Canada’s Cheap Drugs Are Coming? The FDA Says They’ll Help States Make It Happen
- Dave Knapp
- 5 days ago
- 3 min read
After years of bureaucratic dead ends and political chest-thumping, the FDA is now sending letters. Not cease-and-desists. Not threats. Letters of help.
In a move that could be consequential in assisting patients in obtaining affordable medications, the agency on Monday announced it would begin actively assisting states that want to import cheaper drugs from Canada. This is something that’s been legal on paper since 2003, but a bit difficult in practice ever since.
The statement marks the clearest shift in tone since the agency authorized Florida’s importation plan earlier this year. Now, instead of acting like a gatekeeper, the FDA is volunteering to be a guide.
Section 804 of the Food, Drug and Cosmetics Act (the same act that gave us 503A/503B pharmacies) was originally added to U.S. law in 2003 but was never implemented until recently. It gives the FDA the legal authority to let states, tribes, and certain other entities import FDA-approved prescription drugs from Canada if the drugs are:
Proven to be safe and effective,
Labeled correctly,
And offered at a lower cost to U.S. consumers.
States, tribes, and even pharmacists can now submit early versions of their Section 804 importation proposals to the agency for informal review. The FDA says it will offer “technical assistance,” individualized feedback, and new online tools to smooth the process. Translation: With the FDA committed to expediting the Section 804 process, it could make it easier to import cheaper drugs from Canada.
Whether that’s an act of good faith or a public pressure valve remains to be seen.
Behind the sudden enthusiasm is a quiet but growing fire. President Trump’s Executive Order on Most Favored Nation drug pricing is poised to bring benchmark-level pricing for brand-name drugs without generics or biosimilars. While the full implementation roadmap remains murky, the FDA seems to be hedging. If benchmark pricing is coming from the top, state-level importation needs to be more than window dressing.
But don’t mistake this as a massive victory. The FDA’s announcement doesn’t actually guarantee any imports. It doesn’t offer a list of what drugs qualify or what safety hoops must be cleared. It also doesn’t guarantee that Canada will look too favorably on Americans siphoning off their drug supply. It certainly doesn’t give cover from the legal firepower that pharmaceutical companies are gearing up to unleash. We still live in an environment where pharma overprices American drugs, PBMs manipulate formularies and inflate drug costs, and where patients lose coverage over a single clerical error (by design, I might add).
That’s the context. That’s the battlefield.
Still, the symbolism of the FDA volunteering help is not nothing. If more states apply, if more programs get approved, if real savings reach real patients, it will mark the most significant shift in drug pricing policy in a generation. That’s a long shot, but it’s on the table now.
Until then, we’re still mired a system where insulin prices are still life-threatening. Where patients using GLP-1 drugs for obesity still face uphill battles every step of the way. Where access is rationed, innovation is weaponized, and regulators are late to the fight.
Maybe that changes now. Or maybe it’s just another well-written press release. The proof will be when your fridge is well-stocked with affordable versions of the medications you rely on.
Until then, we’ll be watching and keeping you informed.
Stay tuned to On The Pen for more updates and in-depth analysis on the latest developments in obesity and diabetes treatments.
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