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HR 1432 110th Congress House Commerce Antitrust law Competition Drug industry Generic drugs Health Intellectual property Marketing Patent infringement Pharmaceutical research Restrictive trade practices Science, Technology, Communications

Preserve Access to Affordable Generics Act

Introduced: March 9, 2007 See on congress.gov
 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Mar 12, 2007
Referred to the Subcommittee on Commerce, Trade and Consumer Protection.
Mar 9, 2007
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.
Mar 9, 2007
Introduced in House
 Plain-English summary Congressional Research Service

Preserve Access to Affordable Generics Act - Amends the Clayton Act to make it unlawful for a person, in connection with the sale of a drug product, to be 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 product for any period. Excludes a resolution or settlement that includes no more than the right to market the generic product prior to the expiration of the patent.

Amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to set forth additional filing requirements related to agreements between a brand name drug company and a generic drug applicant. Requires the Chief Executive Officer or the company official responsible for negotiating any agreement to file a certification that materials filed with respect to such agreements are complete, final, and exclusive.

Amends the Federal Food, Drug, and Cosmetic Act to provide that forfeiture of the 180-day exclusivity period for the marketing of a generic drug occurs if there is a final decision of the Federal Trade Commission (FTC) or the court that an agreement has violated this Act.

What's happening now March 12, 2007

Referred to the Subcommittee on Commerce, Trade and Consumer Protection.

 Committees of jurisdiction 3