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.”
Q. How does the FDA weigh possible risks of technology like this against its benefits?
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.
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