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Promoting Life-Saving New Therapies for Neonates Act of 2016
Legislative Progress
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
37pct
3d open
vs 6,526 other HR bills in the 114th — cohort avg 56d
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.
These links require the bill number to appear in the filing's source-reported specific issue text. Client expenses and lobbying-firm income are separate disclosure fields.
Filing registrants (7)
2016 · fourth_quarter · Medical/Disease Research/Clinical Labs
Referred to the Subcommittee on Health.
Referred to the House Committee on Energy and Commerce.
Introduced in House
Congress.gov source codes: 1000, Intro-H
Bills with similar content found using semantic analysis.
Sources: Congress.gov
Health care policy. Medical innovation. 21st Century Cures. Cancer treatments. HR 5182/S. 2041, Promoting Life-Saving New Therapies for Neonates Act
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Health Issues
Issues related to Biosimilar Approvals and implementation of biologic price competition and innovation act. H.R. 5182, the Promoting Life-Saving New Therapies for Neonates Act of 2016
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Health Issues
H.R.5182 & S. 2041 - Promoting Life-Saving New Therapies for Neonates Act of 2016
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
S.2041/HR 5182 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information
Client expense: $890,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
2016 · fourth_quarter · Health Issues
Implementation issues related to the Patient Protection and Affordable Care Act (P.L.111-148). S.2041, Promoting Life-Saving New Therapies for Neonates Act of 2015/H.R.5182, Promoting Life-Saving New Therapies for Neonates Act of 2016; neonatal drug issues.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Health Issues
H.R. 34, 21st Century Cures Act; Innovation for Healthier Americans (Senate HELP Committee); Drug safety and drug counterfeiting; Drug importation; Authorized generics; Drug company patent settlements; Prescription drug advertising; Federal preemption for prescription drugs; S. 2041 and H.R. 5182; The Promoting Life Saving New Therapies for Neonates Act of 2015; Implementation of Precision Medicine Initiative; Senate Finance Committee Chronic Care Initiative; White House Cancer Moonshot; H.R. 5858 and S. 3239, RACE for Children Act.
Client expense: Not reported · Firm income: $50,000
2016 · third_quarter · Medical/Disease Research/Clinical Labs
Health care policy. Medical innovation. 21st Century Cures. Cancer treatments. HR 5182/S. 2041, Promoting Life-Saving New Therapies for Neonates Act
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Health Issues
Issues related to Biosimilar Approvals and implementation of biologic price competition and innovation act. H.R. 5182, the Promoting Life-Saving New Therapies for Neonates Act of 2016
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
S.2041/HR 5182 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA Truthful, Non-Misleading Drug Information
Client expense: $1,460,000 · Firm income: Not reported
2016 · third_quarter · Health Issues
H.R.5182 & S. 2041 - Promoting Life-Saving New Therapies for Neonates Act of 2016
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Health Issues
Implementation issues related to the Patient Protection and Affordable Care Act (P.L.111-148). S.2041, Promoting Life-Saving New Therapies for Neonates Act of 2015/H.R.5182, Promoting Life-Saving New Therapies for Neonates Act of 2016; neonatal drug issues.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Health Issues
21st Century Cures legislation; Innovation for Healthier Americans (Senate HELP Committee); Drug safety and drug counterfeiting; Drug importation; Authorized generics; Drug company patent settlements; Prescription drug advertising; Federal preemption for prescription drugs; S. 2041 and H.R. 5182; The Promoting Life Saving New Therapies for Neonates Act of 2015; Implementation of Precision Medicine Initiative; Senate Finance Committee Chronic Care Initiative; White House Cancer Moonshot; H.R. 5858 and S. 3239, RACE for Children Act and H.R. 5182.
