Orphan Drug Fairness Act
Official title: To clarify the exclusion of orphan drug sales from the calculation of the annual fee on branded prescription pharmaceutical manufacturers and importers, and for other purposes.
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Referred to the Subcommittee on Health.
Orphan Drug Fairness Act
This bill amends the Patient Protection and Affordable Care Act (PPACA) to exclude sales of any drug or biological product approved by the Food and Drug Administration solely for rare diseases or conditions (orphan drug) from the calculation of the annual fee on manufacturers or importers with branded prescription drug sales exceeding $5 million.
This Act is effective as if included in PPACA.
- Introduced in House Formatted Text PDF Formatted XML
Cite this page
U.S. Congress. (2026). H.R. 3618: Orphan Drug Fairness Act. 114th Congress. Open America. https://openamerica.io/bill/114-HR-3618/
"H.R. 3618: Orphan Drug Fairness Act." 114th Congress, 2026, Open America, https://openamerica.io/bill/114-HR-3618/.
H.R. 3618, 114th Cong. (2026), https://openamerica.io/bill/114-HR-3618/.
[H.R. 3618: Orphan Drug Fairness Act](https://openamerica.io/bill/114-HR-3618/)