Blood Banking and Regulation: Procedures, Problems, and Alternatives

Forum on Blood Safety and Blood Availability

Division of Health Sciences Policy

INSTITUTE OF MEDICINE

Edward A. Dauer, Editor

NATIONAL ACADEMY PRESS
Washington, D.C. 1996



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Blood Banking and Regulation: Procedures, Problems, and Alternatives Blood Banking and Regulation: Procedures, Problems, and Alternatives Forum on Blood Safety and Blood Availability Division of Health Sciences Policy INSTITUTE OF MEDICINE Edward A. Dauer, Editor NATIONAL ACADEMY PRESS Washington, D.C. 1996

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Blood Banking and Regulation: Procedures, Problems, and Alternatives National Academy Press 2101 Constitution Avenue, NW Washington, DC 20418 NOTICE: The project that oversees this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Science, the National Academy of Engineering, and the Institute of Medicine. The members of the forum responsible for this report were chosen for their special competencies and with regard for appropriate balance. This report has been reviewed by a group other than the authors according to the procedures approved by a Report Review Committee consisting of members of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The Institute of Medicine was chartered in 1970 by the National Academy of Sciences to enlist distinguished members of the appropriate professions in the examination of policy matters pertaining to the health of the public. In this, the Institute acts under both the Academy’s 1863 congressional charter responsibility to be an adviser to the federal government and its own initiative in identifying issues of medical care, research, and education. Dr. Kenneth I. Shine is president of the Institute of Medicine. Support for this project was provided by the Food and Drug Administration (Contract No. 223-93-1025), Abbott Laboratories, Baxter Health Care Corporation, Ortho Diagnostic Systems, the American Association of Blood Banks, the American Red Cross, the American Blood Resources Association, and the Council of Community Blood Centers. This support does not constitute an endorsement of the views expressed in the report. Library of Congress Catalog Card No. 96-69310 International Standard Book Number 0-309-05546-6 Additional copies of this report are available from: National Academy Press, Lock Box 285, 2101 Constitution Avenue, N.W., Washington, D.C. 20055. Call (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area), or visit the NAP on-line bookstore at http://www.nap.edu/nap/bookstore/. Call (202) 334-2352 for more information on the other activities of the Institute of Medicine, or visit the IOM home page at http://www.nas.edu/iom/. Copyright 1996 by the National Academy of Sciences. All rights reserved. Printed in the United States of America The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The image adopted as a logotype by the Institute of Medicine is based on a relief carving from ancient Greece, now held by the Staatlichemuseen in Berlin. Cover design by Francesca Moghari.

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Blood Banking and Regulation: Procedures, Problems, and Alternatives FORUM ON BLOOD SAFETY AND BLOOD AVAILABILITY HENRIK H. BENDIXEN, Chair, Professor Emeritus, Department of Anesthesiology, Columbia University, New York, New York. THOMAS F. ZUCK, Vice Chair, Professor of Transfusion Medicine, University of Cincinnati, Director, Hoxworth Blood Center, Cincinnati, Ohio JOHN W. ADAMSON, President, New York Blood Center, New York, New York ARTHUR L. CAPLAN, Director, Center for Bioethics, University of Pennsylvania, Philadelphia, Pennsylvania WILLIAM COENEN,* Administrator, Community Blood Center of Greater Kansas City, Kansas City, Missouri PINYA COHEN, Vice President of Quality Assurance and Regulatory Affairs, NABI, Boca Raton, Florida EDWARD A. DAUER, Dean Emeritus, College of Law, University of Denver, Denver, Colorado M. ELAINE EYSTER, Distinguished Professor of Medicine, Division of Hematology, The Milton Hershey Medical Center, Hershey, Pennsylvania JOSEPH C. FRATANTONI, Director, Division of Hematology, Office of Blood Research and Review, Food and Drug Administration, Rockville, Maryland HARVEY G. KLEIN, Chief, Department of Transfusion Medicine, Warren Grant Magnuson Clinical Center, National Institutes of Health, Bethesda, Maryland EVE M. LACKRITZ, Medical Epidemiologist, HIV Seroepidemiology Branch, Division of HIV/AIDS, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia PAUL R. McCURDY, Director, Blood Resources Program, National Heart, Lung, and Blood Institute, Bethesda, Maryland PAUL S. RUSSELL, John Homans Professor of Surgery, Massachusetts General Hospital, Boston, Massachusetts CAPT BRUCE D. RUTHERFORD, MSC, USN, Director, Armed Services Blood Program, Falls Church, Virginia WILLIAM C. SHERWOOD, Director, Transfusion Services, American Red Cross Blood Services, Philadelphia, Pennsylvania LINDA STEHLING, Director of Medical Affairs, Blood Systems, Inc., Scottsdale, Arizona *   Served from January 1995 until December 1995.

