3.0.0 1432 2023-01-11T19:54:19Z 2023-01-11T19:54:19Z House H HR 2007-03-09 110 hsif00 Energy and Commerce Committee House Standing hsif17 Innovation, Data, and Commerce Subcommittee Referred to 2007-03-12T19:40:53Z Referred to 2007-03-09T14:02:50Z hsju00 Judiciary Committee House Standing Referred to 2007-03-09T14:03:00Z Preserve Access to Affordable Generics Act 110 316 S 2007-03-07 Committee on the Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights. Hearings held. Related bill CRS 2007-03-12 hsif17 Innovation, Data, and Commerce Subcommittee 1 House committee actions Referred to the Subcommittee on Commerce, Trade and Consumer Protection. Committee 2007-03-09 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. IntroReferral H11100 2 House floor actions hsju00 Judiciary Committee 2007-03-09 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. IntroReferral H11100-A 9 Library of Congress 2007-03-09 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. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2007-03-09 Introduced in House IntroReferral Intro-H 9 Library of Congress 2007-03-09 Introduced in House IntroReferral 1000 9 Library of Congress W000215 Rep. Waxman, Henry A. [D-CA-30] HENRY WAXMAN D CA A. 30 N V000128 Rep. Van Hollen, Chris [D-MD-8] Chris Van Hollen D MD 8 2007-09-24 False Commerce Antitrust law Competition Drug industry Generic drugs Health Intellectual property Marketing Patent infringement Pharmaceutical research Restrictive trade practices Science, Technology, Communications Commerce 00 2007-03-09 Introduced in House 2007-05-04T13:52:45Z 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.

]]> Preserve Access to Affordable Generics Act 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. Introduced in House IH Display Title Preserve Access to Affordable Generics Act Short Titles as Introduced Preserve Access to Affordable Generics Act Introduced in House 2007-03-09T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-110hr1432ih/xml/BILLS-110hr1432ih.xml 2007-03-12 Referred to the Subcommittee on Commerce, Trade and Consumer Protection. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.