FDA task force to work on antibacterial drug development

FDAis supporting antibacterial drug development by launching a new internal task force.

"The creation of this new task force comes at a critical time," said Edward Cox, MD, MPH, 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 will identify priority areas and potential solutions to the challenges of antibacterial drug development, according to the release. There are 19 CDER scientists and clinicians on the task force.

“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," according to the statement. "In the United States, nearly 2 million Americans developed HAIs in 2002, resulting in about 99,000 deaths."

The task force will help develop and revise guidance related to antibacterial drug development, as required by the Generating Antibiotic Incentives Now (GAIN) Title of the FDA Safety and Innovation Act (FDASIA), which was signed into law July 9.

"By establishing this task force, FDA can help make real progress and change the paradigm," said Rachel Sherman, MD, associate director for Medical Policy in CDER, director of CDER's Office of Medical Policy, and co-chair of the task force in the release. "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."

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