RACE for Children Act 2016-07-14 Introduced in Senate 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 requirements for assessing the use of medications in pediatric populations.

Applications and supplements to applications for certain drugs and biological products, including orphan drugs, that could be used to treat pediatric cancer must include an assessment of pediatric use. Upon request, the Food and Drug Administration (FDA) must meet with the sponsor of such a medication to discuss the plan for pediatric studies.

The FDA may require the sponsor of an approved medication that could be used to treat 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 bill limits waivers of pediatric assessment requirements for certain medications that could be used to treat a pediatric cancer for which there is a need for additional treatment options.

The FDA must meet with medication sponsors to discuss a deferral or waiver of the pediatric assessment requirement.]]> 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 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.