FDA Authorizes First Section 804 Importation Program in the U.S.
On January 5, 2024, the U.S. Food and Drug Administration (FDA) authorized Florida’s Agency for Health Care Administration’s drug importation program under section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This is the first step toward Florida facilitating importation of certain prescription drugs from Canada. The authorization holds for 2 years, beginning when Florida notifies the FDA of the first imported drug shipment. This is the first authorization of a section 804 importation program (SIP) in the United States. Although several other states have passed bills that establish drug importation programs, none are certified yet by the FDA. While drug importation on a large scale has the potential to lower prices for cash-paying patients, it is likely not a viable means to an overall lowering of drug prices in the United States, given concerns regarding safety, cold chain logistics, and uncertainty around cost savings.