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Professor Jordan Paradise and Ethan Fitzpatrick '13

Publish 'Synthetic Biology: Does Re-Writing Nature Require Re-Writing Regulation?'

Professor Jordan Paradise and Ethan Fitzpatrick have published an article in the PENN STATE LAW REVIEW (117 PENN. ST. L. REV. 53)considering the impact and implications of synthetic biology upon FDA regulatory schemes.

On May 10, 2010, "the creation of the first synthetic cell-a man-made single-celled organism with the ability to self-replicate" was announced. The article, Synthetic Biology: Does Re-Writing Nature Require Re-Writing Regulation?, notes that "While hailed as a monumental step forward for science, the response from opponents was swift: stop the science from going forward, keep the products off the market, and protect society from the inherent and unknown risks."

The article looks closely at the field of synthetic biology, and concludes that "unlike other developments in the life science, synthetic biology poses potential environmental problems not previously contemplated by the limited life-cycle inquiry undertaken by the FDA, suggesting that it may be necessary to reassess the regulation of medical products using synthetic biology techniques."

Professor Jordan Paradise, long known for her work regarding science, and in particular as of late, nanotechnology and the law, commented that "the article published in the Penn State Law Review was the result of an earlier piece and presentation commissioned by the Department of Energy through the J. Craig Venter Institute's Policy Group. Ethan's background in cellular and molecular biology was extraordinarily significant in this context, and his presentation to scientific and policy experts at the project workshop in Rockville, Maryland in January 2012 was exceedingly well received. He represented Seton Hall Law School well."

Ethan Fitzpatrick noted, "Synthetic biology is inevitably making its way into medical care and medical products. After examining the statutory and regulatory framework for human drugs, animal drugs, and cosmetics, we determined potential gaps in regulation and assessment framework for synthetic biology and suggested mechanisms for the FDA to address these gaps, as well as containment issues. I came to law school to prepare myself to have an impact, but I had no idea that I would have the opportunity to present findings and suggestions to science and policy leaders from across the country before even graduating. It's an amazing honor, and I'm just very happy to have played a part."

Read the full penn state law review article, Synthetic Biology: Does Re-Writing Nature Require Re-Writing Regulation?