Pharmacy Groups Object to Florida’s Drug Importation Program

Washington, D.C.—Major pharmacy associations expressed deep concern about the FDA’s authorization of a state drug importation program in Florida.

“Our pharmacy organizations are deeply concerned about FDA’s recent authorization of a state drug importation program, which could open the door for harmful and counterfeit drugs to enter our nation’s drug supply, with no evidence that this will result in cost savings for our patients,” according to a statement from the American Pharmacists Association, the Academy of Managed Care Pharmacy, the American Association of Colleges of Pharmacy, the American Association of Psychiatric Pharmacists, the American College of Clinical Pharmacy, the American Society of Health-System Pharmacists, the Hematology/Oncology Pharmacy Association, the National Alliance of State Pharmacy Associations, the National Association of Boards of Pharmacy, the National Community Pharmacists Association, the Society of Infectious Disease Pharmacists, and dozens of state and territorial pharmacy groups.

In early January, the FDA authorized Florida’s Agency for Health Care Administration to import certain drugs under specific conditions. Under current law, the FDA can only authorize importation if the program will significantly reduce the cost to the American consumer without imposing additional risk to public health and safety. The pharmacy groups pointed out that FDA’s announcement did not contain any data or information that assure that the standard has been met.

The authorization came under section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). “This is the first step on this pathway toward Florida facilitating importation of certain prescription drugs from Canada,” the FDA said, adding that it might authorize section 804 importation program (SIP) proposals from states or Indian tribes to import certain prescription drugs from Canada if the SIP will significantly reduce the cost to the American consumer without imposing additional risk to public health and safety. 

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