FDA Policy/General

More Gene-Drive Research Needed: Report

A new report from the National Academies of Sciences, Engineering, and Medicine says that while the emerging science of gene drives has the potential to address environmental and public health challenges, gene-drive modified organisms are not ready to be released into the environment and require more laboratory research and highly controlled field trials. The committee that did the study and wrote the report recommends a collaborative, multi-disciplinary, and cautionary approach to research on and governance of gene drive technologies.

Gene drives are defined in the report as systems of biased inheritance that enhance a genetic element’s ability to pass from parent organism to offspring. In principle, gene modifications could be spread throughout a population of living organisms intentionally and quickly via a gene drive, circumventing traditional rules of inheritance and greatly increasing the possibility that an altered gene spreads through a population. Preliminary evidence suggests that gene drives developed in the laboratory could spread a targeted gene through nearly 100% of a population of yeast, fruit flies, or mosquitoes, the National Academies report says.

The committee recommended a phased testing approach to gene drive research to guide it from the laboratory to the field. It says that phased testing can facilitate evidence-based decision-making, with every step promoting careful study and evaluation.

The report also notes that current regulatory practices for assessing risks of potential environmental effects of field experiments or planned releases are inadequate for gene drives. It says that at present the regulation of gene drive research does not fit under any of the federal agencies involved in the Coordinated Framework for the Regulation of Biotechnology — FDA, the Department of Agriculture, and the Environmental Protection Agency. It says that gene drive research also raises regulatory concerns about biosafety, biosecurity, and the potential for this technology intended for human benefit to be intentionally misused for harmful purposes. It calls for flexible and rapidly adaptable government policies, such as the World Health Organization’s Guidance Framework for Testing of Genetically Modified Mosquitoes, to facilitate international coordination and collaboration.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome