HR 3709 · 113th Congress 2013โ€“2015, ended

Protecting Consumer Access to Generic Drugs Act of 2013

Latest action · Jan 27, 2014 Referred to the Subcommittee on Courts, Intellectual Property, and the Internet.

Progress

Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.

  1. IntroducedDec 11, 2013
  2. Passed HouseNot reached
  3. Passed SenateNot reached
  4. To the PresidentNot reached
  5. Became lawNot reached

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.

Cosponsors 5

Members who signed on, in the order they did. Signatures ran from Dec 11, 2013 to Jul 14, 2014; 2 are original cosponsors, there from the day it was introduced.

SeatCosponsorSigned on
D-MDChris Van HollenOriginalDec 11, 2013
D-CAHenry A. WaxmanOriginalDec 11, 2013
D-ILJanice D. SchakowskyDec 12, 2013
D-CAJared HuffmanMay 21, 2014
D-NHCarol Shea-PorterJul 14, 2014

Committees 2

Where it was sent and what each committee and subcommittee did with it, in order.

Actions 5

Everything that happened, newest first.

  1. Jan 27, 2014Referred to the Subcommittee on Regulatory Reform, Commercial And Antitrust Law.
  2. Jan 27, 2014Referred to the Subcommittee on Courts, Intellectual Property, and the Internet.
  3. Dec 13, 2013Referred to the Subcommittee on Health.
  4. Dec 11, 2013Introduced in House
  5. Dec 11, 2013Referred 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.

Research

What has been written about this bill: committee reports, cost estimates, the sponsor’s authority statement, printed hearings and the Congressional Research Service’s work.

Constitutional authority

Congress has the power to enact this legislation pursuant to the following: Article I, Section 8, Clause 3: ``To regulate commerce . . . among the several states . . .'' Article I, Section 8, Clause 8: ``To promote the progress of science . . . by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries.'' Article I, Section 8, Clause 18: ``To make all laws which shall be necessary and proper. . .''

The sponsor’s statement, as printed in the page H7688.

Titles 2

Every title it has carried, official and short, at each stage.

Official Title as Introduced
To prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and for other purposes.
Short Titles as Introduced
Protecting Consumer Access to Generic Drugs Act of 2013

Subjects

Assigned by the Library of Congress. Policy area: Commerce.

Text 1

Each version as it was printed, newest first.

  1. Dec 11, 2013Introduced in House

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Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov; cost estimates are the Congressional Budget Office's, and the hearings are the printed hearings GovInfo publishes, which can appear months after the hearing.