FDA greenlights Florida drug importation program

Jan. 8, 2024

The FDA has greenlit Florida's Agency for Health Care Administration section 804 importation program (SIP), a first step towards facilitating importation of certain prescription drugs from Canada with the aim of reducing costs for U.S. consumers.

In a nation’s first, the program — which the Florida goverment has been attempting to get authorized by the FDA for the last 37 months — allows the state to import eligible prescription drugs from foreign sources, specifically Canada, if doing so will reduce costs to U.S. patients without imposing additional risk to public health and safety.

In its review of Florida's revised SIP proposal submitted on November 16, 2023, the FDA has determined that it meets the statutory requirements outlined in section 804 and 21 CFR part 251. The authorization is valid for a two-year period, with specific labeling corrections shared by the agency

For importation to proceed, the importer must submit a Pre-Import Request to FDA at least 30 calendar days before the scheduled arrival or entry for consumption of eligible prescription drugs covered by the SIP.  The approval process includes various steps, such as testing for authenticity and compliance with established specifications, as well as the submission of labeling corrections for FDA review. Importers are also required to provide a written certification once an eligible prescription drug meets all statutory and regulatory criteria.

In its announcement, the FDA highlights ongoing requirements, including the need for foreign sellers to update registration information and SIP sponsors to submit quarterly reports. SIP sponsors may request extensions or propose modifications, subject to FDA approval.

According to a statement released by Florida Governor Ron DeSantis, the state is expected to save up to $180 million in the first year alone. “After years of federal bureaucrats dragging their feet, Florida will now be able to import low-cost, life-saving prescription drugs,” said DeSantis. “It’s about time that the FDA put patients over politics and the interests of Floridians over big pharma.”

The industry, however, has a different take on the news, with PhRMA President and CEO Stephen J. Ubl calling the FDA decision "reckless" and noting safety concerns.

“We are deeply concerned with the FDA’s reckless decision to approve Florida’s state importation plan. 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,” said Ubl in a statement.