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Health Canada and the FDA: two peas from different pods


Health Canada’s Health Products and Food Branch has a mandate of “minimizing health risk factors to Canadians while maximizing the safety provided by the regulatory system for health products”. The FDA’s mandate is “protecting the public health by assuring that… human and veterinary drugs, and vaccines and other biological products and medical devices intended for human use are safe and effective”. These are pretty similar goals: protect the public by minimizing risks and maximizing safety and effectiveness of foods and drugs. Yet despite being borne from similar mission statements, these cousinly organizations behave very differently.

Nothing exemplifies these differences more than the FDA’s recent decision not to approve a generic version of OxyContin to enter the US market. In its statement, the FDA was clear that:

[B]ecause original OxyContin provides the same therapeutic benefits as reformulated OxyContin, but poses an increased potential for certain types of abuse, the FDA has determined that the benefits of original OxyContin no longer outweigh its risks and that original OxyContin was withdrawn from sale for reasons of safety or effectiveness. Accordingly, the agency will not accept or approve any abbreviated new drug applications (generics) that rely upon the approval of original OxyContin.

With a rejection of the generic version based on the risks and benefits posed to the public, the FDA’s statement rings true with its mission. Health Canada’s statement, however, states:

Following the expiry of the patent held by Purdue Pharma for controlled release oxycodone (brandname: OxyContin), the first generic versions of these products for the Canadian market were authorized today by Health Canada. This decision was made based on a scientific review of evidence that determined these products demonstrate “bioequivalence” to OxyContin (meaning they will behave the same way in the body), which is considered safe and effective under the recommended conditions of use.

Health Canada’s focus on bioequivalence with no mention of its duty to “protect the public by minimizing risks” highlights the difference between the two organizations, and indicates why clinicians and Canadians should be concerned about what’s going on at Health Canada.

The FDA’s approach to the problem of opioid abuse and approving generic OxyContin included calling a hearing to obtain information on issues pertaining to the use of opioid drugs in the treatment of chronic pain. It issued a guidance for industry on developing new formulations for opioids, urging drug manufacturers to adopt deterrence principles when formulating new opioid drugs. To prescribers, it issued an Open Letter to Prescribers urging “all prescribers of opioids to ensure they have thorough knowledge of the FDA-approved product labelling for the opioids they prescribe, and to ensure they have adequate training in opioid therapy.”

It was a consistent message to the scientific community, industry and prescribers that the FDA takes seriously the issue of opioid abuse, and a multi-pronged, transparent discussion with all stakeholders to co-operate with its efforts. These were actions which aligned with the FDA’s mission statement.

Not so with Health Canada. Everyone recognizes that opioid abuse and dependence is a significant problem, on both sides of the border, with Canadians being the highest users of opioid painkillers, per capita, and the US following closely behind. (This wasn’t true as close as 2010.) Discontinuing OxyContin because it could be easily compromised and abused was seen as a step in curbing this trend. And while no one seriously thinks that Purdue was acting altruistically, the release of OxyNEO signalled that there were innovative solutions that could help deter abuse.

In other words, everyone recognized the need to find ways to improve the public health crisis in this area, from industry to Ontario Health Minister Deb Matthews to the Attorney General of Montana. Everyone — that is — except Health Canada.

It’s not that Health Canada doesn’t feel that protecting the public health from possible misuse or abuse of medications isn’t part of its mandate. In 2008, it required all manufacturers to cease marketing of OTC products to children under 6 because “reports of misuse, overdose and very rare serious side-effects have raised concerns about the use of these medicines in children under 6.”

Health Canada has taken the same, multi-pronged approach to the issue of the overuse of antibiotics and the growing concern of antibiotic resistance, educating prescribers, patients, and the agricultural industry on the need to reduce antibiotic use. And the Public Health Agency of Canada, which falls under the federal Health minister’s portfolio, is involved in the surveillance and monitoring of drug abuse in Canada. Yet when it came to blocking the entry of generic OxyContin, it focused on bioequivalence. It’s a strange approach for the nation’s foremost health department.

So it seems that blocking the entry of generic OxyContin to the Canadian market would have been consistent with the department’s previous activities to improve public health and, more importantly, consistent with it’s mission statement. The FDA’s activities suggests there were numerous ways to tackle the issue differently.

If there was a legal requirement to use bioequivalence as the only criteria by which to approve generics, then Health Canada should put forth amendments to change the law.

The FDA proceeded by withdrawing approval for the original formulation of OxyContin based on safety concerns, and it’s unclear why in Canada we couldn’t do the same. And notwithstanding the hazy legal question, Health Canada could still have tried to have open and transparent dialogues with patients, healthcare providers, and industry stakeholders to help determine the best possible course of action.

In the end, while Health Canada and the FDA appear to project the same vision of protecting the health and safety of their citizens, their responses the opioid problems suggest that only one is living up to that mandate. Canadians need to be concerned.

