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H.R. 3678

Preserving Access to Orphan Drugs Act of 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.

Referred to the Subcommittee on Health.

Rep. Kelly, Mike [R-PA-3](R-PA)Sponsor
10 cosponsors2 D8 R
10cosponsors2committees7actions5subjects
  1. Committee

    Referred to the Subcommittee on Health.

    Health Subcommittee
  2. Committee

    Referred to the Subcommittee on Health.

    Health Subcommittee
  3. IntroReferralH11100

    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.

    Energy and Commerce Committee
  4. IntroReferralH11100-A

    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.

  5. IntroReferralH11100

    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.

    Ways and Means Committee
  6. IntroReferralIntro-H

    Introduced in House

  7. IntroReferral1000

    Introduced in House

Preserving Access to Orphan Drugs Act of 2015 — Informed