The Food and Drug Administration has decided to allow the first state to import drugs from Canada, a move that would change the way Americans obtain prescription medicines and could reduce their cost.
The agency said Friday it would allow Florida to import prescription drugs from Canada. Several other states have filed similar requests with the agency.
The plans are likely to face obstacles to taking immediate effect, including lawsuits from drugmakers and opposition from Canadian authorities. The FDA has also raised safety concerns about importing drugs if it can’t vouch for their quality.
But federal and state lawmakers have pushed for drug importation to tackle high drug costs, because the products are often priced lower in Canada and other countries.
If Florida and perhaps other states are allowed to go ahead, imports would open up a new source of medicines, beyond the retail and mail-order pharmacies Americans have relied on for decades to fill prescriptions.
“The FDA is committed to working with states and Indian tribes” seeking to import drugs from Canada, FDA Commissioner Robert Califf said. “These proposals must demonstrate the programs would result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs.”
The FDA’s plans to approve Florida’s request were earlier reported by the New York Times.
The agency’s decision allows Florida to import drugs for two years, and the state must submit quarterly reports to the agency about cost savings and potential safety issues.
Florida has said it would begin importing drugs to help people cared for by state agencies, such as the Department of Corrections or the Agency for Persons with Disabilities. The drugs would treat chronic health conditions such as asthma, diabetes, HIV/AIDS and mental illness.
Later the program would be expanded to import drugs for Medicaid recipients. Gov. Ron DeSantis has estimated the program would save the state up to $150 million in the first year.
Shipments aren’t starting immediately. The FDA will have to approve the labels of any drugs to be imported as well as make sure the imports are authentic and are safe, among other steps.
Drug importation has been a rallying cry for doctors, patients and politicians seeking ways to curb high costs. Yet healthcare researchers say plans like Florida’s may have limited impact on costs.
“There are real constraints on Canada’s ability to even do this, they would basically be giving up drugs that are meant for their population to subsidize drugs for people in Florida, which is not politically reasonable to be asking from people in Canada,” said Stacie Dusetzina, a health-policy professor at Vanderbilt University School of Medicine.