The U.S. Food and Drug Administration (FDA) cleared the way Friday for Florida’s first plan to import lower-cost prescription drugs from Canada, an approach long called for in the United States.
Republican Gov. Ron DeSantis signed the initiative into law in 2019, but the plan required federal review and approval from the FDA, which controls all prescription drug imports into the United States.
Democratic President Joe Biden has supported such programs as a way to lower prices, signing an executive order in 2021 directing the FDA to work with states on drug imports.
Florida’s proposal includes a number of drug classes, including those for asthma, chronic obstructive pulmonary disease, diabetes, HIV AIDS and mental illness.
These imported drugs would only be intended for certain people, including children in foster care, prisoners, certain elderly patients and, possibly, Medicaid beneficiaries.
The new policies represent a major shift in the United States after decades of lobbying by the pharmaceutical industry, which claimed such imports would put American patients at risk from counterfeit or adulterated drugs. The FDA also warned that it could be difficult to ensure the safety of drugs coming from outside the United States.
But the policy has changed in recent years: both parties — including former President Donald Trump — have pushed to revise the approach on imports.
The FDA said Florida’s program would be authorized for two years. Under federal requirements, officials in the state will have to test drugs to ensure their authenticity and relabel them so they meet U.S. standards.
The Florida Department of Health will also be required to provide a quarterly report to the FDA on the types of drugs imported, cost savings and any potential safety and quality issues.
“These initiatives must demonstrate that the programs would result in significant savings for consumers without adding risk of exposure to unsafe or ineffective drugs,” FDA Commissioner Dr. Robert Califf said in a statement.
Many Americans already buy at least some of their medications from pharmacies in Canada or Mexico, even though it is technically illegal to import them into the United States.
Work to allow imports into states began during the presidency of Donald Trump, a fierce critic of industry pricing.
Under current regulations, states can import certain drugs through pharmacies and wholesalers. Governor DeSantis has already estimated that Florida taxpayers could save up to $150 million per year through this program.
Like most developed countries, Canada sets limits on the prices drug makers can charge if they want to enter the market. Health officials have previously suggested that the prescription drug market in their country is too small to have a real impact on prices in the United States.
The United States has long had the highest prescription drug prices in the world, with no government limits on what companies can charge.
It wasn’t until 2022 that Congress passed a law allowing the federal government to negotiate prices for a small number of drugs used by seniors under the Medicare program. The first such negotiations are expected to take place later this year.