What’s Next for Drug Importation? Potential Next Steps After FDA Authorizes Florida’s Section 804 Importation Program

On January 5th, 2024, the U.S. Food and Drug Administration approved Florida’s Section 804 Importation Program, marking the first time that the FDA has approved a program that would enable the importation of Canadian prescription drugs under Section 804 of the Federal Food, Drug, and Cosmetic Act.  The state of Florida is, therefore, closer to implementing a Canadian drug importation program than any state has been before.  In this article, we summarize the remaining, potentially significant hurdles to surmount before drug importation could commence; the prospects of renewed litigation challenging such an importation program; and the legal, policy and market-based implications of Florida’s authorized importation program, assuming importation does indeed begin.

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