biohackers

(Credit: Josiah Zayner/ The ODIN)

Flying in the face of warnings from the federal government about do-it-yourself gene therapy, two companies have stated they’ll continue to offer DNA-altering materials to the public.

The companies, The Odin and Ascendance Biomedical, both recently posted videos online of people self-administering DNA molecules their labs had produced.

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The U.S. Food and Drug Administration last week issued a stern statement cautioning consumers against DIY gene-therapy kits and calling their sale illegal. “The sale of these products is against the law. FDA is concerned about the safety risks involved,” the agency said.

The FDA spoke out after two public demonstrations of unregulated, do-it-yourself genetic engineering. In one, a 27-year-old software engineer injected himself with an unproven gene therapy for HIV while streaming live on Facebook. In the other, a well-known biohacker injected himself with a gene to promote muscle growth at a San Francisco biotech conference. New genetic engineering technologies have encouraged a growing movement of biohackers taking experiments outside of the lab.

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After the initial warning, Gizmodo reached out to the FDA for clarity on how it might affect the biohacking community.

For one, the agency, made clear, it’s not just CRISPR: “Gene editing in humans by any method would be considered gene therapy regulated by FDA,” a spokesperson said, noting that it only mentioned CRISPR because it’s such a buzzy word.

And the selling of kits, it seems, would be considered illegal because, in broad terms, the agency would consider it the sale of any unapproved “gene therapy product” akin to the sale of an unapproved drug. If someone wants to test an unapproved drug in humans, they must first clear a clinical investigation with the FDA.

Per the agency:

A clinical investigation, described in title 21 of the Code of Federal Regulations, part 312.2 is defined as: any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects. An experiment is any use of a drug except for the use of a marketed drug in the course of medical practice.

The clarification makes it appear likely that the warning was motivated by the October experiment involving the unproven gene therapy for HIV. While the subject of the experiment actually injected the vaccine himself, its development was paid for by a company, Ascendence Biomedical. The company plans to sell the “research compounds” used to make the vaccine online and to fund “transparent” clinical trials that would skirt typical regulatory oversight by having people deliver their own treatment. The initial experiment raised significant concerns because there has been no human clinical trials of such an HIV treatment to date.

Ascendence Biomedical says it has no plans to change course based on the warning.

“It sounds like the FDA would like to believe that a research compound expressly not for human consumption becomes a clinical investigation as soon as the individual in receipt of it decides of their own free will to use it for personal research purposes,” CEO Aaron Traywick told Gizmodo. “These definitions were not set in place to regulate such activities, and there appears no specific law regulating such activities.”

In a report by MIT Technology Review, the FDA said that “information about the agency’s inspection and surveillance activities, including whether the agency is considering action, is generally not made available to the public unless and until enforcement action is taken.”

A resolution will likely depend on the nuances of the law as we wait and see if the FDA feel they have the mandate to act to curb the rise of DIY biology.