Increasing Competition in Pharmaceuticals Act

Summary

Increasing Competition in Pharmaceuticals 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 150 days. User fees are waived for such an application unless the drug is under patent. The FDA may expedite the inspection of a facility proposed to manufacture such a drug. The FDA must award a transferrable generic drug priority review voucher to the sponsor of such an application upon approval. A voucher may be used to have the FDA review and take action upon a generic drug application within 150 days of submission. The FDA may revoke a voucher awarded for a drug that is not marketed within one year of approval. This voucher program is terminated at the end of FY2022. The FDA must periodically report on generic drug applications filed before FY2016 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

1. 1 March 2016

   Introduced

   Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

   Source: IntroReferral

2. 1 March 2016

   Introduced

   Introduced in Senate

   Source: IntroReferral

Votes

No vote records are attached yet.

Versions

• Introduced in Senate · 1 March 2016 · Download file

Documents

3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 1 March 2016

  ViewDownloadOpen at official source

• Introduced in Senate (PDF)

  Introduced in Senate · EN · 1 March 2016

  ViewDownloadOpen at official source

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• Introduced in Senate

  summary · EN · 1 March 2016

  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

• Sen. Collins, Susan M. [R-ME] · R · Sponsor
• Sen. McCaskill, Claire [D-MO] · D · Sponsor
• Sen. Tester, Jon [D-MT] · D · Cosponsor
• Sen. Kirk, Mark Steven [R-IL] · R · Cosponsor
• · sshr00 · Standing

Related records

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