Florida is suing the Biden administration's FDA for what Gov. Ron DeSantis called 'unreasonably delayed' approval of a state plan to import prescription drugs from Canada

• Florida is suing the FDA because it hasn't approved its plan to lower prescription-drug prices.
• The state wanted to import cheaper prescriptions from Canada.

Florida is suing the Food and Drug Administration because it hasn't moved to approve a plan from Republican Gov. Ron DeSantis to import less expensive prescription drugs from Canada.

The governor on Wednesday accused the FDA of having "unlawfully withheld" and "unreasonably delayed" approval of Florida's program, saying, "We think this violates federal law." The state is suing to have a federal judge order an end to the delay.

"It's hard to even meet with people at the FDA, very dismissive, very arrogant with how they have gone about this stuff," DeSantis said at a press conference in a pharmaceutical-distribution warehouse in Lakeland, Florida. "But our view is we need to keep pressing forward. After 630 days, we still sit here waiting for an answer, and so it's our view we have waited long enough. Today we are taking action."

DeSantis' office calculates that importing cheaper drugs from Canada could save Florida's government as much as $150 million a year. The imported medicines would include treatments for HIV and AIDS, diabetes, and asthma.

The plan would mostly save money for Florida's Medicaid program and reduce how much the state pays for medicines it provides to people in correctional facilities. Medicaid covers healthcare costs for low-income earners, pregnancies and childbirth, and people with disabilities.

Florida was the first state under President Donald Trump to move to take advantage of a 2003 federal law that allows states to have drug-importation plans approved.

Trump directed the Department of Health and Human Services to set safety rules for the programs, and the Florida Legislature passed an importation law in 2019.

From there, state officials worked with the Trump administration for more than a year to create their plan. They filed it for approval with the federal government soon after Trump lost reelection. Other states are working on plans, including Vermont, New Mexico, Colorado, Maine, and New Hampshire.

Biden promised during his 2020 campaign that he would authorize drug imports as part of a broader plan to lower prescription costs and signed an executive order in July 2021 that would allow for them. DeSantis said that when officials in Florida saw the executive order, they thought they'd get the green light soon.

But Florida's plan remains in limbo.

"This has been a frustrating process from the macro to the micro," Simone Marstiller, the secretary of Florida's Agency for Health Care Administration, said at the Lakeland press conference. "My team and I have had so many meetings with the FDA it's not even funny. But all we have gotten is word salad, bureaucracy, stonewalling, stiff-arming, and stall tactics."

The US pays several times as much for prescription drugs as Canada because Canada has a panel that negotiates the prices of drugs by tying them to the prices of those in similar countries. While Canada's government funds more healthcare services than the US does, many Canadians have to purchase supplemental private insurance to help pay for prescription drugs.

Still, the prices are lower in Canada. The US spent an average of $1,310 a person on prescription drugs in 2021, compared with $868 a person in Canada, according to the Organization for Economic Co-operation and Development.

In response to an inquiry from Insider, the FDA said it "doesn't comment on potential, pending, or ongoing litigation."

Rejecting the proposal could backfire against Biden and allow Republicans to accuse the president of political motivations, even if his deputies cite safety or other concerns for their decision.

DeSantis hinted that he thought politics or pharmaceutical lobbying may be at play, though it's not clear what's behind the delay. Florida filed a public-information request with the FDA to find out what the internal chatter was regarding its plan but hasn't heard back.

"Are they putting politics over patients? Are they putting the interest of Big Pharma over the interests of average Floridians and taxpayers? That's what we need to find out," DeSantis said.

Biden signed the Inflation Reduction Act into law on August 16, and it contains several provisions for drug savings in the Medicare program — which mostly covers adults over 65. But a prescription-drug price-setting portion of the law would apply only to 10 drugs beginning in 2026.

Both Trump and DeSantis bucked their party by pushing for prescription-drug importation, which was originally championed by Sen. Bernie Sanders, a Vermont independent.

The idea of allowing cheaper drug importation is popular with voters, with 78% of respondents in a Kaiser Family Foundation poll saying that they supported it. But the pharmaceutical industry is powerful in Washington and state capitals, with political action committees that shower donations on politicians of both parties.

Drug-industry groups oppose importation, which they say could lead to unsafe medicines reaching the US. Some outside experts have also been skeptical that importation plans would save consumers money, and Canadian officials have raised concerns that importation would cause shortages in that country.

Last year, Sanders told Insider he thought the Biden administration should approve Florida's plan and that it should be taken up nationally.

"I think we should do it for the whole country," he said. "If we can develop a safety protocol — which we absolutely can — then, of course, we should go forward with reimportation."

This story has been updated to include a response from the FDA.