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The Food and Drug Administration on Friday approved Florida’s plan to import cheaper prescription drugs from Canada, a first-in-the-nation move that could reduce costs for Americans but faces fierce opposition from the pharmaceutical industry.
The regulator also said it was committed to working with other states seeking to import drugs from Canada.
The FDA’s approval of Florida’s plan is a significant stride forward in a broader, yearslong effort to rein in drug costs in the U.S. Patients shell out significantly more for medicines than they do in Canada and some other countries.
Drug importation could open up a new and cheaper source of drugs beyond the retail and mail-order pharmacies that Americans typically rely on to fill prescriptions.
Along with Florida, other states such as Colorado, North Dakota and Vermont have their own drug important plans in place, which will require FDA approvals. More than five states have asked the agency to greenlight their programs, according to the National Conference of State Legislatures.
But Florida’s newly approved plan will likely face hurdles before it takes effect, including potential lawsuits from the pharmaceutical industry.
Drugmakers have long argued that importation may introduce counterfeit medicines into the U.S. supply chain and harm patients – a concern the FDA previously raised because the agency can’t guarantee the safety of those drugs.
However, the FDA’s Friday approval appears to have guardrails that aim to mitigate potential safety issues.
Before Florida can distribute Canadian drugs, the state must send the FDA details on the medications it plans to import, ensure that those treatments are not counterfeit or ineffective and relabel those drugs to be consistent with FDA-approved labeling.
Florida must also submit quarterly reports to the agency about cost savings and potential safety issues, among other obligations. The FDA’s approval allows Florida to import drugs for two years from the date of the first drug shipment.
“These proposals must demonstrate the programs would result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs,” FDA Commissioner Robert Califf said in a statement.
The pharmaceutical industry pushed back on the FDA’s move on Friday.
Pharmaceutical Research and Manufacturers of America, the industry’s biggest lobbying group, called the FDA’s approval of Florida’s plan “reckless” and said it is considering “all options for preventing this 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,” Stephen Ubl, the CEO of PhRMA, said. “Politicians need to stop getting between Americans and their health care.”
The group sued the FDA in 2020 over a Trump administration plan to import Canadian drugs, but that lawsuit was later dismissed.
President Joe Biden issued an executive order in July 2021 that included a call for the FDA to work with states on plans for importing drugs from Canada.