12th Annual Meeting DIA Japan 2015

Known as the “Superbugs,” the threat of drug-resistant pathogens to antibacterial drugs is becoming a worldwide issue. However, a wide gap exists between overseas and Japan in coping with new drug development. In the US, the Generating Antibiotic Incentives Now (GAIN) Act was enacted to provide incentives such as exclusivity period for new drugs against drug-resistant pathogens. In 2013, a drafted clinical development guidance was issued for new drugs for serious infectious diseases with unmet medical needs. The plan is now being prepared to promote new antibacterial drugs. In Japan, no plan exists to promote development of antibacterial drugs. For clinical evaluation, a Guideline for the Clinical Evaluation of Antibacterial Drugs (draft) for common infectious disease was issued in 2010. However, no guidance has been issued for drug-resistant pathogens. Such difference in commitment to antibacterial drugs development against drug-resistant pathogens in and outside Japan may lead to future drug lag in antibacterial drugs for drug-resistant pathogens. To contribute to improved public health in Japan, we will discuss the desirable future development of antibacterial drugs surrounding drugresistant pathogens.