title: A comprehensive regulatory framework to address the unmet need for new antibacterial treatments.
abstract: To bring new antibacterial drugs to the market is challenging because discovery of new agents is difficult, two large trials per indication are needed in accordance with traditional regulatory requirements, and the economic reward is limited if the use of new antibiotics is constrained. These challenges have resulted in an alarmingly thin antibiotic pipeline, despite the rapid and continued growth in the need for new drugs. Approaches that balance the quantity of data needed for registration with the unmet medical need would encourage work in this area. Therefore, a tiered regulatory framework that allows either disease-based or pathogen-based label indications is proposed, with label wording that promotes the most appropriate use of new agents. Such a framework is within the bounds of present regulatory approaches, is amenable to international harmonisation, and would be a welcome step towards the facilitation of a robust and sustainable discovery and development infrastructure.
authors: University of Texas Medical School at Houston, Houston, TX, USA. john.rex@astrazeneca.com
authors: John H
authors: JH
authors: Rex
authors: Barry I
authors: BI
authors: Eisenstein
authors: Jeff
authors: J
authors: Alder
authors: Mark
authors: M
authors: Goldberger
authors: Robert
authors: R
authors: Meyer
authors: Aaron
authors: A
authors: Dane
authors: Ian
authors: I
authors: Friedland
authors: Charles
authors: C
authors: Knirsch
authors: Wendy R
authors: WR
authors: Sanhai
authors: John
authors: J
authors: Tomayko
authors: Cindy
authors: C
authors: Lancaster
authors: Jennifer
authors: J
authors: Jackson
mesh_terms: D000900:Anti-Bacterial Agents / Q000494:pharmacology; D002986:Clinical Trials as Topic; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004341:Drug Evaluation; D024881:Drug Resistance, Bacterial; D006801:Humans; D020380:Needs Assessment; D014481:United States
chemical_list: D000900:Anti-Bacterial Agents