Importing Drugs From Canada: How Risky Is It? Former FBI Director Weighs In

Mar 21, 2019

Maine Senate President Troy Jackson and a number of Democratic leaders are pushing forward two bills to explore importing drugs from Canada. One bill would look at allowing individuals to access prescription drugs from Canada, the other would set up a wholesale system.  The bills are aimed at reducing prescription drug costs for Maine residents.

But critics say it's risky business. Former FBI Director Louis Freeh recently released a report criticizing drug importation efforts.  He spoke with Maine Public's Morning Edition host Irwin Gratz earlier from a conference in Florida on the very matter. But it turns out that Freeh's perspective and Sen. Jackson's aren't as far apart as one might expect. Freeh says he worries about where the drugs are manufactured.

LOUIS FREEH: So with respect to medicines, you know we have in the U.S. a closed supply system with respect to pharmaceuticals, which means licensed pharmacists dispense FDA-inspected and approved drugs. What's happening now is a great enhancement - and actually political pressure - to allow foreign-made medicines to come into the United States, on the argument that they can be cheaper and more competitive. And we focused on this because we are finding that many of these are counterfeits. Some of them have dangerous elements such as fentanyl in them. And, more importantly, the manufacturing process is not inspected or regulated. These are medicines which are made in other countries, made under very unsupervised, unsanitary conditions. And then they are transshipped to Canada, and from Canada they come to the U.S. And the Canadian authorities have been very clear that they don't inspect, or even know the content of, these materials, which is why all of our FDA commissioners have refused to allow the importation of foreign-made medicine.

GRATZ: Fair enough. But we can't be the only country that has a really well-established closed system for medication. Are there any places where United States consumers could reasonably look for medications and rely on their efficacy and safety?

FREEH: Yeah, I think I think that's right. I think you could go to Canada, you could go to a licensed pharmacy and buy a prescription, or have a prescription sold there by a doctor, and be fairly confident that the content is safe because it's regulated and inspected by the government there. But that's not the case when you're buying something transshipped into the United States.

GRATZ: OK. So the real problem here is kind of the mail order part of this, and that kind of getting disconnected from those systems.

FREEH: Yes, exactly. It's being untethered from a safety and inspection system. 

GRATZ: OK. Obviously, this desire to do this mail order comes in large part from the fact that prescription medication can be very expensive here. Would you not say that perhaps by having someone - the government, drug companies - deal with the price of medications via other countries, you could essentially eliminate the demand for this kind of activity?

FREEH:  You know, as I've studied this there's smarter and safer ways to reduce pharmaceutical costs than just allowing sort of free market competition from foreign-made pharmaceuticals.

GRATZ:  Such as?

FREEH:  You know, we have - in our system here - we have we have a middle person broker agent who's called the pharmacy benefit manager. They take a large fee and commission for agency work that could probably be substantially reduced.

GRATZ:  Lastly let me just ask you since, you know, limiting the purchase of mail order drugs is a potential benefit to prescription drug companies, have any of them contributed financially toward your work in this area?

FREEH: Yes, they're are sponsors of the Partnership for Safe medicines, which is also made up of law enforcement groups, pharmacists - you know, other interested stakeholders, and, of course, the pharmaceutical companies have a major interest here precisely because a lot of the medicines being made are counterfeit, and they're using their name and brand to sell and distribute to people who think they're taking one substance but it's not what they believe it is.

GRATZ: Director Freeh, thank you again for the time.

FREEH: Sure.

GRATZ: I really appreciate it.

FREEH: You're welcome. 

As far as safety concerns go, Maine Senate President Troy Jackson says that's a priority for him as well.  He cites Canada's Federal Drug Administration classification as one of four "tier 1" countries.

"So the FDA feels that these four countries have as good, if not better, safety standards than the United States. Then there's absolutely no reason that we can't set up a system that we're importing from any number of these countries, " Jackson said.

Regarding Jackson's proposed bill to design a wholesale prescription drug importation program to allow drug imports from Canada, that has been referred to both the House and Senate committees on Health Coverage, Insurance and Financial Services.

Originally posted 6:42 a.m. March 21, 2019.