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Wednesday, March 15, 2017

Researchers Are Divided as FDA Moves to Regulate Gene Editing

Paul Basken
The Chronicle of Higher Education
Originally published February 22, 2017

As U.S. regulators threaten broad new limits on the use of gene-editing technology, a Utah State University researcher now engineering goats to produce spider silk in their milk isn’t particularly worried.

"They’re just trying to modernize" rules to keep up with technology, the Utah professor, Randolph V. Lewis, said of the changes proposed by the U.S. Food and Drug Administration.

But over in Minnesota, a researcher working to create cows without horns — as a way of keeping the animals safe from one another — has a far different take.

"It’s a huge overreach" by the FDA that could stifle innovation, said Scott C. Fahrenkrug, an adjunct professor of functional genomics at the University of Minnesota at Twin Cities.

The FDA is responsible for ensuring the safety of food and drugs sold to Americans, and for years it has defined that oversight to require its approval when genes are added to animals whose products might be consumed. The change it proposed last month would expand that authority to cover new technologies such as CRISPR that enable gene-specific editing, potentially enabling changes not found in any known species.

To supporters, the FDA is simply trying to keep up with the science. To detractors, it’s a reach for authority so broad as to go beyond any reasonable definition of the FDA’s mandate.

The article is here.
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