Increasing Transparency in Generic Drug Applications Act

3.0.0 1114 2025-04-21T12:24:17Z 2025-04-21T12:24:17Z Senate S S 2023-03-30 118 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Reported By 2023-06-22T17:35:37Z Markup By 2023-05-11T14:00:02Z Referred To 2023-03-30T18:10:40Z Increasing Transparency in Generic Drug Applications Act 118 775 S 2023-03-14 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Related bill CRS To amend the Federal Food, Drug, and Cosmetic Act to increase transparency in generic drug applications. 118 3839 HR 2023-06-09 Referred to the Subcommittee on Health. Related bill CRS 2023-06-22 Senate Placed on Senate Legislative Calendar under General Orders. Calendar No. 108. Calendars 2023-06-22 sshr00 Health, Education, Labor, and Pensions Committee Senate Committee on Health, Education, Labor, and Pensions. Reported by Senator Sanders with an amendment in the nature of a substitute. Without written report. Committee 2023-06-22 Committee on Health, Education, Labor, and Pensions. Reported by Senator Sanders with an amendment in the nature of a substitute. Without written report. Committee 14000 9 Library of Congress sshr00 Health, Education, Labor, and Pensions Committee 2023-05-11 sshr00 Health, Education, Labor, and Pensions Committee Senate Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably. Committee 2023-03-30 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2023-03-30 Introduced in Senate IntroReferral 10000 9 Library of Congress S001203 Sen. Smith, Tina [D-MN] Tina Smith D MN N B001310 Sen. Braun, Mike [R-IN] Mike Braun R IN 2023-03-30 True Health Drug safety, medical device, and laboratory regulation 2023-06-08T19:45:24Z Prescription drugs 2023-06-08T19:45:24Z Health 2023-04-19T17:45:16Z

00 2023-03-30 Introduced in Senate 2023-10-12T15:40:26Z Expanding Access to Low-Cost Generics Act of 2023 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) the applicant certifies that there are no conditions that would prevent commercial marketing of the drug within 75 days of approval and that the applicant intends to do so, (3) a first applicant's application has been pending for at least 33 months, (4) the approval of a first applicant's application is not precluded by patent infringement claims asserted against that first applicant, and (5) no first applicant's application has been effectively approved on the date that all such conditions are met. If an applicant fails to begin commercially marketing their drug within 75 days of approval via the aforementioned process, the applicant's approval is deemed tentative and the applicant is no longer eligible for subsequent approvals, unless the applicant certifies that the failure was due to unforeseen issues that have since been resolved.

25 2023-06-22 Reported to Senate 2023-10-12T15:46:42Z Expanding Access to Low-Cost Generics Act of 2023 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) the applicant certifies that there are no conditions that would prevent commercial marketing of the drug within 75 days of approval and that the applicant intends to do so, (3) a first applicant's application has been pending for at least 33 months, (4) the approval of a first applicant's application is not precluded by patent infringement claims asserted against that first applicant, and (5) no first applicant's application has been effectively approved on the date that all such conditions are met. If an applicant fails to begin commercially marketing their drug within 75 days of approval via the aforementioned process, the applicant's approval is deemed tentative and the applicant is no longer eligible for subsequent approvals, unless the applicant certifies that the failure was due to unforeseen issues that have since been resolved. Additionally, the FDA must inform generic drug applicants, upon request or during review, whether the drug is qualitatively and quantitatively the same as the listed brand-name drug (and if not, the reasons why).

Expanding Access to Low-Cost Generics Act of 2023 Display Title 45 Expanding Access to Low-Cost Generics Act of 2023 2024-07-24T15:21:49Z Short Title(s) as Introduced 101 Expanding Access to Low-Cost Generics Act of 2023 2024-05-24T13:41:06Z Introduced in Senate IS Short Title(s) as Reported to Senate 103 Expanding Access to Low-Cost Generics Act of 2023 2024-05-24T13:39:14Z S Senate Reported to Senate RS Official Title as Introduced 6 A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period. 2023-04-18T01:29:12Z Introduced in Senate IS Reported to Senate 2023-06-22T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-118s1114rs/xml/BILLS-118s1114rs.xml Introduced in Senate 2023-03-30T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-118s1114is/xml/BILLS-118s1114is.xml 2023-06-22 Placed on Senate Legislative Calendar under General Orders. Calendar No. 108. 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.