Animal gene-editing researchers leaving US to escape FDA’s ‘regulatory confusion’

Gene-edited animals face uncertain future under proposed FDA regulations

In a few weeks, reproductive biologist Charles Long will travel from Texas to São Paulo, Brazil in search of collaborators willing to take on his studies of gene-edited cattle. He is reluctant to ship the project away from his laboratory at Texas A&M University in College Station. But after 20 years of struggling to win US government funding for his research, Long says that he is done.

“We’ve essentially given up,” he says. “I’m going to move the entire damn project down there.”

US researchers who develop genetically engineered livestock have long dealt with….an uncertain path to market. Many had hoped that the advent of genome-editing technologies….would mean less oversight by the….FDA….

But in 2017, the FDA released draft guidance that suggested it will regulate gene-edited animals, too, as ‘animal drugs’. The only animal that the FDA has approved via that pathway is a fast-growing genetically engineered salmon, in a decision that was decades in the making….


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That leaves US researchers in a bind. Federal funding for genetically engineered or edited livestock is in short supply. Geneticist Kevin Wells of the University of Missouri in Columbia can recall only one such grant in the last 30 years. Researchers have leaned on industry funding to pick up the slack — but this, too, might run dry if companies can’t bring their animals to market.

Read full, original article: Gene-edited animal creators look beyond US market

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