H.R. 10150 — Advancing Botanical Drug Development Act of 2026

This section states congressional findings on the prevalence of chronic and age-related diseases, the limitations of single-pathway therapies, the multi-target potential of FDA-regulated botanical drugs under section 505 of the Federal Food, Drug, and Cosmetic Act, and the unique scientific, manufacturing, and regulatory challenges that limit private investment in their development despite advances in computational biology and artificial intelligence.

This section establishes a 12-year period of market exclusivity for botanical drugs approved under new drug applications submitted after the date of enactment. During that period, no application under subsection (b)(2) or (j) that references or relies on such a drug may become effective.