FDA News Release
FDA Holds Meeting with States on Importation of Lower Cost Drugs
- For Immediate Release:
Earlier this week, the U.S. Food and Drug Administration held a meeting with several states to discuss the section 804 importation program (SIP), which allows states and Indian tribes to import certain prescription drugs from Canada to significantly reduce the cost of these drugs to the American consumer. The gathering was the latest step toward the FDA’s implementation of President’s Trump’s executive order on lowering drug prices.
The meeting provided a forum to exchange information, with the goal of making it easier for states that have expressed interest in the program to obtain authorization without sacrificing safety or quality. Representatives from HHS and the National Academy for State Health Policy also participated.
“We are committed to lowering prescription drug prices for Americans, building on recent MFN wins,” said FDA Commissioner Marty Makary, M.D., M.P.H. “We’re moving forward to implement the president’s executive order as we continue the crucial work of helping states and Indian tribes import reduced cost prescription drugs, while protecting public health and safety.”
Since the executive order was issued, the FDA has been offering individual states and tribes the opportunity to submit a draft SIP proposal for pre-review and meet with the agency to obtain initial feedback prior to formally submitting their SIP proposals. The agency also has been working to assist states and tribes with options to streamline the required cost savings analysis, and to provide input regarding the information states may rely on as they estimate cost savings for American consumers.
Additionally, the section 804 importation program quality assurance (QA) tool — which is designed to assist SIP sponsors prepare proposals that fully comply with the requirements under the final rule — was launched in January 2026. The QA tool offers tips, lessons learned from previous submissions, and practical considerations for sponsors to develop SIP proposals that are complete and consistent with regulatory expectations.
Presentations from the meeting held earlier this week are available for download at: Section 804 Importation Program Policies and Authorizations.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.