True or false: It's illegal for U.S. residents to order and receive prescription medication from pharmacies in Canada.
Okay, how about this one -
True or false: It's illegal for Canadian pharmacies to ship prescription medications to U.S. residents.
The answer: False!
Did you get all that? Allow me to explain...
So, a couple of weeks ago the news broke that Google got into heaps of trouble with the FDA for allowing Canadian pharmacies to post their ads on American websites using their AdWords service. Of course, Google's $500 million settlement was more like a slap on the wrist considering how much the company is worth, but it drove home the point that Canadian pharmacies — and actually all international pharmacies — are not supposed to sell their goods to U.S. residents. It's against the Food, Drug and Cosmetics Act, which specifically states that it is illegal to import controlled substances and unapproved prescription drugs, whether the product is a foreign-made version of a U.S.-approved drug or the exact same drug that U.S. manufacturers send to Canada.
So even if the factory makes the same insulin for both the Canadian market and the U.S., Canada cannot legally turn around and export the insulin to the U.S.
Yep, it's true.
What FDA Forbids
Apparently the folks at FDA have positively convinced themselves that all drugs from outside the United States are evil. Well, sort of...
In 2003, William Hubbard (then commissioner and later founder of the advocacy group Alliance for a strong FDA) testified before the Subcommittee on Human Rights and Wellness House Committee on Government Reform that: "In our experience, many drugs obtained from foreign sources that either purport to be or appear to be the same as U.S.-approved prescription drugs are, in fact, of unknown quality. FDA cannot assure the American public that drugs imported from foreign countries are the same as products approved by FDA."
This is essentially why the re-importation of drugs from anywhere is illegal. But there's really no reason to suspect that Canadian insulins are somehow manipulated or watered down or whatnot. Legitimate, certified pharmacies in Canada are no different than the pharmacies in the United States. Canada receives the same medications as we do here, and Health Canada functions in a similar role as the FDA.
When Meds Cross Borders
So we've established that it's illegal to shuttle in prescription drugs and why, but don't thousands of people do this anyway? Certainly, in economic times like these, and the uber-shady business of price-jacking from Big Pharma and low-coverage from insurance companies don't make it any easier on people. Desperate times call for desperate measures, right? We've read about scores of folks who have either ordered insulin from Canadian pharmacies or at least contemplated it because thanks to Canada's socialized medicine and price caps, insulin and other diabetes supplies are dirt cheap. An insulin bottle can be as little as half the price in Canada as it costs here!
How are so many people getting away it?, we wondered.
Well, for the most part, the FDA and Customs officials don't bat an eyelash over prescription medications crossing the border, so long as they're more or less for personal use and don't appear to exceed a three-month maximum. That doesn't mean they won't seize the package and mark it "Return to Sender." But it doesn't look like you need to fret too much about legal action; there isn't a single documented case of someone getting thrown into the Big House for smuggling in small amounts of medications.
And Canada will keep on shipping here too, as it is perfect legal from their side. Per an official statement from Health Canada in 2004:
"The cross-border sale of drugs to the United States has become an important business in Canada because many Americans are taking advantage of lower Canadian patented drug prices and are purchasing their drugs from Canada. Neither Canada's international trade obligations nor our domestic laws prohibit these exports."
One detection trick that's probably forced on U.S. Pharma is subtle differences in medication labeling. Check out this comparison between two Lantus pens: the solid purple one is sold from Canada, the black and purple one from the U.S.
Will it ever be legal to import meds from our neighbors to the north? Maybe...
Some folks in Washington have been trying over the past few years to open up the door for U.S. customers to order prescription meds from international suppliers. Olympia Snowe, R-ME, has been an ardent supporter of amending the Food, Drug and Cosmetics Act. Her current bill, the Stabenow/Snowe bill (S.319), aims to loosen the restrictions, on both personal and pharmacy importation of prescription drugs.
The bill also adds additional layers of oversight and inspections to drugs, which probably will drive up cost in the long-run, but hopefully won't wipe out price advantages. However, Snowe's previous bill, the Dorgan/Snowe bill, was shot down in the Senate by 51 to 48 in 2009. Similar bills were also brought before Congress in 2005 and 2007. So we won't be holding our breath...
The Deal with Google
Which brings us full circle back to Google, which got busted for violating a federal law (the Food, Drug and Cosmetics Act) that prohibits the "introduction or delivery for introduction into interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded." Any Canadian prescriptions sold to Americans are considered "misbranded" because they're not approved by the FDA. Even if it is, you know, the exact same darn drug.
Tom McGinnis, the FDA's pharmacy affairs director, emphasized to WebMD that, "The agency doesn't go after individuals, per se. (It) has tended to focus its priorities on people making money from this illegal activity."
Like, say, Google, which had $36 billion in cash in June.
Even though Google wasn't fully responsible for the transfer of medications between Canadian pharmacies and American customers, they were still seen as an "accomplice," and were required to fork over that $500 million, which is surprisingly not a fine, but rather the amount of money they made from the ad sales!
To Order or Not to Order?
That is the question. Well, we certainly wouldn't advise anyone to conduct illegal activities, but we won't rat you out either. We get it that for many folks who are out of work and out of options, Canadian insulin is worth the risk. And it's our impression that the risk isn't very high, since enforcement against individuals doesn't seem to be a priority.
As for the safety of online pharmacies, that's definitely something to investigate before ordering, by using a service like PharmacyChecker. You can also look for vendors certified with the Canadian International Pharmacy Association (CIPA) or the Manitoba International Pharmacists Association (MIPA). A legit pharmacy would send you the exact same product in the exact same way a domestic pharmacy would.
Maybe this will all be legal soon...? Our bigger hope for Congress is that they'll finally notice that price gouging and lack of decent insurance coverage is crushing the health of Americans, and not allowing them easy access to affordable medications is doing as much harm as the "phoney Canadian pharmacies" they're so worried about.