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

USA115th CongressHR-7324| House 
| Updated: 1/2/2019
Mike Kelly

Mike Kelly

Republican Representative

Pennsylvania

Ways and Means Committee, Health Subcommittee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
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.)
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Timeline
Dec 17, 2018
Introduced in House
Dec 17, 2018
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.
Jan 2, 2019
Referred to the Subcommittee on Health.
  • December 17, 2018
    Introduced in House


  • December 17, 2018
    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.


  • January 2, 2019
    Referred to the Subcommittee on Health.

Health

Drug safety, medical device, and laboratory regulationDrug therapyHealth care coverage and accessPrescription drugsUser charges and fees

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

USA115th CongressHR-7324| House 
| Updated: 1/2/2019
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.)
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline
Dec 17, 2018
Introduced in House
Dec 17, 2018
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.
Jan 2, 2019
Referred to the Subcommittee on Health.
  • December 17, 2018
    Introduced in House


  • December 17, 2018
    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.


  • January 2, 2019
    Referred to the Subcommittee on Health.
Mike Kelly

Mike Kelly

Republican Representative

Pennsylvania

Ways and Means Committee, Health Subcommittee, Energy and Commerce Committee

Health

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Drug safety, medical device, and laboratory regulationDrug therapyHealth care coverage and accessPrescription drugsUser charges and fees