The Food and Drug Administration is authorizing a plan to let Florida buy medication in bulk from Canada, making it the first state to gain regulatory approval for mass drug imports.
Regulators on Friday said they approved the plan under a program, known as Section 804, which lets states apply for importation permission for large programs like Medicaid so long as the proposal reduces costs for Americans while posing no added risk to public health and safety.
Advocates have pushed for years to let American consumers tap into the market in Canada, pointing to far lower prices there, and the idea received political support from the Trump and Biden administrations.
Yet the pharmaceutical industry fiercely opposes the plan and will probably sue to block the Florida plan.
And Canadian officials have warned they don’t have enough drugs to serve both countries’ markets.
Canada is home to 40 million people, while Florida has 22 million. Since other states might establish importation plans, supply from wholesalers in Canada could be strained.
Some opponents have warned of safety risks, and drugmakers have contracts that bar shipments of drugs from Canada to the U.S.
A major industry lobbying group, the Pharmaceutical Research and Manufacturers of America, said it’s exploring all options to prevent the policy from “harming patients.”
“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,” group CEO Stephen J. Ubl said. “Politicians need to stop getting between Americans and their health care.”
Florida estimates its program could save $150 million per year on drugs for things like HIV/AIDS, diabetes, hepatitis C and mental illness.
Americans favor buying prescription drugs from licensed Canadian pharmacies. A KFF survey from 2019 found 8 in 10 people liked the idea, including three-quarters of Republicans and Democrats and over 80% of independents.
The FDA approval coincides with a political season in which players in both parties vow to cut costs for consumers.
Florida Gov. Ron DeSantis, a GOP candidate for president, is overseeing the state’s importation plan.
“After years of federal bureaucrats dragging their feet, Florida will now be able to import low-cost, life-saving prescription drugs,” Mr. DeSantis said Friday. “It’s about time that the FDA put patients over politics and the interests of Floridians over Big Pharma.”
President Biden, meanwhile, is poised to take credit for overseeing the groundbreaking approval. He frequently touts a part of his 2022 tax-and-climate legislation that allowed Medicare to negotiate down the price of drugs for the first time.
Beyond Florida, eight other states have laws that let them seek approval for drug imports. Colorado, for instance, has a pending application. New Hampshire’s proposal was rejected last year because it didn’t identify a Canadian wholesaler that could provide the drugs.
The FDA said Florida will have to submit a quarterly report on cost savings from imported drugs and any safety or quality issues.
“The FDA is committed to working with states and Indian tribes that seek to develop successful Section 804 importation proposals,” FDA Commissioner Robert M. Califf said Friday. “These proposals must demonstrate the programs would result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs.”
• Tom Howell Jr. can be reached at thowell@washingtontimes.com.
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