What is US Policy on Heritable Genome Editing? What’s Expected in the New Administration?

Biopolitical Times
US Congress

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.

  • New Research Shows That Heritable Genome Editing Is Prohibited in Most Countries with Relevant Policies
    (Center for Genetics and Society press statement | 10.27.2020)
    New research just published in The CRISPR Journal finds that 70 countries categorically prohibit heritable human genome editing. The findings, from researchers at the Center for Genetics and Society and Dalhousie University, are particularly important at a time when high-profile international committees are issuing global policy recommendations.
  • International Group Calls for Course Correction on Heritable Genome Editing
    (Center for Genetics and Society press statement | 01.31.2020)
    The 21 authors of the “Geneva Statement on Heritable Human Genome Editing: The Need for Course Correction” (including Marcy Darnovsky and Katie Hasson from CGS) point to the need to clarify misrepresentations, center societal consequences and concerns, and foster meaningful public empowerment and deliberation on the potential uses of this species-altering technology.
  • Introduction of the Senate Resolution on Gene-Editing Research
    (Center for Genetics and Society press statement | 07.17.2019)
    On July 15, Senators Dianne Feinstein (D-CA), Marco Rubio (R-FL), and Jack Reed (D-RI) introduced a bipartisan resolution calling for the creation of international ethical standards for gene-editing research. The Center for Genetics and Society welcomes the introduction of this resolution, which highlights the importance of international cooperation and broadly inclusive public deliberation in making the consequential decision about whether to allow heritable genome editing.
  • What Rider? Why the June 4 House Appropriations Committee Decision Matters
    (by Adrienne van der Valk, Biopolitical Times | 06.05.2019)
  • The Wrong Way to Make Policy About Heritable Genome Modification
    (by Marcy Darnovsky, The Hill | 05.29.2019)
    A rider to the omnibus federal spending bill bars the Food and Drug Administration from considering clinical trials “in which a human embryo is intentionally created or modified to include a heritable genetic modification.” This is a decidedly suboptimal way to craft policy, especially about such a profoundly consequential matter. But so is precipitously removing or altering it.
  • The White House and National Academies Approaches to Altering The Human Germline
    (Center for Genetics and Society press statement | 05.27.2015)
    The White House Office of Science and Technology Policy (OSTP) released “A Note on Genome Editing” yesterday, 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 “Administration believes that altering the human germline for clinical purposes is a line that should not be crossed at this time.”
  • FDA Should Preserve International Consensus Against Human Germline Modifications
    (Center for Genetics and Society press statement | 02.19.2014)
    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. A sign-on letter with more than 250 signatories calls on the agency “not to allow the techniques under consideration to move to human clinical trial…because of the profound safety, efficacy, policy and social problems they would pose.” The letter was prepared and circulated by the Center for Genetics and Society and the International Center for Technology Assessment, a project of the Center for Food Safety.