The Food and Drug Administration (FDA) has issued a regulation establishing a list of “qualifying pathogens” under the Generating Antibiotics Incentives Now (GAIN) act. Gain, which came into force back in 2012 as part of the Food and Drug Administration Safety and Innovation Act (FDASIA), provides strong incentives to encourage development of new antibacterial and antifungal drugs for treating serious or life-threatening infections. Under GAIN, new qualifying drugs would be awarded an additional five years of exclusivity, priority review, and eligibility for fast track designation. Based on analyses conducted both in the proposed rule and in response to comments, the FDA has now added additional “qualifying pathogens” to the list of pathogens proposed back in 2013. New drugs intended to treat serious or life-threatening infections caused by one of these listed pathogens may be eligible for the GAIN incentives. The new rule takes effect on July 7, 2014. Senator Richard Blumenthal, who has been a strong proponent of Connecticut’s biotechnology industry was originally responsible for introducing the legislation that resulted in the addition of GAIN to FDASIA.

For a list of the currently qualifying pathogens and to read the full test of the FDA rule, see the following link to the Federal Register, June 5, 2014.

https://www.federalregister.gov/articles/2014/06/05/2014-13023/establishing-a-list-of-qualifying-pathogens-under-the-food-and-drug-administration-safety-and

by Anthony D. Sabatelli, PhD, JD
Partner, Dilworth IP

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This article is for informational purposes, is not intended to constitute legal advice, and may be considered advertising under applicable state laws. The opinions expressed in this article are those of the author only.