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Blood Banking and Regulation: Procedures, Problems, and Alternatives EUGENE TIMM,** Member, Board of Directors, American Blood Resources Association, Rochester Hill, Michigan ROBERT M. WINSLOW, Adjunct Professor of Medicine, University of California-San Diego, and Hematology-Oncology Section, Veterans Affairs Medical Center, San Diego, California Project Staff VALERIE P. SETLOW, Director, Health Sciences Policy Division FREDERICK J. MANNING, Project Director KIMBERLY KASBERG MARAVIGLIA, Research Associate MARY JANE BALL, Sr. Project Assistant NANCY DIENER, Financial Associate (until March 1996) JAMAINE TINKER, Financial Associate (after March 1996) **   Served from January 1994 until December 1994.

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Blood Banking and Regulation: Procedures, Problems, and Alternatives PRESENTERS MICHAEL BEATRICE, Deputy Director, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland JAY EPSTEIN, Director, Office of Blood Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland ANNE MARIE FINLEY, Professional Staff, House Government Reform and Oversight Committee, Subcommittee on Human Resources and Intergovernment Relations, Washington, DC PHILIP HARTER, Attorney at Law, Washington, DC MARY K. PENDERGAST, Deputy Commissioner and Senior Advisor to the Commissioner, Food and Drug Administration, Rockville, Maryland LYLE PETERSEN, Chief, HIV Seroepidemiology Branch, Centers for Disease Control and Prevention, Atlanta, Georgia DAVID PRITZKER, Senior Attorney, Regulatory Information Service Center, General Services Administration, Washington, DC MERLYN SAYERS, Director of Transfusion Services, Puget Sound Blood Center, Seattle Washington SIDNEY SHAPIRO, Rounds Professor of Law, University of Kansas School of Law, Lawrence, Kansas JAMES C. SIMMONS, Director, Office of Compliance, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland TOBY SIMON, President, Blood Systems Foundation, Scottsdale, Arizona RICHARD SWANSON, Director, Division of Emergency and Investigative Operations, Office of Regional Operations, Food and Drug Administration, Rockville, Maryland KATHRYN C. ZOON, Director, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, Maryland

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Blood Banking and Regulation: Procedures, Problems, and Alternatives Foreword This is the first of three monographs by the Forum on Blood Safety and Blood Availability. Each monograph provides a review and summary of selected topical presentations at four separate workshops sponsored by the Forum from January 1994 through September 1995. The talks summarized in this document were originally given at workshops on Alterative Regulatory Models (January, 1995); CBER Compliance Activity, Theory and Practice (September, 1995); and Managing Threats to the Blood Supply (September, 1995). The views expressed in this document, unless otherwise noted, are those of the individual presenters and do not reflect the views of the individual's employing agency or the Institute of Medicine. This document is neither a summary of any one workshop nor a comprehensive summary of all of the Forum's workshops. Rather, it is a compilation of talks that were specifically selected to provide a clear and comprehensive perspective of the current decision making and regulatory processes in the blood arena, as well as some alternative regulatory models that have been applied in other regulatory venues (i.e., air traffic control and environmental protection). To promote full participation by Forum members, presenters, and invited guests, the Forum does not draw conclusions or make recommendations. The Forum on Blood Safety and Blood Availability was convened by the Institute of Medicine to provide an environment for the exchange of information about blood safety and blood availability, to identify high-priority issues in these areas, and to promote problem solving activities such as workshops. During its two years of existence, the Forum identified opportunities and problems that are ongoing or expected to arise within the next five years, and has developed approaches to exploiting opportunities or solving problems. During the Forum's final meeting, in September 1995, members of the Forum reviewed its work and addressed the question of how the dialogue that it had fostered might best be continued or improved. One of the questions the group considered was what the criteria should be for any such future venture. Not everyone agreed with everything mentioned, and no votes were taken; consistent with its charter, the Forum reached no specific conclusions or

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Blood Banking and Regulation: Procedures, Problems, and Alternatives recommendations. The group did, however, request that the collected list of criteria be recorded as a possible starting point for any subsequent initiative. The suggestions on that list included the following "Criteria for a Process of Dialogue:" A consensus oriented procedure capable of reaching closure on the issues being discussed. Participation of diverse constituencies, such as designated representatives of the public. Continuity of people and process, so that issues may be addressed as they arise without the need to fashion a structure and process ad hoc. Conditions supporting openness and candor. Opportunities for discussion in a variety of venues, both public and—where permitted by law—private. Prestigious and neutral, a forum that lends dignity and credibility to the discussions. Expert facilitation, though not necessarily subject-matter expertise, by those who run or manage the process. Less time devoted to education about the issues, allowing more direct engagement with decision-making. Available and ready to be utilized whenever an appropriate issue is identified. Fashioned to be persuasive to Congress and others.

