Florida Gets FDA Nod to Import Drugs From Canada

After submitting its plan to import drugs from Canada more than three years ago, Florida’s Agency for Health Care Administration (AHCA) has been notified that the U.S. Food and Drug Administration has approved Florida’s Canadian Prescription Drug Importation Program.

In a Jan. 5 letter to AHCA Secretary Jason Weida, The Office of Compliance Center for Drug Evaluation and Research wrote that under Section 804 Importation Programs (SIP), “Florida has demonstrated that it meets the statutory obligation to ensure that importation under section 804 will significantly reduce the cost of covered products to the American consumer without posing additional risk to the public’s health and safety.”

As a result, the FDA is authorizing for a period of two years, the AHCA to import drugs with certain labeling as required by the SIP.

According to Gov. Ron DeSantis, the approval of the AHCA plan was granted after the state sued the FDA for its delay in approving the program.

“After years of federal bureaucrats dragging their feet, Florida will now be able to import low-cost, life-saving prescription drugs,” DeSantis said. “This approval will save Florida up to $180 million in the first year.”

Specifically, the FDA’s approval letter said that the AHCA must ensure that the drugs Florida seeks to import have been tested for, among other things, authenticity and compliance with the FDA-approved drugs’ specifications and standards and will be relabeled to be consistent with the FDA-approved labeling.

Also, under the approval, Florida’s AHCA must report to the FDA information about the imported drugs, cost savings and any potential safety and quality issues connected to the imported prescription drugs.
According to the Governor’s office, 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.

Those drugs will be available to individuals who are under the care of the Agency for Persons with Disabilities (APD), the Department of Children and Families (DCF), the Department of Corrections (FDC), and the Department of Health (DOH).

Afterward, the program will then expand to include providing imported prescription drugs for Medicaid members across the state.

The approval of the drug import plan will save Floridians an estimated $180 million during the first year, DeSantis’ office said.