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United States · Bill · HR

H.R. 3618 (114th)

Orphan Drug Fairness Act

referredUnited States· United States Congress· EN

Introduced

25 September 2015

Last action

Status

Referred to the Subcommittee on Health.

Sponsors

Subjects

Discovery layer

Source updated

5 December 2025

Summary

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.

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Documents

3 official files

Introduced in House (text)

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