H.R. 946 — ORPHAN Cures Act

This section expands and clarifies the exclusion from selection under the Medicare Drug Price Negotiation Program for orphan drugs (i.e., drugs designated under FDA's orphan drug program solely to treat rare diseases or conditions, as defined in section 526(a)(2) of the Federal Food, Drug, and Cosmetic Act). Specifically, it (1) requires that, in calculating time elapsed since FDA approval or licensure for other exclusion criteria, the Secretary exclude any period during which the drug qualified as an orphan drug; and (2) revises the orphan drug exclusion to apply to drugs designated solely for one or more rare diseases or conditions (from only one rare disease or condition). (Thus, the change broadens eligibility for exclusion and effectively extends time-based protections for drugs that later receive approvals for non-rare uses.)