GAITHERSBURG, Md. — The Food and Drug Administration is weighing a controversial fertility procedure that involves combining the genetic material of three people to make a baby free of certain defects, a therapy that critics say is an ethical minefield and could lead to the creation of designer babies.
The agency has asked a panel of experts to summarize current science to determine whether the approach – which has been performed successfully in monkeys by researchers in Oregon and in people more than a decade ago– is safe enough to be used again in people.
The F.D.A. meeting, which is being held Tuesday and Wednesday, is meant to address the scientific issues around the procedure, not the ethics. Regulators are asking scientists to discuss the risks to both the mother and the potential child, and how future studies should be structured, among other questions. The meeting is being closely watched. The science of gene therapy has advanced dramatically in recent years, and many scientists are urging federal regulators to ease requirements for study in humans.
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