Clostridium difficile poses a serious public health threat and potential treatments should be fast-tracked, the Food and Drug Administration stated in a newly proposed regulation.
The proposed rule would enact the Generating Antibiotic Incentives Now (GAIN) provision of the Food and Drug Administration Safety and Innovation Act of 2012. The provision provides for fast-tracked review of antibiotic and antifungal drugs that would treat especially dangerous pathogens. GAIN would also extend the market exclusivity of these drugs by five years.
The FDA has identified 18 qualifying pathogens for GAIN inclusion, including C. diff. The “high prevalence of C. difficile infections,” the emergence of fatal, antibiotic-resistant strains, and “very limited treatment options” justify the inclusion of C. diff. as a qualifying pathogen, the FDA stated in Tuesday’s Federal Register.
The move to prioritize C. diff treatments comes on the heels of an FDA decision to tighten regulations around fecal transplants. These have proven effective in treating C. diff by repopulating the gut with needed bacteria that are destroyed by antibiotics. Some eldercare professionals have criticized the FDA, saying more stringent transplant oversight is burdensome and unnecessary, and further limits treatment options.
Other pathogens on the GAIN list include streptococcus pneumoniae and Enterobacteriaceae. S. pneumoniae leads to outbreaks of pneumococcal disease in nursing homes. Carbapenem-resistant Enterobacteriaceae is an especially deadly, drug-resistant “super bug” that has increasingly struck long-term care facilities.
Click here to access the complete Federal Register entry. Comments will be accepted through Aug. 12.
