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Out of order: Regulator, go to heal
November 2014
by Randall C Willis  |  Email the author
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As I alluded in my last commentary, life has not been good for the last few months for Health Canada, the governmental department that, among other things, serves the healthcare functions covered in the United States by the FDA. And much of the difficulty has been prompted by one of Canada’s national newspapers, The Toronto Star.
 
First, the Star did an exposé series highlighting the lack of transparency at Heath Canada with regard to post-marketing adverse events, citing the lack of a centralized database that healthcare workers could access and no mechanism (or apparent will) to warn the population about problems as they arise. To support their position, the Star reporters cited information gleaned from an FDA site designed specifically for that purpose, information that was completely hidden in Canada.
 
More recently, the Star published another series on the ineffectiveness of Health Canada in stopping pharmaceutical companies from importing contaminated drug compounds or excipients from other countries for use in Canadian patients. Again, as a comparator and offender-identification resource, the reporters turned to the FDA web site, which highlighted several cases where the U.S. organization fined drug manufacturers for shoddy practices and banned some products from the U.S. market.
 
The Canadian government has slowly responded to the issues raised, but by late September, one commentator had had enough.
 
“We should, in part, abolish Health Canada and harmonize our drug regulation with those foreign agencies that are more competent than our own government,” proclaimed University of Ottawa professor Amir Attaran in a Toronto Star commentary.
 
His demand is not unique, as he quickly points out, citing the European Medicines Agency and discussions within Africa, Asia and South America to regionally harmonize drug and medical device regulations.
 
So, is it time for Health Canada to stick to its HHS-equivalent duties and divest drug and medical device regulations to the FDA?
 
As I have joked with several American friends, we Canadians look just like you. If you give us too much anticoagulant, do we not bleed?
 
Our regulatory approvals are based on the same clinical trials data as yours, so why should drug companies have to double up every time they submit an NDA? And because of the dramatically smaller potential patient populations in Canada, a drug company may find itself spending ungodly amounts of money applying for approval of a drug targeting 400 people or fewer. I have no numbers, but I wonder how many drugs do not come across the border because there is no economic model for profit.
 
Likewise, the practical reality is that neither country lives within a geographic bubble. What happens in one jurisdiction (with the possible exception of Las Vegas) ultimately ripples through the other one.
 
If FDA officials learn of unforeseen post-marketing adverse events and decide to add a black box warning to a drug’s monograph, that same black box often becomes reflected in the Canadian monograph. I leave it to The Star to determine when and why the black box is added in Canada.
 
A merger of the two agencies (or engulfment) would also reflect current Canadian clinical practices. Very often, in my experience, Canadian practice guidelines are adaptations of American guidelines, literally referencing their counterpart and adjusting for local factors such as drug availability and treatment infrastructure. And in some cases, there is no Canadian guidance and clinicians simply work with U.S.-produced guidance.
 
I can hear the Canadian mob marching down the street. (Excuse us, but we are here to flog you. Hope it’s not a bad time. We can come back.) “What about our national autonomy?” they might cry.
 
The science is the science; the medicine is the medicine. As in all other jurisdictions, the true autonomy comes in drug prices and formulary coverage, which are handled regionally, and there is nothing to suggest that this would have to change in a merged North American system.
 
Ultimately, the question (at least north of the border) should come down to what’s in the best interest of Canadians, and as I believe Attaran rightly points out: “The FDA is more transparent, better resourced and scientifically better equipped than Health Canada will ever be.”
 
As for what would be in it for the FDA to accept such a merger: possibly nothing. But then, I really don’t foresee the FDA’s practices needing to change and other than expanding its mailing lists to include Canadian addresses, I don’t foresee any increased burdens, financial or otherwise.
 
And who knows, perhaps the FDA can follow Health Canada’s lead on pharmaceutical marketing, which is dramatically more conservative than the United States’ relative Wild West approach of forgiveness, not permission.
 
In any event, if you don’t hear from me after this is published, it is probably because the pitch-forked, hockey-sticked mob has had its way.

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