Phil Galewitz, KFF Health News
Nearly a yr after the Biden administration gave Florida the inexperienced gentle to turn into the primary state to import lower-cost prescribed drugs from Canada — a longtime objective of politicians throughout the political spectrum, together with President-elect Donald Trump — this system has but to start.
Florida Gov. Ron DeSantis hailed the FDA’s approval of his plan in January, calling it a victory over the drug business, which opposes importation on the grounds that it will result in a surge in counterfeit drugs.
A Florida well being official aware of the importation program informed KFF Health News there was no deliberate date but for the state to start importing medication. The official requested to not be recognized as a result of they weren’t approved to talk publicly about this system.
Florida utilized to create an importation program in November 2020, simply months after the Trump administration gave states the choice. DeSantis, a Republican, complained publicly for years in regards to the tempo of the federal approval course of beneath the Biden administration and in 2022 filed go well with towards the FDA for what he referred to as a “reckless delay.”
Trump touted his administration’s transfer to deliver medicines over the border in a preelection interview published last month by AARP, the advocacy group for older Americans, which helps permitting Americans to purchase medication from Canada. He vowed to “continue my efforts to protect Americans from unaffordable drug prices” in a second time period.
It’s not clear whether or not his second administration will or can do extra to assist Florida and different states arrange packages, as a result of it’s in the end as much as the states to behave. Colorado is the one different state that has an importation plan pending with the FDA.
DeSantis administration officers have refused for months to reply questions from KFF Health News about this system. Alecia Collins, deputy chief of workers for the Florida Agency for Health Care Administration, stated in October that officers had been touring and unavailable. In mid-November, she stated she nonetheless had no solutions.
DeSantis press secretary Jeremy Redfern stated he had been “slammed” for the reason that first week of November and couldn’t reply questions.
FDA spokesperson Cherie Duvall-Jones stated she couldn’t reply whether or not Florida had submitted paperwork the company requires earlier than the state can begin importing medicines. She referred all inquiries to the state.
Drug corporations sometimes promote drugs for a lot much less in Canada than within the United States, on account of Canadian authorities worth controls. But due to security and efficacy considerations, federal regulation prohibits customers from shopping for medication from outdoors U.S. borders besides in uncommon instances.
Politicians starting from conservatives akin to DeSantis to liberals akin to Sen. Bernie Sanders of Vermont have lengthy pushed for importing lower-cost prescribed drugs from Canada.
In 2000, Congress handed a regulation permitting states to import prescribed drugs from north of the border, with the caveat that it might go ahead provided that the secretary of the Department of Health and Human Services affirmed it was secure. That didn’t occur till 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 firm that Florida is paying millions of {dollars} to arrange its drug importation program, together with warehousing its medicines.
Azar on Nov. 13 refused to reply questions from KFF Health News about drug importation, saying he wasn’t approved to talk on the matter.
Florida’s program wouldn’t immediately help customers on the pharmacy. It’s as an alternative geared toward decreasing prices for the state Medicaid program and for the corrections and well being departments.
Matthew Baxter, a senior director at Ontario-based Methapharm Specialty Pharmaceuticals, which has contracted with LifeScience to export medication, wouldn’t say whether or not Methapharm has despatched any medicines over the border.
The pharmaceutical business and the Canadian authorities oppose U.S. drug importation. Drug corporations say importation would improve the chance of counterfeit medication showing on U.S. pharmacy cabinets, whereas the federal government in Ottawa has warned it gained’t enable medicines to be exported if Canadians might expertise shortages in consequence.
Florida’s predicted financial savings would even be comparatively minor. DeSantis estimated this system would save state companies as much as $180 million in its first yr. Florida’s annual Medicaid funds tops $30 billion.
Florida recognized 14 medication, together with for most cancers and AIDS, that it will try to import from Canada for its state companies.
Camm Epstein, a well being coverage analyst in Saratoga Springs, New York, stated drug importation is a seemingly easy idea that resonates with the general public, which is why DeSantis and others have turned to the concept as a response to rising drug costs. “It riles up the crowd,” he stated. “Who doesn’t want to pay lower drug costs?”
But bringing medication over the border is sophisticated due to the FDA’s many necessities, together with discovering corporations to work with — a Canadian exporter and a U.S. importer — and following a course of that ensures the medication are genuine, Epstein stated.
“This was, at best, a boondoggle,” he stated.
Florida has spent tens of thousands and thousands of {dollars} to face up its drug importation program. The state has already paid LifeScience Logistics $50 million to arrange a warehouse to retailer the medicines. DeSantis famous the prices in his 2022 lawsuit towards 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 go well with.
Florida’s delay could also be as a result of operational challenges, Epstein stated. “Predictably, even if they turned on the spigot there would be no flow, because Canada was not going to permit for the supply,” he stated.
Colorado and Florida are amongst a minimum of 9 states which have handed legal guidelines permitting for Canadian drug importation. Colorado’s 2022 utility to the FDA continues to be pending. In December 2023, Colorado officers launched a report noting the state was unable to find a drugmaker prepared to promote it medicines from Canada.
KFF Health News is a nationwide newsroom that produces in-depth journalism about well being points and is among the core working packages at KFF—an impartial supply of well being coverage analysis, polling, and journalism. Learn extra about KFF.
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