The U.S. Food and Drug Administration has approved the importation of prescription drugs from Canada to Florida.
The Florida Department of Health Services proposed an importation model under Section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), citing significant cost benefits for patients.
“FDA is committed to working with states and Indian tribes seeking to make Section 804 import proposals successful,” FDA Commissioner Robert M. Calif, M.D., said in a statement.
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A man approaches the counter of a bilingual pharmacy in Miami Beach, Florida. (Jeffrey Greenberg/Universal Images Group via Getty Images)
“These proposals would need to demonstrate that the program would provide significant cost savings to consumers without increasing the risk of exposure to unsafe or ineffective drugs,” he added.
The Section 804 import program was approved by the FDA for a two-year approval period.
FDA officials say the implementation of the Florida plan supports the directives outlined in President Biden's 2021 Executive Order Promoting Competition in the American Economy.
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A sign can be seen outside the Food and Drug Administration headquarters in White Oak, Maryland. (Reuters/Andrew Kelly/File Photo)
The executive order called on the entire U.S. government to “combat industrial overconcentration,” and specifically mentioned “health care markets, including insurance, hospitals, and prescription drug markets.”
According to the FDA, provincial health departments are responsible for the safe and lawful implementation of Canadian import programs.
“Florida's obligations under FDA regulations include ensuring supply chain integrity, monitoring and filing adverse event reports, complying with drug recall procedures, and quarterly reporting to FDA,” the administration's statement said. It says “included.”
Pictured: Prescription drug shelves at a Walgreens pharmacy in Miami. (Photo by Jeffrey Greenberg/Universal Images Group, Getty Images)
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Additionally, FDA has promised to oversee the program from an administrative level to ensure that Florida “continues to meet the requirements of Section 804 of the FD&C Act and FDA regulations.”
The staggering cost of prescription drugs has become a major issue for Biden and his 2024 Republican rivals.
The prices of widely needed medicines such as insulin have continued to soar, putting pressure on Americans' wallets for years.
