DeSantis sues FDA in push to import prescription drugs from Canada

Florida Gov. Ron DeSantis (R) announced Wednesday that he has filed a lawsuit against the Food and Drug Administration (FDA), claiming the federal agency has unlawfully delayed approval of a state program that would allow the state to import prescription drugs from Canada to lower medication costs for Floridians.

DeSantis said the FDA has violated federal law by dragging out the approval of the Canadian Prescription Drug Importation Program, which he first requested approval for in November 2020.

“It’s our view that we’ve waited long enough,” DeSantis said at a press conference in Lakeland, Fla., announcing the lawsuit. “The clock’s been ticking. We have a right to know what the FDA has been doing the last two years to ensure [whether] they are putting politics over patients [or] putting the interests of Big Pharma over the interests of average Floridians.”

The State of Florida and the Florida Agency for Health Care Administration filed a lawsuit in a Tampa federal court after DeSantis said the FDA failed to respond in time to a July Freedom of Information Act (FOIA) request for information on the drug approval process.

The 42-page lawsuit claims the FDA has violated the Administrative Procedure Act, which governs how federal agencies operate, as well FOIA laws.

The Hill has reached out to the FDA for comment.

Prescription drugs carry abnormally high costs in the U.S., although the recently-passed Inflation Reduction Act allows Medicare to negotiate the price of drugs and cap out-of-pocket costs for medications at $2,000 starting in 2025.

DeSantis signed a law authorizing the Canadian Prescription Drug Importation Program in July 2019, becoming the first state to seek authorization from the FDA to import medications from Canada, where the same prescription drugs can be up to 80 percent cheaper.

Several other states have also moved to import drugs from the country, including New Mexico and Colorado.

The first phase of Florida’s program includes importing drugs used to treat HIV, diabetes, hepatitis C and mental illness. The governor’s office estimates that Floridians will save $150 million annually under the program.

But a 1987 law known as the Prescription Drug Marketing Act prohibits anyone but the pharmaceutical manufacturer from importing drugs from outside of the country, unless the Department of Health and Human Services specifically approves it.

Former President Trump signed an executive order in 2020 to import some prescription drugs from Canada, but the nation’s health agency later that year blocked bulk exports, warning of shortages.

In July 2021, President Biden issued an executive order directing the FDA to work with states on the drug approval process.

Over the spring, the FDA submitted an update on the approval process, but only said it has met with state officials and was “working to implement a statutory pathway” for Canadian drug imports.

DeSantis in his lawsuit claims Florida’s health agency has complied with all FDA requests and yet remains in the dark as the process drags on, only getting vague statements from federal agents including that the “information is currently under evaluation.”

Florida Attorney General Ashley Moody on Wednesday said the state has been “waiting and waiting” for approval on the program.

“This [Biden] administration is not quick to act to get things done for Florida,” she said. “An agency of the administration cannot just sit on applications. They have to act with reasonable timeliness.”