At long last, the Food and Drug Administration has approved Florida’s plan to import prescription drugs from Canada.
The FDA authorized Florida’s Agency for Health Care Administration’s drug importation program under section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) Friday morning.
Under the FD&C Act, the agency can authorize section 804 importation program (SIP) proposals from states to import certain prescription drugs from Canada if the SIP will “significantly reduce” the cost to the American consumer without imposing additional risk to public health and safety.
The move marks the first step toward the Sunshine State importing certain prescription drugs from Canada.
“The FDA is committed to working with states and Indian tribes that seek to develop successful section 804 importation proposals,” FDA Commissioner Robert Califf, M.D. said in a statement. “These proposals must demonstrate the programs would result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs.”
Florida’s SIP is authorized for the first two years after the FDA is notified the first shipment of drugs is imported.
Going forward, Florida’s Agency for Health Care Administration must submit additional drug-specific information to the FDA for approval, ensure the imported drugs have been tested and in compliance with FDA regulations and relabel them to meet domestic labeling guidelines.
This approval has been a long time coming for advocates of importing lower-priced versions of the same branded medications from other countries.
Dating back to the first year of the Trump administration, Sen. Bernie Sanders, (I-VT), introduced the Affordable and Safe Prescription Drug Importation Act to create a legal pathway for American pharmacies to import prescription drugs from Canada and potentially other countries.
In May 2018, Vermont became the first state to allow wholesale drug importation from Canada
The prospect of drug importation has garnered bipartisan support over the intervening years, with Sen. Chuck Grassley, (R-Iowa), backing a bill to allow consumers to purchase prescription drugs from Canadian pharmacies in 2019.
Even then-President Donald Trump tweeted in November 2019 that he and then-HHS Secretary Alex Azar would release a plan to allow states to import prescription drugs.
While many political leaders and healthcare advocates had long sought for the FDA to clear Florida’s drug importation plan, the announcement received a swift rebuke from the Pharmaceutical Research and Manufacturers of America (PhRMA).
“We are deeply concerned with the FDA’s reckless decision to approve Florida’s state importation plan,” PhRMA CEO Stephen Ubl said in a statement. “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. Politicians need to stop getting between Americans and their health care. PhRMA is considering all options for preventing this policy from harming patients.”
For a January 2024 article on how the FDA’s move on drug importation could shape medical marketing, click here.