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HR 3995 112th Congress House

Protecting Consumer Access to Generic Drugs Act of 2012

Official 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.

Introduced: February 13, 2012 See on congress.gov
Commerce Administrative law and regulatory proceduresCompetition and antitrustContracts and agencyFederal Trade Commission (FTC)
More subjectsShow fewer subjects
Intellectual propertyMarketing and advertisingPrescription drugs
This bill died when the 112th Congress ended
It never became law before the 112th Congress (2011–2012) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 4 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Feb 16, 2012
Referred to the Subcommittee on Intellectual Property, Competition and the Internet.
Feb 10, 2012
Referred to the Subcommittee on Health.
Feb 9, 2012
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.
Feb 9, 2012
Introduced in House
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 Latest action February 16, 2012

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

 Plain-English summary Congressional Research Service

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.

 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 4
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APA
U.S. Congress. (2026). H.R. 3995: Protecting Consumer Access to Generic Drugs Act of 2012. 112th Congress. Open America. https://openamerica.io/bill/112-HR-3995/
MLA
"H.R. 3995: Protecting Consumer Access to Generic Drugs Act of 2012." 112th Congress, 2026, Open America, https://openamerica.io/bill/112-HR-3995/.
Bluebook (legal)
H.R. 3995, 112th Cong. (2026), https://openamerica.io/bill/112-HR-3995/.
Markdown link
[H.R. 3995: Protecting Consumer Access to Generic Drugs Act of 2012](https://openamerica.io/bill/112-HR-3995/)
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