FDA authorizes Florida plan to import prescription drugs from Canada

Key takeaways:

• Florida is the first state to receive authorization for a drug importation program.
• The state said it plans to import drugs for HIV/AIDS, mental illness, prostate cancer and urea cycle disorder.

The FDA on Friday authorized a drug importation plan for Florida’s Agency for Health Care Administration that will enable the state to import prescription drugs from Canada, according to an agency news release.

Florida, the first U.S. state to gain approval from the FDA to import prescription drugs under section 804 of the Federal Food, Drug and Cosmetic Act, was authorized to import specific drugs from Canada for 2 years.

“The FDA is committed to working with states and Indian tribes to develop successful section 804 importation proposals,” FDA Commissioner Robert M. Califf, MD, said in the FDA release. “These proposals must demonstrate the programs would result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs.”

In a press release from the Florida governor’s office, the Agency for Health Care Administration (AHCA) said the state will start providing prescription drugs “in a small number of drugs classes” for chronic conditions such as HIV/AIDS, mental illness, prostate cancer and urea cycle disorder.

Initially, the medications will be distributed to people under the care of the state’s Agency for Persons with Disabilities, Department of Children and Families, Department of Corrections and Department of Health. The program will later expand to provide prescriptions for Medicaid members, according to the governor’s office.

Florida officials estimate that importing drugs from Canada, once the program is fully implemented, could save state residents up to $183 million per year.

“After 3 long years of waiting for FDA approval, we are excited to finally have the opportunity to see this vision come to fruition and provide Floridians access to safe and affordable prescription drugs,” Jason Weida, AHCA secretary, said in the governor’s office release.

Reference:

• Florida becomes first in the nation to have Canadian drug importation program approved by FDA. https://www.flgov.com/2024/01/05/florida-becomes-first-in-the-nation-to-have-canadian-drug-importation-program-approved-by-fda/. Published Jan. 5, 2023. Accessed Jan. 5, 2023.