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The Guardian - US
The Guardian - US
Business
Richard Luscombe in Miami

FDA approves program to allow Florida to import Canadian prescription drugs

Prescription drugs spill out of a bottle.
The program is a rare instance of the Trump and Biden administrations backing the same government plan. Photograph: Elise Amendola/AP

A public health policy that won rare backing from both the Biden and Trump administrations looks ready to open a flow of cheaper prescription drugs from Canada to Florida, ending a decades-long block on the importation of certain pharmaceuticals to the US.

The federal Food and Drug Administration (FDA) has granted the state approval under a drugs importation program that seeks to lower the cost of medicines for US consumers without imposing additional risks to their health or safety.

Pharmaceutical companies in the US cited safety concerns in their opposition to the program, which stalled after approval by Congress at the start of the century and was resurrected during Donald Trump’s presidency.

The FDA on Thursday announced that Florida would be the first state allowed to import pharmaceuticals directly from Canadian manufacturers, a victory for the state’s Republican governor, Ron DeSantis, who sued the Biden administration in 2022 for its “reckless delay” in granting approval.

“Florida has been ready to deliver cheaper prescription drugs to those that need them for nearly two years,” DeSantis said at the time, his lawsuit calculating that consumers would save $150m in the first year following approval.

Several steps must still take place before a two-year license can be issued and the first drugs cross the border. Florida must submit to the FDA details of the individual drugs it seeks to import, and verify their authenticity. FDA-approved labels must also be affixed to all imported Canadian pharmaceuticals.

US drug manufacturers, meanwhile, are expected to file lawsuits to try to block the approval, while health authorities in Canada have also taken protective steps. When Trump announced the revival of the import program in 2020, Canadian lawmakers acted to block the export of drugs if it would create a shortage at home.

“Canada’s drug supply is too small to meet the demands of both American and Canadian consumers,” Maryse Durette, a spokesperson for Health Canada, told the New York Times in an email.

Other states seeking or planning to seek FDA approval under the scheme include Colorado, Maine, New Hampshire, New Mexico, North Dakota, Texas, Vermont and Wisconsin, the New York Times reported.

Biden has made the reduction of drug costs to US consumers a policy priority. In a separate initiative, his administration has been negotiating the price of certain essential medicines with US pharmaceutical companies and last August announced the first 10 drugs proposed for price cuts.

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