FDA issues final Guidance for Industry, transferring regulatory authority to EPA
OXFORD, UK, October, 4, 2017 – Following new Guidance issued by the U.S. Food and Drug Administration’s Center for Veterinary Medicine (FDA-CVM), regulatory jurisdiction for Oxitec’s Friendly™ Aedes mosquito (OX513A) will now move under the Environmental Protection Agency (EPA) as a pesticide product. Oxitec has been in consultation with EPA regarding the regulatory process and, given this clarification of the regulatory jurisdiction, intends to submit an application to EPA for registration of OX513A.
The FDA-CVM’s Final Guidance for Industry clarifies “that mosquito-related products intended to function as pesticides by preventing, destroying, repelling, or mitigating mosquitoes for population control purposes, and that are not intended to cure, mitigate, treat or prevent a disease (including by an intent to reduce the level, replication or transmissibility of a pathogen in mosquitoes), are not “drugs” under the Federal Food, Drug, & Cosmetic Act, and will be regulated by the EPA under the Federal Insecticide, Fungicide, and Rodenticide Act…With the issuance of final guidance #236, Oxitec Ltd’s genetically engineered mosquito, with its proposed claim to control the population of wild-type Aedes aegypti mosquitoes, now falls under EPA’s regulatory authority and all related regulatory questions should be directed to the EPA.”
This final guidance underscores the public health urgency in countering the spread of mosquito-borne diseases and highlights the critical role that innovative mosquito control technologies play in combating the spread of such diseases. This updated framework applies regardless of whether or not such products are developed through genetic engineering. The regulatory framework for mosquito-related products, therefore, aligns with longstanding U.S. policy under the Coordinated Framework for Regulation of Biotechnology, which calls for a risk-based, scientifically sound basis for the oversight of products that focuses on the characteristics and intended use of the product, not the process by which the product is created. This change will result in a clearer regulatory process for innovative mosquito control products
Once EPA has granted a registration for OX513A, Oxitec will work with the relevant State and local authorities to coordinate releases of OX513A.
How Friendly™ Aedes works
Oxitec has been working in Aedes aegypti control for over a decade and pioneered the use of a biological method to suppress wild populations of this dangerous mosquito species through the release of Friendly™ Aedes males, which do not bite and do not transmit diseases. When released, these males search for wild females to mate, and their offspring inherit a self-limiting gene that causes them to die before reaching functional adulthood. Friendly™ Aedes’ offspring also inherit a fluorescent marker that allows tracking and monitoring at a level never before achieved, making the assessment of effectiveness more accurate throughout the whole Friendly™ Aedes deployment program. Unlike other approaches, Friendly™ Aedes mosquitoes die along with their along with their offspring, and therefore do not persist in the environment or leave any ecological footprint.
Oxitec is a pioneer in using genetic engineering to control insect pests that spread disease and damage crops, and was founded in 2002 as a spinout from Oxford University (UK). Oxitec is a subsidiary of Intrexon Corporation (NYSE: XON), which engineers biology to help solve some of the world’s biggest problems. Follow us on Twitter at @Oxitec, on Facebook, and LinkedIn
About Intrexon Corporation
Intrexon Corporation (NYSE: XON) is Powering the Bioindustrial Revolution with Better DNA™ to create biologically-based products that improve the quality of life and the health of the planet. The Company’s integrated technology suite provides its partners across diverse markets with industrial-scale design and development of complex biological systems delivering unprecedented control, quality, function, and performance of living cells. We call our synthetic biology approach Better DNA®, and we invite you to discover more at www.dna.com or follow us on Twitter at @Intrexon, on Facebook, and LinkedIn.
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