Florida - Monday January 8, 2024: The DeSantis administration Friday received U.S. Food and Drug Administration (FDA) approval of its Canadian Prescription Drug Importation Program.
“After years of federal bureaucrats dragging their feet, Florida will now be able to import low-cost, life-saving prescription drugs,” said Governor DeSantis.
Florida's Agency for Health Care Administration (AHCA) submitted this first-of-its-kind plan to safely import cheaper drugs from Canada to the FDA nearly 37 months ago, and after filing a lawsuit against the FDA due to delays, has finally received approval. This approval could save Florida up to $180 million in the first year.
“After three 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," said AHCA Secretary Jason Weida.
Receiving authorization from the FDA is a validation of Florida’s commitment to lower prescription drug costs while maintaining the highest safety standards. In its Section 804 Importation Program (SIP) proposal, the State outlined its processes for ensuring these goals by providing the following:
- Detailed information on how Florida will conduct visual inspections and laboratory testing to detect any potential counterfeit drugs and preserve the integrity of the U.S. prescription drug supply.
- A cost analysis demonstrating how importing prescription drugs from Canada will result in savings of up to $183 million per year once the program is fully implemented.
- An explanation of how the State will ensure a secure prescription drug supply chain that is compliant with current federal regulations such as the Drug Supply Chain Security Act and the Pure Food, Drug, and Cosmetic Act.
- A return plan that will protect the safety of Floridians in the event that imported prescription drugs are recalled.
The state will begin by providing prescription drugs in a small number of drug classes which will include maintenance medications to help individuals who have chronic health conditions such as HIV/AIDS, mental illness, prostate cancer, and urea cycle disorder.
These drugs will be for individuals who are under the care of the Agency for Persons with Disabilities (APD), Department of Children and Families (DCF), Department of Corrections (FDC), and Department of Health (DOH). The program will then expand to include providing imported prescription drugs for Medicaid members across the state.