There has been a desperate need for new antibiotics to treat infections caused by multidrug-resistant gram-negative bacilli (GNB) bacteria. In 2010, the Infectious Diseases Society of America (IDSA) launched its 10 x ’20 Initiative, which established a goal to develop 10 new systemic drugs to treat infections caused by resistant GNB bacteria by 2020. Unfortunately, there are still many barriers to the approval of these needed additional antibiotics, and it’s highly unlikely that these new drugs will be
developed by 2020.
Accelerated Efforts on Antibiotic Development Needed
According to recent data, only seven new drugs are currently in development for the treatment of infections caused by GNB bacteria. Since the IDSA’s 10 x ’20 Initiative, only one new systemic antibiotic has been approved. There is also no guarantee that the drugs currently in development will actually gain FDA approval or will work against the most resistant bugs. While some progress has been made, ground is still being lost because new drugs aren’t being developed quickly enough to keep pace with antibiotic resistance.
At this time of greatest need, the number of pharmaceutical companies investing in antibiotic research and development (R&D) has decreased substantially. Only four multinational pharmaceutical companies have engaged in antibacterial discovery. R&D resources are typically strongest for developing drugs for chronic disease like high cholesterol, diabetes, and cancer. These drugs can provide significant financial rewards, partly because they’re intended for use for long periods of time. Antibiotics are a different story because they’re intended to be taken for shorter courses. This has made it less appealing for the pharmaceutical industry to use R&D resources for such medications.
Encouraging Antibiotic Research & Development
The IDSA encourages that several actions be taken to address the anemic antibiotic pipeline and the increase in multidrug-resistant pathogens. A multi-pronged approach is needed to encourage antibiotic R&D. For small and large pharmaceutical companies, fair and appropriate economic incentives and reimbursement (eg, R&D tax credits, grants, and contracts) are needed; increased research funding is paramount. In order to make any real progress, global leaders must collaborate to develop creative incentives that will stimulate new antibacterial R&D. Efforts are needed to create a sustainable global antibacterial drug R&D enterprise with the power in the short term to develop new, safe, and efficacious antibiotics. The FDA’s requirements for antibiotic approval also need better clarification.
In the meantime, it’s critical to preserve antibiotics and focus efforts on infection prevention, especially antimicrobial stewardship. The hope is that such efforts will foster better data collection, improve surveillance of drug resistance, and ensure appropriate use of antibiotics. With time, it may be possible to overcome the dwindling roster of antibiotic developers and perhaps avoid the dire consequences for public health and patient care.
Readings & Resources (click to view)
Boucher HW, Talbot GH, Benjamin DK, et al; for the Infectious Diseases Society of America. 10 × ’20 progress—development of new drugs active against gram-negative bacilli: an update from the Infectious Diseases Society of America. Clin Infect Dis. 2013 Apr 18 [Epub ahead of print].
Society for Healthcare Epidemiology of America, Infectious Diseases Society of America, Pediatric Infectious Diseases Society. Policy statement on antimicrobial stewardship by the Society for Healthcare Epidemiology of America (SHEA), the Infectious Diseases Society of America (IDSA), and the Pediatric Infectious Diseases Society (PIDS). Infect Control Hosp Epidemiol. 2012; 33:322-327.
Page MG, Heim J. New molecules from old classes: revisiting the development of beta-lactams. IDrugs. 2009;12:561-565.
Infectious Diseases Society of America. The 10 × ’20 initiative: pursuing a global commitment to develop 10 new antibacterial drugs by 2020. Clin Infect Dis. 2010;50:1081-1083.