In a strategic move to address America's high prescription drug costs, the FDA announced on May 21, 2025, a refined regulatory pathway to support state and Native American tribe-led importation of certain prescription medications from Canada. The initiative aims to improve drug affordability for American patients while maintaining the agency's rigorous safety and efficacy standards.
FDA Enhances Section 804 Importation Framework
The updated approach centers on optimizing Section 804 of the Federal Food, Drug, and Cosmetic Act, which permits states and tribes to import select prescription drugs from Canada. These enhancements align with President Trump's April 15 Executive Order, "Lowering Drug Prices by Once Again Putting Americans First," which directed the FDA to streamline the importation program within 90 days.
"For too long, Americans have been getting taken advantage of. Drug prices in the US are sometimes 5-10 times higher than in wealthy European countries," said FDA Commissioner Marty Makary, MD. "Today's actions will support the ability to import drugs at much lower prices while also maintaining the high quality and safety of medicines that Americans expect and deserve."
Key improvements to the Section 804 Importation Program (SIP) include allowing states and tribes to submit draft proposals for informal pre-review, followed by optional meetings with FDA representatives. These preliminary consultations are designed to provide early feedback, reduce regulatory burden, and help sponsors develop more robust proposals.
New Tools and Simplified Requirements
The FDA is developing a user-friendly tool to assist stakeholders in preparing proposals that align with agency requirements. This resource will provide structured guidance to help applicants meet submission standards more efficiently, potentially shortening review timelines.
Additionally, the agency is working to simplify the required cost savings analysis by clarifying the types of data states can use to project consumer savings—a central component in SIP proposal approval. The FDA plans to meet with interested states this fall to discuss these improvements, provide technical guidance, and gather feedback on the revised process.
Persistent Challenges Despite Reforms
While these enhancements may accelerate SIP proposal submissions, significant hurdles remain before states can actually begin importing medications. After receiving FDA authorization for a SIP proposal, states must submit a Pre-Import Request within twelve months, which requires extensive information and must be approved before imports can commence.
Florida's experience highlights these challenges. Despite receiving FDA authorization in January 2024—three years after submitting its proposal and after filing a lawsuit over FDA's failure to respond to a FOIA request—Florida has yet to begin importing prescription drugs from Canada. In December 2024, the FDA granted Florida a six-month extension to submit its Pre-Import Request.
Importation Program Requirements
Under the Importation of Prescription Drugs Final Rule, importation program proposals may eventually be submitted by pharmacists and wholesalers in addition to states and tribes. All proposals must demonstrate that the programs pose no additional risk to public health and safety while ensuring significant cost reductions for American consumers.
Eligible drugs must be approved by Canada's Health Products and Food Branch and meet the conditions of an FDA-approved new drug application or abbreviated new drug application. The FDA emphasizes that imported drugs must maintain the same high quality and safety standards as those manufactured domestically.
Looking Forward
While the FDA's announced enhancements represent progress toward more affordable prescription medications, questions remain about whether these changes will meaningfully impact the overall timeline for states to begin importing drugs from Canada. At least five states have submitted SIP proposals to the FDA, but Florida remains the only state to have received authorization thus far.
The success of this initiative will ultimately depend on how effectively the FDA's streamlined processes translate into actual drug imports and measurable cost savings for American patients—a goal that has proven elusive despite years of regulatory efforts.
