WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) recently announced new measures aimed at facilitating state importation programs, advancing its efforts to help Americans access affordable prescription medications without compromising health and safety standards. These steps, initiated under the Executive Order to Lower Drug Prices by Once Again Putting Americans First, are designed to provide clearer guidance and faster review processes for proposals submitted under section 804 of the Federal Food, Drug, and Cosmetic Act.
“For too long, Americans have been getting taken advantage of. Drug prices in the U.S. are sometimes 5-10 times higher than in wealthy European countries,” stated FDA Commissioner Marty Makary, M.D., M.P.H. He emphasized, “These 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.”
The FDA’s enhancements include offering states and Indian tribes informal, optional pre-review meetings to provide feedback on draft proposals for Section 804 Importation Programs (SIP). This approach is intended to reduce administrative burdens and help entities develop streamlined, robust submissions. The FDA also plans to introduce a user-friendly tool to support the preparation of SIP proposals and clarify requirements, potentially shortening the time needed for agency review.
Additionally, the FDA is exploring options to simplify the cost savings analysis required for program approval. The aim is to reduce the complexity of estimating savings while ensuring proposals deliver measurable benefits to consumers.
This fall, the FDA plans to engage with states in a dedicated meeting to discuss these enhancements and gather feedback. The discussions are expected to provide valuable insights to further refine the process, making it easier for states to gain program approval while upholding public safety.
Through these measures, the FDA seeks to support affordable access to vital medications and address the significant disparities faced by American consumers in drug pricing.
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