Now a member of the faculty at UVA’s Frank Batten School of Leadership and Public Policy, Randall Lutter is a former deputy commissioner for policy at the Food and Drug Administration, where he had a leadership role in efforts to regulate genetically engineered animals.
Q. How is genome-editing different from the older processes for creating genetically modified organisms, or GMOs?
A. Using genome-editing techniques such as CRISPR, scientists can cut a cell’s genome at a desired location so that existing genes can be removed, or new ones added. Older techniques differed by requiring the introduction of genetic material from a different species and thus were sometimes called “transgenic.”
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Q. How does the FDA weigh possible risks of technology like this against its benefits?
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A. Weighing risks and benefits requires an assessment specific to the product in question, but FDA’s regulatory decision-making focuses on somewhat narrower questions.
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A key challenge posed by the current regulatory system is that it may approve new products too slowly…Delays in approvals mean continued use of the older and potentially less-safe products, as well as substantially reduced incentives for research and development funding.
The GLP aggregated and excerpted this blog/article to reflect the diversity of news, opinion, and analysis. Read full, original post: Q&A: The Future of Genome Editing and How It Will Be Regulated
