US Congress House Bill 5182 (Prior Session Legislation)

---

Spectrum: Slight Partisan Bill (Democrat 21-13)
Status: Introduced on May 10 2016 - 25% progression, died in committee
Action: 2016-05-13 - Referred to the Subcommittee on Health.
Pending: House Subcommittee on Health Committee
Text: Latest bill text (Introduced) [PDF]

Promoting Life-Saving New Therapies for Neonates Act of 2016 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 bill, 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 2016

Rep. Billy Long [R-MO]	Sen. Ben Lujan [D-NM]	Rep. Alma Adams [D-NC]	Rep. Gerald Connolly [D-VA]
Rep. Marc Veasey [D-TX]	Rep. Bill Pascrell [D-NJ]	Rep. Bruce Poliquin [R-ME]	Rep. Ruben Gallego [D-AZ]
Rep. Donald Norcross [D-NJ]	Rep. Brett Guthrie [R-KY]	Rep. Pete Aguilar [D-CA]	Rep. Patrick Murphy [D-FL]
Rep. Albio Sires [D-NJ]	Rep. Sean Duffy [R-WI]	Rep. Kathleen Rice [D-NY]	Rep. Evan Jenkins [R-WV]
Rep. Leonard Lance [R-NJ]	Rep. Seth Moulton [D-MA]	Rep. Brad Ashford [D-NE]	Rep. Grace Napolitano [D-CA]
Rep. Alexander Mooney [R-WV]	Rep. Gus Bilirakis [R-FL]	Rep. Bobby Rush [D-IL]	Rep. Peter King [R-NY]
Rep. Mike Bishop [R-MI]	Rep. Steve Israel [D-NY]	Rep. Tony Cardenas [D-CA]	Rep. Derek Kilmer [D-WA]
Rep. Robert Dold [R-IL]	Rep. Mike Kelly [R-PA]	Rep. Scott Peters [D-CA]	Rep. David Loebsack [D-IA]
Rep. Erik Paulsen [R-MN]	Rep. David Price [D-NC]

Date	Chamber	Action
2016-05-13	House	Referred to the Subcommittee on Health.
2016-05-10	House	Referred to the House Committee on Energy and Commerce.
2016-05-10	House	Introduced in House

SB2041 (Related) 2015-09-16 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Type	Source
Summary	https://www.congress.gov/bill/114th-congress/house-bill/5182/all-info
Text	https://www.congress.gov/114/bills/hr5182/BILLS-114hr5182ih.pdf