Florida sues FDA over records for program approval of importing prescription drugs from Canada

Gov. Ron DeSantis announces lawsuit in Lakeland

Republican gubernatorial incumbent Gov. Ron DeSantis, speaks to supporters Tuesday, Aug. 23, 2022, in Hialeah, Fla. DeSantis will face U.S. Rep. Charlie Crist in November. (AP Photo/Gaston De Cardenas) (Gaston De Cardenas)

LAKELAND, Fla. – Florida Gov. Ron DeSantis announced a lawsuit against the Food and Drug Administration for “unlawfully” withholding approval of a program that would allow the state to import prescription drugs from Canada.

The governor was joined by Florida Surgeon General Joseph Ladapo and Agency for Health Care Administration Secretary Simone Marstiller for the news conference in Lakeland Wednesday.

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Last month, DeSantis announced an executive order in the meantime to “hold pharmacy benefit managers accountable” and “drive transparency in prescription drug costs.” He also said the AHCA filed a Freedom of Information Act request to learn more about the delay in program approval to get the drugs from Canada.

“They have unlawfully withheld and unreasonably delayed approval of Florida’s program. And we think this violates federal law,” DeSantis said of the lawsuit in Lakeland. “So we’re asking a federal judge to order the FDA to put an end to that delay, and to approve Florida’s program included in the lawsuit or claims under the federal Freedom of Information Act.”

DeSantis said the FOIA request made in July was “to increase transparency on their approval process.” The governor said under the act, the FDA had 30 working days to respond to the request and the state has not received a response.

“All this stuff is locked and loaded, ready to go. And it has been ready to go for quite some time. So we’ve been waiting and waiting and waiting,” he said. “We’ve done everything that we need to do to get this moving and I think it’s really, really important.”

First announced in February 2019, DeSantis said Florida filed a request to import medications from Canada utilizing authority in the 2003 Medicare Modernization Act. Florida submitted a plan to the U.S. Department of Health and Human Services addressing all key components needed to safely import prescription drugs.

[RELATED: Years ago, DeSantis pledged to import cheaper medications from Canada. Here’s why it hasn’t happened]

In November 2020, the state sent in its Section 804 Importation Proposal for Florida’s Canadian Prescription Drug Importation Program in accordance with all requirements from the HHS and Federal Drug Administration.

“This is a new model because it’s the first time this law has been used and so you know, we are taking pains to show how we relabel, making sure everything’s good,” he said. “...But once we do that, you know we’re going to show it works and we want to expand, and we want to get it out to as many people that need it as possible.”

DeSantis said during a news conference in May 2021 the program would save between $80 million to $150 million on drug costs a year.

This comes after the governor on Tuesday announced $2.7 million for infrastructure improvements for the Fort Pierce area.

Later in the day, the Republican governor held a news conference in Live Oak and accused local supervisors of elections of not caring about election laws. It was one of many accusations the governor threw out when asked what role the state played in allowing felons to vote in the 2020 election.

“Some local jurisdictions don’t care about election laws. We do, and we think it’s important. If you’re not able to run an election right, we want to hold people accountable,” DeSantis said.

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About the Author:

Brenda Argueta is a digital journalist who joined ClickOrlando.com in March 2021. She graduated from UCF and returned to Central Florida after working in Colorado.