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21 Jurimetrics J. 264 (1980-1981)
The NIH Guidelines for Recombinant DNA Research and the Authority of FDA to Require Compliance with the Guidelines

handle is hein.journals/juraba21 and id is 282 raw text is: THE NIH GUIDELINES FOR RECOMBINANT DNA RESEARCH AND THE AUTHORITY OF FDA TO REQUIRE COMPLIANCE WITH THE GUIDELINES* Edward L. Korwekt INTRODUCTION What the public has quickly learned to call genetic engineering, the combination and recombination of genetic information of diverse or- ganisms into one biologically active recombinant DNA (rDNA) molecule, is perhaps the most exciting scientific discovery since Einstein gave the world his now-famous equation, E = mc2. Its potential appli- cations are limitless.1 Nevertheless, because the creation of new and different life forms seems unfathomable and mysterious, the public imagination, fueled by science fiction, has seized upon a vision of mad scientists in their laboratories, uncontrolled demigods bent upon creat- ing a Brave New World.'2 This view falls considerably short of the truth. Scientific as well as legal developments have helped reduce some of the fears and uncertainties which often accompany new technological developments of this magnitude. Risk assessment3 based on certain ex- *Reprinted from 35 FOOD, DRUG & COSMETIC L.J. 633 (1980) with subse- quent modifications by the author. tDr. Korwek practices law in Washington, D.C. He received his Ph.D. in biochemistry from the University of Pittsburgh and his J.D. from Duquesne Uni- versity after doing post-doctoral work in molecular biology at the National Cancer Institute. 'For a recent discussion of scientific applications for the new technology, see 209 SCIENCE 1317-1431 (1980). 2See, e.g., Gaylin, The Frankenstein Factor, 297 NEW ENG. J. MED. 665 (1977); Chargaff, On the Dangers of Genetic Meddling, 192 SCIENCE 938 (1976); Davis, The Recombinant DNA Scenarios: Andromeda Strain, Chimera, and Golem, 65 AM. SCIENTIST 547 (1977). 'See, e.g., W. SZYBALSKI, MUCH ADO ABOUT RECOMBINANT DNA REGULA- TIONS, BIOMEDICAL SCIENTISTS AND PUBLIC POLICY (H. Fudenberg & V. Melnick JURIMETRICS JOURNAL

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