[Source: The Lancet Infectious Diseases, full text: (LINK). Abstract, edited.]
The Lancet Infectious Diseases, Early Online Publication, 15 January 2013
A comprehensive regulatory framework to address the unmet need for new antibacterial treatments
Prof John H Rex MD a b, Prof Barry I Eisenstein MD c d, Jeff Alder PhD e, Mark Goldberger MD f, Robert Meyer MD g, Aaron Dane MSc h, Ian Friedland MD d, Charles Knirsch MD i, Wendy R Sanhai PhD j, John Tomayko MD k, Cindy Lancaster JD l, Jennifer Jackson PhD d
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.