United States · Bill · HR
H.R. 3678 (114th)
Preserving Access to Orphan Drugs Act of 2015
Introduced
1 October 2015
Last action
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Status
Referred to the Subcommittee on Health.
Sponsors
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Subjects
Discovery layer
Source updated
12 August 2025
Summary
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.
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Documents
3 official files
Introduced in House (text)
Introduced in House (text)
Introduced in House · EN · 1 October 2015
Introduced in House (PDF)
Introduced in House · EN · 1 October 2015
Introduced in House
summary · EN · 1 October 2015
Sponsors
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Sources
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- Official source: https://www.congress.gov/bill/114th-congress/house-bill/3678
- Open data entity: https://api.congress.gov/v3/bill/114/hr/3678