John Greiss is a pharmacist and lawyer. He writes about pharmacy and health policy at 7drams.ca. Follow John on Twitter @jgreiss.

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6 comments

  1. Sharon Wilton, Project Share

    John…

    It seems the two “issues” are:
    (a) bioequivalence (letter of the law)
    (b) increased potential for certain types of abuse ( spirit of the law )

    In the discipline of law selecting “facts” does not necessarily precede the value of determining the ” issue” that “facts” will be customized to support

    A ISSUE selection
    Q- Is the issue, in reality ,the attempt of Purdue to retain dominance over the sale of Oxycodone by taking the ” letter of the law” fallback position of ? safety?
    OR
    is it because it still holds that patent ( whereas the less safe patent has expired ( opening generic alternative to be produced) ?

    Supportive FACT :
    :

    • Considering the $2.5 billion marketshare for the drug it seems an ethical supplier could control the abuse of the drug by hand delivering and watching the patient swallow

    • Considering: the cost factor (generic cheaper); the “same date” coup of Purdue to make the switch (?ethical base ) means I find the ” our goals are for the safety of the patient ” hard to swallow” (pun intended)

    • Considering the safety factor I get the impression that Canada is no longer a “nanny” government and the acknowledgment of drug addiction as pandemic, and abuse as being ” medicalized ” ( e.g.Insite injection sites) means we are truly in the ” harm reduction” center of Evidence-Based Practice (EBP)

    For sure I think Canadians should be concerned about what it means when we expect the “government” to be our social interventionist and moral compass. We can stop misuse of drugs at a higher level than a windshield survey.

    For sure I believe that Big Pharma reveals in it’s everyday actions that it’s focal point is $ touting safety as a disguise for it’s true intent to pillage while promoting patient ?care

    For sure as Canada follows the “letter” of the law the issues are more distinct and manageable…. for both supplier, provider and user

    Extended argument:
    http://blogs.law.stanford.edu/lawandbiosciences/2013/05/05/purdue-pharma-oxycontin-regulatory-gamesmanship-a-debate/

  2. Dr. Judith Glennie

    Dear John – thanks for your post. All good points. Regulatory frameworks speak only to the scientific standard. In addition, you raise the issue of other means by which the public’s health could/should be protected. %featured%At the end of the day, I think you’ll find that the difference lies in the level of political will and at the same time political independence, in terms of the FDA’s vs. HC’s willingness and/or ability to act on various issues.%featured% Best regards, Judy.

  3. Rob MacDougall

    I’m not sure I understand the substance of the criticism here. Is it just that you support the FDA’s decision to withdraw the original drug, because you think that is safer? In that case, I don’t see what the later decision about generics has to do with it. If Canada is not going to withdraw approval from the original formulation, why would it disapprove of the newer generics? And, in denying the generics based on the recipe for oxycontin, the FDA was also being consistent with its original decision to revoke the original formulation of oxycontin.
    If the real issue is whether oxycontin or only its safer reformulation is approved by these regulatory agencies, then I would think you would have addressed the reasons why these regulatory agencies should be responsible for taking into consideration the safety of drugs when abused. Why should they not be concerned only with safety concerns related to using the drug properly? Shouldn’t considerations of abuse be addressed by other agencies or legal authorities, such as those who normally deal with problems of abuse and dependency?

  4. Adam

    “It seems that blocking the entry of generic OxyContin to the Canadian market would have been consistent with the department’s previous activities to improve public health and, more importantly, consistent with it’s mission statement.”

    To compare the improper use of antibiotics to a social problem of drug abuse is wrong; how does blocking a generic version of an already approved (and effective) drug improve the safety of Canadians? Opiods have many forms and all pose risks if abused; it is up to physicians, nurse practitioners, psychiatrists and the like to ensure they are prescribing the right drug, in the right amounts to the right people. Health Canada would be acting hypocritically to allow one form of the opiod and not the other; what they would have to do in order to fulfill your version of public safety is remove both. At this point you would be removing a safe and effective treatment for all those who have been receiving the proper amounts and have not fallen into abuse, which is the majority. If Health Canada instead decided to recommend other forms of therapy and provided additional education and certification for prescribing the drug in general we would all be better off.

    Logically speaking, oxy use was going up BEFORE generic oxy was created and are therefor hardly even loosely correlated; not a reason to “be concerned”. I’m glad that you are saying that Health Canada needs to be protecting the public from harm but there is only so much that preventing a flavor of ice cream is going to do to stop people from eating ice cream…

  5. BYRON A CANADIAN

    %featured%How about you keep the FDA in the US and Health Canada in Canada. By all comparisons, Health Canada does a better job in health for it citizens. %featured%FDA will allow any drug as long as there is money involved. Also, i hate to say it, buy america is infested with drugs that can do more that what they are assigned to.. they can help more but only alow them for certains uses,….. what they cant controll they outlaw… typical

  6. Willard Bouldin

    Thoughtful writing , I learned a lot from the analysis , Does anyone know if my business could possibly grab a sample a form document to use ?

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