Beyond the GAIN Act: Some Thoughts on Expediting Antibacterial Development to Address the Problem of Antimicrobial Resistance

摘要

The GAIN Act, combined with previous US FDA regulations and in the setting of new guidance and related advisory committee recommendations, provides a path forward to expedite development of new anti-infective products that fulfill unmet need related to treatment of antibiotic-resistant organisms. Unresolved issues include the role of superiority versus non-inferiority trials in the approval of new drugs and the nature of the data package that could support the approval of a drug active against resistant organisms. This paper discusses both these issues and suggests paths forward, while acknowledging the concerns that expedited development will lead to greater uncertainty in efficacy and safety.