June 30, 2015

Congress Weighs In on CRISPR Gene-Editing Technology with Hearings and Proposed Legislation

On two separate fronts, Congress has now engaged with the controversy over the use of genome-editing technology, particularly the CRISPR/Cas9 (CRISPR) protocol. Last week, the House Research & Technology Subcommittee of the Committee on Science, Space and Technology held a hearing, The Science and Ethics of Genetically Engineered Human DNA. The use of CRISPR for editing of the human germline was suddenly a public concern when Chinese scientists published a set of gene-editing human embryo experiments (see here). At the hearing, several scientists testified on the current level of CRISPR development and possible applications. One presenter, Dr. Jennifer Doudna, is one of the developers of the CRISPR technology, and was part of a scientific ad hoc group that published a call for caution in the use of the technology, particularly as applied to reproductive purposes, such as genetic engineering of the human germline (see here). Several themes emerged during the testimony and subsequent questioning by Congressional panel members (the webcast of the House hearing is available here). The application of CRISPR to actual clinical/medical uses is still a work in progress, although panelists agreed that the pace of development is swift, as the relative ease of use and efficiency of the CRISPR technology has excited the scientific community. In the questioning from the House members, some dominant concerns emerged: would potential regulation apply to privately funded research as well as government-sponsored; how would a U.S. based regulatory regimen have any effect on international scientific efforts; is the U.S. at the forefront of technology development in these life science sectors. The hearing was clearly exploratory and a way for concerned representatives to weigh in on an emerging scientific debate. All participants noted that the National Academy of Sciences and National Academy of Medicine will be holding an international summit on gene-editing this fall in order to develop guidelines for use of the technology: 
The committee will consider and recommend standards, guidelines, and practices governing the use of gene-editing technologies in biomedical research and medicine. 
The second intersection of Congress and gene-editing technology comes in the form of an amendment introduced into the current appropriations bill under consideration by the House that would prohibit the FDA from reviewing any application for clinical trials on the use of genome editing in embryos or gametes. It's not clear if this provision could make its way into the final bill, but more importantly, it is likely a shot across the bow to the private sector, creating a roadblock for any commercial endeavors of germline gene-editing in reproduction, as any such government-funded research is already blocked by existing laws that prohibit most embryo-based research.

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