ARTICLE: THE REGULATION OF HUMAN TISSUE IN THE UNITED STATES: A REGULATORY AND LEGISLATIVE ANALYSIS Skip over navigation
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Copyright (c) 1997 The Food and Drug Law Institute 
Food and Drug Law Journal

ARTICLE: THE REGULATION OF HUMAN TISSUE IN THE UNITED STATES: A REGULATORY AND LEGISLATIVE ANALYSIS

1997

52 Food Drug L.J. 409

Author

Marc O. Williams*

Excerpt

I. INTRODUCTION

In the five decades that have elapsed since the inception of human tissue banking and transplantation in the United States, both the medical and economic significance of this technology have ballooned. By 1994, the industry had grown to generate annual revenues of about $ 100,000,000. 1 In spite of this growth, the practice of tissue banking was largely unregulated by the Food and Drug Administration (FDA) prior to December 1993. To the extent that federal regulatory controls were in place before that date, they represented a piecemeal approach, which left most of the industry untouched by FDA. Beginning in the mid-1980s, however, growing concern over such issues as the transmission of communicable diseases through tissue transplants and the safety of tissue imported into the United States from foreign countries created widespread interest within the tissue banking community in the development of a federal regulatory scheme. These issues also sparked congressional concern; although no human tissue legislation was enacted, several bills were put forth for consideration. The effort to craft a legislative solution to the problem of human tissue regulation currently is continuing in Congress. Finally, the growing awareness that the agency's piecemeal approach was no longer adequate to ensure the safety of the nation's human tissue supply led to FDA's promulgation of an interim rule on December 14, 1993. 2 This rule transformed the federal government's approach to human tissue regulation; abandoning its piecemeal approach, FDA adopted a system of uniform, mandatory regulatory standards that apply to all ...
 
 
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