Home Health & Hospice

FDA makes new proposal related to C. diff and other threatening pathogens

Homecare Insider, June 17, 2013

The Food and Drug Administration (FDA) is proposing a regulation to establish a list of “qualifying pathogens” that have the potential to pose a serious threat to public health. One of these pathogens is Clostridium difficile or C.diff, which poses a serious threat in homecare.  

The proposed rule would implement a provision of the Generating Antibiotic Incentives Now (GAIN) title of the Food and Drug Administration Safety and Innovation Act (FDASIA). GAIN is intended to encourage development of new antibacterial and antifungal drugs for the treatment of serious or life-threatening infections, and provides incentives such as eligibility for designation as a fast-track product and an additional five years of exclusivity to be added to certain exclusivity periods.

 FDA is proposing that the following pathogens comprise the list of “qualifying pathogens:”

  • Acinetobacter species
  • Aspergillus species
  • Burkholderia cepacia complex
  • Campylobacter species
  • Candida species
  • Clostridium difficile
  • Enterobacteriaceae (e.g., Klebsiella pneumoniae)
  • Enterococcus species
  • Mycobacterium tuberculosis complex
  • Neisseria gonorrhoeae
  • N. meningitides
  • Non-tuberculous mycobacteria species
  • Pseudomonas species
  • Staphylococcus aureus
  • Streptococcus agalactiae
  • S. pneumonia
  • S. pyogenes
  • Vibrio cholerae

To read the proposed rule in full, click here.