Genetically engineered animals and the FDA

Today, the MIT technology review put out an article about a dog breeder who wanted to fix a genetic disorder in dalmatians, but has been hampered by the FDA. The breeder, David Ishee, wanted to fix a common inherited disorder that prevented dalmatians from clearing out uric acid using CRISPR. However, a new proposed regulation would treat the edited portions of its genome as a veterinary drug, requiring federal approval before the dalmatians (or any transgenic animal, for that matter) could enter the market. While Ishee could still keep the dogs on his property, he couldn't distribute them to other breeders. 

Personally, I think this has significant implications for the more biological grinders out there. It prevents open distribution of any transgenic animals, while also chilling interest in the diyBio scene. Ishee even mentions that when he called the FDA they "seemed pretty nervous, like I [Ishee] was out to get them." I think this represents a blow to the biohacking movement, but one that might be negotiable. What do you guys think?


  • I think it's a shame in a way, but probably necessary.  We will need some form of regulation when distribution is involved.  Personally I want that regulation to be very little and even want to make some of my own crazy stuff, but I think for the safety of everything we need something there.  Anyways I highly doubt they could stop him from just doing it (modifying his dogs) and I wouldn't want them to be able to stop him.  I do understand their fear when it comes to distribution, however I think only major distribution under a company name should be regulated.

    Either way I think this won't be that big of a deal right now and doesn't bear too much worry.
  • edited February 2017
    As far as I can see, the biohacking community is all about the doing rather than sharing the final product. I would imagine that case with the FDA stopping the guy from distributing the tools for transgenic beer yeast (something along those lines) would be far more impactful.

    And even then, all that guy did was just go all "right, these stuff can be used to make transgenic yeast but they don't have to be" and he was ok.
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