ICYMI
20.01.2026 15:25
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ICYMI
True. The joint review mechanism proposed is fine IMO & sharing info between regulators is good. Canada doesn't have the capacity to do foreign inspections at scale.
But that's not equivalent to rubber-stamping new drug approvals thru the 'general deeming' pathway envisioned in the proposal tho.
If you are concerned about this proposal, you can find its details and comment directly on its text via this link:L
gazette.gc.ca/rp-pr/p1/202...
The deadline to weigh in is Feb 28 @ 11:59 pm ET.
One thing I can tell you for certain is that at least some scientists inside Health Canada are alarmed by this proposal.
And given that it's part of the GoC's 'red tape initiative', I'm very worried that this mechanism will be used to justify job cuts to Health Canada's core scientific staff.
It's impossible to know what the intent of this proposal is unless GoC is more transparent about the list of eligible drugs and foreign regulators they plan to include within its scope.
Instead, I worry that this kind of process will be used by sponsors of new drugs that have been fast tracked in other countries, such as #aducanumab (often on the basis of surrogate endpoints) and have limited evidence of effectiveness but high prices.
My theory, tho, is that those + other products aren't here because of our relatively small market size and disinterest from sponsors.
I doubt, in other words, that this reliance procedure will attract those manufacturers to Canada.
I agree those medicines are needed in Canada as @healthlawadamh.bsky.social & co explain here:
www.cmaj.ca/content/195/...
How you view this proposal to rubber-stamp foreign decisions all depends on which kind of cases you are worried about.
As @healthlawadamh.bsky.social points out in this story in @theglobeandmail.com it *could* help effective #TB drugs to finally reach Canada
www.theglobeandmail.com/canada/artic...
I also explain how this mechanism, if in place in 2021, could have allowed the entry of #aducanumab into Canada. A drug USFDA approved for Alzheimer's disease but which our regulator + the European Medicines Agency effectively rejected due to its poor effectiveness and significant safety risks.
Which is why I draw the comparison in @thestar.com to the "tainted blood scandal" of the 1980s when Canada relied on the US for blood products (and USFDA licensed for export to Canada) and thousands of Canadians suffered harm as a result.
On its face, this mechanism - if implemented - would allow Health Canada to rely on the decisions of the US Food & Drug Administration.
That's the same agency that has been going to hell under President Trump and the anti-vaxxer RJK Jr. that he put in charge of the body that oversees USFDA.
It's especially troubling that the list of drugs and foreign regulators that are within the scope of this proposal have NOT been made public.
The GoC is consulting on the proposal till Feb. 28. But how can we comment intelligibly on the proposal when we have no idea of its scope!
But other parts of the proposal, esp. the provision that would allow certain classes of drugs that have received approval in another country to enter the market through a 'General Deeming' (read: rubber stamping) process is completely novel.
Some of what's being proposed has happened for the past several years. Health Canada already collaborates with regulators in other countries to review products. We've written about that here, for eg.:
www.sciencedirect.com/science/arti...
Just before the holidays, the GoC introduced a proposal that *could* create a pathway for new drugs (+ generics) to enter the Canadian market without the regulator vetting their evidence of safety & effectiveness.
That's a landmark change in Cdn law and creates risks to Canadians' health.
My Opinion in @thestar.com today:
www.thestar.com/opinion/cont...
A thread to explain.
CC @picardonhealth.bsky.social @kellygrant1.bsky.social
"If high-level officials at the FDA are interested in the new use of a drug, they should lead with evidence, not with approval, and outline a process to ensure decisional integrity."
@sfu.ca is hiring Canada Impact+ Research Chairs. Research areas include health, including biotechnology; clean technology and resource value chains; environment, climate resilience and the Arctic; democratic and community resilience. Candidates must full Profs or Associate 2 years from promotion.
CC @healthlawadamh.bsky.social
And so for a GoC that is hell bent on standing up for Canada in the face of threats from south of the border, I'm worried that our government will end up both relying on their (decimated) regulator & doing things in the name of efficiency that are downright DOGE-esque.
//end.
I wonder what the scientific reviewers at Health Canada who have dedicated their lives to ensuring the safety of new drugs think about the proposed Order?
If implemented and frequently used, their jobs might soon be in jeopardy.
Why do I say that?
The proposed Order seems in keeping with the spirit of Division 5 of Bill C-15, which as @althiaraj.bsky.social wrote would give sweeping powers to exempt certain products from regulatory safeguards.
www.thestar.com/politics/pol...
But it seems this GoC is full steam ahead on the theory that this might drive industry to launch in Canada and save costs at the same time.
It's part of a larger trend with the Carney government.
That should be reason enough not to go down this road.
But when you take into account the risk of industry capture and what's happening at the @usfda.bsky.social of late, the idea that we would rely upon another regulator looks even worse.
CC @reshmagar.bsky.social @jsross119.bsky.social
In other words, this is hard stuff (to put it mildly). And while industry has long made the argument that we could just have one regulator for the whole world, it's essential IMO that we have as many eyes (i.e., regulatory scientists) looking at the evidence as possible.
Given the complexity of the exercise, regulators - even the most well resourced - sometimes reach different conclusions about whether to approve a new drug while looking at the *same* evidence.
For one thing, regulators make mistakes. Deciding whether to approve a drug is complex scientific assessment, weighing risks/benefits based upon evidence at a point in time. It's further complicated by pressure to meet review deadlines, advocacy by patient organizations, &, at times, politics.
But this new Order, if implemented, would mark profound change in how Health Canada works.
Relying on other regulators' decisions to approve new drugs could become the norm, not the exception.
And that presents potentially huge risks to Canadians.
During COVID, they also worked together more closely as we wrote together here:
www.sciencedirect.com/science/arti...