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FDA issues warning on DIY gene-therapy kits

27 November 2017

By Theofanis Michailidis

Appeared in BioNews 928

The US Food and Drug Administration (FDA) is taking an active stance against the use of 'do it yourself' gene therapy kits.

'[The] 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 agency said in a statement last week. 'The sale of these products is against the law. FDA is concerned about the safety risks involved.'

The warning comes after an incident last month involving biohacker Tristan Roberts, who live streamed injecting himself with an experimental therapy for HIV. Typically the FDA would not intervene in such a case. However, ethical and legal concerns have been raised by experts, particularly over the lack of legislation surrounding self-experimentation.

Eleonore Pauwels, a science policy expert at Wilson Centre in Washington DC, warned about the effects of promoting such actions on social media, highlighting potential risks to vulnerable individuals, such as 'children [or] users with no knowledge or skill' to Gizmodo.

Self-experimentation is not against US law and so cannot be banned, but the FDA can tighten regulation around sale of supplies necessary for self-induced gene therapy, presenting an obstacle to the burgeoning movement of unqualified biohackers who aim to edit the genes of living organisms (including themselves), by ordering the required equipment on the internet.

Gene therapy is the process of inserting working versions of genes into a patient's cells in order to cure or alleviate conditions caused by faulty genes, when no treatment exists. According to the FDA, clinical studies of gene therapy require the submission of an investigational new drug application. Additionally, the marketing of a gene therapy product requires submission and approval of a biologics licence application.

'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,' the agency said.

Boston Business Journal | 22 November 2017
Wall Street Journal | 22 November 2017
FDA | 21 November 2017
Gizmodo | 22 November 2017
Gizmodo | 18 October 2017


20 November 2017 - by Martha Henriques 
The US Food and Drug Administration has announced a fast-track review process for gene therapies and other regenerative medicine treatments...
13 November 2017 - by Jamie Rickman 
The US Food and Drugs Administration has further deregulated direct-to-consumer genetic health risk tests, meaning that some will be approved for market without a pre-market review...
19 October 2017 - by Jennifer Willows 
The US Food and Drug Administration have approved the world’s second gene therapy to target blood cancer...
16 October 2017 - by Rikita Patel 
The US Food Drug and Administration advisory committee has backed the use of gene therapy to treat a hereditary disease for the first time...

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