title: The evolution of the regulatory framework for antibacterial agents.
abstract: The rising tide of antibacterial resistance and the lack of a diverse, vibrant pipeline of novel antibacterial agents is a global crisis that impairs our ability to treat life-threatening infections. The recent introduction of a tiered approach to the regulatory framework in this area offers one path to resolving some of the challenges. By drawing heavily on the predictive power of the related sciences of pharmacokinetics and pharmacodynamics, smaller, focused clinical trial programs have become possible for agents that might not otherwise have been possible to progress. There are limitations to these pathways, and they are not easy to implement, but making reliable noninferiority-based approaches available is critical to reinvigorating the global antibiotic pipeline. With the recognition of these ideas by key regulatory authorities in recent guidance, the next challenges in this area will focus on interpretive breakpoints, the extent of data in the prescribing information, ensuring that multiple agents can be progressed, and the challenge of the antibiotic business model.
authors.affiliation: AstraZeneca Pharmaceuticals, Waltham, Massachusetts; University of Texas Medical School-Houston, Houston, Texas.
authors.forename: John H
authors.initials: JH
authors.lastname: Rex
authors.forename: Mark
authors.initials: M
authors.lastname: Goldberger
authors.forename: Barry I
authors.initials: BI
authors.lastname: Eisenstein
authors.forename: Carrie
authors.initials: C
authors.lastname: Harney
mesh_terms: D000900:Anti-Bacterial Agents / Q000493:pharmacokinetics / Q000494:pharmacology*; D008826:Microbial Sensitivity Tests; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000900:Anti-Bacterial Agents
keywords: antibacterial drug development; antibacterial resistance; regulatory framework