The US Food and Drug Administration (FDA) has set up an Antibacterial Drug Development Task Force internally to address what it describes as “a critical public health care goal”.
Part of the Task Force’s remit will be developing and revising guidance related to antibacterial drug development, as mandated by the Generating Antibiotic Incentives Now (GAIN) Title of the Food and Drug Administration Safety and Innovation Act, which was signed into law last July.
The initiative comes at “a critical time”, said Dr Edward Cox, director of the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research (CDER) and co-chair of the task force.
“Establishing new ways of developing safe and effective new antibacterial drugs is an enormous challenge and not an effort that can be accomplished alone,” Cox added.
Partnerships and collaborations
Accordingly, The Task Force is a multidisciplinary group of 19 CDER scientists and clinicians who will use existing partnerships and collaborations to work with other experts in the field – from industry and academia to professional societies, patient advocacy groups and government agencies – to identify priority areas and develop and implement potential drug-development solutions.
As the agency points out, research and development to generate new antibacterial drugs has been in decline over recent decades, with the number of new FDA-approved products in the category falling steadily since the 1980s.
At the same time, the “persistent and sometimes indiscriminate” use of existing antibacterial drugs worldwide has undermined these agents’ effectiveness, the FDA notes. More than 70% of the bacteria that cause hospital-associated infections are resistant to at least one type of antibacterial most commonly used to treat those infections.
The Task Force aims to:
• Explore novel scientific approaches to facilitating antibacterial drug development, such as broader use of clinical pharmacology data, statistical methods and innovative clinical trial designs.
• Tap into additional available data sources and advance alternative measures to evaluating the clinical effectiveness of potential new antibacterial therapies.
• Identify issues related to unmet medical needs for antibacterial drugs, reasons for the lack of a robust development pipeline, and new approaches to weighing the risks, benefits and uncertainties of potential new antibacterial therapies.
• Evaluate existing FDA guidance on antibacterial drug development, determine if any revisions or elaborations are needed, and identify areas in which future guidance would be helpful.