70 Food & Drug L.J. 339 (2015)
Synthetic Biology in the FDA Realm: Toward Productive Oversight Assessment

handle is hein.journals/foodlj70 and id is 355 raw text is: 





            Synthetic Biology in the FDA Realm:

       Toward Productive Oversight Assessment


                  LEIn FATEHI AND RALPH F. HALL**




I.     INTRODUCTION

   Proactively assessing the oversight challenges of emerging technologies has proven
to be a difficult task despite the need for such assessments never being greater. This
pressing need has most recently been identified for synthetic biology (SB), an emerging
area encompassing a range of tools and approaches for the engineered design and
production of biological components, systems, and even organisms with structures or
functions not otherwise found in nature as a platform for developing new and useful
products and processes.
   SB is expected to have tremendous impacts across a wide range of sectors and
industries,' including in foods, dietary supplements, cosmetics, human and animal drugs,
and diagnostics subject to oversight by the United States Food and Drug Administration
(FDA). In the area of health applications, SB holds great promise for enabling newer,
better, safer, cheaper, and more readily available therapeutics and diagnostics for many
diseases and disorders. Translational SB research is enabling scientists to understand
and control the genetic, genomic, protein, viral, metabolic, and other pathways that
contribute to disease susceptibility and onset, as well as to effective treatment.2 Using
SB methods, scientists are identifying disease mechanisms and drug targets, creating
new tools for drug discovery, and developing new therapeutics and therapeutic delivery
systems.' Efforts are now intensifying to advance from so-called first wave SB research
focused on creating biologically-based components and devices to second wave SB
research in which those components and devices are used to construct complex and
customizable large-scale systems.4 Such second wave SB research has the potential to
enable even greater innovation in human health applications, including the development
ofpersonalized, programmable, and multi-functional therapeutic and diagnostic systems,
such as engineered bacteria that can detect, selectively bind to, and destroy different

    * Leili Fatehi, JD, is Adjunct Associate Professor at the Law School, Lecturer at the Hubert H.
Humphrey School of Public Affairs, and Affiliate Faculty at the Center for Bioethics, all at the University of
Minnesota.
    ** Ralph F. Hall, JD, is Professor of Practice at the University of Minnesota Law School and is Of
Counsel to the law firm of Faegre Baker Daniels where he counsels clients in the area of drug and medical
device regulation and corporate compliance matters. He also serves as CEO of MR3 Medical LLC, a start-up
medical device company.
     1 Jennifer Kuzma & Todd Tanji, Unpackaging Synthetic Biology: Identification of Oversight Policy
Problems and Options, 4 REG. & GOVERNANCE 92, 93 (2010).
    2 Ahmad S. Khalil & James J. Collins, Synthetic Biology: Applications Come of Age, 11 NATURE
REVIEWS GENErics 367, 371-74 (2010).
    3 Id
    4 Priscilla E. M. Purnick & Ron Weiss, The Second Wave of Synthetic Biology: From Modules to
Systems, 10 NATURE REVIEWS MOLECULAR CELL BIOLOGY 410, 410-12 (2009).

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