The Food and Drug Administration on Friday cleared the way for Florida to become the nation's first state to import low-cost prescription drugs from Canada. This is a long-sought approach to obtaining cheaper drugs after decades of dissatisfaction with U.S. drug prices.
Republican Gov. Ron DeSantis signed the plan in 2019, but it required federal review and approval from the FDA, which governs the importation of prescription drugs.
Democratic President Joe Biden has supported such programs as a way to lower prices and signed an executive order in 2021 directing the FDA to work with states on imports.
The policy change represented a seismic shift after decades of lobbying by the pharmaceutical industry, which argued that imports put U.S. patients at risk of counterfeit and adulterated drugs.
The FDA has also previously warned of the difficulty of ensuring the safety of drugs manufactured outside the United States.
But politics have changed in recent years, with both parties, including former President Donald Trump, doubling down on their import approach.
The FDA said Florida's program will be authorized for two years. Under federal requirements, state officials must test the drugs to ensure they are authentic and relabel them to comply with U.S. standards.
The Florida Department of Health is also required to submit quarterly reports to the FDA on the types of drugs being imported, cost savings, and potential safety and quality issues.
“These proposals demonstrate that the program will provide significant cost savings to consumers without increasing the risk of exposure to unsafe or ineffective drugs,” FDA Commissioner Dr. Robert Califf said in a statement. There must be,” he said.
Although many people already buy at least some of their medicines from pharmacies in Canada or Mexico, importing medicines is technically illegal.
Efforts to allow national imports began under President Trump, who has relentlessly criticized the industry's pricing practices.
Current regulations allow states to import certain drugs through pharmacies and wholesalers. DeSantis previously estimated that taxpayers could save up to $150 million a year under the program.
The state's proposal includes many drug classes, including asthma medications. Chronic obstructive pulmonary disease, or COPD; diabetes; HIV and AIDS. and mental illness.
The drug would only be available to certain people, including foster children, prisoners, certain elderly patients, and eventually Medicaid recipients.
Like most developed countries, Canada imposes limits on the prices drug companies can charge if they wish to enter the market. The country's health officials have previously suggested that its prescription drug market is too small to have a real impact on U.S. prices.
The United States has long had some of the highest prescription drug prices in the world, with essentially no government limits on how much companies can charge. It wasn't until 2022 that Congress passed a bill that would allow the federal government to negotiate prices on a small number of drugs used by seniors in the Medicare program. Initial negotiations are expected to take place later this year.
