Senate Drops Orphan Cures Act from Trump’s Tax Bill, Dealing Setback to Biopharma

The Senate version of President Trump's tax bill has dropped the Orphan Cures Act, which would have allowed drugs with multiple rare disease indications to be exempt from Inflation Reduction Act (IRA) price negotiations1.

The proposed bill, known as the 'One Big Beautiful Bill Act,' previously included provisions that would have excluded orphan drugs approved for more than one rare disease from Medicare price negotiations, with changes set to begin in 2028 if enacted3.

The removal of these exemptions marks a setback for the biopharma sector, which had advocated for such protections to incentivize the development of treatments for rare diseases13.

The revised Senate bill was released on June 16, 2025, as part of broader updates to tax and healthcare provisions2.

Despite passing the House by a narrow margin (215–214), the bill faces continued debate and scrutiny as it proceeds through the Senate, with partisan divisions and concerns over healthcare measures5.

Sources:

1. https://www.fiercepharma.com/pharma/orphan-drug-fix-ira-dropped-senate-version-big-beautiful-bill-setback-biopharma

2. https://www.hklaw.com/en/insights/publications/2025/06/holland-knight-health-dose-june-17-2025

3. https://www.biospace.com/policy/changes-to-ira-pill-penalty-conspicuously-absent-as-congress-narrowly-passes-trumps-tax-bill

5. https://www.fiercehealthcare.com/payers/house-gop-advances-budget-megabill-imposing-stricter-medicaid-work-requirements