FAIR Generics Act

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.

Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov