The U.S. Food and Drug Administration is creating an internal task force to help it develop and revise guidance on antibacterial drug development and address the growing crisis of antibiotic resistance.
The Antibacterial Drug Development Task Force is a multi-disciplinary group of 19 FDA scientists and clinicians, who will use existing partnerships and collaborations to develop and implement solutions to high priority challenges of antibacterial drug development.
“The creation of this new task force comes at a critical time,” says Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research 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.”
“By establishing this task force, FDA can help make real progress and change the paradigm,” says Rachel Sherman, associate director for Medical Policy in the FDA’s Center for Drug Evaluation and Research, director of that center’s Office of Medical Policy and co-chair of the task force. “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.”
The FDA initiative follows a recently formed public-private partnership in the European Union that is also aimed at combating antimicrobial resistance and speeding up research for new antibiotics. Five European pharmaceutical companies have teamed up with academics as part of the $285 million Innovative Medicines Initiative, which will take a collaborative approach to address the rising global threat from antibiotic resistance and address some of the key barriers to the development of effective antibiotics.