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Rewriting Life

FDA Mulls Tighter Regulation of Gene-Edited Animals

The regulator has suggested that it treat every edit of an animal’s genome like a new drug, but some scientists think it could slow progress.

Animals could retain their unedited genomes for longer if the new FDA rules are enacted.

If newly proposed U.S. Food and Drug Administration regulations were to go into practice, research labs around the U.S. could find it harder to pursue their work editing the genomes of animals.

Gene-editing of animals, one of our 10 Breakthrough Technologies in 2014, is already underway in many labs around the world. Researchers have used the CRISPR-Cas9 technique, for instance, to heal mice of muscular dystrophy, breed extra-muscular beagles, and create hornless cows (they’re safer to farm). 

But newly proposed regulations from the FDA may make it harder for research scientists to carry out such work. The new guidance suggests that in the future “each specific genomic alteration [to an animal’s genome would be] considered to be a separate new animal drug subject to new animal drug approval requirements.” The FDA, then, would have to examine every intentionally gene-edited animal for safety in a process similar to the way it deals with drugs now.

As a report by Nature reveals, some researchers object to the proposal on the grounds that it would prove overly burdensome for academics. Instead, they argue that only organizations with greater resources—such as private companies—would be able to push on with their own commercial research, while researchers in other countries with different regulatory frameworks would remain unaffected. One scientist told Nature that the new regulations would be a “disservice to innovation” in the U.S.

The other side of the coin, of course, is that the public often gets fidgety about genetically modified crops, and it’s understandable that similar work in animals would evoke a stronger response. The FDA may be trying to head off controversy by ensuring that it checks in on each and every gene-edited animal created in American labs.

These are, however, only proposed guidelines. As the newly empowered Trump administration swings into action, it may seek to do something else entirely with the proposal—from tossing it in the trash to making it even more strict.

(Read more: Nature,  “10 Breakthrough Technologies: Gene Editing,” “Everything You Need to Know About CRISPR Gene Editing’s Monster Year,” “First Gene-Edited Dogs Reported in China”)

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Animals could retain their unedited genomes for longer if the new FDA rules are enacted.
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