Who Should Regulate Preimplantation Genetic Diagnosis in the United States?

Abstract

Unlike in many European countries, preimplantation genetic diagnosis (PGD) is not regulated in the United States. As a result, PGD may be used for any condition for which genetic testing is available, at the discretion of fertility specialists and their patients. This essay explores the question of who should be responsible for regulating PGD in the United States. Federal or state regulation of PGD in the United States is likely to be challenging and problematic for several reasons, including the proximity of PGD to the abortion debate. I propose that PGD regulation in the United States can be most appropriately performed by health professionals using professional society guidelines that set standards for clinical practice. Regulatory Lacuna for Preimplantation Genetic Diagnosis in the United States Preimplantation genetic diagnosis (PGD) is a technique that can be used during in vitro fertilization (IVF) to test an embryo for genetic abnormalities associated with specific disorders before deciding which embryo(s) to transfer to a woman's uterus. PGD is primarily used to help people have children who will not be affected by heritable disorders, such as Tay-Sachs or cystic fibrosis. While these applications of PGD might seem clearly beneficial, the technique has also been used for more controversial purposes. In the United States, a small number of clinics offer PGD to select for a disability, such as deafness or achondroplasia. 1 PGD is also widely offered for sex selection; a 2017 study showed that 72.7% of US fertility clinics offer sex selection, and 83.5% of those clinics offer sex selection for couples without infertility, 2 meaning that a couple would only undergo IVF in order to select their child's sex. Furthermore, some worry that PGD could be used to select for traits such as hair color, height, and athletic ability, although these are unlikely to be single-gene traits for which we can easily select in the near term. PGD can be employed for these "nonmedical" purposes in the United States because there are no legal limitations on the technique's use. It can be used for any condition for which genetic testing is available at the discretion of fertility treatment clinicians and their patients. By contrast, many European countries have rigid legal structures that determine for what indications PGD is permissible. 3

Preimplantation Genetic Testing of Multiple Endocrine Neoplasia Type 2A

“…Chen et al presented a similar case of PGT-M in a Chinese couple where the male had MEN 2A (9). Unlike some other countries, in Denmark PGT is not reserved for specific diseases for which the procedure has been approved (19,20). In each individual case the final decision to offer PGT is made by a clinical geneticist and is based on an assessment of the severity of the given disease.…”

Three models for the regulation of polygenic scores in reproduction

“…18 Due to a liberal approach to regulation for assisted reproductive technologies (ARTs) in the USA, this technology can be accessed by any paying customer. 19 Outside the USA, the more common regulatory model is disease-based, allowing selection against certain specified genetic diseases only. Disease-based models exist in various formats in Australia, the UK, Italy, Switzerland and France among others.…”

“…A more libertarian or laissez-faire approach to PGD exists in the USA, where there are no regulations concerning PGD, or funding for its use. 19 Service providers can offer PGD at their discretion for any testable condition. 19 Current professional guidelines simply recommend that decisions be left to clinicians, thus not providing further regulation.…”

“… 19 Service providers can offer PGD at their discretion for any testable condition. 19 Current professional guidelines simply recommend that decisions be left to clinicians, thus not providing further regulation. 19 Consequently, PGD practice is governed by individual clinician decisions and market forces.…”

“… 19 Current professional guidelines simply recommend that decisions be left to clinicians, thus not providing further regulation. 19 Consequently, PGD practice is governed by individual clinician decisions and market forces. Let’s call this the Libertarian Model.…”