The Congressional Budget Office (CBO) reported unexpected fiscal impacts from the Orphan Cures Act, raising a ten‑year cost estimate as three drugs drove larger‑than‑expected effects on price negotiations and rebate calculations. BioCentury coverage and CBO analysis highlighted that recent policy changes generated windfalls for major firms such as Merck, BMS and J&J. A parallel report described how three specific drug protections pushed CBO’s orphan cost estimate toward $8.8 billion over a decade, prompting renewed scrutiny of incentives and unintended outcomes in orphan‑drug policy. The analysis is likely to shape upcoming congressional and regulatory discussions on incentives, pricing, and market access for rare‑disease therapeutics.