WASHINGTON — The commissioner of the Food and Drug Administration, Scott Gottlieb, waded into a debate about how much control his agency should have over genetic engineering in animals, saying that the resolution of this question will have significant implications for the future of gene-based medicine.
His remarks, in a speech Thursday at the annual conference of the Food and Drug Law Institute, came less than a month after Department of Agriculture Secretary Sonny Perdue told lawmakers at a hearing that the FDA’s regulations on genetically engineered animals could stifle innovation.
Currently, the FDA generally treats genetically engineered animals as “new animal drugs,” even though they aren’t really drugs, as the term “drug” is commonly understood. The USDA’s stance is a different matter. While Perdue issued a statement at the end of March saying that the USDA does not and will not regulate genetically engineered plants “that could otherwise have been developed through traditional breeding techniques,” the question of how genetically engineered animals should be regulated is still a contentious matter.
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