The U.S. Food and Drug Administration is ramping up its efforts to support the development of new antibacterial drugs through the formation of an internal task force.
Officials announced Monday the agency is creating the task force to study why there is not an efficient pipeline of antibacterial drugs in development and examine what regulations are hampering progress.
“The creation of this new task force comes at a critical time,” said Dr. Edward Cox, director of the Office of Antimicrobial Products at the Center for Drug Evaluation and Research, who will serve as 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,” he said in a press release.
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 provision in the Safety and Innovation Act, passed by Congress and signed into law earlier this year.
Research and development for new antibacterial drugs has been in decline in recent decades, and the number of new medicines 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, has become a serious issue of global concern, Cox said.
More than 70 percent of the bacteria that cause hospital-associated infections 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 these infections in 2002, resulting in about 99,000 deaths.
The task force is a multi-disciplinary 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 develop and implement possible solutions to the challenges of antibacterial drug development.
The task force plans to explore novel scientific approaches to facilitate antibacterial drug development, such as the broader use of pharmacology data, innovative clinical trial designs, and the advancement of alternative measures to evaluate the effectiveness of potential new therapies.
Officials will also work to identify issues related to unmet medical needs, the lack of a robust pipeline for antibacterial drug development, and new approaches for weighing the risks, benefits and uncertainties of potential new medicines.
The group will also evaluate existing regulations related to antibacterial drug development, determine if revision or elaboration is needed, and identify areas where future guidance would be helpful.
“By establishing this task force, the FDA can help make real progress and change the paradigm,” said Dr. Rachel Sherman, associate director for Medical Policy at the Center for Drug Evaluation and Research, who will also co-chair the task force.
“Our hope is that this effort will result in important new breakthroughs in the field of antibacterial drug development,” she said, “and help in the fight against antibiotic resistance.”