The U.S. Food and Drug Administration on Friday authorized a Florida program to import prescription drugs from Canada, where they are often much cheaper than in the U.S., making the Sunshine State the first to get the regulator’s green light for such a plan.
The FDA’s action on the plan by Florida’s Agency for Health Care Administration authorizes the program for two years from the date the agency is notified of the first shipment of drugs to be imported.
While individuals in the U.S. can buy medications directly from Canadian pharmacies, state-led programs to buy drugs in bulk have only inched toward implementation in recent years. The U.S. Department of Health and Human Services in 2020 finalized rules allowing states to submit importation-program proposals for FDA review. Under federal law, the FDA can authorize the programs if they significantly cut costs to consumers without posing additional public health and safety risks.
Florida has said that once fully implemented, the program could save the state’s taxpayers up to $150 million a year. In the program’s initial phase, the state has said it plans to import drugs to treat HIV/AIDS, diabetes, hepatitis C, mental illness and other conditions.
Importation programs face stiff industry opposition. Drug-industry trade group Pharmaceutical Research and Manufacturers of America blasted the FDA’s authorization Friday. Calling the move a “reckless decision,” the organization’s president and CEO, Stephen Ubl, said in a statement, “the importation of unapproved medicines, whether from Canada or elsewhere in the world, poses a serious danger to public health.” The trade group “is considering all options for preventing this policy from harming patients,” Ubl said.
The FDA’s authorization comes after Florida in 2022 filed a lawsuit against the agency in a Florida federal court, alleging that its proposal had been pending for nearly two years while the the FDA “provided no outward evidence of substantive progress toward approving the proposal” and seeking records related to the review and approval process.
The FDA in a court filing denied that it had delayed action or been inactive on Florida’s proposal.
Other states that have proposed programs similar to Florida’s include Colorado, New Hampshire and Vermont.
Before drugs can be imported, Florida must submit additional drug-specific information for FDA review, ensure that the drugs it plans to import have been tested for authenticity and compliance with FDA standards, and relabel the drugs to be consistent with FDA-approved labeling, the agency said.
The state must also submit a quarterly report including details on the drugs imported, cost savings and any potential safety or quality issues, the agency said.
