The Food and Drug Administration is pushing harder to make lower-cost Canadian prescription drugs a reality for American consumers. The agency convened state representatives this week to accelerate the Section 804 Importation Program, which allows states and Indian tribes to import eligible drugs from Canada.
The meeting brought together experts from the Department of Health and Human Services and the National Academy for State Health Policy to help states clear bureaucratic hurdles. The FDA is now offering “pre-reviews” of draft proposals, allowing states to get feedback before officially submitting their plans.
“We are committed to lowering prescription drug prices for Americans,” said FDA Commissioner Marty Makary. “We’re moving forward to implement the president’s executive order while protecting public health and safety.”
To support states, the FDA highlighted the Section 804 Importation Program Quality Assurance Tool, launched in January 2026. The resource offers lessons learned from previous submissions, compliance tips, and technical guidance for maintaining supply chain integrity.
The FDA is positioning itself as a partner in the process, offering direct feedback loops and tools it hopes will lead to a significant increase in authorized importation programs by year’s end.
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