The U.S. Food and Drug Administration says it has met with some states and Indigenous communities this month to help them import lower-cost Canadian pharmaceuticals under a program that has met with disapproval from Ottawa.
Under the first Trump administration, the FDA and the U.S. Department of Health and Human Services laid the groundwork for a program that would allow states to import drugs from Canada where average prices are cheaper.
Florida was the first state to get FDA approval to start importing medication in 2024, although as of last month it still had not imported anything.
The FDA announced Friday it had met with “several” representatives of states and Indigenous nations, which the U.S. government refers to as Indian tribes.
The agency declined to specify the identities or number of participants in the meeting when contacted by The Globe and Mail.
In a statement, FDA Commissioner Marty Makary linked the imports to the Trump administration’s wider program of addressing high drug costs. U.S. President Donald Trump issued an executive order last April that directed officials to make the drug-import program easier to access.
April 2025: White House, Florida promote Canada drug imports while tariff threat looms
But the program has generally been in the shadow of much more high-profile efforts, such as threatening tariffs on the pharmaceutical industry or demanding companies lower U.S. prices and raise them in other countries (known as most favoured nation pricing), some of which appear to run at cross purposes with the import scheme.
“We are committed to lowering prescription drug prices for Americans, building on recent MFN wins,” Dr. Makary said in a statement, referencing the most favoured nation program.
The FDA released a copy of the presentation at this month’s meeting, which gave participants guidance on how to demonstrate cost savings in their applications, including a discussion of potential tariffs.
“States may choose to generally identify tariffs as an area of uncertainty or, as appropriate, may assume that tariffs have a neutral impact for the purpose of section 804 demonstration of cost-savings,” according to the presentation, which refers to the import program as Section 804 of the Federal Food, Drug, and Cosmetic Act.
“For example, states could either assume constant tariff rates or omit consideration of a tariff on section 804 drugs imported from Canada entirely.”
Health Canada continued to express concern about the program when contact Monday, a position the department has held since Florida was first approved by the FDA in 2024.
“The Government of Canada is committed to taking all necessary action to safeguard Canada’s drug supply and ensure Canadians have access to the prescription drugs they need,” spokesperson Karine LeBlanc said in an e-mail.
“Under the Food and Drug Regulations, certain drugs intended for Canada cannot be sold for use in other countries if this could cause or worsen shortages in Canada.“
Ms. LeBlanc said manufacturers and distributors licensed by Health Canada that plan to sell a drug intended for Canadians to another market must demonstrate the sale will not cause or worsen a drug shortage in this country.