Americans who have been relying on trips to Canada for cheaper prescription drugs may not be able to do so for about a month, but really who knows how long. As reported in the Washington Post yesterday, to slow the spread of the Coronavirus, President Trump and Prime Minister Justin Trudeau of Canada agreed to close the border yesterday to all but “essential” travel.
SPECIAL NOTE: On this blog I’m sometimes a bit snarky in poking fun at drug companies, drug company-funded groups and the FDA when it comes to their public education information about drug importation and buying drugs online. But let’s face it: we need drug companies and the FDA more than ever right now, and I wish them Godspeed in efforts to find and approve treatments to fight COVID-19. Within that spirit of coming together, I’ll continue to raise the same issues found on this blog.
When the border re-opens, the FDA should immediately, expressly permit personal drug imports from Canada. I’m not talking about “Canadian online pharmacies” or buying on the Internet. I do believe people should be able to do that as well, but my focus for this post is on border crossing prescription drug imports by individuals from Canada.
Last week, many organizations, companies and people submitted public comments in response to the FDA’s Notice of Proposed Rulemaking (NPRM) about Section 804 of the Food, Drug and Cosmetics Act, which makes importation of prescription drugs legal, subject to safety and savings certification by the Secretary of the Department of Health and Human Services (DHHS). The FDA, which is an agency withing the DHHS, plays a big part in making that decision. That NPRM is focused on wholesale importation, but my comments focused on personal importation.
The U.S. accepts that drugs sold in Canada do not pose any additional health risk to those sold here. Even before the Trump administration formally announced its importation proposal, which recognizes the safety of drug importation from Canada, former FDA Commissioner Dr. Scott Gottlieb made this abundantly clear during testimony before Congress in 2019:
“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.”
Federal law under Section 804 J(3) is clear that the Secretary of Health and Human Services can permit Americans to travel to Canada, buy prescription drugs for their own use, and bring them back. It could be done through special waivers or general regulation. It should be a general regulation so that there’s no gray about the policy and Americans don’t have to go through unnecessary red tape to go buy a more affordable prescription drug. For people who take insulin, especially to treat type 1 diabetes, this could be lifesaving.
Yes, I know, millions of Americans already import medicines for personal use from Canada and other countries, but they don’t have express permission and it’s technically illegal under most circumstances. Implementing Part J(3) would not make personal importation expressly legal but it would expressly permit it. Even though there’s no safety and essentially no regulatory risk to such imports now, some may avoid it anyway because of the federal prohibitions or confusion about what to do and what is safe. Express permission to do so from the FDA, at least from Canada, in-person, will mean more people who can obtain medicines at lower cost. It will reduce the number of Americans who are not taking needed medications because of cost. It’s not a greenlight to internet purchases but simply to cross the border for necessary, safe and affordable medicines. It’s the right thing to do.