To amend chapter V of the Federal Food, Drug, and Cosmetic Act to expedite the development and review of breakthrough therapies.

Summary

Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS), at the request of the sponsor of a drug, to expedite the drug's development and review if: (1) it is intended, either alone or in combination, to treat a serious life-threatening disease or condition; and (2) preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. Authorizes the drug's sponsor to request the Secretary to designate the drug as a breakthrough therapy. Requires the Secretary, within 60 days of such request, to determine whether the drug meets such criteria and, if so, make such designation, followed by appropriate actions to expedite its development and review for approval. Requires an annual report from the Secretary to Congress on drugs for which breakthrough designations were requested and approved. Directs the Secretary to issue guidance on implementing requirements with respect to breakthrough therapies and to amend promulgated regulations. Requires the Comptroller General to assess the manner by which the Food and Drug Administration (FDA) has applied the processes established by this Act and their impact on the development and timely availability of innovative treatments for patients affected by serious or life-threatening conditions.

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

Timeline

1. 7 May 2012

   Introduced

   Referred to the House Committee on Energy and Commerce.

   Source: IntroReferral

2. 7 May 2012

   Introduced

   Introduced in House

   Source: IntroReferral

3. 7 May 2012

   Introduced

   Introduced in House

   Source: IntroReferral

4. 11 May 2012

   Referred

   Referred to the Subcommittee on Health.

   Source: Committee

Votes

No vote records are attached yet.

Versions

• Introduced in House · 7 May 2012 · Download file

Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 7 May 2012

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 7 May 2012

  ViewDownloadOpen at official source

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• Introduced in House

  summary · EN · 7 May 2012

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  Leesvertaling

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  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. Bilbray, Brian P. [R-CA-50] · R · Sponsor
• Rep. DeGette, Diana [D-CO-1] · D · Sponsor
• · hsif00 · Standing

Related records

• related to ← Food and Drug Administration Reform Act of 2012
• related to ← Advancing Breakthrough Therapies for Patients Act of 2012
• related to ← Food and Drug Administration Safety and Innovation Act
• related to ← Food and Drug Administration Safety and Innovation Act