FDA approves first state request to import drugs from Canada

Florida’s plan calls for importing medications for several illnesses for residents covered by certain public programs, including Medicaid enrollees and inmates.

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.

“After years of federal bureaucrats dragging their feet, Florida will now be able to import low-cost, life-saving prescription drugs,” DeSantis said in a statement Friday. “It’s about time that the FDA put patients over politics and the interests of Floridians over Big Pharma.”

While US law allows drug importation, it never gained traction because of federal health officials’ concerns over safety and actual savings as well as fierce 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.

Though Biden, Trump and DeSantis are likely to take credit on the campaign trail for initiating drug importation in the US, major hurdles remain before Florida can actually start importing certain medications, 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 chronic health conditions such as HIV/AIDS, mental illness and prostate cancer, the governor’s office said in a press release Friday.

The state would make the imported drugs available to 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 program would then expand to Medicaid enrollees.

Florida expects to save up to $180 million in the first year and around $183 million annually once the program is fully implemented, the state said.

“We’re creating a system with importers and vendors that we as a state will import drugs from Canada, relabel them, get them to Florida and send them out through various state programs that way,” Florida’s Agency for Health Care Administration secretary, Jason Weida, told state lawmakers last month. “That guarantees safety. That guarantees cost savings.”

Seven other states, including Colorado, Maine and Texas, have passed laws that would allow them to create state drug importation programs. Some are in various stages of seeking FDA approval. New Hampshire’s application was rejected in 2022 because it did not identify a Canadian wholesaler.

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.

“These proposals must demonstrate the programs would result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs,” said FDA Commissioner Robert Califf.

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

The Pharmaceutical Research and Manufacturers of America, known as PhRMA, quickly issued a statement that said it is “considering all options for preventing this policy from harming patients.”

“We are deeply concerned with the FDA’s reckless decision to approve Florida’s state importation plan,” said Stephen Ubl, CEO of PhRMA, the main industry group. “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. Politicians need to stop getting between Americans and their health care.”

The Canadian government, which is concerned about its own drug shortages, and independent experts have questioned whether importation would do much to help lower prices in the US since Canada’s drug market is relatively small. In 2020, Canada announced measures to protect its drug supply, including banning the distribution of certain drugs outside of the country that would cause or worsen a shortage. This includes all medications eligible for bulk importation to the US, according to Health Canada, which is responsible for national health policy.

“The Government of Canada is taking all necessary action to safeguard the drug supply and ensure Canadians have access to the prescription drugs they need and has been clear in its position: bulk importation will not provide an effective solution to the problem of high drug prices in the US,” Health Canada said in a statement Friday evening.

But others are more hopeful.

“This is a significant step in moving towards wholesale drug importation and residents of the United States accessing the same drugs at a lower cost,” said Maureen Hensley-Quinn, senior director of coverage, cost and value at the National Academy for State Health Policy, which developed drug importation model legislation that states can use.

This story has been updated with additional information.

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