Florida may soon be able to import prescription drugs from Canada.
The United States Food and Drug Administration authorized the state’s drug importation program – managed by Florida's Agency for Health Care Administration – under section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) on Jan. 5. The authorization cleared the first roadblock for prescription drug importation.
Florida and other states have pushed for prescription drug importation to reduce certain medications' costs by expanding the sources of medicine beyond retail and mail-order pharmacies.
“Through this pathway, the FDA may authorize section 804 importation program (SIP) proposals from states or Indian tribes to import certain prescription drugs from Canada if the SIP will significantly reduce the cost to the American consumer without imposing additional risk to public health and safety,” the federal agency said in its announcement.
The SIP program will be authorized for two years starting on the date the FDA is notified of the first shipment of imported drugs. The state program will remain subject to federal oversight.
Florida will be required to ensure the integrity of the supply chain, submit adverse event reports, and comply with drug recall procedures. The state must also report to the FDA every quarter and detail the drugs that were imported, the cost savings, and any potential safety and quality issues.
“The FDA is committed to working with states and Indian tribes that seek to develop successful section 804 importation proposals,” said FDA Commissioner Robert M. Califf, M.D. “These proposals must demonstrate the programs would result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs.”
Gov. Ron DeSantis signed the plan into law in 2019 but the policy can only take effect after receiving full federal approval. The governor signed the bill at The Villages, the largest retirement community in the nation, where he told the crowd that President Donald Trump was supportive of the policy and “doing whatever we can to lower prescription drug prices.” DeSantis has estimated that the program could save Florida up to $150 million during its first year.
“One fifth of Florida’s population is 65 or older, the highest percentage of senior citizens in the country and a bloc that reliably turns out to vote,” noted POLITICO at the time of the bill signing.
Before shipments can begin, all the labels of any imported drugs must be approved by the FDA.
“The U.S. has long had the highest prescription drug prices in the world, with essentially no government limits on what companies can charge,” reports WTNH. “Only in 2022 did Congress pass a law allowing the federal government to negotiate prices for a small number of medications used by seniors in the Medicare program. The first such negotiations are set to take place later this year.”
