U.S. regulators should prepare for flood of new biotech products, report says

The U.S. regulatory system is likely to be overwhelmed by an onslaught of biotechnology products in coming years, according to a report from the National Academies of Sciences, Engineering & Medicine. In the report, the National Academies committee of academic and industry biotechnology experts recommends strategies to help federal agencies prepare based on predicted future biotechnology products and anticipated regulatory challenges. “The rate at which biotechnology products are introduced, and the types of products, are expected to significantly increase in the next five to 10 years, and federal agencies need to prepare for this growth,” says Richard M. Murray, a Caltech bioengineering professor who chaired the committee. To be prepared, federal agencies should grow in-house expertise on the changing biotechnology landscape, coordinate cross-agency risk assessments for new products, and fund research into ethical, legal, and social implications of emerging biotechnology products, the report says. EPA, FDA, and USDA commissioned the study in 2015 as part of an effort to modernize the U.S. regulatory system for biotechnology products.