H.R. 3995 (112th): Protecting Consumer Access to Generic Drugs Act of 2012

Introduced:
Feb 09, 2012 (112th Congress, 2011–2013)
Sponsor:
Rep. Bobby Rush [D-IL1]
Status:
Died (Referred to Committee)

The bill’s title was written by the bill’s sponsor. H.R. stands for House of Representatives bill.

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Status

This bill was introduced on February 9, 2012, in a previous session of Congress, but was not enacted.

Progress
Introduced Feb 09, 2012
Referred to Committee Feb 09, 2012
Cosponsors
6 cosponsors (6D) (show)
Committees

House Energy and Commerce

House Judiciary

The committee chair determines whether a bill will move past the committee stage.

Full Title

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.

Summary

No summaries available.

Text

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Last updated Feb 09, 2012.
6 pages

Primary Source

View on THOMAS (The Library of Congress)

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Citation

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GovTrack’s Bill Summary

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Library of Congress Summary

The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress.

2/9/2012--Introduced.
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.

House Republican Conference Summary

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No summary available.

House Democratic Caucus Summary

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The bill contains the following citations to other parts of U.S. law:

United States Code

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