Oxitec Mosquito

Oxitec, Ltd. has an open Investigational New Animal Drug file with the FDA’s Center for Veterinary Medicine regarding the company’s genetically engineered mosquitoes. The FDA is reviewing information on the Oxitec mosquito in consultation with government experts from other agencies, including the EPA.

As part of the review, the FDA published for public comment a draft Environmental Assessment (EA) submitted by Oxitec, Ltd. that assesses the potential environmental impacts of conducting a field trial in Key Haven, Florida and a preliminary Finding of No Significant Impact (FONSI). On August 5, 2016, after considering thousands of public comments, the FDA released a final EA and FONSI agreeing with the EA’s conclusion that the proposed field trial would not have significant impacts on the environment.

FDA’s finalization of the EA and FONSI does not mean that Oxitec’s GE mosquitos are approved for commercial use. Following a public referendum on the issue, the local mosquito control authority decided not to go forward with the release in Key Haven.

Oxitec has produced a genetically engineered line of the mosquito Aedes aegypti (OX513A) with the intent of suppressing the population of that mosquito at the release site(s). Ae. aegypti is known to transmit potentially debilitating human viral diseases, including Zika, dengue, yellow fever, and chikungunya and has been found in some U.S. states, but is most prevalent in the South. Open field trials of the OX513A genetically engineered mosquito have been conducted in Brazil, the Cayman Islands, Panama, and Malaysia.

On January 19, 2017, FDA released for a 30-day public comment period Draft Guidance for Industry #236, Regulation of Mosquito-Related Products, that clarifies which mosquito-related products FDA regulates and which such products EPA regulates.

The draft guidance was developed in coordination with EPA and clarifies that mosquito-related products intended to function as pesticides by preventing, destroying, repelling, or mitigating mosquitoes for population control purposes are not “drugs” under the FD&C Act, and, when the guidance is finalized, will be regulated by EPA under FIFRA. Under the draft guidance, FDA would continue to have jurisdiction over mosquito-related products that meet the FD&C Act drug definition, such as those intended to prevent, treat, or cure a disease.