The Food and Drug Administration on Friday cleared the way for Florida's first-in-the-nation plan to import lower-priced prescription drugs from Canada, a long-sought approach to accessing cheaper medications that follows decades of frustration with U.S. drug prices.
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 seismic shift after decades of 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 have shifted in recent years, with both parties — including former President Donald Trump — doubling down on the import approach.
The FDA said Florida’s program will be authorized for two years. Under federal requirements, state officials must test the drugs to make sure they’re authentic and relabel them so that they comply with U.S. standards.
The state must also provide a quarterly report to the FDA on the types of drugs imported, cost savings and any potential safety and quality issues.
“These proposals must demonstrate the programs would result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs,” FDA Commissioner Dr. Robert Califf said in a statement.
Friday’s approval came after lengthy wrangling about the plan and the state filing two lawsuits against the FDA.
“They have set up a number of hoops,” state Agency for Health Care Administration Secretary Jason Weida told the House Health Care Appropriations Subcommittee last month. “We have jumped through them all.”
DeSantis and then-Florida House Speaker Jose Oliva, R-Miami Lakes, made the issue a priority, with the state submitting a proposal to the FDA in November 2020.
The lengthy review included the FDA seeking revisions to the plan. The state filed a revised proposal in October to try to address the federal agency’s concerns, according to court documents.
Among the issues was the FDA noting Florida’s proposal lacked a secured warehouse within 30 miles of an “authorized port of entry” for prescription drugs. The only authorized port of entry was Detroit, while Florida planned to store shipments at a facility in Indiana.
In one of the lawsuits, the state said the program was “stuck in the starting blocks.” and that "the FDA has dragged its feet for so long.”
The state’s lawyers wrote that “it seems the most likely explanation for the FDA’s delay, in the face of near universal support for importation programs, is the FDA’s longstanding symbiotic relationship with big pharmaceutical companies that stand to lose hundreds of millions of dollars if Florida’s SIP proposal is approved.”
In a reply, the Biden administration denied the allegations.
Today, the FDA authorized Florida’s Agency for Health Care Administration’s drug importation program under section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). https://t.co/NhetbVzJsx pic.twitter.com/P2J869LoaK
— U.S. FDA (@US_FDA) January 5, 2024
Many people already buy at least some of their medicines from pharmacies in Canada or Mexico, although technically it’s 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’s 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 — eventually — 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’s 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 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.
The pharmaceutical industry has pushed back on Florida's plan and is expected to sue.
"We are deeply concerned with the FDA's reckless decision to approve Florida's state importation plan," says a statement from Stephen Ubl, president and CEO of the drug industry trade group PhRMA. "Ensuring patients have access to needed medicines is critical, but the importation of unapproved medicines, whether from Canada or elsewhere in the world, poses a serious danger to public health. ... PhRMA is considering all options for preventing this policy from harming patients.
Information from News Service of Florida and NPR was used in this report.
