3.0.0 2041 2023-01-11T13:29:46Z 2023-01-11T13:29:46Z Senate S 2015-09-16 114 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2015-09-16T20:38:04Z Promoting Life-Saving New Therapies for Neonates Act of 2016 114 5182 HR 2016-05-13 Referred to the Subcommittee on Health. Related bill CRS 2015-09-16 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2015-09-16 Introduced in Senate IntroReferral 10000 9 Library of Congress C001070 Sen. Casey, Robert P., Jr. [D-PA] Bob Casey D PA N C001075 Sen. Cassidy, Bill [R-LA] Bill Cassidy R LA 2015-09-16 True M000639 Sen. Menendez, Robert [D-NJ] Robert Menendez D NJ 2015-09-16 True B001288 Sen. Booker, Cory A. [D-NJ] Cory Booker D NJ 2015-10-21 False C001047 Sen. Capito, Shelley Moore [R-WV] Shelley Capito R WV Moore 2016-02-24 False D000607 Sen. Donnelly, Joe [D-IN] Joe Donnelly D IN 2016-02-24 False H001046 Sen. Heinrich, Martin [D-NM] Martin Heinrich D NM T. 2016-05-16 False Health Administrative law and regulatory procedures Child health Congressional oversight Department of Health and Human Services Drug safety, medical device, and laboratory regulation Drug therapy Food and Drug Administration (FDA) Government studies and investigations Health promotion and preventive care Medical research Health 00 2015-09-16 Introduced in Senate 2016-05-19T19:50:05Z Promoting Life-Saving New Therapies for Neonates Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to award the sponsor of a new drug or biological product for the treatment of newborns a neonatal drug exclusivity voucher upon approval of the medication. A neonatal drug exclusivity voucher is a transferable voucher for a one-year extension of all existing patents and marketing exclusivities for a brand name medication. For a sponsor to be eligible for a voucher, the new medication must: (1) treat a condition identified in the Priority List of Critical Needs for Neonates required under this Act, and (2) have been studied in newborns.

A voucher may be revoked if the new medication is not marketed in the United States within one year of approval.

A voucher may not be used: (1) to extend the marketing exclusivity period for a drug for which the FDA requires an assessment of the safety and effectiveness in newborns, or (2) on the same product as a priority review voucher.

A sponsor intending to use a voucher must notify the FDA at least 15 months before the expiration of the patents or exclusivity to be extended.

The Government Accountability Office must study the effectiveness of this voucher program.]]> Promoting Life-Saving New Therapies for Neonates Act of 2015 Display Title Promoting Life-Saving New Therapies for Neonates Act of 2015 Official Title as Introduced A bill to promote the development of safe drugs for neonates. Introduced in Senate IS Short Titles as Introduced Promoting Life-Saving New Therapies for Neonates Act of 2015 Introduced in Senate 2015-09-16T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114s2041is/xml/BILLS-114s2041is.xml 2015-09-16 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.