Tuesday, 8 July 2014

Aspergillus On List of Qualifying Pathogens

Continuing on our recent theme of finding ways to encourage the delivery of new antibiotic and antifungal drugs, in the US the government is taking action by offering a series of incentives to manufacturers including an extra five years of exclusivity during which the original manufacturer is the ONLY permitted source of the new medication. Hopefully this will encourage new products as the potential for profit is consequently increased.

Happily and importantly for those living with fungal infections such as aspergillosis the causal organism of aspergillosis Aspergillus has been added to this US government list of qualifying pathogens.


The Food and Drug Administration (FDA or Agency) is issuing a regulation to establish a list of ‘‘qualifying pathogens’’ that have the potential to pose a serious threat to public health. This final rule implements 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 5 years of exclusivity to be added to certain exclusivity periods. 
Based on analyses conducted both in the proposed rule and in response to comments to the proposed rule, FDA has determined that the following pathogens comprise the list of ‘‘qualifying pathogens:’’ Acinetobacter species, Aspergillus species, Burkholderia cepacia complex, Campylobacter species, Candida species, Clostridium difficile, Coccidioides species, Cryptococcus species, Enterobacteriaceae (e.g., Klebsiella pneumoniae), Enterococcus species, Helicobacter pylori, Mycobacterium tuberculosis complex, Neisseria gonorrhoeae, N. meningitidis, Non-tuberculous mycobacteria species, Pseudomonas species, Staphylococcus aureus, Streptococcus agalactiae, S. pneumoniae, S. pyogenes, and Vibrio cholerae. 
The preamble to the proposed rule described the factors the Agency considered and the methodology used to develop the list of qualifying pathogens. As described in the preamble of this final rule, FDA applied those factors and that methodology to additional pathogens suggested via comments on the proposed rule.
DATES: This rule is effective July 7, 2014.
Original document 

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