Canada’s scientific review process will favour the approval of generic versions of OxyContin, we will later advise whether Health Canada decides to amend the Controlled Drugs and Substances Act to clamp down on prescription drug abuse, whether that be by removing the ability of doctors and pharmacists to provide the drug under certain circumstances, or by imposing new conditions in the licenses of dealers allowed to provide a generic version of OxyContin.  Such regulations, if created, could ultimately impact on other authorized drugs in Canada that are in the same class of drugs as OxyContin.