Michael J. Malinowski, Ernest R. and Iris M. Eldred Endowed Professor of Law. This article draws heavily from the author¥s related work, Choosing the Genetic Makeup of Our Children: Our Eugenics Past-Present, and Future?, 36 CONN. L. REV. 125 (2003), and his participation in this Symposium, Creating Life? Examining the Legal, Ethical and Medical Issues of Assisted Reproductive Technologies (Oct. 8-9, 2004). The author would like to thank Professors Nanette Elster and Ellen Waldman for their thoughtful suggestions. This article was submitted for publication in summer 2005 and does not necessarily reflect changes thereafter.
The awesome capability to intervene at the beginning of human life through medicine-to actually enable the creation of life and choices about human characteristics-has burgeoned in recent years and continues to expand at an ever-quickening pace.1 Assisted reproduction technology (ART) has become an increasingly accessible means for prospective parents to realize parenthood when confronting human health impediments- overcoming infertility, or avoiding an identifiable genetic risk or health impairment. Assisted reproduction (AR), which is carried out in the United States predominantly in hundreds of private, independent clinics, has become a vibrant, highly competitive business that markets itself aggressively and generates billions of dollars annually.2
The revolution in human reproduction through AR (reproduction Page 550 revolution) is broadening parental choice about whether to have children and what genetic characteristics those children will or will not have.3 This reproduction revolution and the genomics revolution, both ongoing and raging, are becoming intertwined through the use of AR technologies.4
Colleagues have termed the nexus "reprogenetics."5 Professor John Robertson, a visionary immersed in the law and policy aspects of AR and genomics, has predicted our society¥s destiny in reprogenetics. As observed by Professor Robertson, "Ultimately, decisions about how to use or not use genomics in human reproduction will be determined, not by biologic necessity or evolutionary theory, but by how those uses fit into the fabric of rights and interests of individual and social choice and responsibility that particular societies recognize."6
The objective of this Article is to question the role of regulation in the field of AR at the present time and over the next several years as the genomics and AR revolutions continue to intensify and integrate. Part II discusses the extent to which AR is a distinguishable field of medicine, and does so from the often conflicting perspectives of patient, provider, and payer. Part III probes the United States¥ unique level of acceptance of AR among industrialized countries, attributable largely to a trilogy of deferences: to human reproduction, to the physician¥s discretion to practice medicine, and to physician-patient decision making. The Article concludes Page 551 that assurance of good medical practices and public accountability through regulation are at least as desirable in AR as in most other areas of medicine. Proposals for regulatory reform include a comprehensive, national licensing requirement for all AR services and the establishment of a federal overseeing authority.
AR is generally performed as a medical clinical service,7 and the Food and Drug Administration¥s jurisdiction historically has been checked not to interfere with physician discretion to practice medicine.8 In fact, the Fertility Clinic Success Rate and Certification Act of 1992 (FCSRCA)9 expressly provides: "In developing the certification program, the Secretary [of the Department of Health and Human Services] may not establish any regulation, standard, or requirement which has the effect of exercising supervision or control over the practice of medicine in assisted reproductive technology programs."10 Consequently, the United States¥ federal regulation consists almost entirely of self-regulation through a program of voluntary reporting and certification.11 The federal system rests largely upon the FCSRCA, pursuant to which the Centers for Disease Control and Prevention (CDC) developed a model certification program for AR laboratories.12 The CDC has contractually outsourced implementation of its responsibilities Page 552 under the FCSRCA to the Society for Assisted Reproductive Technology (SART) and the American Society for Reproductive Medicine (ASRM).13
Most AR providers belong to these organizations and report data to them voluntarily. SART-ASRM then collects, processes, and submits the data to the CDC, which in turn processes that data in a standard format and issues reports annually for public dissemination.14 In addition to the CDC, the Federal Trade Commission (FTC) has jurisdiction to police marketing claims and has used that authority to investigate some AR providers.15 Some states have done the same.16
This author17 and others, including Professor Lars Noah,18 Erik Parens and Lori Knowles,19 and the Food and Drug Administration (FDA),20 have questioned the sufficiency of this voluntary reporting, self-regulation system in the field of AR.21 The FCSRCA did not even introduce a mandatory mechanism to report adverse events associated with fertility treatments,22 and the CDC performs site visits on fewer than ten percent of AR clinics.23
Moreover, states "have failed to offer much direct regulation of fertility clinics."24 As summarized by the FDA: The model certification program for embryo laboratories developed by the Centers for Disease Control and Prevention (CDC) is a voluntary program that States may or may not choose to adopt; its primary focus is not on preventing the transmission of communicable disease. No State has yet adopted CDC¥s model certification program. Membership in professional societies is voluntary. Moreover, many establishments do not report to the Society for Assisted Reproductive Technology.25
Several features of AR support more direct government regulation by the United States. First, the three primary patient groups at issue- prospective parents, pregnant women, and the unborn-are exceptionally vulnerable, and two of these groups (pregnant women and the unborn) have been deemed as such under the Common Rule for the protection of human subjects.26 Second, rapidly emerging technology, experimentation, and the practice of medicine are inherently mixed in AR-much more so than in most other fields of medicine. Novel techniques are often practiced in AR without the prerequisite of sufficient animal studies and human subjects protection oversight.27 Examples include discovery and clinical use of Page 554 intracytoplasmic sperm injection (ICSI);28 cytoplasmic transfer;29 in vitro ovum nuclear transplantation (IVONT);30 and administering extraordinarily high doses of hormones to premenopausal women to impregnate them, even while physicians are being warned to administer only mild doses of estrogen to postmenopausal women, and just when most needed.31 Nevertheless, the field of AR largely circumvents the United States¥ regulations to protect human subjects because the experimentation generally is deemed an extension of clinical service and is not carried out for product review and approval by the FDA.32 "And since [new interventions in the field] are presented as innovative clinical practice rather than as research, oversight of Page 555 them is left to the discretion of the individuals or institutions offering them."33
A third feature necessitating more government regulation is that the majority of AR patients pay out-of-pocket, which means that standard accountability and good medicine checks on clinical practice through third- party payer scrutiny generally do not pertain.34 Fourth, commercial influences, including aggressive direct-to-consumer (DTC) marketing, are intense in AR and carried out regionally, nationally, and even internationally.35 Much of the marketing data equates "success" with live births, regardless of whether those births are seriously premature or suffer serious health problems.36 Fifth, a significant increase in multiple births, associated with premature delivery and health impairments, has already been attributed to AR services.37
When considering the role of regulation in AR at the present time and over the next several years, the distinguishing features of AR must be thought through in the context of ongoing trends in biomedical research and development (R&D). These trends include the mission to make medical sense out of the map of the human genome; the extraordinary and ongoing commercial, governmental, and academic investment to accomplish that mission; and the voluminous and amassing power of bioinformatics.38 The considerable genotype-phenotype connections (connections between genetic characteristics and physical/mental characteristics) being generated by the Page 556 "genomics revolution" must be taken into consideration.39 Although the vast majority of these genotype-phenotype connections are subtle in the context of human health and even negligible for contemporary clinical health application, the capability to test for large numbers of them simultaneously is becoming remarkably easier.40 As clusters of bits of information become larger, cheaper, and collectively more medically meaningful, presumably so will their appeal to patient-consumers.41
Many predict that consumer-driven medicine is the emergent post- managed care era in United States medicine.42 Certainly a reasonable amount of faith must be placed in the judgment of the...