FDA retaining oversight of genetically modified animals for therapeutics will reassure the public

The Trump administration’s decision to relax oversight of genetically modified (GM) animals for food prioritizes big businesses and the livestock industry, while overriding FDA scientists in decisions around GM animal use, says GlobalData, a leading data and analytics company.

As oversight of GM animals for food will move from the FDA to the USDA due to last-day changes by former President Donald Trump’s administration, it is unclear whether President Biden’s administration or the FDA commissioner to be nominated will support these regulatory changes to agricultural biotechnology. The FDA, however, retains oversight of gene editing intended for any purpose other than agricultural use, including Bio/pharma and gene therapies.

Keshalini Sabaratnam, PhD, Analyst, Drugs Database at GlobalData, comments: “GM animals are in development for many potential uses in Bio/pharma, including for pharmaceutical drug production, as research models of human disease, and in xenotransplantation to make cells, tissues, or organs for transplantation into humans. With new gene-editing techniques such as CRISPR-Cas9 making genetic engineering faster and cheaper, Transgenic animals offer the potential to make manufacturing of complex therapeutic proteins cheaper.

“Despite these advantages, progress in the field has been slow due to public concerns over GM animals, including the safety of products derived from these animals. It is therefore reassuring that the FDA will retain oversight of GM animals used for production of therapeutic products, amid the proposed transfer of regulatory power over certain gene-edited animals.”

Several therapeutic recombinant biologic drugs are produced in transgenic (GM) animal expression systems, including four marketed drugs (antithrombin [recombinant], conestat alfa, sebelipase alfa, coagulation factor VIIa [recombinant]).

In 2015, the FDA approved Alexion Pharmaceuticals’ sebelipase alfa, produced in the egg whites of GM chickens, for a rare genetic disease known as lysosomal acid lipase (LAL) deficiency. In 2019, the FDA’s Center for Veterinary Medicine (CVM) approved a GM rabbit that produces the active ingredient of LFB’s coagulation factor VIIa (recombinant). The therapeutic was approved in 2020 for the treatment and control of bleeding episodes occurring in adults and adolescents with hemophilia A or B with inhibitors.

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