# 114-hr-5182: Promoting Life-Saving New Therapies for Neonates Act of 2016

114-hr-5182, Promoting Life-Saving New Therapies for Neonates Act of 2016, is a 114th Congress bill sponsored by Rep. Long, Billy [R-MO-7] (R-MO); status Referred to the Subcommittee on Health. (as of 2025-11-18).

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- As of: 2025-11-18
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Bill: 114-hr-5182
- Congress: 114
- Title: Promoting Life-Saving New Therapies for Neonates Act of 2016
- Status: Referred to the Subcommittee on Health.
- Introduced: 2016-05-10
- Sponsor: Rep. Long, Billy [R-MO-7] (R-MO)
- Cosponsors: 33
- Policy area: Health
- Touches household money: no
- Last recorded action: 2025-11-18

## Summary

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.

## Cosponsors (33)

- Sen. Luján, Ben Ray [D-NM] (D-NM), 2016-05-10T00:00:00.000Z
- Rep. Adams, Alma S. [D-NC-12] (D-NC), 2016-05-23T00:00:00.000Z
- Rep. Connolly, Gerald E. [D-VA-11] (D-VA), 2016-06-08T00:00:00.000Z
- Rep. Veasey, Marc A. [D-TX-33] (D-TX), 2016-06-10T00:00:00.000Z
- Rep. Pascrell, Bill, Jr. [D-NJ-9] (D-NJ), 2016-06-10T00:00:00.000Z
- Rep. Poliquin, Bruce [R-ME-2] (R-ME), 2016-06-10T00:00:00.000Z
- Sen. Gallego, Ruben [D-AZ] (D-AZ), 2016-06-16T00:00:00.000Z
- Rep. Norcross, Donald [D-NJ-1] (D-NJ), 2016-06-16T00:00:00.000Z
- Rep. Guthrie, Brett [R-KY-2] (R-KY), 2016-06-16T00:00:00.000Z
- Rep. Aguilar, Pete [D-CA-33] (D-CA), 2016-06-16T00:00:00.000Z
- Rep. Murphy, Patrick [D-FL-18] (D-FL), 2016-07-05T00:00:00.000Z
- Rep. Sires, Albio [D-NJ-8] (D-NJ), 2016-07-05T00:00:00.000Z
- Rep. Duffy, Sean P. [R-WI-7] (R-WI), 2016-07-05T00:00:00.000Z
- Rep. Rice, Kathleen M. [D-NY-4] (D-NY), 2016-07-05T00:00:00.000Z
- Rep. Jenkins, Evan H. [R-WV-3] (R-WV), 2016-07-06T00:00:00.000Z
- Rep. Lance, Leonard [R-NJ-7] (R-NJ), 2016-07-06T00:00:00.000Z
- Rep. Moulton, Seth [D-MA-6] (D-MA), 2016-07-12T00:00:00.000Z
- Rep. Ashford, Brad [D-NE-2] (D-NE), 2016-07-12T00:00:00.000Z
- Rep. Napolitano, Grace F. [D-CA-31] (D-CA), 2016-07-12T00:00:00.000Z
- Rep. Mooney, Alexander X. [R-WV-2] (R-WV), 2016-07-12T00:00:00.000Z
- Rep. Bilirakis, Gus M. [R-FL-12] (R-FL), 2016-07-13T00:00:00.000Z
- Rep. Rush, Bobby L. [D-IL-1] (D-IL), 2016-07-13T00:00:00.000Z
- PETER KING (R-NY), 2016-07-13T00:00:00.000Z
- Rep. Bishop, Mike [R-MI-8] (R-MI), 2016-07-14T00:00:00.000Z
- STEVE ISRAEL (D-NY), 2016-09-06T00:00:00.000Z
- Rep. Cárdenas, Tony [D-CA-29] (D-CA), 2016-09-06T00:00:00.000Z
- Rep. Kilmer, Derek [D-WA-6] (D-WA), 2016-09-06T00:00:00.000Z
- Rep. Dold, Robert J. [R-IL-10] (R-IL), 2016-09-20T00:00:00.000Z
- Rep. Kelly, Mike [R-PA-16] (R-PA), 2016-09-20T00:00:00.000Z
- Rep. Peters, Scott H. [D-CA-50] (D-CA), 2016-09-22T00:00:00.000Z
- Rep. Loebsack, David [D-IA-2] (D-IA), 2016-09-27T00:00:00.000Z
- Rep. Paulsen, Erik [R-MN-3] (R-MN), 2016-09-28T00:00:00.000Z
- Rep. Price, David E. [D-NC-4] (D-NC), 2016-09-28T00:00:00.000Z

## Related bills

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- 114-hr-5292: Air Traffic Controller Hiring Improvement Act of 2016
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- 114-hr-3929: Office of Strategic Services Congressional Gold Medal Act
- 114-hr-1786: James Zadroga 9/11 Health and Compensation Reauthorization Act

## Sources
- [114-hr-5182 on Congress.gov](https://www.congress.gov/bill/114th-congress/house-bill/5182)

## Related
- [114-hr-5621: To posthumously award a Congressional Gold Medal to Lawrence Eugene "Larry" Dob…](https://policyrisk.com/legislation/114-hr-5621)
- [114-hr-5292: Air Traffic Controller Hiring Improvement Act of 2016](https://policyrisk.com/legislation/114-hr-5292)
- [114-hr-3381: Childhood Cancer STAR Act](https://policyrisk.com/legislation/114-hr-3381)
- [114-hr-2903: Craft Beverage Modernization and Tax Reform Act of 2015](https://policyrisk.com/legislation/114-hr-2903)
- [114-hr-3929: Office of Strategic Services Congressional Gold Medal Act](https://policyrisk.com/legislation/114-hr-3929)
- [114-hr-1786: James Zadroga 9/11 Health and Compensation Reauthorization Act](https://policyrisk.com/legislation/114-hr-1786)
- [All bills in Congress](https://policyrisk.com/legislation)

Source: PRIA, https://policyrisk.com/legislation/114-hr-5182 (as of 2025-11-18).