US SB2041 | 2015-2016 | 114th Congress
Status
Sponsorship: Slight Partisan Bill (Democrat 5-2)
Status: Introduced on September 16 2015 - 25% progression, died in committee
Action: 2015-09-16 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Pending: Senate Health, Education, Labor, And Pensions Committee
Text: Latest bill text (Introduced) [PDF]
Status: Introduced on September 16 2015 - 25% progression, died in committee
Action: 2015-09-16 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Pending: Senate Health, Education, Labor, And Pensions Committee
Text: Latest bill text (Introduced) [PDF]
Summary
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.
Title
Promoting Life-Saving New Therapies for Neonates Act of 2015
Sponsors
| Sen. Robert Casey [D-PA] | Sen. Bill Cassidy [R-LA] | Sen. Robert Menendez [D-NJ] | Sen. Cory Booker [D-NJ] |
| Sen. Shelley Capito [R-WV] | Sen. Joe Donnelly [D-IN] | Sen. Martin Heinrich [D-NM] |
History
| Date | Chamber | Action |
|---|---|---|
| 2015-09-16 | Senate | Read twice and referred to the Committee on Health, Education, Labor, and Pensions. |
Same As/Similar To
HB5182 (Related) 2016-05-13 - Referred to the Subcommittee on Health.
Subjects
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
Health promotion and preventive care
Medical research
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
Health promotion and preventive care
Medical research
US Congress State Sources
| Type | Source |
|---|---|
| Summary | https://www.congress.gov/bill/114th-congress/senate-bill/2041/all-info |
| Text | https://www.congress.gov/114/bills/s2041/BILLS-114s2041is.pdf |
