The state must submit additional information about the drugs it intends to import before the first shipments are sent to the U.S.
Pictured: A Canada.–U.S. border crossing/iStock, ehrlif
The Sunshine State has been given the go-ahead from U.S. regulators to bring in prescription drugs from north of the border.
On Friday, the FDA authorized Florida’s Agency for Health Care Administration’s drug importation program, paving the way for the state to import prescription drugs from Canada. The state importation proposal (SIP) will “significantly reduce the cost” of the drug to consumers, according to the agency’s statement, without adding any additional risks to health and safety.
Florida’s program is authorized for two years from the first date the FDA is notified that the shipment of drugs is to be imported. Still, the state must submit additional drug-specific information for the FDA to review and approve before the first shipments leave Canada. Florida must also demonstrate that the drugs have been tested for compliance and authenticity within the FDA’s specifications and standards and have FDA-approved labels.
Once imports begin, the state must send a quarterly report to the FDA, including information about the imported drugs, cost savings, and any safety and quality issues.
“The FDA is committed to working with states and Indian tribes that seek to develop successful section 804 importation proposals,” FDA Commissioner Robert Califf said in a statement. “These proposals must demonstrate the programs would result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs.”
The FDA will also oversee the project to ensure that the proposal is followed and meets regulations. Florida will also be responsible for maintaining the integrity of the supply chain and compliance with recalls.
Florida’s push for drug importation has been going since at least 2022 when Sen. Marco Rubio (R-FL) penned a letter to Commissioner Califf to approve the state’s proposal.
The approval also comes at a time when consumers continue to pay a higher price for prescription drugs. A 2022 report from PharmacyChecker stated that Americans were paying more for prescription drugs than the nations that were manufacturing them.
Wider importations from Canada were being considered back in 2019 as the former Trump administration announced it was looking at proposals to allow U.S. consumers to buy drugs legally from across the northern border.
Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.
