All Information (Except Text) for S.2041 - Promoting Life-Saving New Therapies for Neonates Act of 2015114th Congress (2015-2016)
|Sponsor:||Sen. Casey, Robert P., Jr. [D-PA] (Introduced 09/16/2015)|
|Committees:||Senate - Health, Education, Labor, and Pensions|
|Latest Action:||Senate - 09/16/2015 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (All Actions)|
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Titles Actions Overview All Actions Cosponsors Committees Related Bills Subjects Latest Summary All Summaries
Actions Overview (1)
|09/16/2015||Introduced in Senate|
09/16/2015 Introduced in Senate
All Actions (1)
|09/16/2015||Read twice and referred to the Committee on Health, Education, Labor, and Pensions.|
Action By: Senate
09/16/2015 Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
|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|
|Committee / Subcommittee||Date||Activity||Reports|
|Senate Health, Education, Labor, and Pensions||09/16/2015||Referred to|
Subject — Policy Area:
One Policy Area term, which best describes an entire measure, is assigned to every public bill or resolution.
- 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
Latest Summary (1)
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.