Shades of Bureaucracy - Differences between the FDA and Health Canada

Differences between the FDA and Health Canada

If you look at both the Food and Drug Administration and Health Canada they have very similar mandates at face value. The basic mantra is approving the safety and distribution of human and veterinary drugs, vaccines, biological products and medical devices for their respective citizens. So, where does medical marijuana fit inside these vision statements? In more traditional pharmaceutical scenarios, drug companies submit applications for drug testing and commercial distribution in North America with respective administrations. In the US this submission process is considered an Investigational New Drug (IND) submission, while in Canada pharmaceutical companies submit a Clinical Trial Application (CTA). In some respects the two organizations have made great efforts to consolidate their submission infrastructure under the Regulatory Cooperation Council (RCC) as a means to streamline certain aspects of drug applications and development.

Over the past half decade the cannabis industry has been poised with compounding excitement, innovation, and anticipation of a legal marketplace. This energy has driven constant development of new cannabis strains and delivery methods for patients and recreational users. But this aggressive market pace has left both federal institutions in stalled positions. The result has been an array of stone-wall tactics and the constant shifting of goal posts for those interfacing these federal institutions.

How does the FDA assess medical cannabis? Well, it doesn't.

In the US there are obviously great legal complications with marijuana, compared with traditional pharmaceutical products. State-level laws for commercial cannabis production / distribution can differ drastically from state to state. To further complicate matters, FDA recommendations and approvals in these grey areas are also passed through the US Drug Enforcement Agency (DEA) that has a relatively narrow view on the legalization of marijuana. Conducting research for the medical effects of marijuana in the US requires that one file an application to receive permission from the DEA to procure sample marijuana from the National Institute on Drug Abuse (NIDA) within the National Institutes of Health, and then seek review by the FDA of an Investigational New Drug (IND) application and research protocol. It's the longest bureaucratic journey you can possibly make for administering cannabis and academically documenting the medical outcomes.

The FDA's recent approval of Syndros, in its liquid gel capsule form, points to greater optimism for an eventual federal approval of natural cannabis. It also highlights an industry's market forces side-stepping the national legalities surrounding marijuana in the US. While the synthetic chemical dronabinol and the natural tetrahydrocannabinol (THC) can not be distinguished in a standard drug testing, there is an expectation by producers that some medical cannabis patients will gravitate toward Syndros to legally protect themselves.

 

Health Canada: Slow, Steady, and Confused

In Canada there simply hasn't been the same commercial or legal pressures to develop synthetic cannabis to satisfy federal governing bodies. Canadian provinces follow the legal and medical direction of the federal institution of Health Canada, working in hand with federal legislation, to dictate public access to medical marijuana. The greatest degree of policy deviation can be found at the doctor / patient level where some doctors simply refuse to prescribe medical marijuana as a viable treatment.

As widely publicized, medical marijuana has been a scaling industry in Canada that initiates directly at the production / manufacturing level. Prospective medical marijuana producers must navigate a lengthy application process with Health Canada that can involve up to 1,500 pages of submitted documentation detailing specs for facility construction, municipal approvals, operational protocols, security measures, and intended management roles.

In these early days of Canadian legal / medical marijuana the government has taken a very corporate and turnkey preference to administering licences. While successfully contested in court, Health Canada's initial steps toward developing a medical marijuana industry had restricted any opportunity for small-scale or personal producers. Instead, Health Canada has insisted on corporate groups that can raise significant capital ($3-5M) with the abilities to plan, propose, and develop large-scale infrastructure that places all elements of the supply chain under a very select number of producers.

The system is also unique in that it presently requires licensed producers to manage the safe distribution of medical marijuana, so there isn't the opportunity for retail-level dispensaries (although many thrive outside the laws). This position may change in 2017 as national retail drug store competitors pressure the Canadian federal government for legislative daylight allowing retail distribution without the costly overhead of growing inventory within house.

2016 brought other interesting updates to Health Canada's stance on medical marijuana that includes permits for international export of Canadian cannabis. Tilray, after a lengthy application process, was successfully granted the ability to ship cannabis in liquid capsule form to medical patients in Croatia. Tilray's President, Brendan Kennedy, has optimism for Europe's growing medical cannabis market and it would seem the Canadian government is willing to evolve the reach of licensed growers to help them access a broader market outside Canada's borders.


Seth MacCallum
Seth MacCallum

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