FDA's authorization of Florida drug importation plan draws heat from US, Canadian trade groups

Florida has secured a major win in its yearslong quest to import cheaper drugs from Canada—though the backlash from pharma trade groups on both sides of the border has been swift and fierce.

The FDA on Friday authorized Florida’s drug importation program, which will be valid for two years after the first shipment of medicines.

But before Florida can actually draw drugs down from the Great White North, the state will need to submit medication-specific information for the FDA’s review and approval, the regulator said in a press release.

Florida must also ensure that the drugs it seeks to import have been tested for, among other things, authenticity and compliance with FDA standards. The imported drugs will also need to be relabeled consistent with FDA regulations.

Florida will also be on the hook to submit a quarterly report to the FDA detailing information about the imported drugs, cost savings and any potential safety and quality issues, the FDA said.

While the FDA is willing to work with states on import programs, the proposals “must demonstrate the programs would result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs,” FDA Commissioner Robert Califf, M.D., stressed in a statement Friday.

The program could save Florida up to $180 million in the first year of full operation, according to a release from the administration of the state’s governor, Ron DeSantis.

Under the program, Florida says it will start providing drugs in a small number of classes—including maintenance medications—for patients with chronic health conditions like HIV/AIDS, mental illness, prostate cancer and urea cycle disorder. 

The FDA’s authorization of the program represents the latest strike in a sustained battle against high U.S. drug prices. Notably, Democrats passed the Inflation Reduction Act in 2022, which will allow Medicare to negotiate prices on select drugs beginning in 2026. Further, the law forces drugmakers to pay rebates to Medicare if their prices rise faster than the rate of inflation.

Still, industry representatives at home and abroad have been quick to strike back against Governor DeSantis’ importation plan.

Innovative Medicines Canada (IMC), which represents major drugmakers in the country, said it was “deeply concerned” by the FDA’s authorization.

“Canada simply can’t supply drugs to Florida, or any other U.S. states, without significantly increasing the risk and severity of drug shortages nationwide,” David Renwick, interim president of IMC, said in a statement.

The U.S. market is nearly 10 times bigger than Canada’s, Renwick pointed out, warning the plan would “harm Canadian patients and disrupt our healthcare system.”

The reception hasn’t been much better in The States, where president and CEO of the trade group the Pharmaceutical Researchers and Manufacturers of America (PhRMA), Stephen Ubl, cautioned that the importation of unapproved medicines, whether from Canada or elsewhere in the world, “poses a serious danger to public health.”

PhRMA is considering “all options for preventing this policy from harming patients," Ubl said.