Florida sues FDA to get Canadian drugs approved in Florida

ByDonald L. Leech

Aug 31, 2022

Accusing the federal government of dragging its feet despite the president’s assurances Joe Bidengovernor Ron DeSantis and attorney general Ashley Moody announced that Florida is suing the Food and Drug Administration (FDA) to allow Florida to import certain prescription drugs from Canada.

The governor, attorney general and others complained at a news conference in Lakeland that the FDA is delaying approval of Florida’s application which has now been pending for more than 630 days.

“It was a frustrating process from macro to micro. My team and I have had so many meetings with the FDA it’s not even funny. But all we got was a salad of words,” the secretary of the Agency for Healthcare Administration said. Simone Martiller.

The frustration centers on a request the DeSantis administration filed with the FDA in late 2020 — when the former president donald trump was still in operation – to allow a limited number of low-cost Canadian prescription drugs to be shipped to Florida for distribution through state agencies.

DeSantis and Marstiller said the program could save up to $150 million a year in costs on these drugs because the same products are sold in the United States for double or more what they cost in Canada.

Moody’s announced the lawsuit to force the FDA to provide more information about why Florida’s application has not yet been approved.

DeSantis said the standard objection was about the safety of Canadian drugs versus American drugs. He scoffed at that, saying Florida officials would test the drugs for content and purity at facilities such as the LifeScience Logistics Distribution Center in Lakeland, which hosted his press conference.

“Basically they tried to say it was a security issue. You know, people use drugs in Canada. It’s not Djibouti,” DeSantis said, referring to the East African nation. “It’s a safe country.”

The Governor has been working on a Canadian drug importation program since first months of his mandate. In late 2020, Florida became the first state to formally seek program approval. In July 2022 Biden issued an executive order directing the FDA to work with states to safely import prescription drugs from Canada.

More than a year later, DeSantis was asking why the FDA’s delay and silence persisted. He accused “big Pharma” of preventing the Biden administration from carrying out Biden’s order. The Agency for Healthcare Administration filed a public registration request with the FDA in July seeking information, but has yet to receive a response.

That’s why Moody’s has filed a federal lawsuit, which asks a federal judge to end any delay in FDA approval and approve Florida’s program.

“They illegally withheld and unreasonably delayed approval of the Florida program and we believe this violates federal law,” DeSantis said.

Florida’s plan provides limited access to Canadian drugs. This would allow the import of a specific list of pills for chronic conditions such as diabetes and heart disease, which would be distributed by state agencies such as the Department of Health, to patients who receive their prescription drugs. through these agencies.

“We started with a limited number of drugs,” Marstiller said.

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