FDA allows Florida to import prescription drugs in bulk from Canada

The Food and Drug Administration said Friday it will allow Florida to buy prescription drugs directly from wholesalers in Canada, a move that is intended to lower the cost of prescription drugs for residents in the state.

Prescription drugs are often much cheaper outside the United States, and some states, including Florida, Vermont and Colorado, have urged the federal government to allow them to import drugs from other countries.

The FDA already permits individuals to buy prescription drugs from Canada under certain circumstances.

The push to allow states to do so has been in the works for years. In 2019, the Trump administration announced preliminary plans to import drugs from Canada, asking states to come up with proposals on how to do so safely. In 2021, President Joe Biden issued an executive order directing the agencies to work with states on the importation plans. 

The FDA’s new policy will allow Florida to purchase prescription drugs in bulk. The medications will be made available to its residents through various state-run health care programs, such as Medicaid.

Meredith Freed, a senior policy analyst with KFF’s Program on Medicare Policy, said it’s unclear when Florida will begin importing the drugs.

Florida must meet certain requirements, such as testing the drugs to ensure they are not counterfeit and relabeling the drugs to be consistent with FDA-approved labeling, Freed said.

The state will also be required to submit a quarterly report to the FDA that includes information about the imported drugs, cost savings, and any potential safety and quality issues under the new policy, according to the agency.

The plan is only authorized for two years from the date the agency is told about the first drug importation shipment, according to the FDA. The agency has the authority to extend the authorization for an additional two years at a time.

Florida’s Agency for Health Care Administration has previously estimated that Canadian drug imports will save the state $150 million annually if enacted.

Stephen Ubl, the president and CEO of the Pharmaceutical Research and Manufacturers of America, the drug industry’s trade group, called the FDA’s decision “reckless.”

“Ensuring patients have access to needed medicines is critical, but the importation of unapproved medicines, whether from Canada or elsewhere in the world, poses a serious danger to public health,” said Ubl, who has previously issued statements opposing the importation plan. (To be eligible for importation, the FDA has said the prescription drugs must be approved by regulatory authorities in Canada.)

Stacie Dusetzina, a health policy professor at Vanderbilt University in Nashville, Tennessee, said she’s skeptical the plan will result in lower drug prices. She has no ties to the FDA or PhRMA.

“Having the FDA approve the importation plan is one step, but there are other major steps that make this difficult to do,” she said. “That includes getting Canada to agree to the importation. They previously have not been willing to do so because drug manufacturers will not sell them enough drugs to supply both the U.S. and Canada.”

Health Canada did not immediately return a request for comment.

Friday’s move comes as the federal government continues to negotiate with major drug companies on the cost of the 10 costliest drugs in the U.S. as part of a provision in the Inflation Reduction Act. The negotiated prices won’t go into effect until 2026.

An analysis published Thursday from the Commonwealth Fund, a research group that studies health care issues, found that the U.S. prices for the 10 drugs were three to eight times higher compared to other countries of similar size and wealth.

States have attempted to lower the cost of drugs for their own residents.

In 2019, Florida Gov. Ron DeSantis signed a bill that would allow the state to import drugs from Canada. However, the legislation still required approval from the Department of Health and Human Services and the FDA. In 2022, DeSantis filed a lawsuit against the federal agencies, accusing them of stalling the state’s plan to import drugs.