Nearly a year after the Biden administration gave Florida the green light to become the first state to import lower-cost prescription drugs from Canada — a longtime goal of politicians across the political spectrum, including President-elect Donald Trump — the program has yet to begin.

Florida Gov. Ron DeSantis hailed the FDA’s approval of his plan in January, calling it a victory over the drug industry, which opposes importation on the grounds that it would lead to a surge in counterfeit medications.

A Florida health official familiar with the importation program told KFF Health News there was no planned date yet for the state to begin importing drugs. The official asked not to be identified because they weren’t authorized to speak publicly about the program.

Florida applied to create an importation program in November 2020, just months after the Trump administration gave states the option. DeSantis, a Republican, complained publicly for years about the pace of the federal approval process under the Biden administration and in 2022 filed suit against the FDA for what he called a “reckless delay.”

Trump touted his administration’s move to bring medicines over the border in a preelection interview published last month by AARP, the advocacy group for older Americans, which supports allowing Americans to buy drugs from Canada. He vowed to “continue my efforts to protect Americans from unaffordable drug prices” in a second term.

It’s not clear whether his second administration will or can do more to help Florida and other states set up programs, because it’s ultimately up to the states to act. Colorado is the only other state that has an importation plan pending with the FDA.

DeSantis administration officials have refused for months to answer questions from KFF Health News about the program. Alecia Collins, deputy chief of staff for the Florida Agency for Health Care Administration, said in October that officials were traveling and unavailable. In mid-November, she said she still had no answers.

DeSantis press secretary Jeremy Redfern said he had been “slammed” since the first week of November and could not answer questions.

FDA spokesperson Cherie Duvall-Jones said she could not answer whether Florida had submitted documents the agency requires before the state can start importing medicines. She referred all questions to the state.

Drug companies typically sell medications for far less in Canada than in the United States, as a result of Canadian government price controls. But because of safety and efficacy concerns, federal law prohibits consumers from buying drugs from outside U.S. borders except in rare cases.

Politicians ranging from conservatives such as DeSantis to liberals such as Sen. Bernie Sanders of Vermont have long pushed for importing lower-cost prescription drugs from Canada.

In 2000, Congress passed a law allowing states to import prescription drugs from north of the border, with the caveat that it could go forward only if the secretary of the Department of Health and Human Services affirmed it was safe. That didn’t happen until 2020, when Trump’s HHS secretary, Alex Azar, made such a declaration.

Since 2022, Azar has been chairman of the board at LifeScience Logistics, a Dallas-based company that Florida is paying millions of dollars to set up its drug importation program, including warehousing its medicines.

Azar on Nov. 13 refused to answer questions from KFF Health News about drug importation, saying he wasn’t authorized to speak on the matter.

Florida’s program would not directly assist consumers at the pharmacy. It’s instead aimed at lowering costs for the state Medicaid program and for the corrections and health departments.

Matthew Baxter, a senior director at Ontario-based Methapharm Specialty Pharmaceuticals, which has contracted with LifeScience to export drugs, would not say whether Methapharm has sent any medicines over the border.

The pharmaceutical industry and the Canadian government oppose U.S. drug importation. Drug companies say importation would increase the risk of counterfeit drugs appearing on U.S. pharmacy shelves, while the government in Ottawa has warned it won’t allow medicines to be exported if Canadians could experience shortages as a result.

Florida’s predicted savings would also be relatively minor. DeSantis estimated the program would save state agencies up to $180 million in its first year. Florida’s annual Medicaid budget tops $30 billion.

Florida identified 14 drugs, including for cancer and AIDS, that it would attempt to import from Canada for its state agencies.

Camm Epstein, a health policy analyst in Saratoga Springs, New York, said drug importation is a seemingly simple concept that resonates with the public, which is why DeSantis and others have turned to the idea as a response to rising drug prices. “It riles up the crowd,” he said. “Who doesn’t want to pay lower drug costs?”

But bringing drugs over the border is complicated because of the FDA’s many requirements, including finding companies to work with — a Canadian exporter and a U.S. importer — and following a process that ensures the drugs are authentic, Epstein said.

“This was, at best, a boondoggle,” he said.

Florida has spent tens of millions of dollars to stand up its drug importation program. The state has already paid LifeScience Logistics $50 million to set up a warehouse to store the medicines. DeSantis noted the costs in his 2022 lawsuit against the FDA.

“Plaintiffs have paid their retained importer and distributor over $24 million thus far — and increasing at the rate of $1.2 million every month — even though not a single prescription pill has been imported, relabeled, or distributed, solely because of the FDA’s idleness,” the state said in its suit.

Florida’s delay may be due to operational challenges, Epstein said. “Predictably, even if they turned on the spigot there would be no flow, because Canada was not going to permit for the supply,” he said.

Colorado and Florida are among at least nine states that have passed laws allowing for Canadian drug importation. Colorado’s 2022 application to the FDA is still pending. In December 2023, Colorado officials released a report noting the state was unable to find a drugmaker willing to sell it medicines from Canada.

©2024 KFF Health News. Distributed by Tribune Content Agency, LLC.