Heritable Genetic Modification Debate May Ignite Again As Technology Advances

CBER Director Peter Marks said the US may have to consider whether to maintain its ban on the practice of creating embryos to include heritable genetic modifications if other countries allow the practice.

gene editing
Members of Congress have questioned whether a blanket ban on intentionally creating an embryo for heritable genetic modification could hinder development in some diseases. • Source: Shutterstock

Debate over allowing a form of gene editing that has long been banned in the US may reemerge, in part because of concerns that the country could lose its life science leadership position if firms are unable to pursue the research.

As it stands now, a rider in fiscal year 2023 appropriations legislation states that the US Food and Drug Administration cannot use funds “to notify a sponsor or otherwise acknowledge receipt of a submission for an exemption for investigational use of a drug or biological product … in research in which a human embryo is intentionally created or

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