United States 114th Congress Status: Died 1 R cosponsors

S 131 — FAIR Generics Act Fair And Immediate Release of Generic Drugs Act

Last action — Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Track this bill free

No card. One bill, free forever — alerts when it moves.

  1. ✓
    Introduced
  2. ✓
    In Committee
  3. Died in session

This bill died with 114th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.

This bill is no longer active — its legislative session has ended, so there is no live prognosis. It would have to be reintroduced in the current session to move again.

Summary

FAIR Generics Act Fair And Immediate Release of Generic Drugs Act This bill amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to disqualify from being a “first applicant” an applicant submitting an abbreviated new drug application (for a generic drug) to the Food and Drug Administration that has entered into a specified agreement. Currently, any generic drug applicant submitting an application on the first day an application is submitted for that drug is a “first applicant” and is granted a 180-day marketing exclusivity period. An agreement that disqualifies a generic drug applicant from being a first applicant is an agreement between the applicant and the holder of the application or a patent for the brand name drug whereby the applicant agrees not to seek approval or begin marketing the generic drug until the expiration of the exclusivity period awarded to another applicant. “First applicant” is expanded to include applicants that did not submit an application on the first day an application was submitted. These first applicants must not have a patent infringement action pending against them and must not have been found to have infringed a patent. If an applicant that submitted an application on the first day an application was submitted has begun marketing the drug, a first applicant that submitted after the first day cannot begin marketing until 30 days after the first day applicant began marketing. A first applicant that has entered into an agreement not to seek approval of an application or begin marketing at the earliest possible date cannot seek approval or begin marketing until the earlier of: (1) the latest date set forth in the agreement, or (2) 180 days after a first day applicant begins marketing. An action for infringement of a drug patent must be brought within the 45-day period described in FFDCA.

Bill Text

We don't have the full text on file for this bill yet.

Read S 131 on the official United States source →

Action History

  1. Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Sponsors

Sponsorship breakdown

Export CSV (upgrade) →

1 sponsors · 0 co-sponsors · 546 not signed on

Sponsors (1)

Co-sponsors (0)

None.

Not signed on (546)

546 members have not signed on to this bill.

Show all 546 →

"Not signed on" means a member has not sponsored or co-sponsored this bill — it does not imply opposition. Members flagged Voted No have a recorded No vote on this bill.

Whip count is in markup. Polling the chamber and every recorded vote this session. Only the first open is slow. It’s instant for you after this. Calling the roll · Tallying · Engrossing

Subjects

Drug safety, medical device, and laboratory regulation Government information and archives Intellectual property Marketing and advertising Prescription drugs Health
Cross-referencing the record. Reading this bill against every other bill in the corpus by meaning, not keywords. Only the first open is slow. It’s instant for you after this. Matching · Ranking · Engrossing

Frequently asked questions

What does S 131 do?
FAIR Generics Act Fair And Immediate Release of Generic Drugs Act This bill amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to disqualify from being a “first applicant” an applicant submitting an abbreviated new drug application (for a generic drug) to the Food and Drug Administration that has entered into a specified agreement. Currently, any generic drug applicant submitting an application on the first day an application is submitted for that drug is a “first applicant” and is granted a 180-day marketing exclusivity period. An agreement that disqualifies a generic drug applicant from being a first applicant is an agreement between the applicant and the holder of the application or a patent for the brand name drug whereby the applicant agrees not to seek approval or begin marketing the generic drug until the expiration of the exclusivity period awarded to another applicant. “First applicant” is expanded to include applicants that did not submit an application on the first day an application was submitted. These first applicants must not have a patent infringement action pending against them and must not have been found to have infringed a patent. If an applicant that submitted an application on the first day an application was submitted has begun marketing the drug, a first applicant that submitted after the first day cannot begin marketing until 30 days after the first day applicant began marketing. A first applicant that has entered into an agreement not to seek approval of an application or begin marketing at the earliest possible date cannot seek approval or begin marketing until the earlier of: (1) the latest date set forth in the agreement, or (2) 180 days after a first day applicant begins marketing. An action for infringement of a drug patent must be brought within the 45-day period described in FFDCA.
Who sponsors S 131?
S 131 is sponsored by David Vitter (R).
What is the current status of S 131?
This bill died with 114th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.
Where can I track S 131?
Track S 131 free on One Click Politics — get push/email alerts when it moves.

Make your voice heard on S 131

Find the representatives who decide this bill and tell them where you stand — for yourself, or mobilize your whole list in one click with One Click Politics advocacy software.

Find my representatives → Run a campaign

Stay ahead of S 131

Last checked for changes about 9 hours ago · updated continuously

One Click Politics tracks every bill in Congress and all 50 states.

Track this bill →