Client expense: Not reported · Firm income: $50,000
2016 · second_quarter · Health Issues
Issues related to Biosimilar Approvals and implementation of biologic price competition and innovation act. H.R. 5182, the Promoting Life-Saving New Therapies for Neonates Act of 2016
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Medical/Disease Research/Clinical Labs
Health care and orphan drug policy. Medical innovation. 21st Century Cures. Cancer treatments. HR 5182/S. 2041, Promoting Life-Saving New Therapies for Neonates Act
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
S.2041/HR 5182 - Promoting Life-Saving New Therapies for Neonates Act of 2015 S.481 - Improving Regulatory Transparency for New Medical Therapies Act H.R.2841 - Fair Access for Safe and Timely Generics Act of 2015 H.R.6 - 21st Century Cures Act Cell & Gene Therapy Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products HR351/S351 - Medicine Decisions Act of 2011 (IPAB) 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program MDUFA (Medical Device User Fee Act) Implementation Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars PDUFA Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs 2015 Omnibus Appropriations bill Part B Demo Regrow Act IPAB Generic Drug Labeling H.R.4784 Lower Drug Costs through Competition Act S.2615 Increasing Competition in Pharmaceuticals Act Outcomes-based Contracting Expanded Access PREA/BPCA BSUFA GDUFA
Client expense: $1,200,000 · Firm income: Not reported
2016 · second_quarter · Health Issues
Implementation of health care reform generally pertaining to pediactric health care and autism services Medicaid program reforms, including hospital outpatient department regulations H.R. 546 and S. 298 (ACE Kids Act of 2015), all provisions Section 340B Drug Pricing Program H.R. 6 (21st Century Cures Act),entire bill and Senate companion FDA reform legislation generally H.R. 5273 (Helping Hospitals Improve Patient Care Act of 2016), Section 201, regarding hospital outpatient departments H.R. 1807 (Sickle Cell Disease Research, Surveillance, Prevention and Treatment Act of 2015), entire bill S. 2614 (Kevin and Avonte's Law of 2016), entire bill H.R. 4725 (Common Sense Savings Act of 2016), section 4, regarding provider taxes Pediatric oncology research and the Pediatric Research Equity Act of 2003 (PREA) Organ Procurement and Transplantation Network (OPTN), liver redistricting proposal S.2041/H.R.5182 (Promoting Life-Saving New Therapies for Neonates Act of 2015), all provisions
Client expense: $122,042 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Health Issues
H.R.5182 & S. 2041 - Promoting Life-Saving New Therapies for Neonates Act of 2016
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Health Issues
Implementation issues related to the Patient Protection and Affordable Care Act (P.L.111-148). S.2041, Promoting Life-Saving New Therapies for Neonates Act of 2015/H.R.5182, Promoting Life-Saving New Therapies for Neonates Act of 2016; neonatal drug issues.
Client expense: Not reported · Firm income: $90,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
| Democratic |
| NM |
| Bill Pascrell, Jr. | Democratic | NJ |
| Bobby L. Rush | Democratic | IL |
| Brad Ashford | Democratic | NE |
| Brett Guthrie | Republican | KY |
| Bruce Poliquin | Republican | ME |
| David E. Price | Democratic | NC |
| David Loebsack | Democratic | IA |
| Derek Kilmer | Democratic | WA |
| Donald Norcross | Democratic | NJ |
| Erik Paulsen | Republican | MN |
| Evan H. Jenkins | Republican | WV |
| Gerald E. Connolly | Democratic | VA |
| Grace F. Napolitano | Democratic | CA |
| Gus M. Bilirakis | Republican | FL |
| Kathleen M. Rice | Democratic | NY |
| Leonard Lance | Republican | NJ |
| Marc A. Veasey | Democratic | TX |
| Mike Bishop | Republican | MI |
| Mike Kelly | Republican | PA |
| Patrick Murphy | Democratic | FL |
| Pete Aguilar | Democratic | CA |
| Peter T. King | Republican | NY |
| Robert J. Dold | Republican | IL |
| Ruben Gallego | Democratic | AZ |
| Scott H. Peters | Democratic | CA |
| Sean P. Duffy | Republican | WI |
| Seth Moulton | Democratic | MA |
| Steve Israel | Democratic | NY |
| Tony Cárdenas | Democratic | CA |
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office