The applicant, medical company Revivicor, plans to use the genetically altered animals in a number of different ways, including to produce drugs, to provide organs and tissues for transplants, and to produce meat that’s safe to eat for people with meat allergies.
FDA Commissioner Dr. Stephen Hahn said it’s the first time the government has approved an animal biotechnology product for both food and as a potential source for biomedicine.
“As part of our public health mission, the FDA strongly supports advancing innovative animal biotechnology products that are safe for animals, safe for people, and achieve their intended results,” Hahn said. Today’s action underscores the success of the FDA in modernizing our scientific processes to optimize a risk-based approach that advances cutting-edge innovations in which consumers can have confidence.”
The pigs have been given the name “GalSafe” because an alpha-gal sugar molecule has been removed from the animals. That molecule can trigger allergic reactions in some people with food allergies.
The FDA said the GalSafe pigs could also provide materials to produce human medical products that don’t have any detectable alpha-gal sugar. For example, they could be used to make a version of the blood-thinning drug heparin that’s free of detectable alpha-gal sugar.
Organs for transplant
Researchers have also suggested that tissues and organs from GalSafe pigs could produce organs for transplant, eliminating or reducing the chances of organ rejection. Alpha-gal sugar is currently believed to be the cause of organ and tissue rejection in some patients.
The FDA said it thoroughly reviewed the safety of the genetic alteration before granting approval, and it determined that food from GalSafe pigs is safe for the general population to eat.
The FDA’s review also focused on ensuring the effectiveness of the IGA through the evaluation of data demonstrating that there is no detectable level of alpha-gal sugar across multiple generations of GalSafe pigs.
Genetic alteration of food products is not new, but has been limited to plants until now. The technology has been used for decades to produce genetically modified organisms (GMO) that are more resistant to disease and drought.