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BIO responds to the President's Council on Bioethics

Leon R. Kass, M.D., Chairman
The President's Council on Bioethics
1801 Pennsylvania Avenue, NW
Suite 800
Washington, DC 20005


Dear Dr. Kass:

Thank you for your letter of March 14, 2003./1 In response, the Biotechnology Industry Organization (BIO) is pleased to provide its views on the values underlying appropriate regulation of biotechnology and biomedical research.

BIO's interests in these issues is deep as it represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers and related organizations in all 50 states and 33 other nations. BIO members conduct genetic, cellular and protein research, and they develop health-care, agricultural, industrial and environmental biotechnology products that are used by billions of people world wide to identify and meet unmet medical needs, improve the quality of the food supply, and broaden scientific understanding.

The biotechnology industry has been a remarkable success story. For example, there are currently 156 FDA-approved products on the market that have helped more than 325 million people worldwide. In 2002 alone, our members had 35 products approved by the FDA as safe and effective opportunities for treating a range of illnesses, including hepatitis B and C, arthritis, multiple sclerosis, and many forms of cancer.

Our industry has achieved these scientific accomplishments in part because the state and federal regulatory system that governs the development and use of our products works. Our nation's regulatory system assures patients and their physicians that they can rely on the safety and efficacy of our products. Biotechnology companies have always worked with and within this regulatory system to ethically bring safe and effective products to market. BIO is proud that scientists are able to sustain aggressive lines of inquiry while complying with a robust and diverse regulatory system including oversight from agencies such as the US Food and Drug Administration and National Institutes of Health.

We believe that knowledge and understanding progresses not only through scientific research, but also through dialogue and discussion. Throughout its history, BIO has been actively involved in bioethics education and discussion inside the industry and at all levels and branches of government.

Several years ago, BIO's Board of Directors adopted a Statement of Ethical Principles that details ethical uses of biotechnology. In addition, our Board and Bioethics Committee have forged timely industry policy on genetic discrimination, medical privacy, gene therapy, stem cell research, cloning, human subjects protection, xenotransplantation, and other issues relevant to biomedical research. We have testified before Congressional committees and administrative agencies, and have informally educated Members of Congress, their staffs, executive branch officials, as well as participated in numerous public fora to engage individuals in discussions on these issues. Moreover, through our dialogues with leaders of major religious traditions and denominations and individual members of the clergy, we encourage greater mutual understanding of the ethical and social aspects of biotechnology and its uses.

BIO's Statement of Principles declares:

The resolution of bioethical issues requires broad public discourse. We acknowledge our responsibility to consider the interests and ideas of all segments of society and to be sensitive to cultural and religious differences. We will seek dialogue with patients, ethicists, religious leaders, health-care providers, environmentalists, consumers, legislators and other groups who share an interest in bioethical issues.

BIO members have a profound respect and appreciation for the cultural values that motivate research and development activities. We value that our nation's political system, through the Bill of Rights, has given rise to a culture grounded in free and open debate regarding human values, aspirations, and needs. For our part, we are acutely aware that as knowledge and human opportunities increase, we must continually re-examine our vision to ensure that biotechnology is used to benefit human kind.

Thus, we appreciate the Council's efforts to join this rich, ongoing public discourse through your Request For Comments ("Request") published in the Federal Register on March 24, 2003. We are, however, perplexed by what appears to be a precipitous leap to investigate the current regulatory systems that assure the safety, efficacy, and appropriateness of assisted reproduction, embryo research, and human genetics research. In providing a forum for a national discussion of these issues, we would have expected you to keep the Council's priorities focused on facilitating a greater understanding based on a consideration of "the need for policy guidance and public education ...; [and] the connection ... to the goal of Federal advancement of science and technology."/2 Although the Council has been charged with investigating bioethics issues, including these topics, in order to advise the President,/3 your request for comments on the "legal authority and institutional competence of the Food and Drug Administration"/4 suggests that the Council is seeking a new and different mandate than the one established by the President on November 29, 2001./5

As noted, the existing regulatory and ethical framework within which biotechnology companies operate has successfully protected patients while allowing critical research to advance. Appropriately, current regulations embody values such as autonomy (for example, whether to participate in a clinical trial), beneficence, and social justice. These values should remain the basis of any regulatory system. In addition, personal autonomy and privacy as well as academic freedom should be a crucial part of the discourse for further understanding the use of what you call "new technologies and practices" in assisted reproduction, embryo research, and human genetics./6

The American legal system is grounded in the fundamental right of individuals to define their own existence through personal and shared decision making. BIO members share the belief inherent in American civil rights laws that our lives are not preordained by our genetics, but are often the result of the choices that individuals make, the choices that parents make for their dependents and the opportunities available in our communities and our physical environment. Individual freedom to make life-altering choices are "central to personal dignity and autonomy." /7 Choices such as whom to marry, whether to have children, how to raise those children, and whether to accept or refuse medical care, have long been protected by the Constitution. /8 The individual has a right to make these decisions, including health care decisions, whether or not biotechnology products or an understanding of genetic factors is involved.

