FAST Act

Summary

Faster Access to Specialized Treatments Act or FAST Act - Expresses the sense of Congress that the Food and Drug Administration (FDA) should apply specified accelerated approval and the fast track provisions to expedite the development and availability of treatments for serious or life-threatening diseases or conditions while maintaining appropriate safety and effectiveness standards. 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 new drug, to include as a fast track product a new drug, either alone or in combination with one or more other drugs, that is intended for the treatment of a serious or life-threatening disease or condition. Permits the Secretary to approve an application for approval of a product for a serious or life-threatening disease or condition, including a fast track product, upon a determination that the product has an effect on: (1) a surrogate endpoint that is reasonably likely to predict clinical benefit; or (2) on a clinical endpoint, including an endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit. Directs the Secretary, in conjunction with other planned reviews of the new drug review process, to contract with an independent entity with expertise in assessing biopharmaceutical development and regulatory review programs to evaluate the FDA's application of the fast track processes on the development and availability of innovative treatments for patients suffering from serious or life-threatening conditions.

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

Timeline

1. 5 March 2012

   Introduced

   Referred to the House Committee on Energy and Commerce.

   Source: IntroReferral

2. 5 March 2012

   Introduced

   Introduced in House

   Source: IntroReferral

3. 5 March 2012

   Introduced

   Introduced in House

   Source: IntroReferral

4. 9 March 2012

   Referred

   Referred to the Subcommittee on Health.

   Source: Committee

Votes

No vote records are attached yet.

Versions

• Introduced in House · 5 March 2012 · Download file

Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 5 March 2012

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 5 March 2012

  ViewDownloadOpen at official source

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• Introduced in House

  summary · EN · 5 March 2012

  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. Stearns, Cliff [R-FL-6] · R · Sponsor
• Rep. Towns, Edolphus [D-NY-10] · D · Sponsor
• Rep. Bilbray, Brian P. [R-CA-50] · R · Cosponsor
• Rep. Pascrell, Bill, Jr. [D-NJ-9] · D · Cosponsor
• Rep. Burgess, Michael C. [R-TX-26] · R · Cosponsor
• Rep. Filner, Bob [D-CA-51] · D · Cosponsor
• Rep. Eshoo, Anna G. [D-CA-18] · D · Cosponsor
• Rep. Roskam, Peter J. [R-IL-6] · R · Cosponsor
• Rep. Ros-Lehtinen, Ileana [R-FL-27] · R · Cosponsor
• Rep. Peterson, Collin C. [D-MN-7] · D · Cosponsor
• Rep. Ross, Dennis A. [R-FL-15] · R · Cosponsor
• Rep. Polis, Jared [D-CO-2] · D · Cosponsor
• Rep. Posey, Bill [R-FL-8] · R · Cosponsor
• Rep. Guthrie, Brett [R-KY-2] · R · Cosponsor
• Rep. Heck, Joseph J. [R-NV-3] · R · Cosponsor
• Rep. Dold, Robert J. [R-IL-10] · R · Cosponsor
• Rep. Deutch, Theodore E. [D-FL-22] · D · Cosponsor
• Rep. Hastings, Alcee L. [D-FL-20] · D · Cosponsor
• Rep. Platts, Todd Russell [R-PA-19] · R · Cosponsor
• Rep. Paul, Ron [R-TX-14] · R · Cosponsor
• Rep. Barletta, Lou [R-PA-11] · R · Cosponsor
• Rep. Hochul, Kathleen C. [D-NY-26] · D · Cosponsor
• · hsif00 · Standing

Related records

• related to ← Food and Drug Administration Reform Act of 2012