Generic Drug and Biosimilar User Fee Act of 2012

Summary

Generic Drug and Biosimilar User Fee Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS), beginning FY2013, to assess and collect the following fees related to generic drugs: (1) a one-time backlog fee for abbreviated new drug applications pending on October 1, 2012; (2) a drug master file fee; (3) an abbreviated new drug application and prior approval supplement filing fee, as well as an additional fee for active pharmaceutical ingredient information not included by reference to Type II active pharmaceutical ingredient drug master file; and (4) a generic drug facility fee and active pharmaceutical ingredient facility fee. Provides that submission of an application for a positron emission tomography drug or active pharmaceutical ingredient for a positron emission tomography drug shall not require the payment of any fee. Sets forth provisions relating to fee amounts and due dates. Terminates the above provisions on October 1, 2017. Requires the Secretary to report to Congress on the progress of the Food and Drug Administration (FDA) in achieving specified safety, access, and transparency goals with respect to generic drugs. Biosimilar User Fee Act of 2012 - Directs the Secretary, beginning FY2013, to assess and collect the following fees related to biosimilar biological products: (1) biosimilar program development fees, encompassing an initial biosimilar biological development fee, an annual biosimilar biological product development fee, and a reactivation fee; (2) a biosimilar biological product application and supplement fee; (3) a biosimilar biological product establishment fee; and (4) a biosimilar biological product fee. Waives the above fees for the first biosimilar biological product application of a small business. Terminates the above provisions on October 1, 2017. Requires the Secretary to report to Congress on the progress of the Food and Drug Administration (FDA) in achieving specified goals with respect to biosimilar biological products.

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Timeline

1. 8 February 2012

   Introduced

   Referred to the House Committee on Energy and Commerce.

   Source: IntroReferral

2. 8 February 2012

   Introduced

   Introduced in House

   Source: IntroReferral

3. 8 February 2012

   Introduced

   Introduced in House

   Source: IntroReferral

4. 10 February 2012

   Referred

   Referred to the Subcommittee on Health.

   Source: Committee

Votes

No vote records are attached yet.

Versions

• Introduced in House · 8 February 2012 · Download file

Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 8 February 2012

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 8 February 2012

  ViewDownloadOpen at official source

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• Introduced in House

  summary · EN · 8 February 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. Murphy, Tim [R-PA-18] · R · Sponsor
• Rep. Pallone, Frank [D-NJ-6] · D · Sponsor
• Rep. Pitts, Joseph R. [R-PA-16] · R · Sponsor
• Rep. Waxman, Henry A. [D-CA-33] · D · Sponsor
• Rep. Dingell, John D. [D-MI-12] · D · Cosponsor
• · hsif00 · Standing

Related records

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