Policy ForumSCIENCE AND REGULATION

The FDA is prohibited from going germline

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Science  05 Aug 2016:
Vol. 353, Issue 6299, pp. 545-546
DOI: 10.1126/science.aag2960

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Summary

A potentially renewable provision of the Consolidated Appropriation Act of 2016 forestalling the prospect of human germline modification was signed into law on 18 December 2015 (1). The provision, also known as a rider (an amendment extraneous to the main purpose of the bill to which it is attached), stipulates that “none of the funds made available by this Act [to the FDA] may be used to review or approve an application for an exemption for investigational use of a drug or biological product… in which a human embryo is intentionally created or modified to include a heritable genetic modification” (1). Destined to expire at the conclusion of this fiscal year (30 September 2016), the rider has since been incorporated yet again into the House and Senate appropriation bills for the fiscal year ending 30 September 2017 (2, 3). Subject to ongoing annual renewal, this congressionally legislated ban undermines ongoing conversations on the possibility of human germline modification, its likely distant time horizon notwithstanding (4). Also affected are ongoing efforts of the FDA to review the prevention of mitochondrial DNA diseases through germline modification of human zygotes or oocytes at risk (5).