Regulatory Incentives for Antibiotic Drug Development: A Review of Recent Proposals

Bioorg Med Chem. 2016 Dec 15;24(24):6446-6451. doi: 10.1016/j.bmc.2016.08.033. Epub 2016 Aug 22.


Two primary regulatory mechanisms have been proposed to incentivize new antibiotic development: (1) changing Food and Drug Administration (FDA) approval processes to expedite antibiotic approval; and (2) offering enhanced possibilities for market exclusivity. Changes to the FDA regulatory approval process include greater reliance on surrogate endpoints such as biomarkers, use of noninferiority hypothesis designs for key preapproval clinical trials, and development of an expedited development track specific for antibiotics called the Limited Population pathway. The second strategy intended to encourage new antibiotic development has been to provide additional market exclusivity incentives based on regulatory approval. While these pathways have some positive attributes, they also present enhanced risks to patients associated with lower regulatory barriers and the market exclusivity incentives may not efficiently direct resources to the true origins of antibiotic innovation.

Keywords: Antibiotics; FDA; Market exclusivity.

Publication types

  • Review
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Animals
  • Anti-Bacterial Agents / chemical synthesis*
  • Anti-Bacterial Agents / chemistry
  • Drug Approval
  • Drug Discovery*
  • Humans
  • United States
  • United States Food and Drug Administration


  • Anti-Bacterial Agents