Trump’s executive order on drug importation directs the Secretary of Health and Human Services (HHS) to grant waivers expressly allowing personal drug importation. Unlike most of his executive orders, this one is fully consistent with federal law [18 USC 384(J)] (“Part J”). During the executive order signing ceremony a few weeks back, HHS Secretary Alex Azar bragged about Trump’s willingness to move forward on personal importation:
“Presidents before you have promised over and over again to allow importation; the safe importation of drugs from lower cost countries, you’re the first present to deliver on it.”
Not so fast! The executive order does empower greater action on Part J but a next step is where the rubber hits the road. What Americans want now, Republicans and Democrats among them, is to receive those waivers!
Keep in mind, the whole of Part J does not limit personal imports to those from Canada. Under Part J, consumers could import medicines from anywhere. In fact, Part J (1) protects those imports already but you can read more about that here. Currently, Americans are not just importing prescription drugs from Canada but from Australia, India, New Zealand, Turkey, the UK and other countries, too. In contrast, J (3) specifically relates to Canada and recommends creating basic safety rules to allow it.
The Executive Order specifically references Part J (2), which states:
“The Secretary shall publish, and update as necessary, guidance that accurately describes circumstances in which the Secretary will consistently grant waivers on a case-by-case basis under subparagraph (A), so that individuals may know with the greatest practicable degree of certainty whether a particular importation for personal use will be permitted.”
As noted in my public comments to the FDA’s December Notice of Proposed Rulemaking on Importation, the agency used tired drug company talking points about online pharmacies and counterfeit drugs as an excuse to declare that the new rule is not implementing new provisions to Part J. But that was then. Now, Azar must do so.
I recommended many ideas for how to do this, but today I put forth the idea that a waiver should simply be granted to anyone who travels to Canada and wants to import a prescription drug purchased in a Canadian pharmacy. Brand name drugs are often 75% less in Canada than in the United States. It’s not that people should be stopped from buying drugs online from Canada or other places. Obviously, they should be allowed to. But the FDA has no excuse on a Canada-only by travel personal drug importation waiver. There is no online pharmacy boogeyman to lead on. Former FDA Commissioner Scott Gottlieb stated:
“Canadians have safe drugs and if you go into a brick and mortar pharmacy and you purchase a drug, you’re getting a safe and effective drug. I have confidence in the Canadian drug regulatory system.”
The FDA could set up a portal for residents who wish to sign up for waivers, which should be easily obtained. Some people might wonder why this should be done when people already travel to Canada and Mexico, not to mention other countries, and bring back much more affordable drugs without fear of legal trouble. The reason is to alert more people who are struggling to afford their medication that it can be done, and it’s something the government now expressly permits.