BPCA and PREA Reauthorization Act of 2012

Summary

BPCA and PREA Reauthorization Act of 2012 - Makes permanent the provisions of the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act of 2003 (PREA). Amends the Federal Food, Drug, and Cosmetic Act to revise provisions concerning pediatric research requirements and the granting of exclusivity. Extends the period for mandatory reporting of adverse events to the Office of Pediatric Therapeutics to 18 months after an approved label change. Requires a product sponsor to submit an Initial Pediatric Plan as part of the drug application process and sets forth the process for such submission. Authorizes the Secretary of Health and Human Services (HHS) to: (1) grant a deferral extension, and sets forth the conditions for such deferral; and (2) issue a non-compliance letter to a product sponsor failing to meet post-marketing requirements, and requires the product sponsor to respond in writing. Authorizes the Pediatric Review Committee to review deferral extensions. Requires the Office of Pediatric Therapeutics to include a neonatologist and pediatric epidemiologist. Reauthorizes the Pediatric Advisory Committee and the Pediatric Subcommittee of the Oncologic Drugs Advisory Committee.

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Timeline

1. 28 March 2012

   Introduced

   Referred to the House Committee on Energy and Commerce.

   Source: IntroReferral

2. 28 March 2012

   Introduced

   Introduced in House

   Source: IntroReferral

3. 28 March 2012

   Introduced

   Introduced in House

   Source: IntroReferral

4. 30 March 2012

   Referred

   Referred to the Subcommittee on Health.

   Source: Committee

Votes

No vote records are attached yet.

Versions

• Introduced in House · 28 March 2012 · Download file

Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 28 March 2012

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 28 March 2012

  ViewDownloadOpen at official source

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• Introduced in House

  summary · EN · 28 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. Rogers, Mike J. [R-MI-8] · R · Sponsor
• Rep. Eshoo, Anna G. [D-CA-18] · D · Sponsor
• Sen. Markey, Edward J. [D-MA] · D · Sponsor
• · hsif00 · Standing

Related records

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