Certainly, an individual's personal decisions affect those around us, including our children. Yet our Constitutional tradition so values our right to make these decisions that it requires the state to have a compelling interest for intruding on the individual's freedom. It has long been established in our law that the government's interest in improving citizens' morals in and of itself does not permit the imposition of a regulatory scheme rooted in one or another particular moral vantage point. The United States Supreme Court established in 1923, "[t]hat the state may do much, go very far, indeed, in order to improve the quality of its citizens, physically, mentally and morally, is clear; but the individual has certain fundamental rights which must be respected." /9

The individual's freedom of self-determination extends to parental rights. American law and societal norms have historically respected the family's right to autonomy, and have long recognized parents' rights and responsibilities to make important decisions that affect their children's futures. /10 These rights and duties should be read to include the responsible use of genetic information as well as other medical, social and personal information about the child. Americans would be justifiably concerned about any attempt by the state to curtail parental rights based on a spurious distinction between genetic and other medical knowledge.

The exercise of personal autonomy relies upon the freedom to learn about the world around us. Since the nation's founding, America has "regarded education and acquisition of knowledge as matters of supreme importance which should be diligently promoted." /11 The Supreme Court has been highly skeptical of intrusions into the freedom to teach and learn. /12

BIO strongly supports education about biotechnology and genetics and the freedom to explore their potential uses for the benefit of humankind. Teaching and learning are essential not only to the advancement of science, but also the broadening of human minds. State and federal regulatory systems must support and promote the "freedom of responsible inquiry" /13 which is at the heart of First Amendment-protected academic freedom. Any efforts by the state to regulate research must not interfere with in "that restless, enduring process of extending the bounds of understanding and wisdom, to assure which the freedoms of thought, of speech, of inquiry, of worship are guaranteed by the Constitution of the United States against infraction by national or state government." /14

These values animate our members' research and their development of products that licensed practitioners use to provide services that may be elected by individuals for themselves and their children. Such products and services allow millions of people to pursue their own destinies as they choose to live productive and healthy lives.

Conclusion. Members of the biotechnology industry respect the power of the technology they are developing, and accept the need for appropriate regulation. In our view, appropriate regulation of biotechnology is solidly rooted in values such as autonomy, privacy, beneficence, social justice, and intellectual freedom.

BIO works with state, federal and international regulatory bodies to shape the development of regulatory policies that foster safe, effective and beneficial products. Moreover, BIO supports responsible and ethical testing of new technologies and believes that decisions regarding whether and how to use medical products and technologies always must be made with profound respect for the rights of patients.

We cannot condone any form of regulation that curtails the intellectual freedom of researchers to think and dream in the pursuit of greater understanding which could lead to a better life for all of us. Patients and their families are counting on our companies to develop products to meet unmet medical and health care needs. Thank you for the opportunity to express these views.


Michael J. Werner Vice President, Bioethics

/1 Letter from Leon R. Kass, Chairman, President's Council on Bioethis letter to Carl Feldbaum, President, Biotechnology Industry Organization (March 14, 2003).
/2 Executive Order 13237, Section 2(a) and (f).
/3 Executive Order 13237, Section 2(a)-(b).
/4 68 Fed. Reg. 14239 (March 24, 2003).
/5 The Council's Charter explicitly denies it responsibility for "devising and overseeing regulations for specific government agencies." Executive Order 13237, Section 2(d).
/6 See note 1, Kass letter to Feldbaum.
/7 Casey, 505 U.S. 833, 581 (1992).
/8 See, e.g., Loving, 388 U.S. 1 (1967); Griswold, 381 U.S. 479 (1965); Pierce, 268 U.S. 510 (1925); Cruzan, 497 U.S. 261 (1990).
/9 Meyer, 262 U.S. 390, 401 (1923).
/10 See, e.g., Pierce, 268 U.S. 510 (1923).
/11 Meyer, 262 U.S. 390, 400 (1923).
/12 Barenblatt, 360 U.S. 109, 112 (1959).
/13 Wieman, 344 U.S. 183, 196 (Frankfurter concurrence).
/14 Wieman, 344 U.S. 183, 196 (Frankfurter concurrence).