In a first, FDA says Florida can import prescription drugs from Canada
The Food and Drug Administration on Friday cleared the way for Florida’s first-in-the-nation plan to import prescription drugs from Canada, a long-sought approach to accessing cheaper medications that follows decades of frustration with U.S. drug prices.
Republican 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 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 shift after years of successful 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 ensuring the safety of drugs originating outside the United States.
Americans routinely skirt federal law by crossing into Canada and Mexico or tapping online pharmacies abroad to buy prescription medications at a fraction of the price they would pay at home.
But the politics surrounding the issue have shifted in recent years, with both political parties — including Republican former President Trump — favoring the import approach.
The FDA said Florida’s program will be authorized for two years, though imports won’t begin immediately.
Under federal requirements, state officials must first test the drugs to make sure they’re authentic and relabel them so that they comply with U.S. standards.
Florida’s health department 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 Robert Califf said in a statement.
DeSantis, who is battling Trump for the Republican presidential nomination, previously sued the Biden administration for allegedly delaying approval of the import program.
“After years of federal bureaucrats dragging their feet, Florida will now be able to import low-cost, life-saving prescription drugs,” DeSantis said in a statement.
Gov. Gavin Newsom’s new state budget will call for California to produce its own brand of generic prescription drugs to drive down healthcare costs.
While Florida is the first U.S. state to receive FDA permission to proceed with Canadian drug imports, several others — including Colorado, Maine, New Hampshire, New Mexico, North Dakota, Vermont and Wisconsin — also have laws creating importation programs, according to the National Conference of State Legislatures.
Applications from Colorado, Maine and New Mexico are still before the FDA. The agency has rejected Vermont’s filing as incomplete and New Hampshire’s because the state failed to identify which Canadian supplier it would work with.
Bills proposing similar programs have been considered in a dozen more states, according to the National Academy for State Health Policy.
A similar program has been floated in California. In 2021, the state Assembly considered a bill to establish the Affordable Prescription Drug Importation Program. Had the bill passed, the state’s Health and Human Services Agency would have had until June 1, 2022, to seek federal approval for an importation program similar to Florida’s.
Under the proposed program, HHSA would have had to procure a list of wholesale prescription drugs with the highest potential cost savings and been authorized to contract with Canadian suppliers of those drugs when certain conditions were met.
The bill died in committee. Its author, former Assemblymember Sydney Kamlager-Dove (D-Los Angeles), is now a freshman member of the U.S. House of Representatives.
The feds have never used the 50-year-old ‘march-in’ rights that have given them power over drug prices. Biden has signaled that he may do so
The FDA is likely to face legal challenges over the Florida decision, which the pharmaceutical industry’s trade group called “a serious danger to public health.”
“We are deeply concerned with the FDA’s reckless decision to approve Florida’s state importation plan,” the Pharmaceutical Research and Manufacturers of America group said in a statement Friday.
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’s administration.
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 (COPD), diabetes, HIV/AIDS and mental illness.
The medications would be only for certain people, including foster children, inmates, some elderly patients and — eventually — Medicaid recipients.
Gov. Gavin Newsom has launched several initiatives to cut rising drug prices, but the savings haven’t been as large as he promised.
The White House called Friday’s action “a step in the right direction,” and encouraged more states to apply for importation.
“For too long, Americans have been forced to pay the highest prescription drug prices of any developed nation,” White House spokesperson Kelly Scully said in a statement. “President Biden believes this is unacceptable and is laser-focused on actions to cut the cost of medicine families need.”
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.
Perrone writes for the Associated Press. Times staff writer Corinne Purtill and AP writer Zeke Miller contributed to this report.
