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FDA Allows Florida to Import Prescription Drugs From Canada

This first approval of an importation plan paves the way for cheaper medications

spinner image two pill capsules one resembles the american flag with blue and white pellets making up the stars on one half and red and white stripes on the other half and the other one resembles the red and white canadian maple leaf flag
ExtraDryRain / Getty Images

For the first time, the U.S. Food and Drug Administration (FDA) has given the OK for a state to import prescription drugs from Canada, where the prices for many life-sustaining medications are far lower than in the United States. This approval allows Florida’s health agency to begin putting in place a drug importation process for some state health programs.

States began passing importation laws in 2019 to bring down the runaway prices of prescription drugs. The first law was passed in Colorado, and since then, similar measures have been enacted in Florida, Maine, New Hampshire, New Mexico, North Dakota, Texas and Vermont. Even though Congress passed a law in 2003 allowing foreign-drug importation, federal health officials never moved ahead on such plans, citing safety concerns. Florida sued the FDA over the delay in approving the Sunshine State’s importation plan, and a federal judge gave the agency until Jan. 5 to act on the state’s application.

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As part of its campaign to lower medication prices, AARP has supported state and federal efforts to help consumers save money on prescription drugs, including drug importation. 

“The FDA approval is evidence that efforts to allow states to safely import prescription drugs from Canada are moving forward,” says Leigh Purvis, AARP prescription drug policy principal. “This is part of what is a growing list of efforts to try and reduce prescription drug prices and costs for the people who need them.”

AARP also successfully fought for provisions in a 2022 federal law, including Medicare negotiation of some medications for the first time, a $35 monthly copay cap on insulin, and rebates to Medicare for drug price increases that exceed the rate of inflation. This year, people with Medicare drug coverage will no longer have to pay any out-of-pocket costs after they qualify for catastrophic coverage. In 2025, a $2,000 out-of-pocket cap on Medicare-covered drugs will take effect under the law. 

AARP’s support for drug importation is rooted in the “common knowledge that Americans pay significantly higher prices for the same prescription drugs that other countries have,” Purvis says. “Being able to take advantage of the lower prices that are available in other countries is something that’s been very appealing for a long time.”

Long road ahead for states that want to import drugs

The approval of Florida’s application is just the first step in the drug importation process, and there are obstacles states might face before being able to implement their plans. The pharmaceutical industry has strongly opposed such efforts and is expected to legally challenge the latest importation plans. Canadian officials have expressed concerns that widespread drug importation programs could threaten the supply of some prescription drugs in their country.

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It’s unclear what effect state importation programs would have on individual consumers. Florida’s plan, for example, is to import medicines in bulk for its Medicaid program, public health clinics and prisons. “It remains to be seen how many people would potentially benefit from these types of programs,” Purvis says.

The FDA set conditions that must be met before Florida can implement its program. 

“These proposals must demonstrate the programs would result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs,” FDA Commissioner Robert Califf said in announcing the approval. Before Florida’s plan can go forward, the FDA will review which medications the state plans to import, and the state must ensure that those drugs comply with FDA safety rules and standards.

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