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The US Food and Drug Administration will allow Florida to import medicines from Canada, making it the first state to capitalise on rules designed to lower the cost of prescription drugs.
Robert Califf, the FDA commissioner, said Florida’s proposals had to demonstrate that such imports would result in “significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs”.
The US pays the highest prices in the world for drugs and studies have estimated that the country pays about two to three times more for branded medicines than Canada. But drugmakers have opposed plans to import drugs bought at lower prices, citing safety concerns.
The approval comes after Florida Governor Ron de Santis, now a candidate for the Republican presidential nomination, sued the FDA in 2022 for taking too long to authorise Florida’s plans.
The authorisation is based on a law passed by Congress more than two decades ago, but which both President Joe Biden and former President Donald Trump have put pressure on officials to take action to implement in recent years.
Biden signed an executive order in 2021 that instructed the FDA to work with states and Indian tribes to work on these plans to import drugs as part of broader efforts to reduce the high prices of prescription medicines, including allowing Medicare, the state-backed health insurer, to negotiate on drug prices for the first time. Biden’s executive order followed similar plans by the Trump administration, unveiled in 2019.
Florida has estimated that it could save up to $150mn a year by importing key medicines for treating diabetes, infectious diseases such as HIV and hepatitis C, and mental health conditions. The Florida Agency for Health Care Administration did not respond to a request for comment.
The drug industry’s lobby group, PhRMA, has previously argued that importation could have “life-threatening consequences” by allowing counterfeit, substandard or diverted, repackaged and adulterated drugs into the supply chain.
Stephen Ubl, PhRMA chief executive, said on Friday that the FDA decision was “reckless” and that the lobby group was considering “all options” to prevent the policy from harming patients.
“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,” he said.
Friday’s decision comes after the state of New Hampshire failed in its bid to receive FDA permission because it did not identify a pharmaceutical wholesaler which could deliver the drugs. Colorado is also seeking FDA approval for a similar programme, and several other states have passed laws enabling them to set up such importation agreements with FDA permission.
The programme is set to last two years from when the first shipment of drugs is imported. Florida must now submit specific information to the FDA on the drugs it wishes to import, ensure they have been tested for authenticity, and relabel them in line with FDA standards.
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