Florida Is First State Allowed to Import Drugs From Canada in Bid to Reduce Costs

The approval opens the door to a new, lower-cost source of prescription drugs, beyond the retail and mail-order pharmacies—and the U.S. supply chain they are part of—that Americans have relied on for decades to fill prescriptions. 

After years of complaining about expensive medicines, government officials have begun taking action recently. The Inflation Reduction Act gave the federal government legal authority to negotiate prices of certain drugs, while effectively capping at roughly $3,300 the yearly out-of-pocket costs for drugs in Medicare Part D plans.

Plans such as Florida’s to import drugs are likely to face obstacles, including lawsuits from drugmakers and opposition from Canadian authorities. The FDA also has raised safety concerns about importing drugs if it can’t vouch for their quality.

Yet the agency’s decision to give Florida permission adds momentum to governments’ burgeoning attempts to put a lid on soaring drug spending. The products are often priced lower in Canada and other countries. 

“The FDA is committed to working with states and Indian tribes” seeking to import drugs from Canada, FDA Commissioner Robert Califf said. “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 agency’s decision, which was earlier reported by the New York Times, allows Florida to import drugs for two years, and the state must submit quarterly reports to the agency about cost savings and potential safety issues.

Florida has said it would begin importing drugs to help people cared for by state agencies, such as the Department of Corrections or the Agency for Persons with Disabilities. The drugs would treat chronic health conditions such as asthma, diabetes, HIV/AIDS and mental illness. 

Later the program would be expanded to import drugs for Medicaid recipients. Gov. Ron DeSantis estimated the program would save the state up to $180 million in the first year.

“After years of federal bureaucrats dragging their feet, Florida will now be able to import low-cost, lifesaving prescription drugs,” DeSantis said. “It’s about time that the FDA put patients over politics and the interests of Floridians over Big Pharma.”

Shipments aren’t starting immediately. The FDA will have to approve the labels of any drugs to be imported as well as make sure the imports are authentic and are safe, among other steps.

Other obstacles could also get in the way of immediate imports. Drugmakers are expected to challenge the FDA decision in court. 

“We are deeply concerned with the FDA’s reckless decision to approve Florida’s state importation plan,” said Stephen Ubl, chief executive of the Pharmaceutical Research and Manufacturers of America, an industry trade group. “PhRMA is considering all options for preventing this policy from harming patients.”

Canadian authorities also may seek to block shipments to ensure their patients have sufficient supplies. Last year, British Columbia moved to restrict sales to Americans of drugs used for weight loss. In 2020, Canadian Minister of Health Patricia Hajdu ordered companies not to export any drugs if doing so would create or worsen shortages at home in Canada.

On Friday, Canada’s Health Minister Mark Holland said the country has regulations in place to ensure ample supply of pharmaceuticals. “Canadians can be confident that our government will continue to take all necessary measures to protect the drug supply in Canada,” he said in a statement. 

“The FDA knows full well Canada is going to steadfastly resist,” said Eric Miller, a former senior Canadian official who is now a U.S.-Canada trade consultant. He said drugmakers may curtail sales to Canada should policymakers in Ottawa allow the country to be an “entrepôt for drug sales into the U.S.”

Given the hurdles to getting a significant volume of imports, health-policy experts say the shipments are likely not going to be big enough to have an impact on drug costs.

“There are real constraints on Canada’s ability to even do this, they would basically be giving up drugs that are meant for their population to subsidize drugs for people in Florida, which is not politically reasonable to be asking from people in Canada,” said Stacie Dusetzina, a health-policy professor at Vanderbilt University School of Medicine.

American patients seeking lower-priced drugs have for years sought products in Canada, buying them online or taking trips north. But the practice was, for the most part, illegal.

Legalizing drug importation has been a rallying cry for doctors, patients and politicians seeking ways to curb high costs. 

The Trump administration first pushed for drug importation, finalizing a rule to allow states to do it in 2020. The Biden administration followed suit and issued an executive order to instruct FDA to work with states on their plans. 

Florida first filed its application with the FDA in 2020. DeSantis later accused the agency of unreasonable delay. In 2022, the state sued the FDA, prompting the agency to set a deadline for its decision—a date that went through several revisions before settling on Jan. 5. 

Several other states have submitted similar requests to FDA or have expressed interest. The agency is weighing Colorado’s application. New Hampshire’s was rejected in 2022.

Vermont’s application was deemed incomplete. The state has said it is waiting to see how the FDA handles other state’s applications before resubmitting. The Vermont health department didn’t immediately respond to a request for comment.

Paul Vieira contributed to this article.

Write to Liz Essley Whyte at liz.whyte@wsj.com