The FDA sent a warning letter to an online Canadian company selling prescription medication.
Canada is often seen as the cure for the stabbing pain that many Americans feel in the wallet every time their doctor writes them a prescription.
The Great White North, a land of low-priced prescription drugs, is no myth, either. Many medications are cheaper in Canada, especially brand name drugs. Even U.S. politicians talk about letting Americans legally buy prescription drugs from Canada.
But not all “Canadian” sources of prescription drugs are alike.
The Food and Drug Administration (FDA) recently sent a warning letter to a Canadian company selling prescription drugs online to Americans.
The agency has pointed out that where you buy medications outside of the United States can make the difference between taking a pill that improves your health and getting one that doesn’t help. It may even harm you.
The FDA recently raised this issue last week when it sent a warning letter to Windsor, Ontario-based CanaRx, saying the company has sent “unapproved” and “misbranded” drugs to U.S. consumers, putting their health and safety at risk.
The company denies any wrongdoing or that it is putting the health of Americans at risk.
Although people turn to companies like CanaRx for cheaper medications, they are not online pharmacies.
Joseph Morris, CanaRx’s legal counsel, said in an email that the company passes its customers’ prescription orders onto “an actual licensed and regulated pharmacy in the dispensing jurisdiction.”
The company’s website states that this includes Canada, the United Kingdom, and Australia.
The prescription is filled “as directed in the medical orders, conforming to dose and other requirements,” said Morris. A “complete paper trail” of the order and the source of the medications is maintained.
Only approved brand name drugs — not generics — can be ordered through the CanaRx program.
The medications are “packaged and sealed by the original manufacturer, for direct delivery to all participants,” the company states on its website.
The FDA still has concerns about where those medications are really coming from.
FDA Commissioner Dr. Scott Gottlieb said in a press release, “When [an American] consumer goes online to buy medicines purportedly from Canada, they may get a medicine sourced from elsewhere that could be counterfeit, expired or misbranded.”
This was echoed by Robert Stein, PharmD, JD, a professor of practice for pharmacy law and ethics and healthcare information technology at the Keck Graduate Institute School of Pharmacy and Health Sciences:
“Companies like CanaRx are deliberately misleading American consumers because they imply the drugs are coming from Canada,” he said, “when in fact they are, in many cases, coming from Third World countries.”
One concern raised by experts is that companies like CanaRx bypass the protections that the FDA has in place to protect the health and safety of Americans buying prescription medications.
The FDA ensures that the medication you buy is what you expect, at the right dose and free of contaminants. It issues recalls when problems with the drugs are detected.
The FDA also inspects facilities where medications sold legally in the United States are manufactured, even for drugs made outside the country.
And companies handling prescription drugs have to follow FDA guidelines on how they are stored and shipped.
These protections all go out the window when Americans buy medications online from outside the country, leaving behind many questions.
“Some of the products coming from outside the country may be fine pharmaceuticals, but some of them may not be. You just don’t know if you’re getting a good one or a bad one,” said Marvin Shepherd, PhD, professor emeritus, College of Pharmacy, at the University of Texas at Austin.
Morris said “CanaRx has never had a complaint about a substituted product or a failure to comply with a doctor’s orders.”
Shepherd, though, pointed to a case a few years ago in which a company from Manitoba, Canada, sold counterfeit Avastin, Roche’s colon cancer drug, to U.S. physicians.
The FDA reports that last year one of the men involved in that case was sentenced for selling misbranded and counterfeit prescription drugs in the United States.
In spite of unsettling counterfeit drug cases like this, Shepherd said if an American goes to a brick-and-mortar pharmacy in Canada, they can trust that they are getting high-quality drugs.
That’s because Health Canada has a first-class drug regulatory process, he said, on par with the FDA’s.
If you are determined to save money by getting your prescriptions in Canada, one way to do it is to personally head north.
Stein said this would involve “physically going to Canada, obtaining a prescription from a Canadian physician — relatively easy if one has a valid prescription issued in the U.S. — and having it filled at a Canadian pharmacy.”
The FDA offers tips for Americans returning to the United States with medications.
You are only allowed to bring back a 90-day supply of medication, in its original container. And you will need a valid prescription or doctor’s note.
Stein said “controlled substances — such as opioids, benzodiazepines and amphetamine analogues — can only be brought in to the U.S. in quantities of 50 dosage units or less.”
This applies only to validly obtained controlled substances.
It’s best to check the U.S. Customs and Border Protection regulations before bringing medications back into the country.
And while you’re in Canada, enjoy one of those cold fronts that the country is famous for at this time of year.