DeSantis Slaps the FDA with a Lawsuit for 'Putting Politics Over Patients'

By Abby Liebing August 31, 2022 at 2:12pm

Florida Gov. Ron DeSantis announced on Wednesday that his state has filed a lawsuit against the U.S. Food and Drug Administration for delaying the approval of a program that would give Floridians access to cheaper medication.

DeSantis’ office announced in a news release that the lawsuit is a response to the FDA’s “unreasonable delay of more than 630 days in approving Florida’s proposal for its Canadian Prescription Drug Importation Program.”

Florida’s Agency for Health Care Administration in Florida submitted a plan to the FDA to import cheaper drugs from Canada in 2020, according to the News Service of Florida.

But, as the release states, that was “nearly 21 months ago.”

Federal approval is the last challenge facing the AHCA plan, but “Florida’s ability to begin operating the Program is stuck in the starting blocks because of Defendant FDA, which must first approve the Program,” the lawsuit argues.

The result has not been good for the Sunshine State, according to the governor’s news release.

“Florida has been ready to deliver cheaper prescription drugs to those that need them for nearly two years,” DeSantis in the release.

This plan has the potential to cut consumer costs, perhaps by half, by importing drugs from Canada, WFTS-TV reported.

The Trump administration supported this idea in 2020 and created two new pathways for states to apply for safe drug importation through the Department of Health and Human Services, according to the station.

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However, according to the News Service of Florida, the Pharmaceutical Research & Manufacturers of America launched a legal challenge that’s still in federal court in Washington, the News Service of Florida reported.

In May 2021, the Biden administration sided with Florida and New Mexico — the only other state that has applied to begin accepting Canadian imports — and asked the court to dismiss the industry challenge, according to Politico.

But Florida still hasn’t gotten a response from the FDA.

“After 630 days, we still sit here waiting for an answer,” DeSantis said Wednesday, according to Florida’s Voice, an online news site. “We have a right to know what the FDA has been doing for the last 2 years. Are they putting politics over patients?”

#BREAKING: Gov. Ron DeSantis files lawsuit against the FDA for holding out on approving Florida’s application to lower drug prices for Floridians

“After 630 days, we still sit here waiting for an answer. It’s our view that we’ve waited long enough.” pic.twitter.com/VSTBBezQTj

— Florida’s Voice (@FLVoiceNews) August 31, 2022

The reason behind the FDA’s stalling on Florida’s plan is unclear.

“The lack of transparency by the Biden administration during the approval process, and failure to provide records on the importation proposal, is costing Floridians who are facing rising prices across the board due to inflation. Florida is confident in our importation model, and we continue to look for more ways to lower drug costs for Floridians while the FDA delays approval of this importation proposal,” DeSantis added.

Due to the delay, the AHCA filed a Freedom of Information Act in early July, hoping to obtain records from the FDA regarding the request, WFTS reported.

The FDA had 30 working days to respond to the FOIA, but DeSantis said the agency has not yet received a response — nearly two months later.

The FDA’s failure to cooperate has simply prolonged the already-long delay the AHCA was facing.

“We sent it up to Washington during the Trump Administration for approval from the FDA,” DeSantis said, according to WFTS. “It’s just been sitting at FDA for months.”

“They have unlawfully withheld and unreasonably delayed Florida’s program and we think this violates federal law,” he added. “So we’re asking a federal judge to order the FDA to put an end to that delay and to approve Florida’s program.”

Florida Attorney General Ashley Moody and Agency for Health Care Administration Secretary Simone Marstiller also commented on the situation.

“Gov. DeSantis and I are fighting to lower prescription drug costs, but Washington bureaucrats are blocking our efforts. Today, we filed litigation to force the FDA to accept our medication importation proposal. This action will save Florida $150 million a year,” Moody said in the release.

“Thanks to the decisive leadership of Gov. DeSantis and his commitment to empowering patients, we will continue to fight for Floridians and the ability to import high-quality prescription drugs from Canada at a significantly lower price,” Marstiller said in the release.

“With each passing day, the complacency of the federal government continues to appear to be a ruse to protect the pharmaceutical industry’s ‘power’ over patients.”

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