US regulators on Friday approved Florida’s plan to import prescription drugs from Canada, making it the first state to win such authorization, in a bid to lower costs for American consumers.
The Food and Drug Administration’s (FDA) green light marks a step forward in reducing drug costs in the country, although such a move has faced strong opposition from the pharmaceutical industry.
According to Florida’s estimates, its program could save taxpayers up to $150 million annually.
Several other states have also submitted their drug importation programs for FDA approval.
President Joe Biden has been pushing to lower health care costs ahead of this year’s elections, and in a 2021 executive order called for officials to continue working with states on importation plans.
Individuals can buy drugs from Canadian pharmacies, but states’ efforts would allow them to buy drugs in bulk from wholesalers.
In a statement, FDA Commissioner Robert Califf said the agency is “committed” to working with states and Indian tribes looking to develop similar import proposals.
“These proposals must demonstrate the programs would result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs,” Califf added.
In pushing back against imports, the pharmaceutical industry argues there is a risk of counterfeit or substandard products entering the country.
But in authorizing Florida’s program, the FDA laid out rules aiming to mitigate concerns.
Before drugs can be imported, state authorities must submit more specific details for FDA approval, and ensure the medicines have been tested for authenticity and compliance with standards.
Meanwhile, Florida authorities must submit a quarterly report to the FDA, including details on cost savings and possible safety issues.
The approval allows Florida to import drugs for two years, from the date that the FDA is informed of the first shipment.
The authorization has already drawn criticism from the pharmaceutical industry.
Stephen Ubl, president of lobbying group Pharmaceutical Research and Manufacturers of America, said in a statement it was “deeply concerned with the FDA’s reckless decision.”
Arguing that such imports pose “serious danger to public health,” Ubl added that “PhRMA is considering all options for preventing this policy from harming patients.”
© 2024 AFP
Florida gains FDA approval to import drugs from Canada (2024, January 6)
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