The United States Food and Drug Administration has reportedly approved the use of genetically engineered pigs for food as well as for medical purposes. This is the first time the regulator has given clearance to use of such deliberate genomic alteration. Reportedly called GalSafe pigs, these pigs are devoid of a sugar on their skin that could lead to a severe allergic reaction in some people.
According to the Commissioner of FDA, Stephen M. Hahn, M.D., the first ever approval of an animal biotechnology product as a plausible source for biomedical usage as well as for food marks a significant milestone for the purpose of scientific innovation. As part of the country’s public health drive, the regulator is in strong support of furthering innovative animal biotechnology products that are safe for people, safe for animals, and also achieve intended results, added Hahn.
This step highlights the success of the FDA in the modernization of scientific processes for the optimization of a risk-based approach that would advance cutting-edge innovations in which consumers could have confidence, asserted the FDA Commissioner.
For the record, IGA (intentional genomic alteration) was approved in 2009 for modified goats that would produce a drug in their milk that is utilized for the prevention of blood clots. The therapy with the milk is known as ATryn and is administered to those having hereditary antithrombin deficiency, which is a rare disease.
The modification of chickens was permitted in 2015 for the production of a drug from their eggs for the treatment of a protein deficiency. Also, in 2015, salmon was the first to undergo genetic engineering for food.
The GalSafe pigs are, however, the first in history to obtain regulatory approval for both therapeutics and food. These pigs are being licensed by Revivicor, a spinoff from PPL Therapeutics, known for cloning the first mammal from Dolly the sheep, an adult mammal, in 1996.