Canada is vowing to safeguard its drug supply after the Food and Drug Administration earlier this month authorized Florida’s plan to import cheaper drugs en masse from America’s northern neighbor.
Florida is the first state to gain regulatory approval for its plan to import cheaper drugs from Canada, sparking fears that a massive U.S. market would siphon too many medicines from the low-population country.
Some Canadian experts warned they don’t have enough drugs to serve both countries. 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.
“Canada has about the same population as California, and we simply do not have the supply for a country nine times larger than ours without provoking massive drug shortages here,” said University of Ottawa law professor Amir Attaran.
Canadian officials said they are monitoring supplies and there are regulations in place to prevent exports that would cause shortages.
“I want to assure Canadians that they will continue to have access to medications they need when they need them,” Health Minister Mark Holland said in a statement shared with the Canadian Broadcasting Corporation. “Canadians can be confident that our government will continue to take all necessary measures to protect the drug supply in Canada.”
U.S. regulators approved the plan under a program, known as Section 804, which lets states apply for importation permission for large programs like Medicaid as 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.
The pharmaceutical industry fiercely opposes the plan and will probably sue to block the Florida plan. Opponents 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 or PhRMA, 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,” said PhRMA CEO Stephen J. Ubl. “Politicians need to stop getting between Americans and their health care.”
Florida estimated it 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 consumer costs.
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. “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 the groundbreaking approval. He frequently touts a part of his 2022 tax-and-climate legislation that allowed Medicare for the first time to negotiate down the price of drugs.
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.
• Tom Howell Jr. can be reached at thowell@washingtontimes.com.
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