On May 9, an FDA Advisory Committee held a public meeting to discuss ooplasmic transfer, the fertility technique used by researchers to produce what they provocatively - and in part misleadingly -- announced in March 2001 was "the first case of human germline genetic modification." The following month, FDA told fertility clinics to stop offering the experimental procedure.
While seemingly concerned about the social as well as the medical risks of ooplasmic transfer, FDA is legally forbidden to address issues other than safety and efficacy, and is largely limited to procedural matters. The agency asserted its jurisdiction over the ooplasmic transfer procedure, said it would not permit it until more pre-clinical work is done, and called for further public discussion.
In a statement issued at the meeting, FDA expressed concerns about this "de facto germ line gene transfer" technique, including its potential to alter the germline, the serious medical risks associated with it, the high incidence of Turner's syndrome in fetuses reported in one study (2 of 13 reported pregnancies), and the paucity of animal studies and other pre-clinical data....