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Congressional Research Service
Version 00 · Introduced in House · Oct 1, 2015
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.
People & committees
Rep. Kelly, Mike [R-PA-3] · R–PA
Legislative record
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Referred to the Subcommittee on Health.
Referred to the Subcommittee on Health.
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.
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.
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.
Introduced in House
Introduced in House
Primary sources
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Source last updated: Aug 12, 2025. Consult Congress.gov for the current record.
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