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27-09-2012 | Article

FDA forms task force to battle super-bad bugs

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medwireNews: The Food and Drug Administration (FDA) is doing its bit to fight back against the growing threat of multidrug-resistant bacteria.

The agency has formed an Antibacterial Drug Development Task Force to help expedite the development of new antibacterial drugs, as specified by the Generating Antibiotic Incentives Now (GAIN) Title of the FDA Safety and Innovation Act (FDASIA), which was signed into law in July 2012 by President Obama.

"The creation of this new task force comes at a critical time," said Edward Cox, 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 FDA reports that more than 70% of bacteria responsible for hospital-associated infections (HAIs) are resistant to one or more categories of antibacterial agents. In 2002, HAIs were responsible for approximately 99,000 deaths in the USA alone, an FDA statement says.

The task force is composed of 19 clinicians and scientists in CDER's offices of antimicrobial and anti-infective products, medical policy, biometrics, biostatistics, and clinical pharmacology. The members will work with colleagues in academia, the pharmaceutical industry, professional societies and other government agencies, and with patient advocacy groups to identify areas of greatest need for new antibacterial agents.

Task force members are charged with expediting drug development through a variety of approaches, including the use of new techniques for assessing clinical pharmacology data, identification of alternative clinical endpoints, new trial designs, and incorporation of existing data.

The task force will also explore why antibacterial drug development appears to take a back seat in efforts to find the next blockbuster drug, or develop "me-too" agents that copy the mechanism of existing drugs, and will zero in on areas where the need for novel agents is particularly acute.

In addition to the clinical challenges, task force members will tackle more wonkish questions, such as whether FDA guidances can be streamlined to improve the approval process, and whether collaborations with outside experts can help to identify new drug study signs and analytical methods.

By Neil Osterweil, medwireNews reporter