Health Canada has reaffirmed its commitment to safeguarding the country’s drug supply, stating it is “taking all necessary action” to ensure Canadians have continued access to essential prescription medications. This comes as the United States pushes forward with plans to import lower-cost drugs from Canada.
On Wednesday, the U.S. Food and Drug Administration (FDA) introduced new guidance to advance President Donald Trump’s drug pricing initiative. The guidance invites states and tribal entities to develop proposals for importing prescription drugs from Canada, under the FDA’s Section 804 Importation Program. This program aims to provide Americans access to more affordable medications, especially branded drugs, which are often significantly cheaper in Canada.
The move follows an executive order signed by Trump directing health agencies to leverage all available tools to reduce drug prices. Among those tools is increased access to foreign drug markets, particularly Canada’s. The administration has warned pharmaceutical companies to meet new pricing targets or face consequences—including expanded drug importation efforts.
Last year, the FDA approved a plan by Florida to begin importing Canadian drugs. However, there is no clear evidence that any medications have actually been imported under this plan so far.
In response to the U.S. efforts, Health Canada emphasized that Canadian drug manufacturers, distributors, and wholesalers are prohibited under the country’s Food and Drug Regulations from exporting medications if doing so could lead to or worsen a domestic drug shortage. The agency warned it will take swift action against any violations, which could include public advisories, enforcement actions, or the revocation of licenses.
Health Canada also issued a reminder to pharmaceutical companies operating in Canada that compliance with national regulations is mandatory and essential to maintain drug availability within the country.
Meanwhile, the U.S. Department of Health and Human Services (HHS) released additional details on its drug pricing targets. Pharmaceutical companies will be expected to match the lowest prices found in member countries of the Organization for Economic Cooperation and Development (OECD) with gross domestic products at least 60% of that of the U.S.—including countries like Canada and various European nations.
The U.S. remains committed to lowering prescription drug costs, but the success of its importation strategy will ultimately depend on Canada’s willingness to cooperate—something its health authorities appear reluctant to do amid concerns about domestic shortages.
