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FDA Classification Prevents Emergency Authorization For Potential Zika Prevention Technology

The Hill: FDA’s hostility blocks Zika-prevention technology
Henry I. Miller, physician, fellow at Stanford University’s Hoover Institution, and founding director of the Office of Biotechnology at the FDA, and Drew L. Kershen, professor at the University of Oklahoma College of Law

“…One promising unapproved ‘drug’ that could control the vector that spreads Zika, and whose progress has been stymied by regulators, is a genetically engineered Aedes aegypti mosquito product made by Oxitec … [T]he FDA can authorize the emergency use of an unapproved product in a situation that poses a public health emergency, such as an emerging disease like a new strain of pandemic influenza or a Zika outbreak. … However, the FDA has resisted [issuing an Emergency Use Authorization (EUA)], on the grounds that the statutory language permits the emergency use only of human drugs but not animal drugs, and that because the agency has classified the Oxitec mosquito as an ‘animal drug’ … [the EUA] is not applicable. The FDA’s legal interpretation is not only incorrect but also fails the common sense test. … The available evidence suggests that the genetically engineered mosquitoes are a safe, effective, and environmentally friendly approach to reducing exposure to the several viral diseases spread by Aedes aegypti. The FDA’s unwillingness to issue an Emergency Use Authorization appears to reflect its years-long antagonism toward the Oxitec genetically engineered mosquitoes…” (10/28).