Skip to main content
HR 3678 114th Congress House

Preserving Access to Orphan Drugs Act of 2015

Official title: To clarify the orphan drug exception to the annual fee on branded prescription pharmaceutical manufacturers and importers, and for other purposes.

Introduced: October 1, 2015 Introduced by: Kelly, Mike Republican · Pennsylvania See on congress.gov
Health Drug safety, medical device, and laboratory regulationDrug therapyHealth care coverage and accessPrescription drugsUser charges and fees
Sign in to write a letter Sign in to watch
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 4 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Oct 2, 2015
Referred to the Subcommittee on Health.
Oct 1, 2015
Referred to the Subcommittee on Health.
Oct 1, 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.
Oct 1, 2015
Introduced in House
 Ask about this bill AI · grounded in the bill text

Have a question about what this bill does? Ask in plain English; the answer is drawn from the bill's actual text and official record, and it'll tell you when something isn't in the text rather than guess.

AI answers can be imperfect; always confirm against the full bill text.

 Latest action October 2, 2015

Referred to the Subcommittee on Health.

 Plain-English summary Congressional Research Service

Preserving Access to Orphan Drugs Act of 2015

This bill amends the Patient Protection and Affordable Care Act to expand the definition of orphan drug for purposes of the annual fee paid by brand name prescription drug manufacturers and importers to include medications for rare conditions that were, prior to 2011, approved or in clinical trials. (Drug manufacturers and importers pay an annual fee based on their sales of brand name prescription drugs, excluding sales of orphan drugs.) Currently, only medications for rare conditions for which a tax credit for clinical trials was allowed are considered orphan drugs.

This Act applies to fees paid after 2014.
 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 4
 Cosponsors 4
All 4 Democratic 1
Holding, George
· Oct 1, 2015
 D
Neal, Richard E.
Massachusetts · Oct 1, 2015
Nunes, Devin
· Oct 1, 2015
TIBERI, PATRICK
· Oct 1, 2015
Cite this page click to expand
APA
U.S. Congress. (2026). H.R. 3678: Preserving Access to Orphan Drugs Act of 2015. 114th Congress. Open America. https://openamerica.io/bill/114-HR-3678/
MLA
"H.R. 3678: Preserving Access to Orphan Drugs Act of 2015." 114th Congress, 2026, Open America, https://openamerica.io/bill/114-HR-3678/.
Bluebook (legal)
H.R. 3678, 114th Cong. (2026), https://openamerica.io/bill/114-HR-3678/.
Markdown link
[H.R. 3678: Preserving Access to Orphan Drugs Act of 2015](https://openamerica.io/bill/114-HR-3678/)
Report a problem