Florida becomes first in the nation to have Canadian Drug Importation Program approved by FDA

Press release from the Office of Governor Ron DeSantis

TALLAHASSEE, Fla. — Today, the DeSantis administration received U.S. Food and Drug Administration (FDA) approval of its Canadian Prescription Drug Importation Program. The 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 will save Florida up to $180 million in the first year.

“After years of federal bureaucrats dragging their feet, Florida will now be able to import low-cost, life-saving prescription drugs,” said Governor Ron DeSantis. “It’s about time that the FDA put patients over politics and the interests of Floridians over Big Pharma.”

“Another win against Biden and his heavy-handed bureaucrats,” said Attorney General Ashley Moody. “Florida has won many legal battles against the Biden administration, and I am pleased they finally decided to back down and stop standing between Florida and lower prescription drug prices. Great to work with Governor DeSantis, who showed strong leadership in this important fight.”

“Under Governor DeSantis’ leadership, Florida has led the nation in developing a plan to effectively and safely import prescription drugs from Canada,” said AHCA Secretary Jason Weida. “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. As we move forward, we will continue to work every day to find ways to lower costs for Florida’s vulnerable populations.”

Since 2020, Governor DeSantis and his administration have applied pressure to the Biden administration — including suing the FDA — to get approval of this critical drug importation program.

Receiving authorization from the FDA is a validation of Florida’s commitment to reduce 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 that 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.