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HR 1506 116th Congress House Health Drug safety, medical device, and laboratory regulation Government information and archives Intellectual property Marketing and advertising Prescription drugs

FAIR Generics Act

Introduced: March 5, 2019 Introduced by: Barragán, Nanette Diaz Democratic · California See on congress.gov
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 Everywhere this bill has been 4 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Apr 8, 2019
Referred to the Subcommittee on Courts, Intellectual Property, and the Internet.
Mar 6, 2019
Referred to the Subcommittee on Health.
Mar 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.
Mar 5, 2019
Introduced in House
 Plain-English summary Congressional Research Service

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.

What's happening now April 8, 2019

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

 Committees of jurisdiction 4