Health and Human Services (HHS) Secretary Alex Azar July 31 announced a new action plan to lay the foundation for the importation of certain prescription drugs from Canada and other countries.
The Safe Importation Action Plan describes two pathways to “provide safe, lower cost drugs to consumers.” The first is through a Notice of Proposed Rulemaking that would rely on current Food and Drug Administration (FDA) authority to authorize demonstration projects to allow importation of drugs from Canada. The demonstration projects would be time-limited and include conditions to ensure safety and achieve significant cost savings to consumers. Certain drugs, including biologics, infused drugs, and intravenously injected drugs, would be ineligible for importation.
Under the second pathway, the FDA would provide recommendations to manufacturers that voluntarily choose to import versions of FDA-approved drugs that they sell in foreign countries. In this situation, manufacturers that choose to offer lower-cost versions of drugs that are already on sale in the United States could repackage the drugs and sell them as different products. The manufacturer would need to establish with FDA that the foreign version is the same as the U.S. version. This pathway does not exclude any class of drugs.
FDA Acting Commissioner Ned Sharpless, MD, highlighted his support of this plan and added, “We know there are many operational challenges to address through each of these pathways, and are actively working through them as we look to formally announce these policies, with opportunity for public comment, in the coming months.”