FDA creates antibiotic development task force
SILVER SPRING, Md. — The Food and Drug Administration is creating a new task force to support the development of new drugs for bacterial infections, the agency said Monday.
The FDA said the Antibacterial Drug Development Task Force would assist in developing and revising guidance related to development of antibiotics, as required by the Generating Antibiotic Incentives Now Title of the FDA Safety and Innovation Act, which president Barack Obama signed into law on July 9.
"The creation of this new task force comes at a critical time," FDA Office of Antimicrobial Products director Edward Cox said. "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 agency, research and development for new antibacterial drugs has been in decline in recent decades, as has the number of new antibiotics approved by the FDA, which has been falling since the 1980s. At the same time, overuse of antibiotics has reduced their effectiveness and resulted in antibiotic-resistant bacteria.
More than 70% of the bacteria that cause hospital-associated infections are resistant to at least one type of commonly used antibiotic. Nearly 2 million people in the United States developed such infections in 2002, and 99,000 died.
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