Florida wins first FDA approval to import drugs from Canada

The Food and Drug Administration on Friday approved Florida’s plan to import cheaper pharmaceuticals from Canada, a first-in-the-nation move that might reduce costs for Americans but faces fierce opposition from the pharmaceutical industry.

The regulator also said it was committed to working with other states looking for to import drugs from Canada. 

The FDA’s approval of Florida’s plan is a big stride forward in a broader, yearslong effort to rein in drug costs within the U.S. Patients shell out significantly more for medicines than they do in Canada and another countries.

Drug importation could open up a latest and cheaper source of medicine beyond the retail and mail-order pharmacies that Americans typically depend on to fill prescriptions. 

Together with Florida, other states equivalent to Colorado, North Dakota and Vermont have their very own drug vital plans in place, which is able to require FDA approvals. Greater than five states have asked the agency to greenlight their programs, in accordance with 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 priority the FDA previously raised since the agency cannot guarantee the protection of those drugs.

Nevertheless, the FDA’s Friday approval appears to have guardrails that aim to mitigate potential issues of safety. 

Before Florida can distribute Canadian drugs, the state must send the FDA details on the medications it plans to import, make sure that those treatments will not be 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 issues of safety, amongst other obligations. The FDA’s approval allows Florida to import drugs for 2 years from the date of the primary drug shipment. 

“These proposals must reveal the programs would end in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs,” FDA Commissioner Robert Califf said in an announcement. 

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’s considering “all options for stopping this policy from harming patients.”

“Ensuring patients have access to needed medicines is critical, however the importation of unapproved medicines, whether from Canada or elsewhere on this planet, poses a serious danger to public health,” Stephen Ubl, the CEO of PhRMA, said. “Politicians have 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.