(The Center Square) – The U.S. Food and Drug Administration approved Florida’s request to import prescription drugs on Friday, ending a prolonged legal battle and providing Republican Gov. Ron DeSantis a key policy victory.
In a letter, the FDA said it authorized the program for two years under the Section 804 Importation Program.
State officials say the new program could save the state $180 million per year.
“After years of federal bureaucrats dragging their feet, Florida will now be able to import low-cost, life-saving prescription drugs,” DeSantis said in a release. “It’s about time that the FDA put patients over politics and the interests of Floridians over Big Pharma.”
One of the conditions of the approval will require the state’s Agency for Health Care Administration to submit drug-related information to the FDA for review and approval. Another is a requirement that the drugs be tested for authenticity and compliance with the specifications and standards for previously-approved medications.
The imported drugs would also have to be relabeled consistent with FDA regulations and the state agency would have to file quarterly reports with the feds detailing information about the imported drugs, cost savings and any potential safety and quality issues.
“The FDA is committed to working with states and Indian tribes that seek to develop successful section 804 importation proposals,” FDA Commissioner Dr. Robert M. Califf said in a release. “These proposals must demonstrate the programs would result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs.”
DeSantis and the state’s Agency for Health Care Administration filed a Section 804 Importation Program proposal to the FDA in November 2020, with the hope of reducing the cost of prescription drugs statewide.
Nearly two years later in August 2022, the DeSantis administration filed a lawsuit against the FDA for what he called a reckless and unreasonable delay after 630 days had elapsed since the proposal was filed. The lawsuit sought records that would possibly implicate the federal government in its delay of authorizing the program.
That litigation is ongoing, but could be dismissed in light of the FDA’s decision. The next deadline in the case is Feb. 20, when the FDA is due to present a Vaughn index to the state of Florida.