Canadians, Pharmacists Skeptical of Florida Drug-Import Plan

Florida’s proposal to reduce state pharmaceutical spending through foreign imports of HIV pills and other costly medications faced serious challenges, including efforts by Canadian officials to prevent drug shortages in their own nation.

Whether those challenges can be overcome may determine whether this novel approach to addressing the soaring costs of drugs in the United States will work.

The Canadian government has publicly expressed its concerns about Florida’s plan after the US Food and Drug Administration (FDA) on January 5 announced the state had cleared an administrative hurdle in its importation efforts.

Canadian Health Minister Mark Holland on January 16 issued a statement, recapping his talks with his US counterpart, Health and Human Services Secretary Xavier Becerra. Canada will not allow Florida to tap into its national drug supply to an extent that it causes shortages there.

“I want to assure Canadians that they will continue to have access to medications they need when they need them,” Holland said in a statement. “Canada has strong regulations in place to protect supply. Canadians can be confident that our government will continue to take all necessary measures to protect the drug supply in Canada.”

At this time, people in the United States and Canada likely have misconceptions about the plan for Canadian drug imports that the FDA is reviewing for Florida, pharmacy experts said.

They said consumers in both countries may wrongly think that the FDA has opened a broad path for consumers to have drugs shipped to them from Canada, when in fact the agency is still scrutinizing a plan for limited shipments of select drugs.

Still, Canada has experienced shortages when people stocked up due to expected increased demand for medicines, as happened during the pandemic, said Joelle Walker, vice president for public and professional affairs at the Canadian Pharmacists Association.

This is not a similar situation. People should not stock up ahead of a major rerouting of Canadian medicines into the United States, which is unlikely to happen, she said.

“Canadians shouldn’t worry, there’s no immediate threat to our supply, and people shouldn’t rush to pharmacies to fill, to refill their prescriptions early in some kind of anticipation” of a shortage caused by exports to Florida, she said.

In fact, it’s unclear how well Florida’s plan for imports will work out even if it does secure full FDA sign-off for this plan, she said.

The FDA on January 5 announced what it called “the first step on this pathway toward Florida facilitating importation of certain prescription drugs from Canada.” Florida’s Agency for Health Care Administration and its contractor must still provide the FDA with more information about the medicines it intends to import, the agency said in a letter.

A release from Florida Gov. Ron DeSantis (R) said the state’s initial imports would be of drugs for HIV/AIDS, mental illness, prostate cancer, and urea cycle disorder for people under the care of state agencies, including the Agency for Persons with Disabilities, Department of Children and Families, and Department of Corrections. Florida would then like to expand this program in time to import drugs for people enrolled in Medicaid.

For many years, people who live in states close to Canada have traveled there in search of better prices on medicines. Lawmakers in both parties have supported the concept of allowing states to do this as well, leading the FDA to finalize a rule in 2020 on importation. This rule established a framework for steps states would need to take to try to win FDA clearance for large-scale import programs.

Ally Dering-Anderson, PharmD, RP, was among the more than 1000 people and organizations who submitted comments to the FDA about its plan. Dering-Anderson teaches at the University of Nebraska College of Pharmacy but offered her comments to the FDA as a private citizen speaking on her own behalf.

In an interview this month, Dering-Anderson reiterated the concerns she outlined in her 2020 comment, including questions about safeguarding consumers against the threat of counterfeit drugs.

Opening a pathway for imported drugs appears to run counter to the efforts underway across to the 2013 Drug Supply Chain Security Act. Drugmakers, pharmacies, and US health systems have been investing for years in better tracking of medicines as they move from factories to consumers.

Still, FDA staff have signaled great interest in making sure that any state import plan contains significant safeguards, Dering-Anderson said. The FDA’s January 5 letter to Florida officials outlined steps that would need to be completed before legal importation, including quality testing.

“What the FDA said was, ‘Yes, you may submit a plan, and we will look at it,'” Dering-Anderson said. “At no point did they say, ‘Oh, yeah, send us something and we’ll approve it.'”

Dering-Anderson said the FDA staff should scrutinize Florida’s plan for Canadian drug importation. “Look at it and poke holes in it and find all of the problems, so that you can find them on paper so that we don’t need to find them once patients have been harmed,” she said.

Outcome Closely Watched

How Florida’s plan works — if it does at all — will be closely watched in other state capitols. Other states have tried, or are trying, to get similar programs started.

The FDA in 2022 rejected a request from New Hampshire, citing a lack of key information, including details on the expected supplier of the medicines. Other states where lawmakers have seriously considered drug importation include Colorado, Maine, New Mexico, Ohio, and Vermont, according to a December 2023 report from the Texas Health and Human Services department.

In a statement after the FDA allowed Florida’s plan to proceed, FDA Commissioner Robert M. Califf, MD, said his agency will work with other states and with Native American tribes on plans for importing drugs.

“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 in a statement.

Drugmakers’ Decisions

Dering-Anderson shares the same doubts as Walker of the Canadian Pharmacists Association about whether Florida could obtain a significant supply of the medicines it is seeking in Canada.

For a state import scheme to have any notable effect on prices, drugmakers would have to reroute their limited supply of medicines from the United States, where they often get better prices, into Canada, where the costs are lower.

“It’s absurd to think that the drug companies will fund shipping drugs to Canada, so that they get shipped back to Miami. That costs them profit,” Dering-Anderson said.

Walker said it’s counterintuitive for a pharmaceutical company to increase shipments of drugs to Canada in cases where the new bump in supply would result in getting paid less in Florida.

“To me, it seems like not a likely business proposition,” Walker said. “I don’t think that’s going to work.”

In a January 17 joint statement, the American Society of Health-System Pharmacists, the American Pharmacists Association, and about 70 other pharmacy group’s also questioned Florida’s strategy. In its January 5 press release, the office of Florida Gov. DeSantis said Canadian drug imports could save Florida as much as $180 million in the first year.

But neither that release nor the one issued by the FDA provided significant data or information to describe how these savings would be achieved, the US pharmacy associations said.

In an interview, Jillanne Schulte Wall, senior director of health and regulatory policy at the American Society of Health-System Pharmacists, said she understands the appeal of Canadian drug imports.

This approach can work on an individual level where a person visits a trusted pharmacy in Canada to obtain drugs. But there are significant hurdles that would make it difficult for a state to achieve these kinds of savings, including the reluctance of drugmakers to increase shipments to Canada.

“Part of the appeal here is that this seems like a quick fix,” she said. “But at the end of the day, a lot of the promise is going to evaporate very quickly. I also think this is gonna get mired in litigation” with drugmakers filing court challenges.

Kerry Dooley Young is a freelance journalist based in Washington, DC.