ORPHAN Cures Act

The ORPHAN Cures Act (HR 946) adjusts how the government calculates approval timelines for certain rare disease treatments under the Drug Price Negotiation Program. It clarifies that periods when a drug was previously designated as an "orphan drug" (for rare diseases) won't count toward the timeline for price negotiations. The bill also broadens the definition of "rare disease" to cover multiple conditions simultaneously, aligning with existing federal law. This directly affects manufacturers of orphan drugs by potentially extending their exclusivity periods before price negotiations begin.