Scott Lassman, JD, partner in Goodwin's Technology and Life Sciences Group, explains some of the challenges with proposals to allow the United States to import cheaper drugs from Canada or other highly regulated pharmaceutical markets.
Can you comment on what some of the regulatory challenges would be with importing drugs from Canada, or from other well-regulated nations?
I think the main issue—there’s 2 main issues. One, if you look at it from the FDA point of view, it really undercuts FDA’s authority because what you’re saying is that, even if a drug isn’t approved in the United States, it can come in to the United States and be marketed here, and FDA really has not say over it. I think that’s something the FDA doesn’t like, just from an institutional point of view.
On the safety side, though, I think there are some real concerns, because even though some of these products may come from well-regulated companies, the way the drug distribution system is now, you don’t really know where things are coming [from]. So, things may look like they’re coming from Canada, and they’re really coming from—I don’t want to disparage any countries—but you know, from a less well-regulated country.
Particularly with all the concerns that have been swirling around in recent years about drug counterfeits, once you open the spigots that way, it makes it almost impossible to prevent and stop these counterfeit products from coming in, or at least it makes FDA’s job much more difficult.
There actually is a law on the books right now which would allow imports from Canada, I believe, but the Secretary of HHS has to make a certification that it can be done safely and thus far, I think this goes back to, I want to say back to Bush but, thus far, no HHS Secretary has been willing to make that certification, and I think that’s because of drug safety issues.