Trump administration announces plan to import drugs from Canada
This morning, the Trump administration announced it will begin the process of setting up a system for the importation of drugs into the US from Canada. The announcement follows months of consumer complaints regarding the high costs of drugs, and conversations with individual states regarding the potential importation.
“The landscape and the opportunities for safe linkage between drug supply chains has changed. That is part of why, for the first time in HHS’s history, we are open to importation. We want to see proposals from states, distributors, and pharmacies that can help accomplish our shared goal of safe prescription drugs at lower prices,” Azar said during the announcement.
The plan establishes two pathways for importation. The first would permit states, wholesalers, or pharmacists to submit plans for demonstration projects for HHS to review how they would import Health-Canada approved drugs that are in compliance with section 505 of the FD&C Act. The first pathway sets standard rules and regulations for the process.
“The importation would occur in a manner that adequately assures the drug is what it purports to be and that meets the cost requirements of the rulemaking. The demonstration projects would be time-limited and require regular reporting to ensure safety and cost conditions are being met,” the plan explains.
The second pathway provides guidelines for how the importation of drugs from Canada would be allowed. The FDA would provide recommendations to manufacturers of FDA-approved drugs who seek to import into the U.S. versions of those drugs they sell in foreign countries. Under this pathway, manufacturers would use a new National Drug Code (NDC) for those products, potentially allowing them to offer a lower price than what their current distribution contracts require, according to the report.
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The plan states that the administration believes that the second pathway may be the best option to provide Americans with the lower cost option.
“A manufacturer that met the requirements for this pathway could sell a foreign version of a drug product in the U.S. under a different NDC number than the U.S. version, which could allow the manufacturer to introduce the product at a lower price,” the report explains.
The administration will further research the efficacy of this option to see if costs can be significantly reduced and if there is additional need for Pathway 1 altogether.
Canadian officials have warned against the importation of drugs to the US for fear that it may negatively impact their drug supply, and increase prices for Canadians.