Talk Bio

In July 2025, President Trump signed the One Big Beautiful Bill Act (OBBBA), a tax and budget reconciliation law that amends the Inflation Reduction Act's orphan drug exclusion 1 2 . The tweak broadens the exclusion to cover orphan drugs designated for one or more rare diseases, as long as all approved indications are for rare conditions, previously limited to single rare disease indications 1 2 . It delays negotiation eligibility for orphan drugs approved for non-orphan indications, starting the clock from the non-orphan approval date instead of the original approval 1 2 . This will increase Medicare spending by $8.8 billion from 2025-2034 per updated CBO estimates, affecting drugs like Keytruda, Opdivo, and Darzalex, and delaying their price negotiations starting in 2026 1 . By simplifying orphan drug eligibility rules for Medicare negotiation, the changes reduce administrative complexity for CMS and FDA in designating and tracking orphan statuses, making regulatory proce...