The U.S. Food and Drug Administration has approved importation of prescription drugs from Canada into the state of Florida.
Citing significant cost benefits for patients, Florida’s Agency for Health Care Administration proposed the import model under section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
“The FDA is committed to working with states and Indian tribes that seek to develop successful section 804 importation proposals,” FDA Commissioner Robert M. Califf, M.D., said in the 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,” he added.
The section 804 importation program was approved by the FDA for a two-year authorization period.
FDA officials say implementing the Florida program supports the directives outlined in President Biden’s “Executive Order on Promoting Competition in the American Economy” in 2021.
The executive order urged the entire U.S. government to “combat the excessive concentration of industry,” specifically mentioning the “healthcare markets (including insurance, hospital, and prescription drug markets).”
The state health agency will be responsible for the safe and legal implementation of the Canadian import program, the FDA said.
The administration’s statement reads, “Florida’s obligations under the FDA’s regulations will include, among other things: ensuring supply chain integrity, monitoring and submitting adverse event reports, complying with drug recall procedures and reporting quarterly to the FDA.”
Additionally, the FDA has promised oversight of the program from the executive level, ensuring Florida “continues to meet the requirements in section 804 of the FD&C Act and the agency’s regulations.”
The staggering cost of prescription medication has become a flagship issue for Biden and his 2024 Republican rivals.
Costs for widely needed medicine such as insulin have put a crunch on the U.S. public’s wallet for years as prices continue to climb.