The FDA Warns Biohackers Working on DIY Gene Therapies
The FDA has warned that it will be coming down hard on anyone carrying out do-it-yourself gene therapy.
According to Gizmodo, the statement comes following a live streamed video on Facebook, from a 27-year-old software engineer who injected himself with an unproved gene therapy for HIV designed by three biohacker friends.
“FDA is aware that gene therapy products intended for self-administration and ‘do it yourself’ kits to produce gene therapies for self-administration are being made available to the public. The sale of these products is against the law. FDA is concerned about the safety risks involved,” said the company.
They continued, “Consumers are cautioned to make sure that any gene therapy they are considering has either been approved by FDA or is being studied under appropriate regulatory oversight.”
Although very much disagreeing with such practices, and strongly discouraging them, the FDA has never actually intervened themselves with individuals.
The statement doesn’t pinpoint exactly which laws the selling of DIY gene therapy supplies is violating, or even how the agency will enforce such laws.
However, one technique in particular it is concerned about is CRISPR. It explained that it “considers any use of CRISPR/Cas9 gene editing in humans to be gene therapy.”
It would seem that biohackers should be cautious of the FDA in the future, when attempting DIY therapies themselves.