New Regulatory Pathways for Antibacterial Drugs

Abstract

Starting at the turn of the century, we descended from an open and enlightened approach to regulatory approval of antibacterial drugs back to the middle ages, as requirements for clinical trial stringency increased dramatically. In 2006, we descended even further into the dark ages where, at least for the US Food and Drug Administration, it became infeasible to develop new antibacterial drugs for most infections. However, in 2012, the FDA made a remarkable turnaround, and over the last 5 years, a number of new, feasible, and streamlined pathways for the development of these needed drugs have become available. These new pathways include streamlined non-inferiority trial strategies that allow approval for multiple indications with fewer trials. New endpoints for skin and skin-structure infections and for respiratory infections have been defined, mainly by the FDA for US regulatory approval. Some endpoints remain controversial, but trial designs using these endpoints are now at least feasible. One area in which the regulatory agencies and their partners, such as the Infectious Diseases Society of America, are still working diligently to develop new, feasible pathways for development is that of antibacterial drugs targeting a narrow spectrum of bacterial pathogens. Because of great differences in approach, this chapter does not deal with the development of agents specifically targeting Mycobacterium tuberculosis or Neisseria gonorrhoeae.