Literature DB >> 25646108

Repairing the broken market for antibiotic innovation.

Kevin Outterson1, John H Powers2, Gregory W Daniel3, Mark B McClellan4.   

Abstract

Multidrug-resistant bacterial diseases pose serious and growing threats to human health. While innovation is important to all areas of health research, it is uniquely important in antibiotics. Resistance destroys the fruit of prior research, making it necessary to constantly innovate to avoid falling back into a pre-antibiotic era. But investment is declining in antibiotics, driven by competition from older antibiotics, the cost and uncertainty of the development process, and limited reimbursement incentives. Good public health practices curb inappropriate antibiotic use, making return on investment challenging in payment systems based on sales volume. We assess the impact of recent initiatives to improve antibiotic innovation, reflecting experience with all sixty-seven new molecular entity antibiotics approved by the Food and Drug Administration since 1980. Our analysis incorporates data and insights derived from several multistakeholder initiatives under way involving governments and the private sector on both sides of the Atlantic. We propose three specific reforms that could revitalize innovations that protect public health, while promoting long-term sustainability: increased incentives for antibiotic research and development, surveillance, and stewardship; greater targeting of incentives to high-priority public health needs, including reimbursement that is delinked from volume of drug use; and enhanced global collaboration, including a global treaty. Project HOPE—The People-to-People Health Foundation, Inc.

Entities:  

Keywords:  Biotechnology; Business Of Health; International/global health studies; Legal/Regulatory Issues; Pharmaceuticals

Mesh:

Substances:

Year:  2015        PMID: 25646108     DOI: 10.1377/hlthaff.2014.1003

Source DB:  PubMed          Journal:  Health Aff (Millwood)        ISSN: 0278-2715            Impact factor:   6.301


  23 in total

1.  Developing Outcomes Assessments as Endpoints for Registrational Clinical Trials of Antibacterial Drugs: 2015 Update From the Biomarkers Consortium of the Foundation for the National Institutes of Health.

Authors:  George H Talbot; John H Powers; Steven C Hoffmann
Journal:  Clin Infect Dis       Date:  2015-12-13       Impact factor: 9.079

2.  Design, synthesis, and antimicrobial evaluation of 1,4-dihydroindeno[1,2-c]pyrazole tethered carbohydrazide hybrids: exploring their in silico ADMET, ergosterol inhibition and ROS inducing potential.

Authors:  Mohd Adil Shareef; K Sirisha; Irfan Khan; Ibrahim Bin Sayeed; Surender Singh Jadav; Gopathi Ramu; C Ganesh Kumar; Ahmed Kamal; Bathini Nagendra Babu
Journal:  Medchemcomm       Date:  2019-04-26       Impact factor: 3.597

3.  Leveraging Marine Natural Products as a Platform to Tackle Bacterial Resistance and Persistence.

Authors:  M Alejandro Valdes-Pena; Nicholas P Massaro; You-Chen Lin; Joshua G Pierce
Journal:  Acc Chem Res       Date:  2021-03-18       Impact factor: 22.384

4.  An international legal framework to address antimicrobial resistance.

Authors:  Steven J Hoffman; Kevin Outterson; John-Arne Røttingen; Otto Cars; Charles Clift; Zain Rizvi; Fiona Rotberg; Göran Tomson; Anna Zorzet
Journal:  Bull World Health Organ       Date:  2015-02-01       Impact factor: 9.408

Review 5.  A systematic review and critical assessment of incentive strategies for discovery and development of novel antibiotics.

Authors:  Matthew J Renwick; David M Brogan; Elias Mossialos
Journal:  J Antibiot (Tokyo)       Date:  2015-10-14       Impact factor: 2.649

Review 6.  Incentivising innovation in antibiotic drug discovery and development: progress, challenges and next steps.

Authors:  Victoria L Simpkin; Matthew J Renwick; Ruth Kelly; Elias Mossialos
Journal:  J Antibiot (Tokyo)       Date:  2017-11-01       Impact factor: 2.649

7.  Development Time and Patent Extension for Prescription Drugs in Canada: A Cohort Study.

Authors:  Joel Lexchin
Journal:  Int J Health Policy Manag       Date:  2021-08-01

8.  The Ethical Significance of Antimicrobial Resistance.

Authors:  Jasper Littmann; A M Viens
Journal:  Public Health Ethics       Date:  2015-09-30       Impact factor: 1.940

9.  Insights into early stage of antibiotic development in small- and medium-sized enterprises: a survey of targets, costs, and durations.

Authors:  Christine Årdal; Enrico Baraldi; Ursula Theuretzbacher; Kevin Outterson; Jens Plahte; Francesco Ciabuschi; John-Arne Røttingen
Journal:  J Pharm Policy Pract       Date:  2018-04-05

10.  Feasibility of de-linking reimbursement of antimicrobials from sales: the Australian perspective as a qualitative case study.

Authors:  Nadine T Hillock; Tracy L Merlin; Jonathan Karnon; John Turnidge; Jaklin Eliott
Journal:  JAC Antimicrob Resist       Date:  2020-05-10
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