Let’s get into semantics. The word “ensure” is defined as to secure or guarantee, to make sure or certain, or to make secure or safe, as from harm. I submit that the FDA cannot ensure the safety of Canadian OR U.S. drugs, but that doesn’t mean they are not safe and effective…
Pharmaceutical Regulation in Canada
The precise communications of the U.S. Food and Drug Administration have changed over the years on why it’s illegal for Americans to buy medications from Canada by personally importing them. Often the implication is that the agency cannot “ensure” or “guarantee” the safety of medications sold in Canadian pharmacies – and that’s why it’s illegal. Additionally, another reason used by the FDA is that the drugs sold in Canada may not be approved by the FDA. These are not good arguments against buying lower cost medications from Canada because the Therapeutic Products Directorate of Health Canada, the FDA’s counterpart, is responsible for regulating the prescription drugs sold in Canadian pharmacies. Like the U.S., Canada has very strict rules to help ensure drug safety.
Neither country can guarantee the safety, efficacy and quality of medications in the two countries. However, their regulatory mechanisms have proven more than adequate, if not superior, so that patients buying medications will almost always obtain a properly manufactured medication.
Opponents of importation argue that Health Canada does not guarantee that medications exported to the U.S. are safe and effective or that such prescription drugs are even authorized for sale in Canada (meaning they could be transshipped from China to Canada to the U.S., for example). But, if you can buy a medication from a Canadian pharmacy and import it, then you are getting a medication regulated by Health Canada, and there’s little to nothing to suggest that those products are less safe than the ones sold here.
Let’s take it a step further and dissect the FDA’s language on the legality of personal drug imports. The FDA writes:
“In most circumstances, it is illegal for individuals to import drugs into the United States for personal use. This is because drugs from other countries that are available for purchase by individuals often have not been approved by FDA for use and sale in the United States. For example, if a drug is approved by Health Canada (FDA’s counterpart in Canada) but has not been approved by FDA, it is an unapproved drug in the United States and, therefore, illegal to import. FDA cannot ensure the safety and effectiveness of drugs that it has not approved.”
From that language, it appears crystal clear that there are instances in which it’s legal for individuals to import medications. Otherwise, why state that it’s illegal “in most circumstances?” We also learn that some drugs made and sold in other countries are FDA-approved while others are not. So why can’t we buy those FDA-approved drugs from Canada? It would appear that’s it’s actually legal to import FDA-approved drugs—at least by pharmaceutical companies. In fact, most medications sold in U.S. pharmacies are imported! And yet it’s not expressly legal for consumers to get them from Canada for themselves. Why? The answer is because the labeling is different or they may have been manufactured in the U.S., and the law bans the re-importation of medication except by the manufacturer of those drugs. But notice that the FDA doesn’t say above that it’s illegal to import FDA-approved drugs from Canada, just ones that are unapproved – so what does that mean?
Any foreign version of a drug sold in Canada that has a U.S. counterpart with the same active ingredient but not made in an FDA-registered plant is considered an “unapproved drug” – but that doesn’t mean it’s not equally as safe as the one sold in the U.S. There are many generic drugs sold in Canada, which are “unapproved” versions of the brand name sold here. Again, those are medications regulated by Health Canada, which has advanced protocols for evaluating medications before approving them for sale.
A little history before we conclude…
In 2007, during congressional testimony, expert witnesses informed Congress that the FDA is unable to ensure drugs sold in the U.S. are safe. That testimony was based on the fact that so many drugs sold in the U.S. are made in foreign manufacturing plants that had not been inspected for years or at all. I believe even at that time medications sold in the U.S. were among the safest sold in any country. Was it safer to buy medication in Canada at that time? No. All countries, including the richest ones with the strongest regulations cannot guarantee drug safety, including Canada. But those are not good reasons to prevent people from buying lower cost medications from other countries.
Since 2007, the FDA has substantially but imperfectly improved its oversight of foreign drug manufacturers, in part due to new funding by generic drug companies mandated under the Food and Drug Administration Safety and Improvement Act of 2012, which helped pay for more inspections. These are welcome improvements and others are in the pipeline to bring about a more advanced system of the tracking and tracing of medications. The elephant in the room is that Canada and many other countries, including the UK, have much less expensive medications that are just as safe and effective as the ones here. At this time—and perhaps never—the FDA cannot ensure their safety, but luckily for the Canadians and British, their governments do a great job at helping to do so. Semantics.Tagged with: ensure, health canada, regulation