S. 316 · 110th Congress
Preserve Access to Affordable Generics Act
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Never voted on. It didn't reach a floor vote before the 110th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
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KohlSponsor10 cosponsors · 9 D, 1 R
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Feingold
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Grassley
PL
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Leahy
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Schumer
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Kennedy
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Durbin
TJ
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Johnson
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Obama
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Brown
AK
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Klobuchar4 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
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…
What it does: CRS summary · Reported to Senate without amendment · Feb 27, 2007
(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.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Preserve Access to Affordable Generics Act
Latest action (Mar 7, 2007): Committee on the Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights. Hearings held.
Policy area: Commerce · Origin: Senate · Introduced: Jan 17, 2007
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.