FDA approves first state request to import drugs from Canada

Originally Published: 05 JAN 24 10:42 ET By Tami Luhby, CNN

(CNN) — The Food and Drug Administration has approved Florida’s request to import certain drugs from Canada, marking the first time a state has been authorized to buy lower-cost medications in bulk from abroad.

The historic move is the latest salvo in the long-running battle to lower drug prices, one of Americans’ biggest health care headaches and a major element of President Joe Biden’s reelection campaign. Florida Gov. Ron DeSantis, who is seeking the Republican presidential nomination, is also highlighting his importation proposal as he seeks to curtail drug costs.

While US law allows drug importation, it never gained traction because of federal health officials’ concerns over safety and actual savings as well asfierce opposition from American drug manufacturers and Republican lawmakers.

Former President Donald Trump, however, made drug importation a centerpiece of his effort to reduce drug costs and pushed for federal approval of Florida’s proposal. In 2020, the Department of Health and Human Services issued a final rule establishing a path for states and certain other entities to set up drug importation programs. The next year, Biden issued an executive order directing the FDA commissioner to work with states that want to develop importation programs.

Major hurdles remain before Florida can actually start importing certain drugs, and it could be a while before the state and its residents see savings. The drug industry is expected to continue its efforts to prevent the importation of drugs, and Canada has opposed the mass importation of its medications.

Florida’s proposal

Florida, which filed its proposal with the FDA in 2020, initially wants to import drugs to treat conditions such as HIV/AIDS, diabetes, hepatitis C and mental illness.

It would make them available to Medicaid recipients, patients at county health departments managed by the state Department of Health, inmates at state correctional facilities and certain others served by state agencies.

The state has said it estimates the program could save taxpayers up to $150 million annually once fully implemented.

Several other states have passed laws that would allow them to create state drug importation programs, and they are in various stages of seeking FDA approval.

Florida must meet certain FDA requirements before drugs can be imported. It must submit additional drug-specific information for the agency’s approval, ensure that the medications have been tested and comply with FDA standards, and relabel the medications consistent with FDA rules. In addition, the state must submit a quarterly report about the imported drugs, cost savings and potential safety and quality issues.

The state’s plan is authorized for two years from the date the FDA is notified of the first drug shipment.

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