The FDA has taken a significant step to address the rising cost of prescription drugs in the U.S. by enhancing state importation programs under section 804 of the Federal Food, Drug, and Cosmetic Act (FDCA). Announced on May 21, 2025, these updates aim to provide Americans with access to safe, effective, and more affordable medications through imports from Canada.
This initiative aligns with the Executive Order on lowering drug prices, reflecting the FDA’s commitment to ensuring high-quality medicines at competitive prices.
Key Enhancements
- Pre-Review Opportunities: States and Indian tribes can now submit draft proposals for early FDA feedback, helping them refine their submissions.
- User-Friendly Tools: The FDA will provide resources to streamline proposal development, reducing review timelines.
- Streamlined Cost Analysis: Guidance will help states estimate cost savings more accurately, ensuring robust proposals.
- Collaborative Meetings: The FDA plans to meet with interested states this fall to foster feedback and ease the process.
Balancing Safety with Affordability
As FDA Commissioner Marty Makary, M.D., M.P.H., stated, “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.”
Why This Matters
These enhancements empower states and tribes to lower drug prices while safeguarding public health. For patients, this holds the promise of significant cost savings and improved access to life-saving medications.
Now is the time to act. States and tribes should take advantage of these FDA enhancements to create effective programs that address rising drug prices and benefit their communities.
