New FDA Task Force Supports Development of Antibacterial Drugs
Number of agency-approved antibacterials has been declining since 1980s (Sept. 24)
The FDA announced on September 24 that it has formed a new internal task force that will support the development of antibacterial drugs — a critical public healthcare 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 FDA 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 agents has been declining steadily since the 1980s, the agency says. 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 U.S., nearly 2 million Americans developed HAIs in 2002, resulting in approximately 99,000 deaths.
The task force consists of a multidisciplinary group of 19 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 to develop and implement possible solutions to the challenges of antibacterial drug development.
For more information, visit the FDA Web site.