The FDA Is Going After Drug-Resistant Bugs

     WASHINGTON (CN) – The Food and Drug Administration has issued a list of pathogens likely to pose a serious threat to public health, to encourage the development of new drugs to treat them.
     This action 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.
     The FDA’s list includes pathogens that cause: Valley Fever, staph infections, such as MRSA, pneumonia, meningitis, sepsis, tuberculosis, gonorrhea and cholera.
     In creating the list, the FDA, in consultation with experts, considered: The drug-resistant organism’s impact on the public health; the rate of growth of the drug-resistant organisms in humans; the increase in resistance; and how often the disease the organism produces occurs and how often it is fatal.
     This action is effective July 7, 2014.

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