Protecting Consumer Access to Generic Drugs Act of 2013
Bill journey · stage 2 of 5
Under committee review
What it doesSummary introduced in house (Dec 11, 2013)
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.
What just happenedJan 27, 2014
Referred to the Subcommittee on Courts, Intellectual Property, and the Internet.
Who’s behind it
- Introduced in HouseDec 11, 2013
- Jan 27, 2014Committee
Referred to the Subcommittee on Courts, Intellectual Property, and the Internet.
- Jan 27, 2014Committee
Referred to the Subcommittee on Regulatory Reform, Commercial And Antitrust Law.
- Dec 13, 2013Committee
Referred to the Subcommittee on Health.
- Dec 11, 2013IntroReferralH11100
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.
- Dec 11, 2013IntroReferralH11100
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.
- Dec 11, 2013IntroReferralIntro-H
Introduced in House
- Dec 11, 2013IntroReferral1000
Introduced in House