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FDA has determined that the benefits of original OxyContin no longer outweigh its risks and that original OxyContin was withdrawn from sale for reasons of safety or effectiveness.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.
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.