The world of assisted reproductive technologies (ART) has forced our society to confront scenarios that were unimaginable a mere quarter century ago. The birth of Louise Brown in 1978, the first child conceived through in vitro fertilization (IVF), introduced to the world the notion of asexual reproduction. The bitter battle over the parental status of Baby M., a baby born by a surrogate mother in the early 1980s, engendered a public debate over the interaction between contract law, family law and reproductive liberties that still rages today. In 1992, the highly publicized divorce of Junior and Mary Sue Davis focused national attention on the issue of proper disposition of frozen embryos. This case highlighted the fact that conception and pregnancy could be separated by a significant amount of time as a result of cryopreservation. While each of these events marked a step forward in the march toward total technological mastery of human reproduction, they also suggest that future struggles involving ART will grow increasingly fierce and complicated as our fund of knowledge increased. This Article suggests that current disputes over the disposition of frozen embryos are emblematic of that struggle.

The global Human Genome Project (HGP) promises dramatic advances in biomedical science and in identifying and treating diseases and illnesses that exact an enormous toll on people throughout the world. The HGP portends a conceptual revolution in health care: many foresee a new “predictive medicine” based on the development of genetic screening, testing and gene therapy.

Although advances in genetic science create the potential for dramatic progress against disease in rich and poor states, they also pose profound national and global policy concerns, including the potential impact of the scientific developments on human rights and public health. The development of more precise genetic information raises the specter of genetic discrimination by public and private sectors in all nations with access to the new technologies. In addition, nations will grapple increasingly with the appropriate balance between screening for and treatment of genetic diseases in order to promote public health and protect individual rights to privacy and confidentiality. Genetic screening and services also raise human rights questions relating to equitable resource allocation and the protection of public health.

Prompted by criticisms of long delays in its drug approval processes, the Food and Drug Administration (FDA or the Administration) took a number of measures in recent years to expedite access and increase availability of new drugs for terminally ill patients. These reforms began in the late 1980s, as acquired immune deficiency syndrome (AIDS) advocacy organizations openly criticized the FDA, noting that its policies were insufficient to address the prevalence of AIDS and the lag time for FDA approval of new AIDS treatments. The FDA's primary responsibility is to promote efficacy and ensure safety of new drugs. Consequently, the FDA must balance patients' desires to obtain new medications to treat serious and lifethreatening illnesses against government's desires to protect patients from abuses of the new drug approval process. The structure of the FDA's regulatory procedures is, therefore, essential to providing safe, effective medical treatments to patients. FDA regulations and guidelines set forth standards and practices that pharmaceutical companies must follow to gain approval of newly developed drugs.