On July 31, the U.S. Department of Health and Human Services (HHS) announced a Safe Importation Action Plan (“Action Plan”) created with the Food and Drug Administration (FDA) to “allow the importation of certain prescription drugs originally intended for foreign markets,” particularly Canada. According to the HHS Secretary Alex Azar, “[the Action Plan] outlines the pathways the Administration intends to explore to allow safe importation of certain prescription drugs to lower prices and reduce out of pocket costs for American patients.” The two pathways describe (1) the application of existing legislation to allow the import of specific drugs from Canada and (2) FDA guidance to allow manufacturers to import cheaper versions of their FDA-approved drugs that are being sold in foreign countries.
Under Pathway 1, a Notice of Proposed Rulemaking (NPRM) relying on section 804 of the Federal Food, Drug and Cosmetic Act (FD&C Act), would, when finalized, authorize proposals (“demonstration projects”) from States, wholesalers, and pharmacists that describe how they would import drugs from Canada. Demonstration projects would be required to provide a detailed plan for the safe import of Health-Canada approved drugs that are in compliance with section 505 of the FD&C Act. Only drugs that are versions of FDA-approved prescription medications would be eligible for importation, and controlled substances, biological products, infused drugs, intravenously injected drugs, drugs inhaled during surgery, and certain parenteral drugs listed in section 804(a)(3) would be excluded from consideration. Key points addressed by the NPRM include the provision of certification to Congress that implementation of section 804 to the drug would pose no additional risk to the public’s health and safety, and evidence that a significant reduction of the cost of the covered product to the American consumer would be achieved.
Under Pathway 2, manufacturers of FDA-approved drug products would be able to import versions of their approved drugs that they sell in foreign countries into the U.S. To use this pathway drug manufacturers would have to establish that the foreign version is the same as the U.S. version (for example, with manufacturing records). The Administration expressed that this pathway may provide an opportunity for manufacturers to offer Americans lower cost versions of their own drugs that they would otherwise be unable to achieve due to contract agreements with suppliers. Notably, while the import of biosimilars is likely precluded under Pathway 1 under the umbrella of “biological products”, there is no explicit prohibition on the import of biosimilars under Pathway 2.
Joelle Walker, vice president of public affairs for the Canadian Pharmacists Association, suggested that the Action Plan may exacerbate drug shortages in Canada, stating “we aren’t equipped to deal with a country that is ten times our size.” FDA Acting Commissioner Ned Sharpless stated “[the FDA] recognizes there are many operational challenges and questions that we need to overcome before these policies can be implemented” and that “HHS and FDA will continue to work through these questions and look forward to announcing the NPRM and draft guidance for public comment in the coming months.”