Protecting Consumer Access to Generic Drugs Act of 2012

Summary

Protecting Consumer Access to Generic Drugs Act of 2012 - 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. 9 February 2012

   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. 9 February 2012

   Introduced

   Introduced in House

   Source: IntroReferral

3. 9 February 2012

   Introduced

   Introduced in House

   Source: IntroReferral

4. 10 February 2012

   Referred

   Referred to the Subcommittee on Health.

   Source: Committee

5. 16 February 2012

   Referred

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

   Source: Committee

Votes

No vote records are attached yet.

Versions

• Introduced in House · 9 February 2012 · Official file

Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 9 February 2012

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 9 February 2012

  ViewDownloadOpen at official source

• Introduced in House

  summary · EN · 9 February 2012

  Open at official source

Sponsors

• BOBBY RUSH · D · Sponsor
• Rep. Waxman, Henry A. [D-CA-24] · D · Sponsor
• Sen. Van Hollen, Chris [D-MD] · D · Cosponsor
• Rep. Pallone, Frank [D-NJ-6] · D · Cosponsor
• Rep. Schakowsky, Janice D. [D-IL-9] · D · Cosponsor
• G. K. Butterfield · D · Cosponsor
• Diana DeGette · D · Cosponsor
• · hsju00 · Standing
• · hsif00 · Standing

Related records

No cross-record relationships stored yet.