1506 -- FAIR Generics Act | Poliscope

FAIR Generics Act

1506

116th Congress

Health

In Committee

FAIR Generics Act

Legislative Progress

✓

Introduced

Committee

Floor Vote

Other Chamber

Enacted

Introduced

March 5, 2019

Latest Action

April 8, 2019

Primary Sponsor

Nanette Diaz BarragánDemocratic(CA)

Momentum (last 30 days)

score

0 actions · 0 new cosponsors · 0 votes

Speed vs cohort

81pct

34d open

vs 9,062 other HR bills in the 116th — cohort avg 39d

Summary

Fair And Immediate Release of Generic Drugs Act or the FAIR Generics Act This bill disqualifies from being a first applicant an applicant submitting a generic drug application to the Food and Drug Administration if the applicant has entered into a specified disqualifying 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. A disqualifying agreement 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. The bill expands the definition of first applicant to include applicants that did not submit an application on the first day an application was submitted. To be included, 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 may not begin marketing until 30 days after the first-day applicant began marketing. A first applicant that has entered into an agreement to not seek approval of an application or begin marketing at the earliest possible date may not 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.

Lobbying filings that explicitly cite this bill (50)

These links require the bill number to appear in the filing's source-reported specific issue text. Client expenses and lobbying-firm income are separate disclosure fields.

Filing registrants (18)

WEST FRONT STRATEGIES LLC (8)COVINGTON & BURLING LLP (1)GOVERNMENT COUNSEL, LLC (2)WILEY REIN LLP (1)ABBVIE, INC. (5)AMERICA'S HEALTH INSURANCE PLANS, INC. (AHIP) (4)APOTEX CORP. (1)ASSOCIATION FOR ACCESSIBLE MEDICINES (5)BRISTOL-MYERS SQUIBB COMPANY (11)GLENMARK PHARMACEUTICALS USA (6)

Show 8 more registrants

GREATER NEW YORK HOSPITAL ASSOCIATION

Subjects (5)

Drug safety, medical device, and laboratory regulation

Government information and archives

Intellectual property

Marketing and advertising

Prescription drugs

Actions (4)

April 8, 2019

Referred to the Subcommittee on Courts, Intellectual Property, and the Internet.

March 6, 2019

Referred to the Subcommittee on Health.

March 5, 2019

Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

March 5, 2019

Introduced in House

Congress.gov source codes: 1000, Intro-H