FDA approves Florida’s drug importation plan

by | Jan 5, 2024



The U.S. Food and Drug Administration has reportedly approved Florida’s plan to import prescription drugs from Canada, a move expected to save the state $80-$150 million in its first year.


The U.S. Food and Drug Administration (FDA) on Friday approved Florida’s proposed Canadian pharmaceutical drug importation plan.

This first-of-its-kind approval will allow Florida to buy medicines in bulk for Medicaid, government clinics, and prisons. State officials project that the initiative will save the state between $80 and $150 million in the first year alone.

Originally introduced by Gov. Ron DeSantis and the State Legislature in 2019, lawmakers sanctioned a strategy to integrate imported medications into public programs like Medicaid, the state’s correctional system, and services managed by the Department of Children and Families. The initial focus of the importation is to target diseases including HIV/AIDS, hepatitis C, diabetes, and mental health conditions, as outlined in a related legal document. An attempt to contact the Executive Office of the Governor for direct confirmation was not immediately responded to.

“Huge win for Floridians. Huge L for Big Pharma,” said DeSantis Presidential Campaign Rapid Response Director Christina Pushaw on X.

Florida’s approval follows a protracted process of regulatory and legal challenges. With delays initiated under President Donald Trump and continued by President Joe Biden, the state filed a lawsuit against the FDA over the lag in approving the proposal. The lawsuit also included allegations of violations of the Administrative Procedure Act and the Freedom of Information Act, relating to the FDA’s handling of the proposal and response to information requests. DeSantis stated last August that the FDA engaged in a delay of 630 days in approving Florida’s proposal.

In September, The FDA submitted a supplemental status report in which it identified supposed deficiencies in Florida’s proposal, particularly related to drug supply chain security, product identifiers, and cost reduction for consumers.

Moreover, legal firms representing pharmaceutical and health organizations last month called on the FDA to withhold authorization of Florida’s proposal.

The supplement, representing the Pharmaceutical Research and Manufacturers of America (“PhRMA”), Partnership for Safe Medicines (“PSM”), and the Council for Affordable Health Coverage, pointed to an alleged lack of transparency in the state’s crafting of its proposal. The document asserted that purported incomplete information would hinder a comprehensive assessment of whether the proposed importation scheme complies with statutory and regulatory requirements.

“We are deeply concerned with the FDA’s reckless decision to approve Florida’s state importation plan,” PhRMA President and CEO Stephen J. Ubl told The Capitolist following Friday’s order. “Ensuring patients have access to needed medicines is critical, but the importation of unapproved medicines, whether from Canada or elsewhere in the world, poses a serious danger to public health. Politicians need to stop getting between Americans and their health care. PhRMA is considering all options for preventing this policy from harming patients.”

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