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HR 3618 114th Congress House

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.

Introduced: September 25, 2015 See on congress.gov
Health Drug safety, medical device, and laboratory regulationDrug therapyIncome tax creditsPrescription drugsUser charges and fees
This bill died when the 114th Congress ended
It never became law before the 114th Congress (2015–2016) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Oct 2, 2015
Referred to the Subcommittee on Health.
Sep 25, 2015
Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Sep 25, 2015
Introduced in House
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 Latest action October 2, 2015

Referred to the Subcommittee on Health.

 Plain-English summary Congressional Research Service

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.

 Related & companion bills 1
 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 3
Cite this page click to expand
APA
U.S. Congress. (2026). H.R. 3618: Orphan Drug Fairness Act. 114th Congress. Open America. https://openamerica.io/bill/114-HR-3618/
MLA
"H.R. 3618: Orphan Drug Fairness Act." 114th Congress, 2026, Open America, https://openamerica.io/bill/114-HR-3618/.
Bluebook (legal)
H.R. 3618, 114th Cong. (2026), https://openamerica.io/bill/114-HR-3618/.
Markdown link
[H.R. 3618: Orphan Drug Fairness Act](https://openamerica.io/bill/114-HR-3618/)
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