For the first time, the Food and Drug Administration has authorized a U.S. state to import prescription drugs from Canada, granting Florida preliminary clearance to bulk purchase medicines from wholesalers there.
The decision is a major policy shift for the agency, which has long resisted drug importation efforts on grounds that it couldn’t ensure the safety and supply of medicines shipped from abroad. Supporters have argued that importing drugs from Canada, where medicines cost far less than in the U.S., could help rein in pharmaceutical costs.
In a statement, FDA Commissioner Robert Califf said the agency is “committed” to working with states as well as Indian tribes to develop successful importation proposals. “These proposals must demonstrate the programs would result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs,” he added.
Florida has estimated its importation plan could save state taxpayers $150 million annually once fully implemented.
However, it’s unclear whether that kind of effect would actually materialize. Canada has taken steps to prevent distribution of drugs outside of the country if shortages would result. The country’s population is also far smaller than the U.S.’s, totaling about two times the population of Florida, potentially limiting the supply that would be available in any case.
The FDA’s clearance also comes with requirements for Florida to submit detailed information on the drugs it proposes to import, as well as ensure they comply with FDA standards. Florida must handle relabeling the imported drugs in line with FDA-approved prescribing information.
The agency, in its statement, described the authorization as a “first step” toward helping Florida import drugs from Canada.
The pharmaceutical industry, which has vehemently opposed importation plans, may also sue to block Florida’s plan.
“We are deeply concerned with the FDA’s reckless decision to approve Florida’s state importation plan,” a spokesperson for the industry lobby PhRMA said in an email. “PhRMA is considering all options for preventing this policy from harming patients.”
The push to import cheaper drugs from Canada dates back to the 1990s. Proponents argued such a step could help people who were struggling to pay for their medicines, particularly before the U.S. expanded the Medicare program to cover prescription drugs for the elderly in 2003.
Opponents, including drugmakers, have claimed reimporting drugs will put U.S. patients at risk because the FDA won’t be able to conduct proper oversight.
Former President Bill Clinton signed a law in October 2000 permitting reimportation. But the FDA didn’t publish final regulations for another 20 years, under the administration of former President Donald Trump and his Health and Human Services chief, Alex Azar.
The final regulations instruct importers on what steps they need to take to assure product safety, including inspection history, a laboratory testing plan, and an explanation of the differences in Canadian and U.S. labeling. After the final regulations went into effect, Canada’s government issued an order banning drug exports unless it wouldn’t cause or worsen a drug shortage.
Florida was quick to submit a proposal, sending one to the FDA in November 2020 that went through five additional revisions before its final plan was submitted in October 2023.
Florida’s plan is authorized for two years from when the FDA first receives notification of a shipment of drugs to be imported from Canada.
Other states, including Colorado, New Hampshire, Texas and Wisconsin, have laws allowing drug importation and have sought FDA approval. Colorado’s application is pending, while New Hampshire’s was rejected last year
