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United States · Bill · HR

H.R. 3709 (113th)

Protecting Consumer Access to Generic Drugs Act of 2013

referredUnited States· United States Congress· EN

Introduced

11 December 2013

Last action

27 January 2014 · Referred

Status

Referred to the Subcommittee on Courts, Intellectual Property, and the Internet.

Sponsors

Rep. Rush, Bobby L. [D-IL-1], Sen. Van Hollen, Chris [D-MD], Rep. Waxman, Henry A. [D-CA-33], Rep. Schakowsky, Janice D. [D-IL-9], Rep. Huffman, Jared [D-CA-2], Rep. Shea-Porter, Carol [D-NH-1]

Subjects

Discovery layer

Source updated

12 August 2025

Summary

Protecting Consumer Access to Generic Drugs Act of 2013 - Prohibits, as an unfair and deceptive act or practice and an unfair method of competition in or affecting interstate commerce, any person from being a party to any agreement resolving or settling a patent infringement claim in which: (1) an abbreviated new drug (generic) application filer receives anything of value; and (2) such filer agrees not to research, develop, manufacture, market or sell the generic drug. Excludes a resolution or settlement that includes no more than: (1) the right to market the generic drug before the expiration of the patent or other exclusivity period, or (2) the waiver of a patent infringement claim for damages. Authorizes the Federal Trade Commission (FTC) to exempt agreements in furtherance of market competition and for the benefit of consumers. Amends the Federal Food, Drug, and Cosmetic Act to deem an applicant to have forfeited market exclusivity if the applicant enters into an agreement that violates this Act. Amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to revise reporting requirements related to agreements between a generic drug applicant and a brand name drug company to include: (1) a description of the subject matter of other agreements between the parties; and (2) a certification that the materials filed represent the complete, final, and exclusive agreement between the parties.

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

Timeline

  1. 11 December 2013

    Introduced

    Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

    Source: IntroReferral

  2. 11 December 2013

    Introduced

    Introduced in House

    Source: IntroReferral

  3. 11 December 2013

    Introduced

    Introduced in House

    Source: IntroReferral

  4. 13 December 2013

    Referred

    Referred to the Subcommittee on Health.

    Source: Committee

  5. 27 January 2014

    Referred

    Referred to the Subcommittee on Regulatory Reform, Commercial And Antitrust Law.

    Source: Committee

Votes

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Versions

Documents

3 official files

Introduced in House (text)

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  • Introduced in House (text)

    Introduced in House · EN · 11 December 2013

    ViewDownloadOpen at official source

  • Introduced in House (PDF)

    Introduced in House · EN · 11 December 2013

    ViewDownloadOpen at official source

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  • Introduced in House

    summary · EN · 11 December 2013

    Open at official source

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Sponsors

Related records

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Sources

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