Responding to Criticism of ‘State Pharmaceutical Importation Programs Threaten Patients and Innovation

A recent article by Dr. Kristina M. L. Acri née Lybecker highlighted her research about the fiscal workability of state pharmaceutical importation programs from two aspects:

Cost of counterfeit testing of products that have been handled by unregulated entities

Because these medicines will be handled by unregulated entities, they need to be subjected to finished product testing using statistical sampling to ensure they’re genuine. The counterfeit pharmaceutical business is well established and has even involved licensed Canadian pharmacies and wholesalers, so no entity in Canada can be trusted, especially since we’ve previously had difficulties extraditing them for trial.

Cost of adverse medical events due to counterfeits vs. potential savings achievable

If you do miss a counterfeit and an American patient has an adverse medical event, how much of your savings that you got from “buying from Canada” gets wiped out?

Dr. Acri’s whole paper is very good. I recommend you read it if you’re into policy and not sound bites. I noticed, however, that the comments on the article elicited some common myths about Canadian drug importation that are important to address if we’re going to really understand this issue. Here are a few of them.

“I must say that I probably have as much confidence in Canadian and European Drug Control as in the [Food and Drug Administration] FDA.”

This is a common misunderstanding for people not familiar with the world of perfect-looking counterfeit medicines. Yes, the legitimate Canadian drug supply is safe, but that doesn’t mean that if you buy something that looks like a Canadian medication, even from a Canadian vendor, it’s actually a legitimate Canadian drug supply product.

In fact, there are plenty of examples of Canadians taking advantage of Americans and selling them fake medication (Quantum Solutions, TC/SB Medical). Some of the criminals have even operated as licensed Canadian wholesalers (CanadaDrugs.com) and pharmacists (Andrew Strempler).

“Any drug marketed in the USA is subject to Adverse Effect control and reporting by/to the FDA. Imported drugs are not an exception…There is of course no reason to re-check imported drugs”

The implication here is that if there’s anything wrong with a medicine, it will get caught by a healthcare practitioner and they’ll file an adverse event with the FDA, so we don’t need to do the expensive finished-product testing Dr. Acri’s models in her paper.

While it’s true that some kinds of counterfeits, like the kind made with too much fentanyl, will cause you to drop dead immediately, many other kinds with insufficient or no active ingredient are silently deadly and leave no trace or cause for a Medical Adverse Event report. There is no unusual medical adverse event even to report when you have cancer, you get a counterfeit oncology medicine, and you die of cancer. This isn’t theoretical. Counterfeits with insufficient active pharmaceutical ingredients being shipped under the 2013 Maine importation program were discovered by Dr. Kenneth McCall before a federal court invalidated the program.

Having your blood pressure spike because you’re taking a counterfeit with no active ingredient will result in your physician upping your dose or switching your medication. It’s not likely to cause them to file a medical adverse event report.

All of these reasons and many more are why four former FDA commissioners, the American and Canadian Pharmacists Association, and many law enforcement groups have all come out against Canadian drug importation as a policy. You can learn more on our website.