The Food and Drug Administration on Friday authorized Florida’s plan to import certain prescription drugs from Canada, making it the first state to receive such approval.
The plan is authorized for two years from the date of the first shipment, according to the FDA. The state must submit quarterly reports to the agency outlining cost savings and any safety issues.
The approval comes after three years of delay and two lawsuits. But FDA Commissioner Robert Califf said he is committed to working with states and tribes looking to import drugs.
“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 said.
The FDA must still approve requests from individual pharmacies and wholesalers before they can import specific drugs. Any importer must submit details of individual drugs they expect to purchase.
The state says the program is ready to launch, with a foreign seller and domestic distributor on tap. The plan would apply to recipients in state programs, such as Medicaid and prisons, which Florida estimates could save up to $150 million.
Florida Gov. Ron DeSantis, a Republican presidential candidate, submitted the final plan in November 2020. But delays prompted him to sue the FDA in August 2022 and again in April 2023 over alleged violations of both the Administrative Procedure Act and the Freedom of Information Act.
The FDA, on the other hand, alleged serious safety deficiencies in the plan.
Florida is one of at least six states seeking permission to import drugs. Colorado, Maine, New Hampshire, New Mexico and Vermont have also submitted plans, but all have either encountered obstacles or their requests are still pending.
Colorado discovered that many drugmaker contracts prohibit Canadian wholesalers from exporting products to the U.S. The state asked the FDA to issue new guidance addressing the oversight, since drug manufacturers are vehemently opposed to importation.
The FDA rejected New Hampshire’s plan because the state was also unable to identify a Canadian wholesaler.
The concept of drug importation has a tortuous history. A 2000 law granted the Department of Health and Human Services the authority to greenlight importation plans from pharmacies and wholesalers, but that authority was never used.
Pharmaceutical industry groups oppose the idea, arguing that states like Florida are simply importing “price controls” that the U.S. is unwilling to impose on drug manufacturers directly. The Pharmaceutical Research and Manufacturers of America, an industry group, previously sued over the 2020 rule allowing state imports, but lost.
“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,” PhRMA CEO Stephen J. Ubl said. “Politicians need to stop getting between Americans and their health care. PhRMA is considering all options for preventing this policy from harming patients.”
Canadian officials have also expressed concerns about the idea of mass drug exports to the U.S., noting that demand could outstrip supply for Canadian residents.
Lawmakers in both parties have pushed the strategy for years. But the idea gained steam as part of a populist upswell under former President Donald Trump. In 2020, the Trump administration finalized a rule to authorize state importation plans. President Joe Biden reiterated that the FDA should work on state and tribal plans in a July 2021 executive order.