Legis Daily

To promote the development of safe drugs for neonates.

USA115th CongressHR-2641| House 
| Updated: 5/26/2017
Billy Long

Billy Long

Republican Representative

Missouri

Cosponsors (37)
Stacey E. Plaskett (Democratic)Donald Norcross (Democratic)John Garamendi (Democratic)Roger Marshall (Republican)Marc A. Veasey (Democratic)Erik Paulsen (Republican)Alexander X. Mooney (Republican)Brett Guthrie (Republican)Peter T. King (Republican)Lisa Blunt Rochester (Democratic)Kathleen M. Rice (Democratic)Raul Ruiz (Democratic)Derek Kilmer (Democratic)Ben Ray Luján (Democratic)Pete Aguilar (Democratic)Bobby L. Rush (Democratic)Lynn Jenkins (Republican)Leonard Lance (Republican)Tony Cárdenas (Democratic)Scott H. Peters (Democratic)Bruce Poliquin (Republican)Jason Smith (Republican)Gus M. Bilirakis (Republican)Sean Patrick Maloney (Democratic)Mark DeSaulnier (Democratic)Peter J. Roskam (Republican)Richard Hudson (Republican)David E. Price (Democratic)Anna G. Eshoo (Democratic)Ron Kind (Democratic)Rodney P. Frelinghuysen (Republican)Seth Moulton (Democratic)Scott R. Tipton (Republican)Gwen Moore (Democratic)Gerald E. Connolly (Democratic)Bill Pascrell (Democratic)Grace F. Napolitano (Democratic)

Health Subcommittee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
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.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline
May 24, 2017
Introduced in House
May 24, 2017
Referred to the House Committee on Energy and Commerce.
May 26, 2017
Referred to the Subcommittee on Health.
  • May 24, 2017
    Introduced in House


  • May 24, 2017
    Referred to the House Committee on Energy and Commerce.


  • May 26, 2017
    Referred to the Subcommittee on Health.

Health

Administrative law and regulatory proceduresChild healthCongressional oversightDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationDrug therapyFood and Drug Administration (FDA)Government studies and investigationsHealth promotion and preventive careMedical research

To promote the development of safe drugs for neonates.

USA115th CongressHR-2641| House 
| Updated: 5/26/2017
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.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline
May 24, 2017
Introduced in House
May 24, 2017
Referred to the House Committee on Energy and Commerce.
May 26, 2017
Referred to the Subcommittee on Health.
  • May 24, 2017
    Introduced in House


  • May 24, 2017
    Referred to the House Committee on Energy and Commerce.


  • May 26, 2017
    Referred to the Subcommittee on Health.
Billy Long

Billy Long

Republican Representative

Missouri

Cosponsors (37)
Stacey E. Plaskett (Democratic)Donald Norcross (Democratic)John Garamendi (Democratic)Roger Marshall (Republican)Marc A. Veasey (Democratic)Erik Paulsen (Republican)Alexander X. Mooney (Republican)Brett Guthrie (Republican)Peter T. King (Republican)Lisa Blunt Rochester (Democratic)Kathleen M. Rice (Democratic)Raul Ruiz (Democratic)Derek Kilmer (Democratic)Ben Ray Luján (Democratic)Pete Aguilar (Democratic)Bobby L. Rush (Democratic)Lynn Jenkins (Republican)Leonard Lance (Republican)Tony Cárdenas (Democratic)Scott H. Peters (Democratic)Bruce Poliquin (Republican)Jason Smith (Republican)Gus M. Bilirakis (Republican)Sean Patrick Maloney (Democratic)Mark DeSaulnier (Democratic)Peter J. Roskam (Republican)Richard Hudson (Republican)David E. Price (Democratic)Anna G. Eshoo (Democratic)Ron Kind (Democratic)Rodney P. Frelinghuysen (Republican)Seth Moulton (Democratic)Scott R. Tipton (Republican)Gwen Moore (Democratic)Gerald E. Connolly (Democratic)Bill Pascrell (Democratic)Grace F. Napolitano (Democratic)

Health Subcommittee, Energy and Commerce Committee

Health

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Administrative law and regulatory proceduresChild healthCongressional oversightDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationDrug therapyFood and Drug Administration (FDA)Government studies and investigationsHealth promotion and preventive careMedical research