FDA on Friday announced that it will allow Florida to mass import prescription drugs from Canada — a move that could provide Americans with more drugs at lower costs. However, health policy experts say the change is unlikely to significantly impact drug costs or how patients access medication. 

FDA allows Florida to import drugs from Canada

FDA on Friday said it will allow Florida to import prescription medications from Canada under the Federal Food, Drug, and Cosmetic Act. While federal law has allowed importation for decades, health officials long delayed implementing it. In 2020, President Donald Trump announced that states could submit importation proposals to FDA for review and authorization.

FDA's decision allows Florida to purchase medication from Canadian wholesalers for two years, which will then be used by state agencies, government clinics, prisons, and more. The medications will be used to treat several chronic health conditions, such as asthma, diabetes, HIV/AIDs, and mental illness.

According to Florida Gov. Ron DeSantis (R), the program will save the state an estimated $150 million in its first year. According to the Wall Street Journal, the state also plans to expand the program to purchase medications for Medicaid recipients in the future.

Before any drugs are imported, FDA will have to approve medication labels and make sure all imports are authentic and safe. Florida is also required to submit quarterly reports to FDA about the program's cost savings and any potential safety issues.

Aside from Florida, eight other states — Colorado, Maine, New Hampshire, New Mexico, North Dakota, Texas, Vermont, and Wisconsin — have enacted laws that allow for a state importation program. Many of these states have also applied or are planning to apply for FDA approval.

According to FDA Commissioner Robert Califf, the agency "is committed to working with states and Indian tribes" that want to import prescription medications from Canada.

"These proposals must demonstrate the programs would result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs," he said.

Reaction

According to the New York Times, there is broad political and public support for drug importation. In a 2019 poll from KFF, almost 80% of respondents were favorable of importing drugs from licensed Canadian pharmacies.

"Importation is an idea that resonates with people," said Meredith Freed, a senior policy analyst with KFF. "They don't fully understand why they pay more for the same drug than people in other countries."

However, even with widespread support, efforts to implement drug importation in the United States has been largely limited, in part due to pushback from the pharmaceutical industry.

In the past, the Pharmaceutical Research and Manufacturers of America has sued over state importation efforts and is expected to file a suit against Florida's program. Some drug manufacturers also have agreements with Canadian wholesalers that prevent them from exporting their medications.

Canadian health officials have also been wary of importing drugs to the United States, with some arguing that it could lead to shortages or higher costs for Canadians. In 2020, Canada issued a rule preventing domestic manufacturers and wholesalers from exporting drugs in short supply.

"There are real constraints on Canada's ability to even do this, they would basically be giving up drugs that are meant for their population to subsidize drugs for people in Florida, which is not politically reasonable to be asking from people in Canada," said Stacie Dusetzina, a health policy professor at Vanderbilt University School of Medicine.

Health policy experts have also expressed skepticism about the potential impact of drug importation, especially on reducing costs. Companies that manufacture expensive brand-name drugs are likely to prevent wholesalers from exporting those medications at lower costs.

"I think it's going to be hard for states to import drugs like that in any kind of scale that would make a difference in terms of lowering prices for patients," said Aaron Kesselheim, a professor of medicine at Harvard Medical School.

Overall, "Canada's drug supply is too small to meet the demands of both American and Canadian consumers," said Maryse Durette, a spokesperson for Health Canada. "Bulk importation will not provide an effective solution to the problem of high drug prices in the U.S." (Jewett/Stolberg, New York Times, 1/5; Roush, Forbes, 1/5; Gilbert, Washington Post, 1/5; Whyte, Wall Street Journal, 1/5; Lopez, Bloomberg, 1/5)