United States 115th Congress Status: In Committee Bipartisan · 23 D · 15 R cosponsors

HR 2641 — Promoting Life-Saving New Therapies for Neonates Act of 2017

Last action — Referred to the Subcommittee on Health.

  1. ✓
    Introduced
  2. 2
    In Committee
  3. 3
    Passed House
  4. 4
    Passed Senate
  5. 5
    To Executive
  6. 6
    Enacted

This bill died with 115th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.

This bill is no longer active — its legislative session has ended, so there are no live odds of enactment. It would have to be reintroduced in the current session to move again.

In plain language

The bill promotes safe drug development specifically for neonates.

This bill aims to encourage the creation of safe and effective drugs for newborns by offering exclusivity incentives to developers. It establishes a framework for providing vouchers that extend patent protections for qualifying neonatal drugs.

What this means for you
  • Healthcare: This means healthcare providers may see more options for treating neonatal conditions due to increased drug development.

Summary

Promoting Life-Saving New Therapies for Neonates Act of 2017 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.

Bill Text

Action History

  1. Introduced in House

  2. Introduced in House

  3. Referred to the House Committee on Energy and Commerce.

  4. Referred to the Subcommittee on Health.

Sponsors

Sponsorship breakdown

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1 sponsors · 37 co-sponsors · 509 not signed on

Sponsors (1)

Co-sponsors (37)

Not signed on (509)

509 members have not signed on to this bill.

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"Not signed on" means a member has not sponsored or co-sponsored this bill — it does not imply opposition. Members flagged Voted No have a recorded No vote on this bill.

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Subjects

healthcare health-insurance
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Frequently asked questions

What does HR 2641 do?
Promoting Life-Saving New Therapies for Neonates Act of 2017 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.
Who sponsors HR 2641?
HR 2641 is sponsored by Long, Billy (Republican), Luján, Ben Ray (Democratic), Napolitano, Grace F. (Democratic), Garamendi, John (Democratic), Pascrell, Bill (Democratic), Cárdenas, Tony (Democratic), Kilmer, Derek (Democratic), Moulton, Seth (Democratic), Connolly, Gerald E. (Democratic), Rice, Kathleen M. (Democratic), Peters, Scott H. (Democratic), DeSaulnier, Mark (Democratic), Blunt Rochester, Lisa (Democratic), Guthrie, Brett (Republican), Lance, Leonard (Republican), Poliquin, Bruce (Republican), Jenkins, Lynn (Republican), Aguilar, Pete (Democratic), Tipton, Scott R. (Republican), Mooney, Alexander X. (Republican), Paulsen, Erik (Republican), Kind, Ron (Democratic), Bilirakis, Gus M. (Republican), Smith, Jason (Republican), Moore, Gwen (Democratic), Maloney, Sean Patrick (Democratic), Norcross, Donald (Democratic), Hudson, Richard (Republican), Veasey, Marc A. (Democratic), Frelinghuysen, Rodney P. (Republican), King, Peter T. (Republican), Roskam, Peter J. (Republican), Rush, Bobby L. (Democratic), Price, David E. (Democratic), Marshall, Roger (Republican), Eshoo, Anna G. (Democratic), Plaskett, Stacey E. (Democratic), and Ruiz, Raul (Democratic).
What is the current status of HR 2641?
This bill died with 115th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.
Where can I track HR 2641?
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