Lower Drug Costs through Competition Act

Summary

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.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

1. 30 January 2017

   Introduced

   Referred to the House Committee on Energy and Commerce.

   Source: IntroReferral

2. 30 January 2017

   Introduced

   Introduced in House

   Source: IntroReferral

3. 30 January 2017

   Introduced

   Introduced in House

   Source: IntroReferral

4. 3 February 2017

   Referred

   Referred to the Subcommittee on Health.

   Source: Committee

Votes

No vote records are attached yet.

Versions

• Introduced in House · 30 January 2017 · Download file

Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 30 January 2017

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 30 January 2017

  ViewDownloadOpen at official source

  Leesvertaling

  Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.

  Vertaal naarNL · DutchDE · GermanFR · FrenchES · SpanishIT · ItalianPL · PolishPT · PortugueseSV · SwedishDA · DanishFI · FinnishEL · GreekCS · CzechHU · HungarianRO · RomanianBG · BulgarianHR · CroatianSK · SlovakSL · SlovenianLT · LithuanianLV · LatvianET · EstonianGA · IrishMT · Maltese

  Vertaal document

  Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

• Introduced in House

  summary · EN · 30 January 2017

  Open at official source

  Leesvertaling

  Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.

  Vertaal naarNL · DutchDE · GermanFR · FrenchES · SpanishIT · ItalianPL · PolishPT · PortugueseSV · SwedishDA · DanishFI · FinnishEL · GreekCS · CzechHU · HungarianRO · RomanianBG · BulgarianHR · CroatianSK · SlovakSL · SlovenianLT · LithuanianLV · LatvianET · EstonianGA · IrishMT · Maltese

  Vertaal document

  Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

Sponsors

• Rep. Schrader, Kurt [D-OR-5] · D · Sponsor
• Rep. Bilirakis, Gus M. [R-FL-12] · R · Sponsor
• Rep. Lipinski, Daniel [D-IL-3] · D · Sponsor
• Rep. Moulton, Seth [D-MA-6] · D · Sponsor
• Rep. Bera, Ami [D-CA-6] · D · Sponsor
• Sen. Sinema, Kyrsten [I-AZ] · D · Sponsor
• Rep. Cooper, Jim [D-TN-5] · D · Sponsor
• Rep. Posey, Bill [R-FL-8] · R · Sponsor
• Rep. Costa, Jim [D-CA-21] · D · Sponsor
• Rep. Peters, Scott H. [D-CA-50] · D · Sponsor
• Rep. Peterson, Collin C. [D-MN-7] · D · Cosponsor
• Rep. O'Halleran, Tom [D-AZ-1] · D · Cosponsor
• Rep. Guthrie, Brett [R-KY-2] · R · Cosponsor
• Rep. Cuellar, Henry [D-TX-28] · D · Cosponsor
• Rep. Walz, Timothy J. [D-MN-1] · D · Cosponsor
• Rep. Soto, Darren [D-FL-9] · D · Cosponsor
• Rep. Bishop, Sanford D. [D-GA-2] · D · Cosponsor
• Rep. Crist, Charlie [D-FL-13] · D · Cosponsor
• Rep. Schneider, Bradley Scott [D-IL-10] · D · Cosponsor
• Rep. Bacon, Don [R-NE-2] · R · Cosponsor
• Rep. Fortenberry, Jeff [R-NE-1] · R · Cosponsor
• Rescom. González-Colón, Jenniffer [R-PR-At Large] · R · Cosponsor
• Rep. Gottheimer, Josh [D-NJ-5] · D · Cosponsor
• Rep. Gianforte, Greg [R-MT-At Large] · R · Cosponsor
• Rep. Knight, Stephen [R-CA-25] · R · Cosponsor
• · hsif00 · Standing

Related records

• related to ← Increasing Competition in Pharmaceuticals Act
• related to ← Lower Drug Costs through Competition Act