FDA Approves Florida Plan to Import Drugs from Canada

Jan. 5, 2024 – U.S. regulators on Friday approved a plan to allow Florida to import medicines, describing this as a step toward allowing the state to purchase medicines directly from Canada at a lower cost.

The FDA authorized Florida’s Agency for Health Care Administration’s drug importation program. The state must next fulfill several obligations, including showing that the drugs it seeks to import have been tested for, among other things, authenticity and compliance with FDA specifications and standards, the agency said.

This is the first approval of a state drug importation plan. It marks a win for lawmakers in both parties who have for many years seen Canadian drug importation as a way to reduce U.S. pharmaceutical costs. Backers of this concept include both Democrats, like President Joe Biden and U.S. Sen. Elizabeth Warren of Massachusetts, and Republicans, like former President Donald Trump and Florida Gov. Ron DeSantis.

But pharma groups in the U.S. vowed to fight the plan. 

In a Friday statement, the trade group for drugmakers, Pharmaceutical Research and Manufacturers of America (PhRMA) said it is considering “all options” for blocking Florida’s plan to import medicines from Canada.

And it’s unclear how well state drug importation plans would work out in practice if they go into effect. 

Canadian officials and medical organizations have long objected to the idea of massive importation into the United States. For example, the Canadian Pharmacists Association in 2020 warned the FDA during the Trump administration that such a diversion of its medicines would be “devastating” to a nation, aggravating drug shortages and increasing drug costs.

Many people in the U.S. already make trips to Canada and Mexico in search of lower prices. 

The FDA has been working for years on regulations to allow broader drug imports. The agency in 2022 rejected a request from New Hampshire, citing a lack of key information, including details on the expected supplier of the medicines. Other states where lawmakers have seriously considered drug importation include Colorado, Maine, New Mexico, Ohio, and Vermont, according to a December 2023 report from the Texas Health and Human Services department.

In a Friday statement, FDA Commissioner Robert M. Califf, MD, said his agency will work with other states and with Native American tribes on plans for importing drugs.

“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 said in a statement.