S.316 - Preserve Access to Affordable Generics Act

A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market. view all titles (3)

All Bill Titles

  • Short: Preserve Access to Affordable Generics Act as introduced.
  • Official: A bill to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market. as introduced.
  • Short: Preserve Access to Affordable Generics Act as reported to senate.

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Introduced
 
Senate
Passes
 
House
Passes
 
President
Signs
 

 
01/17/07
 
 
 
 
 
 
 

Official Summary

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 f

Official Summary

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.

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