FDA will hold a public hearing on Feb. 4-5 to obtain input on creating a new approval pathway for therapeutics for limited, well-defined subpopulations of patients with serious or life-threatening conditions, including infections caused by antibiotic-resistant bacteria. According to the agency, such a pathway could allow companies to evaluate safety and efficacy in subpopulations of patients with more serious manifestations of a condition. The result, said FDA, could be smaller, more rapid clinical trials than studies in a broader group of patients with a wide range of clinical manifestations. The agency said a narrow indication of therapeutics approved via such a pathway could be expanded based on additional data demonstrating efficacy and safety in a broader population.
FDA is seeking input on the need for and feasibility of such a pathway, as well as its potential advantages and disadvantages. The agency is asking stakeholders to discuss which diseases or conditions would benefit from such an approval pathway, as well as whether the pathway would increase the number of therapeutic options in the context of the agency's existing expedited processes, including accelerated approval and the Fast Track program. FDA also is seeking input on how the agency could monitor use of drugs approved under the pathway. Comments are due March 1.
