In a move FDA says is aimed at improving drug affordability without compromising safety or efficacy, the administration is refining its regulatory pathway to support state- and Native American tribe-led importation of certain prescription medications from Canada, according to a news release on May 21, 2025 (1). These enhancements fall under FDA’s implementation of the Presidential Executive Order Lowering Drug Prices by Once Again Putting Americans First (2) and are intended to reduce pharmaceutical costs for American patients while upholding strict quality standards.
Key Takeaways
·FDA announced plans to streamline importation proposals, offering pre-reviews and guidance tools to help states develop compliant programs for drug imports from Canada.
·Regulatory burden is reportedly set to be reduced via informal meetings and simplified cost analysis aimed at accelerating approval of state importation plans.
·High drug quality and safety standards remain central to the plans, ensuring imported drugs meet US manufacturing and compliance expectations despite lower costs.
Section 804 of the Federal Food, Drug, and Cosmetic Act
The update centers on Section 804 of the Federal Food, Drug, and Cosmetic Act, which permits states and tribes to import select prescription drugs from Canada. FDA is optimizing this framework to remove administrative barriers and encourage broader participation.
“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 in the news release (1). “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.”
To support this goal, FDA will now allow states and tribes to submit draft proposals for informal pre-review. These preliminary reviews, followed by optional meetings with FDA representatives, are intended to provide early feedback, reduce the regulatory burden, and help sponsors craft more robust and technically sound Section 804 Importation Program (SIP) proposals (3).
User-friendly tool on the horizon
A new, user-friendly tool is also in development to assist stakeholders in preparing proposals that align with FDA requirements (1). This tool will provide structured guidance, helping applicants meet submission standards more efficiently and thereby shortening the agency’s review timeline.
In parallel, FDA is working on options to simplify the required cost savings analysis. This includes clarifying the types of data states can use to project consumer savings, which remains a central component in SIP proposal approval.
The agency plans to meet with interested states this fall to discuss these improvements, provide technical guidance, and gather feedback on the revised process. These discussions aim to foster collaboration and innovation while maintaining FDA’s commitment to public health and safety.
A closer look at program proposals
The Importation of Prescription Drugs Final Rule (4) from the Secretary of Health and Human Services notes that importation program proposals may be submitted in “certain future circumstances” by pharmacists and wholesalers in addition to states and tribes. Importation program proposals must explain how the programs pose no additional risk to public health and safety and explain how the sponsor will ensure significant reductions in American consumer costs for products covered under the program. Drugs included in a program must also be approved by Canada’s Health Products and Food Branch, or HPFB, and meet the conditions of an FDA-approved new drug application or abbreviated new drug application. Additional information is available via the Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, and Combination Products under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act, Guidance for Industry (5).
References
- FDA. FDA Takes Steps to Enhance State Importation Programs to Help Lower Prescription Drug Prices. Press Release. May 21, 2025.
- The White House. Lowering Drug Prices by Once Again Putting Americans First. WhiteHouse.gov,April 15, 2025 (accessed May 22, 2025).
- FDA. Importation Program under Section 804 of the FD&C Act, updated May 21, 2025 (accessed May 22, 2025).
- FDA and HHS. Importation of Prescription Drugs Final Rule (accessed May 22, 2025).
- FDA. Guidance for Industry, Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, and Combination Products under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act (CDER/CBER/OCP/ORA, September 2020).
