States Eye Canadian Drug Imports Despite Delays, Tariffs (1)

State leaders are reviving talk of importing prescription drugs from Canada, even as US drugmakers and health-care attorneys warn that logistical obstacles and looming tariffs might prevent lower prices for patients at pharmacies.

New York Gov. Kathy Hochul (D) announced in her State of the State address in January that her office is exploring participation in the Food and Drug Administration’s pathway allowing states to import cheaper medicines from Canada.

Florida is the only state with an FDA-approved importation program. Six other states have enacted laws allowing them to set up importation plans, and legislation has been filed recently in New York, Illinois, and Mississippi to join that list.

But Florida’s program has yet to get off the ground more than a year after approval. President Donald Trump’s planned tariffs on Canadian goods is on hold for now, but the trade tax threatens any savings importation could potentially provide, analysts say.

These factors, as well as drug safety concerns and the stringent requirements states must meet to get FDA approval, leave doubts across the industry that any state program will get off the ground and bring significant savings to patients.

“I haven’t seen meaningful analysis of how this type of a program would actually lower out-of-pocket costs for a consumer at the pharmacy counter,” said Margaux Hall, a partner in the health-care practice at Ropes & Gray LLP who counsels drugmakers, investors, and others.

Importation Support

State conversations on drug importation grew after the FDA gave Florida the green light to begin setting up its program, amid larger debates on the affordability of medicines across the country.

A 2024 report by the Department of Health and Human Services noted that US prices for brand-name drugs in 2022 were more than three times higher than prices in Australia, Canada, France, and more than two dozen other comparison countries.

While Trump hasn’t publicly commented on drug importation beyond the tariff threats since his reelection, it’s reasonable that more states will take action to pursue the pathway championed by his first administration, Hall said.

Besides Florida, legislation to establish drug importation programs has passed in Colorado, Maine, New Hampshire, New Mexico, Texas, and Vermont, according to the National Conference of State Legislatures. Two additional states—North Dakota and Virginia—have laws that established workgroups to examine drug importation.

Hochul has yet to release additional details on her office’s plans, but listed possible importation as part of her mission “to address the drug affordability crisis” in her state.

New York State Sen. James Skoufis (D), the sponsor of a bill (SB 371) to establish a wholesale prescription drug importation program there, said his team hadn’t spoken directly with Hochul’s office on his proposal, but “was thrilled to learn of the Governor’s support.”

“Increasing competition in our drug supply via importation could be monumental for lowering costs for common prescriptions” and “keeping more money in New Yorkers’ pockets,” Skoufis said in an email.

Drug importation legislation previously filed in 2024 in Illinois (HB 1272) and Mississippi (HB 18) were reintroduced in recent weeks, but the Mississippi bill died in a state House committee Tuesday.

A bill filed in Texas (HB 1319) would add European Union suppliers to the state’s drug importation law, though existing FDA regulations only allow for Canadian imports.

Florida Delays

The lack of movement on Florida’s program brings uncertainty on the feasibility of prescription drug importation.

The FDA’s 2020 final rule said that after the agency approves a program, a state must satisfy several requirements before drugs can be imported. This includes submitting a pre-import request to the FDA at least 30 calendar days before an eligible drug’s scheduled arrival.

The FDA said in a Dec. 20 letter to the Florida Agency for Health Care Administration that it had yet to receive updates on the program’s progress and granted a six-month extension for the state to move forward with its plans.

Days later, the Florida health agency said in a press release that it is “currently in the process of completing the next steps” of the program, including “working with its importer to negotiate deals with Canadian manufacturers.”

The state agency didn’t respond to multiple requests for comment.

Hall said, “it certainly doesn’t seem like it’s been easy for them to get this program off the ground.”

Beyond the program’s technical requirements, Canadian Health Minister Mark Holland told senior US officials last year that Canada “will take all necessary measures to protect the Canadian drug supply.”

Hall said “it’s very possible that manufacturers wouldn’t be able to satisfy demand under the program with Canadian drugs,” noting Canada’s population of roughly 40 million and Florida’s approximately 23 million.

Savings, Safety Doubts

The US pharmaceutical industry has repeatedly opposed state drug importation, citing safety concerns and other affordability challenges that could still exist for patients.

“There’s no guarantee of safety, there’s no guarantee of greater accessibility or affordability for prescription medications,” said Stami Turk, director of state public affairs for the Pharmaceutical Research and Manufacturers of America, or PhRMA.

Turk pointed to the Virginia workgroup’s November recommendation to hold off on importation “until other states have proven that drugs can be successfully imported from Canada under the current federal structure.”

The Trump administration’s threats of 25% tariffs on Canada and Mexico could also “undermine any type of savings” from prescription drug imports, Hall said. Trump announced a 30-day pause on the tariffs Monday.

Skoufis, however, said that even with tariffs, prescriptions from Canada “would still be substantially lower than those sold by Big Pharma in the United States.”

Another issue is that FDA regulations exclude biologic products from importation, making injectable autoimmune treatments like Humira, Enbrel, and some of the other most expensive brand-name prescriptions in the US ineligible.

“If you layer on top of that potential real consumer concerns regarding the safety and efficacy of these products, there are questions regarding the extent to which the market would meaningfully respond,” Hall said.