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To increase competition in the pharmaceutical industry.

USA115th CongressHR-749| House 
| Updated: 2/3/2017
Kurt Schrader

Kurt Schrader

Democratic Representative

Oregon

Cosponsors (24)
Tom O'Halleran (Democratic)Brett Guthrie (Republican)Darren Soto (Democratic)Sanford D. Bishop (Democratic)Scott H. Peters (Democratic)Collin C. Peterson (Democratic)Greg Gianforte (Republican)Gus M. Bilirakis (Republican)Don Bacon (Republican)Jim Cooper (Democratic)Kyrsten Sinema (Independent)Timothy J. Walz (Democratic)Ami Bera (Democratic)Stephen Knight (Republican)Daniel Lipinski (Democratic)Henry Cuellar (Democratic)Jim Costa (Democratic)Jeff Fortenberry (Republican)Charlie Crist (Democratic)Seth Moulton (Democratic)Bill Posey (Republican)Josh Gottheimer (Democratic)Jenniffer González-Colón (Republican)Bradley Scott Schneider (Democratic)

Health Subcommittee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Lower Drug Costs through Competition Act This bill amends the Federal Food, Drug, and Cosmetic Act to revise provisions regarding review and approval of generic drug applications or supplements to generic drug applications for drugs: (1) for which there is a shortage, or (2) that have not been recently introduced to the market by more than one manufacturer and for which tentative approval has not been granted to more than two applications. The Food and Drug Administration (FDA) must prioritize the review of such submissions and act on them within 180 days. The FDA may expedite the inspection of a facility proposed to manufacture such a drug. Beginning FY2019, the FDA must award a transferrable generic drug priority review voucher to the sponsor of such an application once the drug has a sustained market presence. A voucher may be used to have the FDA review and take action upon a generic drug application within 180 days of submission. The FDA must establish an additional user fee for applications subject to a voucher. This voucher program is terminated at the start of FY2024. The FDA must periodically report on generic drug applications filed before FY2018 that are still pending. For a new drug application to be eligible for a priority review voucher as a tropical disease product application, the application must include new, essential clinical investigations. The Government Accountability Office must study the FDA's program for drug risk evaluation and mitigation strategies.
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Timeline
Jan 30, 2017
Introduced in House
Jan 30, 2017
Referred to the House Committee on Energy and Commerce.
Feb 2, 2017

Latest Companion Bill Action

S 115-297
Introduced in Senate
Feb 3, 2017
Referred to the Subcommittee on Health.
  • January 30, 2017
    Introduced in House


  • January 30, 2017
    Referred to the House Committee on Energy and Commerce.


  • February 2, 2017

    Latest Companion Bill Action

    S 115-297
    Introduced in Senate


  • February 3, 2017
    Referred to the Subcommittee on Health.

Health

Related Bills

  • S 115-297: A bill to increase competition in the pharmaceutical industry.
Congressional oversightDrug safety, medical device, and laboratory regulationDrug trafficking and controlled substancesGovernment studies and investigationsInfectious and parasitic diseasesLicensing and registrationsPrescription drugsUser charges and fees

To increase competition in the pharmaceutical industry.

USA115th CongressHR-749| House 
| Updated: 2/3/2017
Lower Drug Costs through Competition Act This bill amends the Federal Food, Drug, and Cosmetic Act to revise provisions regarding review and approval of generic drug applications or supplements to generic drug applications for drugs: (1) for which there is a shortage, or (2) that have not been recently introduced to the market by more than one manufacturer and for which tentative approval has not been granted to more than two applications. The Food and Drug Administration (FDA) must prioritize the review of such submissions and act on them within 180 days. The FDA may expedite the inspection of a facility proposed to manufacture such a drug. Beginning FY2019, the FDA must award a transferrable generic drug priority review voucher to the sponsor of such an application once the drug has a sustained market presence. A voucher may be used to have the FDA review and take action upon a generic drug application within 180 days of submission. The FDA must establish an additional user fee for applications subject to a voucher. This voucher program is terminated at the start of FY2024. The FDA must periodically report on generic drug applications filed before FY2018 that are still pending. For a new drug application to be eligible for a priority review voucher as a tropical disease product application, the application must include new, essential clinical investigations. The Government Accountability Office must study the FDA's program for drug risk evaluation and mitigation strategies.
View Full Text

Suggested Questions

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

Timeline
Jan 30, 2017
Introduced in House
Jan 30, 2017
Referred to the House Committee on Energy and Commerce.
Feb 2, 2017

Latest Companion Bill Action

S 115-297
Introduced in Senate
Feb 3, 2017
Referred to the Subcommittee on Health.
  • January 30, 2017
    Introduced in House


  • January 30, 2017
    Referred to the House Committee on Energy and Commerce.


  • February 2, 2017

    Latest Companion Bill Action

    S 115-297
    Introduced in Senate


  • February 3, 2017
    Referred to the Subcommittee on Health.
Kurt Schrader

Kurt Schrader

Democratic Representative

Oregon

Cosponsors (24)
Tom O'Halleran (Democratic)Brett Guthrie (Republican)Darren Soto (Democratic)Sanford D. Bishop (Democratic)Scott H. Peters (Democratic)Collin C. Peterson (Democratic)Greg Gianforte (Republican)Gus M. Bilirakis (Republican)Don Bacon (Republican)Jim Cooper (Democratic)Kyrsten Sinema (Independent)Timothy J. Walz (Democratic)Ami Bera (Democratic)Stephen Knight (Republican)Daniel Lipinski (Democratic)Henry Cuellar (Democratic)Jim Costa (Democratic)Jeff Fortenberry (Republican)Charlie Crist (Democratic)Seth Moulton (Democratic)Bill Posey (Republican)Josh Gottheimer (Democratic)Jenniffer González-Colón (Republican)Bradley Scott Schneider (Democratic)

Health Subcommittee, Energy and Commerce Committee

Health

Related Bills

  • S 115-297: A bill to increase competition in the pharmaceutical industry.
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Congressional oversightDrug safety, medical device, and laboratory regulationDrug trafficking and controlled substancesGovernment studies and investigationsInfectious and parasitic diseasesLicensing and registrationsPrescription drugsUser charges and fees