title: Repairing the broken market for antibiotic innovation.
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.
authors: Kevin Outterson (mko@bu.edu) is a professor at the School of Law, Boston University, in Massachusetts, and an associate fellow at the Royal Institute of International Affairs at Chatham House, in London, England, where he coordinates a working group on new business models for antibiotics. He is also a member of the Centers for Disease Control and Prevention's Antimicrobial Resistance Working Group, in Atlanta, Georgia.
authors: Kevin
authors: K
authors: Outterson
authors: John H. Powers is an associate clinical professor of medicine at the George Washington University School of Medicine, in Washington, D.C.
authors: John H
authors: JH
authors: Powers
authors: Gregory W. Daniel is managing director for evidence development and innovation at the Engelberg Center for Health Care Reform at Brookings, in Washington, D.C.
authors: Gregory W
authors: GW
authors: Daniel
authors: Mark B. McClellan is a senior fellow and director of the Health Care Innovation and Value Initiative at the Engelberg Center for Health Care Reform at Brookings.
authors: Mark B
authors: MB
authors: McClellan
mesh_terms: D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000191:economics* / Q000592:standards; D001424:Bacterial Infections / Q000188:drug therapy / Q000191:economics*; D035843:Biomedical Research / Q000191:economics* / Q000592:standards / Q000639:trends; D002986:Clinical Trials as Topic / Q000191:economics / Q000592:standards; D017277:Drug Approval / Q000191:economics / Q000331:legislation & jurisprudence; D016527:Drug Costs / Q000639:trends; D004345:Drug Industry / Q000191:economics* / Q000592:standards / Q000639:trends; D024901:Drug Resistance, Multiple, Bacterial / Q000187:drug effects*; D005380:Financing, Government / Q000592:standards / Q000639:trends; D006801:Humans; D007391:International Cooperation; D009936:Organizational Innovation / Q000191:economics; D009965:Orphan Drug Production / Q000191:economics / Q000331:legislation & jurisprudence; D011306:Prescription Fees / Q000639:trends; D011358:Product Surveillance, Postmarketing / Q000191:economics / Q000592:standards / Q000639:trends; D011634:Public Health / Q000191:economics* / Q000592:standards / Q000639:trends; D055818:Public-Private Sector Partnerships / Q000191:economics / Q000639:trends; D012052:Reimbursement, Incentive / Q000191:economics / Q000331:legislation & jurisprudence / Q000639:trends; D014481:United States
chemical_list: D000900:Anti-Bacterial Agents
keywords: Biotechnology; Business Of Health; International/global health studies; Legal/Regulatory Issues; Pharmaceuticals