Decoding FDA’s Statement on DIY Gene Therapies

Claud Mccoid

By Patti Zettler, Affiliate Professor, Ga State University Higher education of Law and CLB Fellow Alumna

Cross-posted on Aim Intent

In late November, Fda posted a statement on its site about the “self-administration of gene therapy”—which a variety of media outlets interpreted as a reaction to some providers lately publishing movies of shoppers “self-experimenting” with gene therapy. A person concern that arose in some of the reporting—and in an exchange on twitter—is, what is FDA’s authority to regulate do-it-you (Diy) gene therapy?

In shorter, Fda did not say that shoppers who engage in self-experimentation with gene therapy, them selves, are violating the legislation. As an alternative, the company said the “sale” of gene therapy items intended for self-administration violates the legislation. Considering the fact that 1986, Fda has said that human gene therapy items are biological drugs (see 51 Fed. Reg. 23309 (June 26, 1986)). So, FDA’s stance on … Read More