S. 504: FAIR Generics Act

Before you vote › Federal bills

S. 504: FAIR Generics Act

113th Congress · introduced 2013-03-07 · Health · Latest: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

federal

Save to my notebook What does this mean? Print

Official title

FAIR Generics Act

Plain 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applicant is not the first generic applicant; (2) either no action for patent infringement was brought, such action was withdrawn or dismissed by a court without a decision that the patent was valid and infringed, or the court decided that the patent was invalid or not infringed; and (3) the applicant does not begin commercial marketing of such drug until 30 days after the first applicant began such commercial marketing. Prohibits a party that enters an agreement to delay seeking approval of its generic drug application or to delay the commercial marketing of a generic drug from seeking approval of its application or beginning commercial marketing before the earlier of: (1) the latest date set forth in the agreement to seek approval or market the drug without regard to any earlier date under the agreement when commercial marketing could begin, or (2) 180 days after another first applicant begins commercial marketing of such drug. Requires notice to the Secretary of the Health and Human Services (HHS) of the details of any agreement under this Act not later than ten business days after execution of the agreement. Declares that the exclusive remedy for an infringement of a patent included within a new drug application shall be an action brought under the FFDCA within the 45-day period prescribed.

Congressional Research Service summary (Introduced in Senate), quoted unchanged (nonpartisan). Read the source.

What a vote does

PSI Sci description of the legislative step (not an opinion).

The strongest published arguments

Alternatives

Needs sources: no published alternatives yet (for example a different bill, a law instead of an amendment, or keeping current law). We only show items backed by a published source. Suggest one.

How did my representative vote? · This bill's floor votes

Officials and money

Sponsor: Sen. Franken, Al [D-MN] · 6 cosponsors

Cost estimate: No cost estimate published yet.

Cosponsors on this site

Richard J. Durbin (D-IL), Jeanne Shaheen (D-NH), Bernard Sanders (I-VT), Amy Klobuchar (D-MN)

No linked floor roll calls in our collected records yet. This does not mean the bill has never had a vote. Check the official bill history.

Sources

• Congressional Research Service summary (Introduced in Senate)
• Congress.gov
• Data: GovInfo BILLSTATUS bulk data (Library of Congress), BILLSTATUS-113s504.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/113/s>

Record fed-us-cong113-s504 · catalog fed-us-congress-bills-cong113 · updated 2026-11-15 by psicol fed-bills-cong113