The FDA has formed a new internal task force to help jumpstart the development of new antibiotics, as required by the Generating Antibiotic Incentives Now (GAIN) Act, which was signed into law in July 2012.
Research and development for new antibiotics has lagged, and the number of newly approved medications has dropped consistently since the 1980s. At the same time, overuse of existing antibiotics has led to antibiotic resistance, reducing the drugs’ effectiveness. The agency’s new Antibacterial Drug Development Task Force aims to:
Explore the latest scientific approaches to developing new antibiotics
Identify obstacles to the development of new antibiotics
Determine whether FDA guidance on developing new antibiotics should be updated
Work with leaders in the field to explore ways of fostering development of new antibiotics
The task force’s activities may lead to revised guidelines for how clinical trials of new antibiotics are conducted and updated standards for approving new antibiotics. As an added incentive to drug manufacturers, the GAIN Act offers an extra 5 years of patent protection to antibiotics that treat serious or life-threatening diseases.