Explaining unapproved drugs to payors: FDA offers pharma new guidance to avoid pitfalls

FDA has issued a June 2026 draft guidance that clarifies how drug and device makers can communicate information about unapproved drugs and unapproved uses of approved products to payors without running afoul of advertising and promotion rules.

The revised draft explicitly confirms that communications about unapproved products and unapproved uses—whether or not they are strictly "investigational"—can be shared with payors as long as they meet specific statutory conditions on truthfulness, required disclosures, and no prohibited claims about safety or efficacy.

The guidance codifies that manufacturers must update payors if previously shared information becomes materially outdated (e.g., trial failure, regulatory setback), turning what was once a recommendation into a statutory requirement.

Permissible information includes product descriptions, indications under study, anticipated approval timelines, pricing, utilization projections, product-related programs, and factual study results—provided safety and efficacy are not characterized.