FDA Should Preserve International Consensus against Human Germline Modifications

On February 25-26, the US 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.

"The number of people who signed this letter, from thirteen different countries, 42 states and diverse professions and interests, speaks to the widespread concern about efforts to genetically engineer humans,” said Marcy Darnovsky, PhD, executive director of the Center for Genetics and Society.

The FDA meeting will not consider what its briefing document recognizes as “ethical and social policy issues related to genetic modification of eggs and embryos” that “have the potential to affect regulatory decisions.” It puts these issues “outside the scope of this meeting.” Further, none of the FDA committee members are social scientists, bioethicists, or policy experts; nor does the committee include public interest advocates, women's health advocates, or children's advocates.

“We commend the FDA for holding a public meeting and inviting public comments on this controversial issue,” Darnovsky said. “But narrowing the deliberations – and the deliberators – this way means that key concerns will be difficult or impossible even to raise.”

Some 40 countries, including many with robust biotechnology and biomedical sectors, have adopted laws to prohibit human germline modification. If the United States chooses to violate this international near-consensus, especially without having any laws in place to regulate the usage or safety of the techniques, it would set an extremely troubling global precedent.

“This is a biologically extreme procedure that puts any resulting children at serious risk, and that breaks a long-standing international consensus against producing genetically engineered humans,” Darnovsky continued. “Its developers defend oocyte modification as a way to allow a small number of women who are affected by a rare form of mitochondrial disease to have an unaffected and mostly genetically related child. But there are safer alternatives available for these few at-risk people. The case for such socially problematic and risky experimentation is simply not there.”