ORPHAN Cures Act

This bill amends the Social Security Act to expand and clarify the exclusion for orphan drugs under the Drug Price Negotiation Program. It changes how the time since a drug's approval is calculated for determining eligibility for negotiation, and it broadens the definition of orphan drugs to include those designated for one or more rare diseases or conditions.

Sec. 2, Expanding and clarifying the exclusion for orphan drugs under the Drug Price Negotiation Program: The bill adds a new provision stating that when calculating the time elapsed since a drug's approval for the purpose of the orphan drug exclusion, the Secretary must not count any period during which the drug was designated as an orphan drug. It also changes the orphan drug definition from covering only one rare disease or condition to covering one or more rare diseases or conditions, and updates the reference to the Federal Food, Drug, and Cosmetic Act accordingly.