Viewpoint: How might the Biden Administration regulate heritable human gene editing?

Credit: Kevin Lamarque/Reuters
Credit: Kevin Lamarque/Reuters

The new Biden-Harris Administration faces a number of harrowing challenges in which science and technology policies will be critical. Along with the devastating COVID pandemic and the climate crisis, it will have to grapple with important decisions about US federal policy on heritable genome editing.

The Center for Genetics and Society will continue to track, and hope to influence, policy developments related to heritable genome editing that take shape in the White House, Congress, the National Institutes of Health, the Food and Drug Administration, and other relevant government bodies. Here, we are sharing some of our recent commentaries and press statements about this topic.

[As for precedent,] The White House Office of Science and Technology Policy (OSTP) released “A Note on Genome Editing,” [in 2015] a week after the National Academies announced “a major initiative to guide decision making about controversial new research involving human gene editing.” The Center for Genetics and Society welcomes the precautionary approach reflected in OSTP’s statement that the [Obama] “Administration believes that altering the human germline for clinical purposes is a line that should not be crossed at this time.”

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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. 

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