The Trump administration issued rules in 2020 allowing states to apply for drug importation. Florida was the first to apply and would later sue the FDA in 2022 for its “reckless delay” in approving the request.
The agency has now authorized the state’s section 804 importation program (SIP) — referring to section 804 of the Federal Food, Drug, and Cosmetic Act — for two years.
Under this program, Florida can import certain prescription drugs from Canada if doing so reduces costs for Americans without endangering public health and safety.
Americans have long been allowed to buy prescriptions from Canada as individuals, but this is the first time a state has been permitted to do the same.
Efforts to import cheaper drugs from abroad have been brought up for years but were stymied by concerns over safety.
The FDA expressed these concerns amid Florida’s plans and will be requiring quarterly reports from the state’s health agency on any potential safety or quality issues.
Other states including Vermont, Colorado and Maine have also applied for SIP authorization, though some have run into roadblocks during the process.
“After years of federal bureaucrats dragging their feet, Florida will now be able to import low-cost, life-saving prescription drugs,” Florida Gov. Ron DeSantis (R) said on Friday. “It’s about time that the FDA put patients over politics and the interests of Floridians over Big Pharma.”
The types of drugs expected to be imported include those that treat asthma, COPD, diabetes, HIV/AIDS and mental illnesses.
The U.S. pharmaceutical industry is likely to put up a legal fight against this cost-cutting measure.
The industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA), which previously sued over the Trump administration’s importation plans, said it was “considering all options” to prevent the policy from going into effect.
“We are deeply concerned with the FDA’s reckless decision to approve Florida’s state importation plan,” PhRMA President and CEO Stephen J. Ubl said. ”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.”
