The Food and Drug Administration (FDA) has given its approval to Florida’s groundbreaking plan to import prescription drugs from Canada, marking a significant step towards accessing more affordable medications and addressing the long-standing issue of high drug prices in the United States. The plan, signed into law by Republican Governor Ron DeSantis in 2019, required federal review and approval by the FDA, which has jurisdiction over prescription drug imports.
President Joe Biden, a Democrat, has shown support for such programs as a means to lower prices. In fact, he signed an executive order in 2021 that directed the FDA to collaborate with states on drug imports. The White House has hailed the FDA’s action as “a step in the right direction” and has encouraged other states to apply for importation, with White House spokesperson Kelly Scully stating, “For too long, Americans have been forced to pay the highest prescription drug prices of any developed nation.”
While American politicians celebrate the plan, Canadian healthcare providers have expressed concerns about its feasibility due to existing supply challenges in Canada. Joelle Walker, a spokesperson for the Canadian Pharmacists Association, mentioned historical drug shortages in Canada, stating that the idea of importing drugs from Canada is not realistic.
This policy represents a significant shift in the U.S. after years of successful lobbying by the pharmaceutical industry, which has argued that imports would expose American patients to counterfeit or adulterated drugs. The FDA has previously cautioned about the difficulties of ensuring the safety of drugs originating from outside the U.S. However, the political landscape has evolved in recent years, with both major parties, including former President Donald Trump, embracing the import approach.
Jeff Johnson, director for AARP Florida, expressed excitement about the federal decision, recognizing that it is just one step towards lowering prescription drug costs. Johnson noted that while most individuals may not notice immediate savings, the state of Florida will ultimately save money. He emphasized the potential impact of multiple measures aimed at reducing drug prices, stating, “If there are enough different things out there that help reduce drug prices, together they’ll make a difference.”
The FDA has authorized Florida’s importation program for a period of two years, although the actual imports will not commence immediately. State officials must first test the drugs to ensure their authenticity and then relabel them to comply with U.S. standards, as required by federal regulations. Florida’s health department is also required to provide quarterly reports to the FDA regarding the imported drugs, cost savings, and any safety and quality concerns.
As reported by The New York Times, the FDA’s action comes after Governor DeSantis, who is currently vying with Donald Trump for the Republican presidential nomination, previously filed a lawsuit against the Biden administration for allegedly delaying approval of the import program. Several other states are also awaiting federal approval.
The FDA’s decision is expected to face legal challenges, with the pharmaceutical industry’s trade organization, the Pharmaceutical Research and Manufacturers of America, deeming it “a serious danger to public health.” Despite the technical illegality, many individuals already purchase some of their medicines from pharmacies in Canada or Mexico.
Efforts to allow state imports began under the Trump administration, during which the issue of high drug pricing was consistently criticized. Currently, states can import certain medicines through pharmacies and wholesalers. Governor DeSantis has estimated that taxpayers in Florida could save up to $150 million annually through the import program.
The state’s proposal covers various drug classes, including medications for asthma, chronic obstructive pulmonary disease (COPD), diabetes, HIV/AIDS, and mental illness. Initially, the medications will be available to specific groups such as foster children, inmates, certain elderly patients, and eventually Medicaid recipients.
Like other developed countries, Canada imposes price limits on drugmakers seeking to enter its market. Canadian health officials have suggested that their country’s prescription drug market is too small to have a substantial impact on U.S. prices.
Until recently, the U.S. government had limited influence over drug prices set by pharmaceutical companies. It was only in 2022 that Congress passed a law allowing the federal government to negotiate prices for a small number of medications used by seniors in the Medicare program. The first negotiations under this law are scheduled to take place later this year.