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

United States115th CongressHR-7324House of Representatives
Updated: Jan 2, 2019

Summary

Preserving Access to Orphan Drugs Act of 2018 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.)

Bill texts

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Introduced (House)View official text

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Timeline

  1. 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.

    House of Representatives

  2. Introduced in House

  3. Referred to the Subcommittee on Health.

    House of Representatives

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