FDA Issues Proposed Rule and Draft Guidance on Drug Importation

King & Spaulding

In late December 2019, the Food and Drug Administration (FDA), an agency operating within the Department of Health and Human Services (HHS), issued two documents—a Proposed Rule and a Draft Guidance—intended to establish two pathways for drug importation. HHS previewed these approaches in its Safe Importation Action Plan last July.

These proposed pathways are broadly, if not necessarily effectively, aimed at reducing U.S. drug prices in two different ways:

1. The Proposed Rule sets out a means by which States and certain other non-federal governmental entities would be permitted to import certain drugs (notably excluding biologics and many specialty pharmaceuticals) from Canada. Manufacturer consent is not required for importation under this “Pathway I,” but many manufacturer obligations and risks flow from it.

2. The Draft Guidance creates a framework under which manufacturers could choose to bring their drugs that are manufactured and intended for sale outside the U.S. into the U.S. market. This “Pathway II” would permit both “domestic” National Drug Codes (NDCs) and “imported” NDCs of the same product to be marketed simultaneously.

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