Repairing the broken market for antibiotic innovation

• Published in: Health Affairs Vol. 34; no. 2; pp. 277 - 285
• Main Authors: Outterson, Kevin, Powers, John H, Daniel, Gregory W, McClellan, Mark B
• Format: Journal Article
• Language: English
• Published: United States The People to People Health Foundation, Inc., Project HOPE 01.02.2015
• Subjects: Anti-Bacterial Agents - adverse effects; Anti-Bacterial Agents - economics; Anti-Bacterial Agents - standards; Antibiotics; Bacterial diseases; Bacterial Infections - drug therapy; Bacterial Infections - economics; Biomedical Research - economics; Biomedical Research - standards; Biomedical Research - trends; Clinical Trials as Topic - economics; Clinical Trials as Topic - standards; Competition; Cost; Diseases; Drug Approval - economics; Drug Approval - legislation & jurisprudence; Drug Costs - trends; Drug Industry - economics; Drug Industry - standards; Drug Industry - trends; Drug resistance; Drug Resistance, Multiple, Bacterial - drug effects; Drugs; Financing, Government - standards; Financing, Government - trends; Health policy; Humans; Innovations; International Cooperation; Investments; Markets; Multidrug resistant organisms; Organizational Innovation - economics; Orphan Drug Production - economics; Orphan Drug Production - legislation & jurisprudence; Payment; Pharmaceutical industry; Prescription drugs; Prescription Fees - trends; Private sector; Product development; Product Surveillance, Postmarketing - economics; Product Surveillance, Postmarketing - standards; Product Surveillance, Postmarketing - trends; Public health; Public Health - economics; Public Health - standards; Public Health - trends; Public-Private Sector Partnerships - economics; Public-Private Sector Partnerships - trends; R&D; Regulatory reform; Reimbursement, Incentive - economics; Reimbursement, Incentive - legislation & jurisprudence; Reimbursement, Incentive - trends; Research & development; Research and development; Return on investment; Sales; Studies; Surveillance; Threats; Treaties; United States; United States Food and drug administration; United States > US; A, Atlantic; Biotechnology; Business Of Health; Legal/Regulatory Issues; International/global health studies; Pharmaceuticals
• ISSN: 0278-2715; 1544-5208
• DOI: 10.1377/hlthaff.2014.1003

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.