Florida Sues FDA over Prescription Drug Program

by Bethany Blankley


The state of Florida is suing the U.S. Food and Drug Administration (FDA) over claims its review of the state’s Canadian Prescription Drug Importation Program has taken more than 630 days.

“Florida has been ready to deliver cheaper prescription drugs to those that need them for nearly two years,” Gov. Ron DeSantis said at a  Wednesday news conference announcing the lawsuit with Attorney General Ashley Moody. “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.”

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

The lawsuit was filed in the U.S. District Court Middle District of Florida Tampa Division. The FDA and its commissioner, Robert Califf, and the U.S. Department of Health and Human Services and its secretary, Xavier Becerra, are named as defendants.

In 2019, DeSantis and the state legislature created the program to lower prescription drug costs for millions of Floridians. In November 2020, Florida’s Agency for Health Care Administration (AHCA) submitted its proposal to HHS for it to consider and approve. Once approved, Florida planned to import a few drug classes, including maintenance medications for individuals with chronic health conditions like asthma, COPD, diabetes, and HIV/AIDS.

AHCA then planned to contract with a vendor to manage and oversee all aspects of the program and ensure Canadian suppliers and eligible importers were in compliance with all federal and state laws. Eligible importers would be limited to wholesalers and pharmacists that dispense prescription drugs to consumers served by certain state and government programs.

In late July 2020, HHS published its Safe Importation Action plan outlining measures it and the FDA would take to allow for the safe importation of certain prescription drugs. It published its final rule about the plan last November. Yet, since November 2020, Florida doesn’t have a response.

The AHCA also said it filed a Freedom of Information Act request to learn the status of its proposal and still hasn’t received a response. As a result, the AHCA is a plaintiff in the state’s lawsuit against the FDA and HHS.

“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,” AHCA Secretary Simone Marstiller said.

“The reality is that people cannot wait upwards of two years to improve access to essential prescriptions,” Florida Surgeon General Dr. Joseph Ladapo said. “Instead, the federal government is dragging their feet when Americans need affordable prescriptions, now more than ever.”

Earlier this month, DeSantis authorized the AHCA via executive order to negotiate prices for drugs ineligible for importation, including insulin and epinephrine.

Dean Clancy, senior health policy fellow at Americans for Prosperity, told The Center Square that Congress should be following DeSantis’ lead. Instead, Democrats in Congress passed the Inflation Reduction Act, which Clancy and others argue will increase the cost of prescription drugs.

“Governor DeSantis’ EO contains the kind of reforms Congress should be looking at instead of imposing government price controls,” he said. “Ensuring more transparency for the monopolistic middlemen who help drive up pharmaceutical costs will reduce prices and give Americans a personal option for prescription drugs.”

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Bethany Blankley is a contributor to The Center Square. 
Photo “Walmart Pharmacy” Mike Mozart. CC BY 2.0.




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