Give Kids a Chance Act of 2024

3.0.0 1214 2025-12-05T21:17:26Z 2025-12-05T21:17:26Z Senate S S 2023-04-19 118 https://www.congress.gov/bill/118th-congress/senate-bill/1214 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Reported By 2023-06-22T17:37:36Z Markup By 2023-05-11T14:00:00Z Referred To 2023-04-19T20:24:50Z Give Kids a Chance Act of 2024 118 3433 HR 2024-09-24 Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Related bill CRS RARE Act 118 7383 HR 2024-02-16 Referred to the Subcommittee on Health. Related bill CRS 2023-06-22 Senate Placed on Senate Legislative Calendar under General Orders. Calendar No. 109. Calendars 2023-06-22 sshr00 Health, Education, Labor, and Pensions Committee Senate Committee on Health, Education, Labor, and Pensions. Reported by Senator Sanders without amendment. Without written report. Committee 2023-06-22 Committee on Health, Education, Labor, and Pensions. Reported by Senator Sanders without amendment. 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 without amendment favorably. Committee 2023-04-19 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2023-04-19 Introduced in Senate IntroReferral 10000 9 Library of Congress B001230 Sen. Baldwin, Tammy [D-WI] Tammy Baldwin D WI N B001310 Sen. Braun, Mike [R-IN] Mike Braun R IN 2023-04-26 False Health Drug safety, medical device, and laboratory regulation 2023-06-08T19:45:24Z Drug therapy 2023-06-08T19:45:24Z Licensing and registrations 2023-06-08T19:45:24Z Prescription drugs 2023-06-08T19:45:24Z Health 2023-04-27T16:45:54Z

00 2023-04-19 Introduced in Senate 2023-11-29T20:23:41Z Retaining Access and Restoring Exclusivity Act or the RARE Act This bill specifies that the seven-year market exclusivity period for drugs for rare diseases or conditions (i.e., orphan drug exclusivity period) prohibits the approval of the same drug for the same approved use or indication with respect to the disease or condition. Current law grants a seven-year period of market exclusivity for an approved orphan drug, during which the Food and Drug Administration (FDA) may not approve an application from another manufacturer for the same drug for the same disease or condition. The FDA's regulations provide that this exclusivity is specific to the same approved use or indication of the drug, rather than all uses or indications, for the disease or condition. However, in Catalyst Pharmaceuticals, Inc. v. Becerra, a court held that exclusivity did extend to all uses or indications for the disease or condition. The bill provides statutory authority for the FDA's regulations.

25 2023-06-22 Reported to Senate 2023-11-29T21:17:20Z Retaining Access and Restoring Exclusivity Act or the RARE Act This bill specifies that the seven-year market exclusivity period for drugs for rare diseases or conditions (i.e., orphan drug exclusivity period) prohibits the approval of the same drug for the same approved use or indication with respect to the disease or condition. Current law grants a seven-year period of market exclusivity for an approved orphan drug, during which the Food and Drug Administration (FDA) may not approve an application from another manufacturer for the same drug for the same disease or condition. The FDA's regulations provide that this exclusivity is specific to the same approved use or indication of the drug, rather than all uses or indications, for the disease or condition. However, in Catalyst Pharmaceuticals, Inc. v. Becerra, a court held that exclusivity did extend to all uses or indications for the disease or condition. The bill provides statutory authority for the FDA's regulations.

RARE Act Display Title 45 RARE Act 2024-07-24T15:21:49Z Short Title(s) as Introduced 101 RARE Act 2024-05-24T13:40:49Z Introduced in Senate IS Short Title(s) as Introduced 101 Retaining Access and Restoring Exclusivity Act 2024-05-24T13:40:49Z Introduced in Senate IS Short Title(s) as Reported to Senate 103 RARE Act 2024-05-24T13:39:13Z S Senate Reported to Senate RS Short Title(s) as Reported to Senate 103 Retaining Access and Restoring Exclusivity Act 2024-05-24T13:39:13Z S Senate Reported to Senate RS Official Title as Introduced 6 A bill to set forth limitations on exclusive approval or licensure of drugs designated for rare diseases or conditions. 2023-04-26T01:58:43Z Introduced in Senate IS Reported to Senate 2023-06-22T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-118s1214rs/xml/BILLS-118s1214rs.xml Introduced in Senate 2023-04-19T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-118s1214is/xml/BILLS-118s1214is.xml 2023-06-22 Placed on Senate Legislative Calendar under General Orders. Calendar No. 109. 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.