S. 1862 — ORPHAN Cures Act

This section expands and clarifies the exclusion from selection under the Drug Price Negotiation Program for orphan drugs (i.e., drugs approved by FDA solely for the treatment of a rare disease or condition, affecting fewer than 200,000 persons in the U.S., to incentivize rare disease drug development). (1) Requires that, in calculating elapsed time since FDA approval of a drug or licensure of a biological product for exclusion purposes, the Secretary exclude any period during which the drug or product qualified as an orphan drug. (Thus, drugs later approved for non-rare indications retain exclusion eligibility longer.) (2) Revises the orphan drug definition to include drugs approved solely for one or more rare diseases or conditions (from only one rare disease or condition), as defined in section 526(a)(2) of the Federal Food, Drug, and Cosmetic Act.