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3 Hous. J. Health L. & Pol'y 1 (2002-2003)
Human Tissues and Reproductive Cloning: New Technologies Challenge FDA

handle is hein.journals/hhpol3 and id is 7 raw text is: 3 Hous. J. HEALTH L. & POL'Y 1-82 1 Copyright © 2002 Richard A. Merrill, Houston Journal of Health Law & Policy ISSN 1534-7907 HUMAN TISSUES AND REPRODUCTIVE CLONING: NEW TECHNOLOGIES CHALLENGE FDA Richard A. Merrill* INTRODUCTION It is conventional wisdom that regulatory agencies possess dis- cretion to interpret their program statutes in new ways in order to meet challenges that the congressional authors did not, and in many cases could not, anticipate. The Supreme Court's famous Chevron decision promises, even if it does not guarantee, that reviewing courts will defer to an agency's modernizing initiatives unless it can be shown that Congress specifically foreclosed them.' Thus we have come to expect that agencies will often confront new chal- lenges by adapting traditional tools, rather than reflexively re- turning to the legislature for new authority or instructions. Indeed, agencies often prefer to work within the framework of their original charters, both so as to appear responsive and to avoid the real risk that new legislation will repudiate or undo policies to which they have long been committed. There must, of course, be limits to administrative interpolation, though it may be futile to attempt to describe them in general terms. Chevron's dictate, that when Congress has spoken clearly to the pre- *Daniel Caplin Professor of Law, University of Virginia, A.B., Columbia, 1959; M.A., Ox- ford, 1961; LL.B., Columbia, 1964. Mr. Merrill served as Chief Counsel to the U.S. Food and Drug Administration from 1975 to 1977. Since 1991 he has been Senior Of Counsel to the law firm of Covington & Burling, where he specializes in food and drug law and advises many clients engaged in biomedical research and the development and marketing of medical products, including the American Association of Tissue Banks. The views ex- pressed in this article are entirely his own. I want in particular to express appreciation to Bryan Rose of the University of Virginia Law School Class of 1999, who educated me about the science underlying and the debate surrounding cloning. Thanks also for re- search assistance provided by Michael Brunet of the University of Virginia Law School Class of 2004. 1 Chevron, U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 844 (1984).

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