3.0.0 705 2025-11-21T18:15:45Z 2025-11-21T18:15:45Z Senate S S 2025-02-25 119 https://www.congress.gov/bill/119th-congress/senate-bill/705 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred To 2025-02-25T16:08:58Z 2025-02-25 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S1347) IntroReferral 2025-02-25 Introduced in Senate IntroReferral 10000 9 Library of Congress R000122 Sen. Reed, Jack [D-RI] John Reed D RI F. N C001047 Sen. Capito, Shelley Moore [R-WV] Shelley Capito R WV Moore 2025-02-25 True Health Cancer 2025-07-24T14:24:30Z Child health 2025-07-24T14:24:26Z Congressional oversight 2025-07-24T14:25:08Z Drug safety, medical device, and laboratory regulation 2025-07-24T14:24:54Z Drug therapy 2025-07-24T14:24:50Z Government information and archives 2025-07-24T14:24:59Z Government studies and investigations 2025-07-24T14:25:03Z Medical research 2025-07-24T14:24:40Z Prescription drugs 2025-07-24T14:24:45Z Research administration and funding 2025-07-24T14:24:35Z Health 2025-03-21T13:51:33Z

00 2025-02-25 Introduced in Senate 2025-11-21T18:14:18Z <p><strong>Innovation in Pediatric Drugs Act of 2025</strong></p><p>This bill expands the Food and Drug Administration’s (FDA’s) authority with respect to research on rare pediatric diseases, including by permitting the FDA to require pediatric studies on certain orphan drugs and to take enforcement action against drug sponsors that fail to satisfy pediatric study requirements.</p><p>Specifically, the bill would impose pediatric study requirements on drugs for rare diseases or conditions (i.e., orphan drugs) if the FDA determines that (1) the drug could improve the treatment, diagnosis, or prevention of a disease compared with currently available products for the relevant pediatric population; or (2) there is a need for additional options within the drug’s class or indication. (Under current law, pediatric study requirements generally do not apply to orphan drugs.) The FDA must issue guidance describing how these changes will be implemented, including information on how waivers will be granted.&nbsp;</p><p>The bill also permits the FDA to take enforcement action against drug sponsors that fail to comply with pediatric study requirements, if such sponsors demonstrated a lack of due diligence in satisfying the requirements.</p><p>Additionally, the bill authorizes the National Institutes of Health to allot a certain amount of funds for priority pediatric research, including research on drugs with no remaining patents on which pediatric studies are needed.</p><p>Finally, the Government Accountability Office must report on the bill’s impact on rare disease drug development and on the availability of pediatric information on orphan drugs.</p>

Display Title 45 2025-03-20T03:23:18Z Short Title(s) as Introduced 101 2025-03-20T03:23:17Z Introduced in Senate IS Official Title as Introduced 6 2025-03-20T03:18:22Z Introduced in Senate IS Introduced in Senate 2025-02-25T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-119s705is/xml/BILLS-119s705is.xml 2025-02-25 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S1347) 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.