FDA: Florida Can Import Cheaper Drugs From Canada

The U.S. Food and Drug Administration (FDA) on Friday authorized Florida to directly import prescription drugs from Canada, making it the first state to get approval for a plan aimed at bringing cheaper medicines to Americans.

Drug costs in the United States are higher than any other nation in the world by two to three times.

Supporters of importation policy, which has been considered for years, have said buying drugs from another country could help lower costs in the United States.

The pharmaceutical industry has opposed the plans and said it will not lead to lower costs for consumers and put the safety of the U.S. drug supply at risk.

The industry's major lobbying organization, the Pharmaceutical Research and Manufacturers of America (PhRMA), said it was "deeply concerned with the FDA's reckless decision to approve Florida's state importation plan" and considering "all options to prevent the policy from harming patients."

"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 in an emailed statement.

Former U.S. President Donald Trump in 2020 finalized a plan that included a measure allowing states to submit import proposals to the FDA. The Biden administration subsequently followed with an order for the FDA to work with states on the plans.

The regulator said on Friday it was committed to working with other states seeking to gain similar approvals.

FDA Commissioner Robert Califf said proposals from other states "must demonstrate the programs would result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs."

Before Florida can import drugs, it needs to submit more drug-specific information for the FDA's review and approval, and evidence that the drugs it seeks to import have been tested to comply with FDA's standards, the agency said.

Florida's administration will also be required to submit a quarterly report that includes information about the imported drugs, cost savings and any potential safety and quality issues, the FDA said.