3.0.0 1506 2022-11-01T17:03:24Z 2022-11-01T17:03:24Z House HR 2019-03-05 116 From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Ms. BARRAGAN:H.R. 1506.Congress has the power to enact this legislation pursuantto the following:Article 1, Section 8, Clause 3[Page H2369]]]> hsju00 Judiciary Committee House Standing hsju03 Courts, Intellectual Property, and the Internet Subcommittee Referred to 2019-04-08T20:45:31Z Referred to 2019-03-05T17:01:25Z hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2019-03-06T22:00:34Z Referred to 2019-03-05T17:01:20Z Affordable Medications Act 116 1801 S 2019-06-12 Read twice and referred to the Committee on Finance. Related bill CRS 2019-04-08 hsju03 Courts, Intellectual Property, and the Internet Subcommittee 1 House committee actions Referred to the Subcommittee on Courts, Intellectual Property, and the Internet. Committee 2019-03-06 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2019-03-05 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. IntroReferral H11100 2 House floor actions hsju00 Judiciary Committee 2019-03-05 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. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2019-03-05 Introduced in House IntroReferral Intro-H 9 Library of Congress 2019-03-05 Introduced in House IntroReferral 1000 9 Library of Congress B001300 Rep. Barragan, Nanette Diaz [D-CA-44] Nanette Barragan D CA Diaz 44 N Health Drug safety, medical device, and laboratory regulation Government information and archives Intellectual property Marketing and advertising Prescription drugs Health 00 2019-03-05 Introduced in House 2021-09-12T16:22:17Z 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.

]]> FAIR Generics Act Display Title FAIR Generics Act Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act to ensure that valid generic drugs may enter the market. Introduced in House IH Short Title(s) as Introduced FAIR Generics Act Introduced in House IH Short Title(s) as Introduced Fair And Immediate Release of Generic Drugs Act Introduced in House IH Introduced in House 2019-03-05T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116hr1506ih/xml/BILLS-116hr1506ih.xml 2019-04-08 Referred to the Subcommittee on Courts, Intellectual Property, and the Internet. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.