WASHINGTON 鈥� The Food and Drug Administration on Friday cleared the way for Florida's first-in-the-nation from Canada, a long-sought approach to accessing cheaper medications that follows decades of frustration with U.S. .
Republican Gov. Ron DeSantis signed the plan into law in 2019, but it required federal review and approval by the FDA, which controls prescription drug imports.
Democratic President Joe Biden has backed such programs as a way to lower prices, signing an executive order in 2021 that directed the FDA to work with states on imports.
The policy change represented a shift after years of successful lobbying by the pharmaceutical industry, which said imports would expose U.S. patients to risks of counterfeit or adulterated drugs. The FDA also previously warned of the difficulties of assuring the safety of drugs originating from outside the U.S.
But the politics surrounding the issue have shifted in recent years, with both parties 鈥� including 鈥� doubling down on the import approach.
The FDA said Florida鈥檚 program will be authorized for two years, though imports won't begin immediately. Under federal requirements, state officials must first test the drugs to make sure they鈥檙e authentic and relabel them so that they comply with U.S. standards.
READ MORE: Patients with narcolepsy face a dual nightmare of medication shortages and stigma
Florida鈥檚 health department must also provide a quarterly report to the FDA on the types of drugs imported, cost savings and any potential safety and quality issues.
鈥淭hese proposals must demonstrate the programs would result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs,鈥� FDA Commissioner Dr. Robert Califf said in a statement.
DeSantis, who is battling Trump for the Republican presidential nomination, previously for allegedly delaying approval of the import program. Several other states are also awaiting federal approval.
The FDA is likely to face legal challenges over the decision, which the pharmaceutical industry's trade group called 鈥渁 serious danger to public health.鈥�
鈥淲e are deeply concerned with the FDA鈥檚 reckless decision to approve Florida鈥檚 state importation plan," Pharmaceutical Research and Manufacturers of America said in a statement Friday.
Many people already buy at least some of their medicines from pharmacies in Canada or Mexico, although technically it鈥檚 illegal to import them.
Work on allowing state imports began under Trump, a relentless critic of industry pricing.
Under the current regulations, states can import certain medicines through pharmacies and wholesalers. DeSantis has previously estimated taxpayers could save up to $150 million annually under the program.
The state鈥檚 proposal includes a number of drug classes, including medications for asthma; chronic obstructive pulmonary disease, or COPD; diabetes; HIV and AIDS; and mental illness.
The medications would be only for certain people, including foster children, inmates, certain elderly patients and 鈥� eventually 鈥� Medicaid recipients.
Like most developed nations, Canada sets limits on the prices drugmakers can charge if they wish to enter the market. Health officials there previously have suggested their country鈥檚 prescription drug market is too small to have any real impact on U.S. prices.
The U.S. has long had the highest prescription drug prices in the world, with essentially no government limits on what companies can charge. Only in 2022 did Congress allowing the federal government to used by seniors in the Medicare program. The first such negotiations are set to take place later this year.
___
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute鈥檚 Science and Educational Media Group. The AP is solely responsible for all content.
