Americans could lose access to cheap Canadian prescription drugs. Here's how much U.S. imports

Americans once spent US$1 billion on prescription drugs from Canada, but new import rules might mean they no longer spend anything at all.

It’s the consequence of a new rule published in the U.S. Federal Register on June 24, which enforces an indefinite suspension of the de minimis exemption that allows imports valued at $800 or less to arrive through the international postal network without formal customs paperwork.

And it could result in millions of Americans who use foreign mail-order pharmacies, mostly from Canada, having their supply cut off, according to the Canadian International Pharmacy Association (CIPA).

The text doesn’t specifically address prescription drugs, but it does say that formal entry is now required for any shipments regulated by Partner Government Agencies (PGA). This includes the U.S. Food and Drug Administration (FDA), which has historically used enforcement discretion for personal-use medicines, with the agency’s personal importation guidance explaining that some shipments of medication may be allowed if the quantity is no more than a three-month supply.

National Post spoke to Tim Smith, general manager at CIPA, which represents licensed Canadian pharmacies that ship to U.S. patients. He explained that the FDA policy “allows agents to use their discretion when a package is coming in for personal use in a quantity not exceeding 90 days,” and that this is the way the system has operated for the past 25 years. “What goes into effect on October 22 is a new system that is much more complicated,” he said.

This is because, in most cases, drugs purchased from other countries have not been approved for use and sale in the U.S. by the FDA, making them illegal to import. It means that, from Oct. 22, medications mailed from abroad will go through a customs process requiring a licensed customs broker and a financial guarantee.

“The understanding we have at this point is that the FDA is no longer going to exercise the discretion that they have done traditionally,” said Smith.

A 2020 study published in JAMA Network Open estimated that 2.3 million U.S. individuals who take prescription drugs bought them from outside the country to save money.

And while recent data on the value of these purchases is limited, a Congressional Research Report published in 2007 said that, in 2003 alone, U.S. consumers bought more than $1 billion in prescription drugs from Canada.

The demand is largely due to Canada having generally lower prices for prescription medication because of government price controls. Smith explained that Americans who purchase medication from Canada can expect to save 50 to 80 per cent on drugs like Eliquis, which prevents blood clots, and Crestor, which lowers cholesterol.

Meanwhile, the Campaign for Personal Prescription Importation (CPPI), an advocacy organization that campaigns for Americans’ access to prescription medications from Canada, recently published a price study comparing the cost of 10 commonly prescribed brand-name medications in the U.S. and Canada.

They found that American consumers could save an average of 65 per cent by purchasing these medications from licensed Canadian pharmacies. Savings were highest for Jublia, which is used to treat fungal infections and costs $2,422 for a 90-day supply, compared to $257.77 in Canada.

Xifaxan, which treats IBS, costs $11,919 for a 90-day supply in the U.S. compared to $2,325.78 in Canada, according to the CPPI study, while Rybelsus, which is prescribed for type 2 diabetes, cost $2,913 in the U.S. and $1,193.99 in Canada.

But Smith said that, following the rule change, CIPA expects the FDA to take a path of “complete enforcement” against all packages entering the U.S., meaning Americans should expect virtually all prescription orders mailed from Canada — and other international pharmacies — to be unable to reach them.

He is calling on the FDA, along with U.S. Customs and Border Protection (CBP), to assure the American public that their ability to purchase affordable medications for personal use will be maintained past Oct. 22.

Until then, CIPA is advising all U.S. patients to order refills before the deadline and start looking for alternative places to purchase their medication.

National Post has contacted the FDA and CBP for clarification, but did not receive a response before publication.

As for how the changes will impact Canadian online pharmacies, Smith says: “Because they’re in the mail order business for their service to the United States, some of our pharmacies have located themselves close to international mail facilities. As a result of that, they have less presence in neighbourhoods, shopping malls or areas where people live and would go to a pharmacy.”

He added that these pharmacies may need to make “adjustments” as a result of the change, but that all of CIPA’s members are licensed pharmacies in Canada and serve Canadians too, even if a large portion of their patients may be based in the U.S.

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