Florida becomes first state allowed to import prescription drugs from Canada

The U.S. Food and Drug Administration on Friday authorized Florida to directly import prescription drugs from Canada, making it the first state to gain such approval. Although Gov. Ron DeSantis signed the plan into law in 2019, it required federal review and approval by the FDA.

The White House called the approval “a step in the right direction” and encouraged more states to apply for importation. “For too long, Americans have been forced to pay the highest prescription drug prices of any developed nation,” spokesperson Kelly Scully said.

Importation supporters long have said that buying drugs from another country could help lower costs in the United States, where more than half of Americans are covered by private health plans. The U.S. government has taken steps to start negotiating prices. Under the Inflation Reduction Act, Medicare will be authorized to negotiate prices with drugmakers, but only for a limited number of medications, starting in 2026.

However, Canada’s drug industry tapped the brakes on the plan. In the past, the nation’s government has opposed any U.S. plans to buy Canadian prescription drugs, citing threats to the country’s drug supply or higher costs for its own citizens.

“Historically, we’ve had some pretty devastating drug shortages in Canada,” said Joelle Walker, spokesperson for the Canadian Pharmacists Association. “So the idea that they could import them from us is not really feasible.”

Drug pricing experts said the import plan would be difficult to put into place. The U.S. population is nearly 10 times the size of Canada, said Dan Ollendorf, chief scientific officer at the Institute for Clinical and Economic Review. “This is probably another area of leverage as opposed to anything that will materially make an impact,” he said. “Just the idea that a state could bring in drugs from Canada might help with negotiations over discounts and rebates.”

The U.S. pharmaceutical industry said the plan will not lead to lower costs for consumers and will put the safety of the U.S. drug supply at risk. The Pharmaceutical Research and Manufacturers of America said it is deeply concerned about the plan and is looking at its options. “The importation of unapproved medicines, whether from Canada or elsewhere in the world, poses a serious danger to public health,” PhRMA CEO Stephen Ubl said.

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Florida still must submit drug-specific information for FDA review and approval, as well as provide evidence that the drugs it seeks to import have been tested to comply with FDA standards, the agency said. FDA Commissioner Robert Califf said other states seeking similar approvals “must demonstrate the programs would result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs.”