The U.S. Food and Drug Administration today announced the formation of an internal task force that will support the development of new antibacterial drugs, a critical public health care goal and a priority for the agency.
As part of its work, the Antibacterial Drug Development Task Force will 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), signed into law on July 9, 2012.
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. During this time, the persistent and sometimes indiscriminate use of existing antibacterial drugs worldwide has resulted in a decrease in the effectiveness of these drugs. This phenomenon, known as antibacterial drug resistance or antibiotic resistance, has become a serious issue of global concern.
More than 70 percent 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 United States, nearly 2 million Americans developed HAIs in 2002, resulting in about 99,000 deaths.
“The creation of this new task force comes at a critical time,” said Edward Cox, M.D., M.P.H., 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.”
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 and implement possible solutions to the challenges of antibacterial drug development.