New FDA task force to support antibacterial drug development
Multi-disciplinary group will identify priority areas and develop solutions
The US Food and Drug Administration (FDA) has created a task force to support the development of new drugs for bacterial infections.
The FDA said the Antibacterial Drug Development Task Force would assist in developing and revising guidance related to antibacterial drug development, as required by the Generating Antibiotic Incentives Now (GAIN) Title of the Food and Drug Administration Safety and Innovation Act (FDASIA), which President Obama signed into law on 9 July.
Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research (CDER) and co-chair of the task force, said: ‘The creation of this new task force comes at a critical time. Establishing new ways of developing safe and effective new antibacterial drugs is an enormous challenge and not an effort that can be accomplished alone.’
The US regulator said research and development for new antibacterial drugs has been in decline in recent decades, and the number of new FDA-approved antibacterial drugs has been falling steadily since the 1980s.
More than 70% of the bacteria that cause hospital-associated infections (HAIs) are resistant to at least one type of antibacterial drug most commonly used to treat these infections. In the US, nearly two million Americans developed HAIs in 2002, resulting in about 99,000 deaths.
The task force is a multi-disciplinary group of 19 CDER scientists and clinicians who will use existing partnerships and collaborations to work with other experts in the field, including from academia, industry, professional societies, patient advocacy groups, and government agencies, to identify priority areas and develop solutions to the challenges of antibacterial drug development.
‘Our hope is that this effort will result in important new breakthroughs in the field of antibacterial drug development and help in the fight against antibiotic resistance,’ said Rachel Sherman, associate director for Medical Policy in CDER, director of CDER’s Office of Medical Policy and co-chair of the task force.