3.0.0 456 2023-01-11T13:34:44Z 2023-01-11T13:34:44Z Senate S 2017-02-27 115 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2017-02-27T22:57:50Z RACE for Children Act 115 1231 HR 2017-03-03 Referred to the Subcommittee on Health. Identical bill CRS 2017-02-27 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2017-02-27 Introduced in Senate IntroReferral 10000 9 Library of Congress B001267 Sen. Bennet, Michael F. [D-CO] Michael Bennet D CO N R000595 Sen. Rubio, Marco [R-FL] Marco Rubio R FL 2017-02-27 True V000128 Sen. Van Hollen, Chris [D-MD] Chris Van Hollen D MD 2017-02-27 True G000562 Sen. Gardner, Cory [R-CO] Cory Gardner R CO 2017-02-27 True K000383 Sen. King, Angus S., Jr. [I-ME] Angus King I ME S. 2017-08-02 False Health Cancer Child health Congressional oversight Drug safety, medical device, and laboratory regulation Drug therapy Medical research Health 00 2017-02-27 Introduced in Senate 2017-09-14T16:17:09Z Research to Accelerate Cures and Equity for Children Act or the RACE for Children Act

This bill amends the Federal Food, Drug, and Cosmetic Act to expand Food and Drug Administration (FDA) requirements for sponsors of certain drugs and biological products for adult cancer to assess the use of their medications in pediatric populations. (Currently, applications for FDA approval of new medications or new uses of medications must include pediatric assessments of safety and effectiveness for claimed indications, with exceptions.) The pediatric assessment for medications, including orphan drugs, that are used to treat cancer in adults and target a molecule germane to pediatric cancer must assess the safety and effectiveness of the medication for pediatric cancer. The bill limits waivers of pediatric assessments for medications that target a molecule germane to a pediatric cancer for which there is a need for additional treatment options.

The FDA may require the sponsor of an approved medication that targets a molecule germane to pediatric cancer to complete a pediatric assessment if: (1) the medication is used for a substantial number of pediatric cancer patients, or (2) there is reason to believe the medication would have a meaningful therapeutic benefit over existing therapies for pediatric cancer patients.

The FDA committee that reviews requests for pediatric studies must implement a plan to achieve earlier submission of pediatric studies. (Currently, completion of pediatric clinical studies requested by the FDA extends the patents or marketing exclusivity period for a medication by six months, with exceptions.)

The FDA must act within 120 days on proposed pediatric study requests and proposed amendments to requests.
]]> RACE for Children Act Display Title RACE for Children Act Official Title as Introduced A bill to amend the Federal Food, Drug, and Cosmetic Act to establish a program to increase the development of new drugs to treat pediatric cancers, and for other purposes. Introduced in Senate IS Short Titles as Introduced RACE for Children Act Short Titles as Introduced Research to Accelerate Cures and Equity for Children Act Introduced in Senate 2017-02-27T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-115s456is/xml/BILLS-115s456is.xml 2017-02-27 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. 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.