FDA to Hold Public Meeting about a Form of Human Germline Modification

Biopolitical Times | September 12, 2013

By Jessica Cussins

On October 22-23, an advisory committee of the Food and Drug Administration (FDA) will hold a public meeting on “oocyte modification in assisted reproduction for the prevention of transmission of mitochondrial disease or treatment of infertility.”

That description – which is the sum total of the information the FDA has so far released about the meeting – is a mouthful. What it apparently means is that the agency will, for the first time in over a decade, be considering a technique that would constitute a form of human inheritable genetic modification. It is the first time that the FDA has ever held a public meeting to discuss such a technique. That the agency is providing a forum for public comment seems like a good sign; the FDA surely realizes there are broad issues and profound societal consequences to consider.

The term the FDA has adopted – “oocyte modification” – is a new and somewhat strange framing. Though there is no way to be sure, oocyte modification for “treatment of infertility” may refer to a new in vitro fertilization technique being developed by a Boston-based company called Ovascience.  The technique involves combining the egg of an older woman with mitochondria from egg precursor cells taken from her body. Ovascience had started enrolling women in a clinical trial, but this week the FDA sent the company a letter asserting its oversight and telling Ovascience it could not proceed without approval.

Read the entire article here