Creating Hope Act of 2011

Summary

Creating Hope Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to revise the priority review voucher program for tropical diseases to: (1) include rare pediatric diseases; (2) allow unlimited transfers of vouchers under the program; and (3) require a sponsor intending to use a voucher to notify the Secretary of Health and Human Services (HHS) at least 90 days (currently, 365 days) before submission of the application. Revises provisions regarding the priority review user fee, including to make it payable upon notification of the Secretary of intent to use the voucher. Authorizes the Secretary, upon request of the manufacturer or sponsor of a new drug, to designate that a new drug is: (1) for a rare pediatric disease, and (2) an innovative treatment. Requires the Secretary to deem a rare pediatric disease product application to be incomplete if it does not contain a description of the sponsor's plan to market the product in the United States. Authorizes the Secretary to refuse to issue a priority review voucher upon the approval of a rare pediatric disease application if the Secretary finds that the sponsor lacks a good faith intention to market the product in the United States. Directs the Secretary to issue a guidance document setting forth the evidentiary support necessary to demonstrate such a good faith intention. Requires sponsors of applications under the priority review voucher program to report to the Secretary within five years after the approval of the application on the demand and distribution of the product within the United States.

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Timeline

1. 17 March 2011

   Introduced

   Introduced in Senate

   Source: IntroReferral

2. 17 March 2011

   Introduced

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

   Source: IntroReferral

Votes

No vote records are attached yet.

Versions

• Introduced in Senate · 17 March 2011 · Download file

Documents

3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 17 March 2011

  ViewDownloadOpen at official source

• Introduced in Senate (PDF)

  Introduced in Senate · EN · 17 March 2011

  ViewDownloadOpen at official source

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• Introduced in Senate

  summary · EN · 17 March 2011

  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. Casey, Robert P., Jr. [D-PA] · D · Sponsor
• Sen. Brown, Scott P. [R-MA] · R · Sponsor
• Sen. Brown, Sherrod [D-OH] · D · Sponsor
• Sen. Isakson, Johnny [R-GA] · R · Sponsor
• Sen. Franken, Al [D-MN] · D · Sponsor
• Sen. Gillibrand, Kirsten E. [D-NY] · D · Cosponsor
• Sen. Blumenthal, Richard [D-CT] · D · Cosponsor
• Sen. Blunt, Roy [R-MO] · R · Cosponsor
• Sen. Crapo, Mike [R-ID] · R · Cosponsor
• Sen. Vitter, David [R-LA] · R · Cosponsor
• Sen. Schumer, Charles E. [D-NY] · D · Cosponsor
• Sen. Lautenberg, Frank R. [D-NJ] · D · Cosponsor
• · sshr00 · Standing

Related records

• related to → Creating Hope Act of 2011