Viewpoint: ‘Archaic’ FDA regulation hinders animal gene-editing innovation

| | January 17, 2020
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CRISPR-edited pigs and other biotech animals are strictly regulated by the FDA
This article or excerpt is included in the GLP’s daily curated selection of ideologically diverse news, opinion and analysis of biotechnology innovation.

Around the world, countries are experimenting, implementing, and – importantly – properly regulating gene editing in livestock. China has been pursuing gene editing since 2016, while Brazil, Canada, and Argentina are advancing the technology.

Gene editing technology allows for precise, small changes to specific genes. The technology will allow us to produce animals that are more resistant to disease, require less antibiotics and have a better environmental footprint.

Unfortunately, the future of gene editing is uncertain in the United States due to an archaic regulatory framework being advanced by FDA, stymying advancement and putting our competitors in the driver’s seat of agricultural innovation.

Related article:  ‘Genetic crapshoot’: Two studies suggest clinical use of CRISPR hampered by off-target editing

Currently, the FDA has regulatory control over this technology, but the …. USDA is the only organization with the understanding and history of working directly with livestock and agriculture.

Nevertheless, [the FDA] is claiming the right to regulate gene-edited farm animals and their offspring as drugs under a decades-old administrative decision designed with laboratory animals in mind. The FDA has little experience with on-farm production, while the USDA has thousands of people solely dedicated to regulating farming operations, the health of livestock, and food safety.

Read full, original article: Opinion: FDA needs to stop standing in the way of progress on gene editing

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