FDA to allow Florida to import prescription drugs in bulk from Canada

January 8, 2024

The Food and Drug Administration said on Friday, January 8, that 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, reports NBC News.

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 that the prescription drugs must be approved by regulatory authorities in Canada.)

Friday’s move comes as the federal government continues to negotiate with major drug companies on the cost of the ten costliest drugs in the United States 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 ten drugs were three to eight times higher compared to other countries of similar size and wealth.

Research contact: @NBCNews