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Blood Banking and Regulation: Procedures, Problems, and Alternatives Preface The Forum on Blood Safety and Blood Availability was convened by the Institute of Medicine in the spring of 1994 with the objective of providing a forum within which representatives of blood banking and transfusion medicine, representatives of the Food and Drug Administration (FDA) and other government agencies, and interested members of the public could meet to discuss informally and freely questions of common interest. That common interest was defined to be the safety and availability of the nation's supply of blood and blood components. It became apparent early in the course of the Forum's meetings that the topic of regulation should have a place on the agenda. Regulation may be taken formally to mean the method by which government authority shapes the activities of firms and organizations in the private sector, in accordance with policy directives established by the legislative and executive branches of the federal government. Less formally, but of equal importance in a field like blood banking, which operates in the public interest and where the expertise required for good decision-making lies as much outside government as within it, regulatory methods are among the vehicles by which that expertise is shared and applied to the issues that both the public and private sectors face. Particularly in recent years, questions had been raised about the ways in which both the formal and less formal functions of regulation had been working. At the same time, developments in alternative forms of regulation in general had progressed quite markedly. "Negotiated Rule-making," for example, was formally sanctioned and encouraged by a federal statute enacted in 1990. During the early 1990s, the Administrative Conference of the United States, then a federal agency service office, supported several experiments in regulatory alternatives, many of them notably successful. Field experience with and a mature literature about the new techniques were being developed, and individuals in the upper levels of the Executive Branch had itself taken note of these alternative models. These two streams converged: the sense among some in blood banking, inside government and out, that the regulatory process could profitably undergo some deliberate reconsideration, and the emergence of demonstrated

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Blood Banking and Regulation: Procedures, Problems, and Alternatives alternative techniques for government regulation. The Forum therefore devoted a significant portion of its working time to the exploration of these questions: How well does the present regulatory system work? Are there alternatives that hold promise for enhancing its functions? The principal discussions of regulation and alternative regulation occurred during the Forum session of January 1995. The ideas advanced at that time generated additional questions and suggestions, resulting in a further discussion among Forum members at their meeting in June 1995. The meeting in September 1995 included several segments of closely related material, specifically the enforcement side of regulation and the role and direction of congressional oversight of blood safety and availability. This report includes selections from each of those three meetings, but they are rearranged to create a more continuous sequence. The usual way of proceeding at the Forum meetings was through panel discussions. One or more speakers would offer an initial set of prepared remarks. This would be followed by a period of open discussion among the speakers and the Forum members and guests. The principal selections included in this report are edited versions of the speakers' presentations. They have been edited to change the patterns of an oral presentation into the more readable patterns of a written text, and in a few instances they have been edited for length. No effort has been made to integrate or summarize the individual presentations. In each case the views expressed are those of the individual speaker and not those of the Forum or the Institute of Medicine. Although the discussion sessions were in many senses the greatest success of the Forum meetings, they required more extensive editing to create a text that was readable rather than one that jumped abruptly from one subject to the next. The give and take of an open discussion does not always translate well when reported verbatim. In some places in this report a question put to a speaker, and its answer, may be reported in full; in other cases, the editor has taken the liberty of combining related aspects of the discussion into a composite narrative. Although some of the liveliness may thus be subdued, it is hoped that the accessibility of the subject to the reader will have been improved. Edward A. Dauer

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Blood Banking and Regulation: Procedures, Problems, and Alternatives Contents I Overview of Regulatory and Policy-Making Procedures in Blood Banking   1     FDA Policy and Regulation, Michael Beatrice,   3     CDC Recommendations, Lyle Petersen,   9     Blood Banking's Policy Groups and Procedures, Toby Simon,   13     Opportunities and Venues for Dialogue, Merlyn Sayers,   19     Discussion,   25 II Regulatory Enforcement and Compliance   27     CBER Compliance Activity, James Simmons,   29     FDA Practice in the Field, Richard Swanson,   33     Challenges and Questions About Compliance, William Sherwood,   35     Discussion,   41 III Innovations and Alternatives in Regulation   47     Regulatory Alternatives, Sidney Shapiro,   49     Specific Techniques, David Pritzker,   55     Negotiated Rule-Making, Philip Harter,   61     Panel Discussion on Applications of Negotiated Rule-Making to Issues in Blood Banking,         Kathryn C. Zoon,   73     Jay Epstein,   76     Toby Simon,   81     General Discussion of Issues for Negotiated Rule-Making,   87 IV Congressional Oversight and Regulatory Initiatives   91     Congressional Oversight of Blood Safety Issues, Anne Marie Finley,   93     DHHS Task Force on HIV and the Blood Supply, Mary Pendergast,   99

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Blood Banking and Regulation: Procedures, Problems, and Alternatives V Postscript   103     Investing in Regulatory Quality, Edward A Dauer,   105 Appendixes   107 A   Negotiated Rule-Making Procedure,   109 B   Workshop Participants,   121 C   Acronyms,   125