Public interest groups prepare for battle as FDA addresses human germline modifications

Feb. 19, 2014

On February 25-26, the U.S. Food and Drug Administration will hold a public meeting to discuss “oocyte modification in assisted reproduction for the prevention of transmission of mitochondrial disease.” This will be the first public meeting ever held by the FDA to consider a form of human germline modification – inheritable genetic changes made to eggs, sperm or embryos.

The technique (which has also been referred to as “mitochondrial manipulation,” mitochondrial replacement” and “three-parent IVF”) raises grave safety and social concerns. It carries a wide range of predictable and unpredictable risks for any resulting children and for future generations, and could open the door to further germline manipulations. If the FDA were to approve a human clinical trial of oocyte modification, it would be the first time any jurisdiction in the world has authorized intentional genetic modification of children and their descendants.

A sign-on letter with more than 250 signatories echoes these concerns, and calls on the agency “not to allow the techniques under consideration to move to human clinical trial…because of the profound safety, efficacy, policy and social problems they would pose.” The letter was prepared and circulated by the Center for Genetics and Society and the International Center for Technology Assessment, a project of the Center for Food Safety, and has been sent to the FDA

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