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Task Force for Antibacterial Drug Development

Task Force for Antibacterial Drug Development

On September 24, 2012, the US Food and Drug Administration officially announced the formation of an internal task force focused on the development of new antibacterial drugs. 

The FDA reports that research and development for new antibacterial drugs has decreased since the 1980s.  Because of the lack of development, the phenomenon called antibacterial drug resistance has become a serious global issue. 

According to the FDA, “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.”

Edward Cox, the director the Office of Antimicrobial Products under the Center for Drug Evaluation and Research, states, “The creation of this new task force comes a critical time.  Establishing new ways of developing safe and effective new antibacterial drugs is an enormous challenge and not an effort that can be accomplished alone.” 

According to the FDA, the new task force plans to do the following:

·   use pharmacology data, statistical methods, new trial designs, and other data resources to develop alternative measures and new therapies

·   find “unmet medical needs” for antibacterial drugs and the development of these drugs

·   finding the risks and benefits of new antibacterial drugs

·   review guidelines by the FDA for antibacterial development and assess if changes need made

·   work within think tanks to explore new approaches to antibacterial development, “including innovative study designs and statistical analytical methods”

The FDA efforts to increase research and funding for antibacterial drugs will still take years.  While collaboration and research comes together, the FDA will also work with other federal agencies to create a national plan in approaching resistance to antibiotics. 

Source: Food and Drug Administration