3.0.0 2853 2023-03-08T20:11:59Z 2023-03-08T20:11:59Z House HR 2021-04-26 117 [Congressional Record Volume 167, Number 71 (Monday, April 26, 2021)][House]From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mr. SCHRADER:H.R. 2853.Congress has the power to enact this legislation pursuantto the following:Article 1, Section 8, clause 3.[Page H2115]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2021-04-27T13:20:41Z Referred to 2021-04-26T16:04:15Z 2021-04-27 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2021-04-26 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2021-04-26 Introduced in House IntroReferral Intro-H 9 Library of Congress 2021-04-26 Introduced in House IntroReferral 1000 9 Library of Congress S001180 Rep. Schrader, Kurt [D-OR-5] Kurt Schrader D OR 5 N Health Competition and antitrust Drug safety, medical device, and laboratory regulation Health care costs and insurance Health care coverage and access Licensing and registrations Marketing and advertising Prescription drugs Health 00 2021-04-26 Introduced in House 2021-09-01T17:26:04Z Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2021 or the BLOCKING Act of 2021

This bill modifies provisions related to market exclusivity for a generic drug.

Currently, the Food and Drug Administration (FDA) awards 180 days of exclusivity on the market to a first applicant to file a qualifying application for market approval of a generic drug. Generally, this exclusivity period begins upon a first applicant's commercial marketing of the drug.

The bill authorizes the FDA to approve a subsequent generic drug application prior to a first applicant's first date of commercial marketing if (1) the subsequent application is ready for full approval, (2) a first applicant's application has been pending for at least 30 months, and (3) the approval of a first applicant's application is not precluded by patent infringement claims asserted against that first applicant.

]]> Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2021 Display Title Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2021 Official Title as Introduced To amend the Federal Food, Drug, and Cosmetic Act, with respect to eligibility for approval of a subsequent generic drug, to remove the barrier to that approval posed by the 180-day exclusivity period afforded to a first generic applicant that has not yet received final approval, and for other purposes. Introduced in House IH Short Title(s) as Introduced Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2021 Introduced in House IH Short Title(s) as Introduced BLOCKING Act of 2021 Introduced in House IH Introduced in House 2021-04-26T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-117hr2853ih/xml/BILLS-117hr2853ih.xml 2021-04-27 Referred to the Subcommittee on Health. 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.