S.504: FAIR Generics Act

About this Bill

You can read the bill
Sponsor Al Franken, D-Minn.
Total Cosponsors 6 (4 Democrats, 1 Independent, 1 Republican)
Introduced March 7, 2013
Latest Major Action March 7, 2013
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Bill Progress

  • Bill introduced in the Senate   
  • Bill passed in the Senate   
  • Bill passed in the House   
  • Bill signed into law

Bill Summary

Fair And Immediate Release of Generic Drugs Act or FAIR Generics Act - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise the definition of “first applicant” for purposes of the 180-day exclusivity period given to first applicants to file an abbreviated new drug application (generic drug). Makes applicants for a generic drug eligible for the exclusivity period only if they have not entered into a disqualifying agreement (an agreement between a generic drug applicant and the holder of the application for the listed drug [brand name drug] or the patent holder for the brand name drug whereby the generic drug applicant agrees not to seek approval of its generic drug or not to begin the commercial marketing of its generic drug until the expiration of the exclusivity period awarded to another generic applicant).

Expands the definition of “first applicant” to include an applicant that meets the following criteria: (1) the applicant is not th...

(Source: Congressional Research Service)

Bill Actions

Date Description
March 7, 2013 Read twice and referred to the Committee on Health, Education, Labor, and Pensions.