FDA Warns against ‘Do It Yourself’ Gene Therapy Kits

November 27, 2017

(Boston Business Journal) – The U.S. Food and Drug Administration has issued a stern warning against the use of “do it yourself” gene therapy kits, pushing back against a nascent “biohacker” movement that seeks to make experimental medicines and technologies available to the masses, often by circumventing regulators. A statement posted on the FDA’s website on Tuesday cautions that it is illegal to sell gene therapy products and kits intended for self-administration. Gene therapy involves inserting new, healthy genes into cells to cure diseases that are caused by faulty genes. The FDA has classified gene editing — cutting out and replacing parts of faulty genes — as a form of gene therapy.

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