The Biden administration has given the green light to Florida’s plan to import cheaper prescription drugs from Canada, a move that may encourage other states to follow suit.
The Food and Drug Administration approved Florida’s plan on Friday, requiring the state’s health department to provide quarterly reports to the agency, including information on cost savings and potential safety and quality issues.
In a statement, FDA Commissioner Robert Califf said the agency is committed to working with states and Indian tribes on importation proposals that demonstrate significant cost savings without adding risk of exposure to unsafe or ineffective drugs.
The FDA’s decision is the first time the agency has authorized a state to import drugs in bulk from a foreign country. Several states have similar importation laws, and more than five have requested FDA approval.
Pharmaceutical industry experts have expressed skepticism about the potential for cost savings from importing drugs from Canada, citing concerns about potential shortages in Canada and the impact on the U.S. biopharmaceutical supply chain.
Pushback From Drug Industry
The pharmaceutical industry is already pushing back on the FDA’s announcement. The Pharmaceutical Research and Manufacturers of America (PhRMA) called the approval of Florida’s plan “reckless,” and the Biotechnology Innovation Organization (BIO) also spoke out against the decision.
PhRMA has sued the FDA over similar importation plans in the past, and the group is considering all options for preventing the policy from harming patients.
Skepticism on Savings
There is skepticism about the potential for real savings from the approved importation plan. Federal regulations and Florida’s plan require the Canadian exporter to acquire product directly from the manufacturer, which may discourage manufacturers from making such sales.
Florida’s plan is to first provide prescription medications for various conditions before broadening the program to offer imports to state Medicaid members.
President Joe Biden issued an executive order in July 2021 calling for the FDA to work with states on importing drugs from Canada. In August 2022, Florida sued the FDA, claiming the agency was standing in the way of its drug importation plan.
Washington law firm Boyden Gray PLLC, which advised Florida in obtaining FDA approval, said the state will save between $150 million and $200 million a year through Canadian drug imports and that the drugs will help state Medicaid recipients and other patients in state-run facilities.