The Regulation of Assisted Reproduction

As scientific developments progress, the use of assisted reproductive technology has become increasingly commonplace. Such developments have increased calls for improving the regulation of fertility treatments. The Centers for Disease Control and Prevention (CDC) defines assisted reproductive technology as any fertility treatment in which medical professionals handle or manipulate eggs or embryos. Traditional in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI) are the most common assisted reproductive technology procedures provided by fertility clinics, with IVF targeting female infertility while ICSI addresses male infertility. The first infant conceived in the United States using assisted reproductive technology was born in 1981, but the use of advanced infertility treatments has since increased dramatically. In 2019, approximately 2 percent of all infants born in the United States were conceived through the use of assisted reproductive technology. This translates to over 80,000 infants born in that year. Despite the surging popularity of assisted reproductive technology and the associated rise in the number of fertility clinics, the industry remains largely unregulated. Sometimes referred to as the “Wild West” of fertility treatments, the United States’ regulatory scheme is one in which, as one commentary has provocatively put it, “cash is king and informed consent is optional.” Due to the federal government’s reluctance to fund research on reproductive treatments, the U.S. Department of Health and Human Services exerts only limited oversight over fertility clinics. The U.S. Food and Drug Administration (FDA) limits its oversight of assisted reproductive technology to its general regulation of drugs, devices, and donor tissue, while the CDC tracks laboratory certifications and successful birth rates but shirks many more direct regulatory opportunities. Although a dearth of federal regulatory oversight does leave the states with room to regulate assisted reproductive technology, most states have failed to do so to any substantial degree, relying instead on industry standards and self-regulation to protect patients. In this week’s Saturday Seminar, scholars explore the possibility of reforming and standardizing the regulation of assisted reproductive technology in the United States