HHS Seeks Input on Potential Benefits and Risks of Synthetic Biology

By Ricardo Carvajal –

According to one working definition, synthetic biology encompasses "the design and fabrication of biological components and systems that do not already exist in the natural world" and "the re-design and fabrication of existing biological systems."  Recent developments in the field prompted the Presidential Commission for the Study of Bioethical Issues, housed with the Department of Health and Humans Services, to publish a Federal Register notice seeking comment on:

• the potential benefits and risks of synthetic biology;
• consideration of ethical boundaries that should apply; and
• strategies to ensure that the public benefits from product and tools derived through synthetic biology.

The Commission was formed by executive order in November 2009 to “advise the President on bioethical issues that may emerge as a consequence of advances in biomedicine and related areas of science and technology.”  In May 2010, the President directed the Commission to address synthetic biology in the wake of the announcement by the J. Craig Venter Institute that its researchers had constructed the “first self-replicating synthetic bacterial cell.”

Broadly defined, synthetic biology has already generated numerous medical and agricultural applications that have required the attention of FDA.  However, further advances in the field (particularly those geared toward the creation of what could be dubbed artificial life), are certain to present additional challenges to the agency.  Those challenges were acknowledged by the Commissioner in a recent speech stressing the importance of developing the agency's regulatory science capabilities – an issue we recently blogged on.