The US Food and Drug Administration has approved Florida’s request to import prescription drugs from Canada to rein in drug prices in the state.
Medicines in Canada can be nearly half the price of US counterparts and some drugs cost almost $400 a pill in Florida.
The FDA’s decision could open the door for other states to follow suit.
The major policy shift overrides decades of opposition from the US pharmaceutical industry.
The industry’s major lobbying group has already indicated it will try to intervene.
Florida estimates the programme, which allows the import of certain prescription drugs used to treat conditions such as HIV/AIDS, diabetes, hepatitis C and mental illness, will save state taxpayers up to $150m (£118m) a year.
The sky-high costs of prescription drugs have been an ongoing political issue in the US, where prices are among the highest in the world.
According to a report by the OECD group of industrialised nations, the US spends more than double the average amount spent by other member countries on prescription medicines per capita.
For example, where the UK paid approximately £246 ($314) per head in 2023, the US paid $1,139.
In a statement announcing the FDA’s authorisation, Commissioner Robert Califf said the administration would continue to work with states and Indian tribes on these proposals.
“These proposals must demonstrate the programmes would result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs,” he said.
Florida’s approval does come with requirements, including how the drugs are labelled and ensuring they meet FDA specifications and standards.
The state’s health care administration will need to submit quarterly reports to the FDA that outlines cost savings and any potential safety and quality issues.
There will also be restrictions on who can access the imported drugs.
The FDA’s decision comes after President Joe Biden’s executive order in 2021 – which directed federal agencies to work with states on lowering costs through importation plans.
An online statement published on Thursday from the Pharmaceutical Research and Manufacturers of America President and CEO Stephen J Ubl said the FDA’s decision was “reckless”.
He said his organisation would consider “all options for preventing this policy from harming patients”.
It is not known how Canada’s healthcare system will react to Florida’s plan, but it could stoke fears of drug shortages for its own citizens.
Canada banned the export of some prescription medicines in 2020 to prevent a shortage in the country after then-US President Donald Trump proposed a plan to import drugs from Canada to make them cheaper for Americans.