3.0.0 316 2023-01-11T20:05:30Z 2023-01-11T20:05:30Z Senate S S 2007-01-17 110 ssju00 Judiciary Committee Senate Standing ssju01 Competition Policy, Antitrust, and Consumer Rights Subcommittee Hearings by 2007-03-07T22:55:24Z Reported by 2007-02-27T20:43:19Z Markup by 2007-02-15T17:45:33Z Hearings by 2007-01-18T00:25:25Z Referred to 2007-01-17T19:56:38Z Preserve Access to Affordable Generics Act 110 1432 HR 2007-03-12 Referred to the Subcommittee on Commerce, Trade and Consumer Protection. Related bill CRS 2007-03-07 ssju01 Competition Policy, Antitrust, and Consumer Rights Subcommittee Senate Committee on the Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights. Hearings held. Committee 2007-02-27 Senate Placed on Senate Legislative Calendar under General Orders. Calendar No. 59. Calendars 2007-02-27 ssju00 Judiciary Committee Senate Committee on the Judiciary. Reported by Senator Leahy without amendment. Without written report. Committee 2007-02-27 Committee on the Judiciary. Reported by Senator Leahy without amendment. Without written report. Committee 14000 9 Library of Congress ssju00 Judiciary Committee 2007-02-15 ssju00 Judiciary Committee Senate Committee on the Judiciary. Approved for reporting without amendment favorably. Committee 2007-01-17 ssju00 Judiciary Committee Senate Committee on the Judiciary. Hearings held. Committee 2007-01-17 ssju00 Judiciary Committee Senate Read twice and referred to the Committee on the Judiciary. (text of measure as introduced: CR S679-680) IntroReferral 2007-01-17 Sponsor introductory remarks on measure. (CR S679) IntroReferral B00100 9 Library of Congress 2007-01-17 Introduced in Senate IntroReferral 10000 9 Library of Congress K000305 Sen. Kohl, Herb [D-WI] HERBERT KOHL D WI H. N G000386 Sen. Grassley, Chuck [R-IA] Charles Grassley R IA E. 2007-01-17 True L000174 Sen. Leahy, Patrick J. [D-VT] Patrick Leahy D VT 2007-01-17 True S000148 Sen. Schumer, Charles E. [D-NY] Charles Schumer D NY E. 2007-01-17 True F000061 Sen. Feingold, Russell D. [D-WI] RUSSELL FEINGOLD D WI D. 2007-01-17 True K000105 Sen. Kennedy, Edward M. [D-MA] EDWARD KENNEDY D MA MOORE 2007-02-14 False D000563 Sen. Durbin, Richard J. [D-IL] Richard Durbin D IL J. 2007-02-27 False J000177 Sen. Johnson, Tim [D-SD] TIM JOHNSON D SD 2007-04-11 False O000167 Sen. Obama, Barack [D-IL] Barack Obama D IL 2007-09-12 False B000944 Sen. Brown, Sherrod [D-OH] Sherrod Brown D OH 2007-12-18 False K000367 Sen. Klobuchar, Amy [D-MN] Amy Klobuchar D MN 2008-09-08 False Commerce Antitrust law Competition Congress Congressional reporting requirements Crime and Law Enforcement Criminal investigation Drug industry Generic drugs Governmental investigations Health Intellectual property Marketing Patent infringement Pharmaceutical research Restrictive trade practices Science, Technology, Communications Commerce 00 2007-01-17 Introduced in Senate 2007-03-15T20:19:17Z 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.

Requires the FTC to study the prevalence of anticompetitive agreements in the pharmaceutical industry and their impact. Requires the Attorney General or FTC to consider whether any additional enforcement action is necessary.

]]> 80 2007-02-27 Reported to Senate without amendment 2007-04-27T18:05:20Z (This measure has not been amended since it was introduced. The summary has been expanded because action occurred on the measure.)

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: (1) are complete, final, and exclusive; (2) include any ancillary agreements that are contingent upon, provide a contingent condition for, or are otherwise related to, the agreement; and (3) include written descriptions of any relevant oral agreements, representations, commitments, or promises between the parties that have not been reduced to writing.

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.

Requires the FTC to study the prevalence of anticompetitive agreements in the pharmaceutical industry and their impact. Requires the Attorney General or FTC to consider whether any additional enforcement action is necessary.

Authorizes appropriations.

]]> Preserve Access to Affordable Generics Act Official Title as Introduced A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market. Introduced in Senate IS Display Title Preserve Access to Affordable Generics Act Short Titles as Introduced Preserve Access to Affordable Generics Act Short Titles as Reported to Senate Preserve Access to Affordable Generics Act S Senate Reported to Senate 2007-02-27T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-110s316rs/xml/BILLS-110s316rs.xml Introduced in Senate 2007-01-17T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-110s316is/xml/BILLS-110s316is.xml 2007-03-07 Committee on the Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights. Hearings held. 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.