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Titles (2)

Short Titles

Short Titles - Senate

Short Titles as Introduced

Promoting Life-Saving New Therapies for Neonates Act of 2015

Official Titles

Official Titles - Senate

Official Titles as Introduced

A bill to promote the development of safe drugs for neonates.

Actions Overview (1)

Date Actions Overview
09/16/2015Introduced in Senate

All Actions (1)

Date All Actions
09/16/2015Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Action By: Senate

Cosponsors (6)

* = Original cosponsor
CosponsorDate Cosponsored
Sen. Cassidy, Bill [R-LA]* 09/16/2015
Sen. Menendez, Robert [D-NJ]* 09/16/2015
Sen. Booker, Cory A. [D-NJ] 10/21/2015
Sen. Capito, Shelley Moore [R-WV] 02/24/2016
Sen. Donnelly, Joe [D-IN] 02/24/2016
Sen. Heinrich, Martin [D-NM] 05/16/2016

Committees (1)

Committees, subcommittees and links to reports associated with this bill are listed here, as well as the nature and date of committee activity and Congressional report number.

Committee / Subcommittee Date Activity Reports
Senate Health, Education, Labor, and Pensions09/16/2015 Referred to

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Latest Summary (1)

There is one summary for S.2041. View summaries

Shown Here:
Introduced in Senate (09/16/2015)

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.