Medical societies such as the Infectious Diseases Society of America, governmental regulatory agencies such as FDA and EMA, and politicians agree that the normal process for new drug approval is too lengthy and costly to meet the urgent need for new agents to treat serious infections caused by multi-drug resistant pathogens. However, while EMA has released clear guidance that provides a development pathway for a pathogen-focused indication, FDA appears constrained by its existing rules.
FDA has made some progress in re-evaluating the clinical requirements for approval of new antibacterial agents, but it has not yet clarified the pathway for pathogen-focused development programs.
During a meeting on Dec. 4-5, 2014, FDA's Anti-Infective Drugs Advisory Committee discussed issues related to clinical development programs and trial designs for antibacterial products to treat patients with serious bacterial infections for which there are limited or no therapeutic options. Edward Cox, director of FDA's Office of Antimicrobial Products, said, "We're talking about more streamlined programs, so there will be greater uncertainty around safety and efficacy. But if