The FDA recently met with several states to discuss the Section 804 Importation Program, which allows states and tribes to propose plans to import certain lower-cost prescription drugs from Canada.
The meeting — held with representatives from HHS and the National Academy for State Health Policy — was part of ongoing federal efforts to reduce drug prices and advance President Trump’s pricing agenda.
The program aligns with a broader “most-favored-nation” strategy that ties U.S. drug prices to those in other high-income countries. It also builds on recent agreements with major drugmakers, including Pfizer, AstraZeneca, Eli Lilly and Novo Nordisk. Those deals helped lay the groundwork for TrumpRx, a federal platform launched in February that sells discounted drugs directly to consumers, bypassing traditional pharmacy benefit managers.
The FDA also introduced a new Quality Assurance Tool designed to help Section 804 sponsors prepare proposals that meet regulatory requirements. Launched in January, the tool outlines key components of a complete SIP proposal and shares lessons learned from previous submissions to reduce the risk of rejection or delays. It includes checklists and guidance on complying with rules related to cost savings, labeling, drug testing and supply chain security.
Florida remains the only state with an authorized SIP, though imports have not yet begun. Colorado, New Hampshire, Vermont and New Mexico have either submitted draft plans or expressed interest in participating. The FDA has encouraged states to seek early feedback through pre-review submissions, which the agency said can help streamline the formal approval process.
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