Quick Policy Note - 📝 Orphan Cures Act(rare-disease) in Big Beautiful Bill

H.R.1 makes key changes to Medicare’s drug price negotiation program, specifically expanding exemptions for orphan drugs those intended to treat rare diseases.

H.R.1 makes key changes to Medicare’s drug price negotiation program, specifically expanding exemptions for orphan drugs those intended to treat rare diseases.

Under current law, only orphan drugs approved for a single rare condition are exempt from negotiation. H.R.1 broadens this significantly:

• Any period during which a drug held an FDA orphan designati…