Innovation on Antibacterial Drug Development

The FDA announced that is has formed a task force to support the development of new antibacterial drugs, which the agency has deemed a critical public health care goal.  Under the Food and Drug Administration Safety and Innovation Act’s (FDASIA) GAIN title, (Generating Antibiotic Incentives Now), the Antibacterial Drug Development Task Force will assist in developing and revising guidance related to antibacterial drug development.

As we noted in December of 2011, antibacterial drug development has been a worldwide issue being tackled by the Infectious Disease Society of America (IDSA), the European Centre for Disease Prevention and Control (ECDC), the World Health Organization (WHO). The concern is that overuse of antibiotics and the increasing drug resistance of pathogens will lead to ineffective antibiotics and strains of bacteria that cannot be controlled with modern medicine.

Generating novel antibiotics to tackle new strains of bacteria is important for domestic and global health. According to the FDA, the task force plans to:

  • explore novel scientific approaches to facilitate antibacterial drug development, like the broader use of clinical pharmacology data, statistical methods, innovative clinical trial designs, use of additional available data sources, and the advancement of alternative measures to evaluate clinical effectiveness of potential new therapies;
  • identify issues related to unmet medical needs for antibacterial drugs, reasons for the lack of a robust pipeline for antibacterial drug development, and new approaches for weighing the risks, benefits, and uncertainties of potential new antibacterial drugs;
  • evaluate existing FDA guidances related to antibacterial drug development, determine if revision or elaboration is needed, and identify areas where future guidance would be helpful, as set forth in the GAIN Title of FDASIA; and
  • use existing collaborative agreements to work with think tanks and other thought leaders to explore various approaches that could enable antibacterial drug development, including innovative study designs and statistical analytical methods.

The FDA has also been working to reduce the use of antibiotics in food-producing animals, creating the National Antimicrobial Resistance Monitoring System (NARMS) a surveillance program to track antibiotic resistance in foodborne bacteria, and educating the public on the perils of misusing antibiotic medications.