Document Type
Article
Publication Date
2017
College/Unit
WVU College of Law
Abstract
Biotechnology is about to spill the banks of federal regulation. New genetic engineering techniques like CRISPR-Cas9 promise revolutionary breakthroughs in medicine, agriculture, and public health-but those techniques would not be regulated under the terms of the Coordinated Framework for Regulation of Biotechnology. This revolutionary moment in biotechnology offers an opportunity to correct the flaws in the framework, which was hastily patched together at the advent of the technology. The framework has never captured all relevant technologies, has never satisfied the public that risk is being effectively managed, and has never been accessible to small companies and publicly-funded labs that increasingly are positioned to make radical, life-saving innovations. This Article offers a proposal for new legislation that would reshape biotechnology regulation to better meet these goals. Key reforms include tying regulation to risk rather than technology category; consolidating agency review; capturing distinct regulatory expertise through inter-agency consultations; creating a clearinghouse to help guide applicants and disseminate information; setting up more comprehensive monitoring of environmental effects; and providing federal leadership to fill key data gaps and address socio-economic impacts.
Original Publication Title
Food and Drug Law Journal
Digital Commons Citation
Peck, Alison, "Re-Framing Biotechnology Regulation" (2017). Law Faculty Scholarship. 56.
https://researchrepository.wvu.edu/law_faculty/56
Source Citation
72 Food & Drug L.J. 314
Comments
The article is included in the Research Repository @ WVU with the permission of the Food and Drug Law Journal.