Florida drug importation plan stalls nearly a year after approval: 5 notes

Almost a year after receiving FDA approval, Florida's plan to import lower-cost prescription drugs from Canada remains mired in delays, KFF Health News reported Nov. 21.

 Despite the green light from the Biden administration and expectations that the initiative would lower costs for state health programs, the program has yet to take effect.

Here are five notes:

1. In January 2024, the FDA approved Florida's plan to import cheaper medications from Canada, making it the first state to receive such authorization. However, Florida health officials have not yet announced a start date for the program and the state has not submitted the necessary documents for the importation process to proceed. 
   
   
2. Florida Gov. Ron DeSantis filed a lawsuit in September 2022, accusing the agency of unjustified delays in approving the proposal. The lawsuit claims the state has spent over $24 million setting up the program, but the FDA's continued inaction is costing taxpayers. The lawsuit also alleges that the FDA's delay violates a law passed in 2019 and blames the administration for a lack of transparency during the approval process. 
   
   
3. The importation program was expected to save Florida up to $180 million in its first year, primarily benefiting state Medicaid and other government health programs. However, the predicted savings are relatively small in comparison to Florida's overall Medicaid budget of $30 billion. 
   
   
4. The Canadian government has warned that exporting drugs could lead to shortages in Canada, while the pharmaceutical industry has raised concerns about the potential for counterfeit drugs entering the U.S. market with these issues complicating the implementation of the importation plan. 
   
   
5. Several pharmacy associations, including the American Society of Health-System Pharmacists have criticized the program. They argue that importing drugs from Canada could disrupt the pharmacist-patient relationship and "because it is not a meaningful response to drug pricing." Others, including the American Pharmacists Association, said it jeopardized patient safety by exacerbating the risk of counterfeit drugs entering the market.