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

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