FDA authorizes Florida drug importation proposal

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On January 5, 2024, FDA authorized Florida’s Section 804 Importation Program (SIP) proposal to allow Florida’s Agency for Health Care Administration (AHCA) to import drugs from Canada for a period of two years. AHCA revised their 2020 proposal to the FDA several times and submitted clarifying communications prior to the agency’s determination. While eight other states have laws that permit drug importation, and six of them are seeking FDA approval, this is the first time that the FDA has approved a state entity to import drugs from another country.[1][2]

For a state to be able to import drugs, there are a number of hurdles it must overcome. Section 804 of the of the Federal Food, Drug, and Cosmetic Act requires the state to ensure that importation of drugs from Canada will significantly reduce the cost of the drugs to the consumer without posing additional risk to health and safety. The sponsor must specify the drugs that will be imported, and those drugs must be approved by Health Canada’s Health Products and Food Branch (the Canadian equivalent to FDA).