Three-parent Babies and Fda Jurisdiction: the Case for Regulating Three-party in Vitro Fertilization as a Drug and Biologic

• Publication year: 2022

53 Creighton L. Rev. 427. THREE-PARENT BABIES AND FDA JURISDICTION: THE CASE FOR REGULATING THREE-PARTY IN VITRO FERTILIZATION AS A DRUG AND BIOLOGIC

THREE-PARENT BABIES AND FDA JURISDICTION: THE CASE FOR REGULATING THREE-PARTY IN VITRO FERTILIZATION AS A DRUG AND BIOLOGIC

-Hallie A. Hamilton '21

I. INTRODUCTION

The United States Food and Drug Administration ("FDA") should prepare itself for a legal battle over a question of jurisdiction: advanced assisted reproductive technologies in general and three-party in vitro fertilization ("IVF") in particular. ^[1] In 2001, the FDA asserted jurisdiction over cytoplasmic transfer, a three-party IVF technique, as a drug and a biologic. ^[2] In the United States at the time, at least twenty-three children had been born through the technique, three clinics had published research about the procedure, and five clinics were advertising cytoplasmic transfer online. ^[3]

Under the FDA's theory that three-party IVF is a drug and biologic, researchers and practitioners need to complete an Investigational New Drug ("IND") application. ^[4] This is a time-consuming and expensive process. ^[5] In 2015, the government went a step further by preventing the FDA from issuing INDs for publicly or privately funded research through the omnibus spending bill. ^[6] If the FDA has jurisdiction to regulate three-party IVF as a drug and biologic, the addition of the language in the omnibus spending bill results in a de facto ban on three-party IVF in the United States. ^[7] Despite the de facto ban, a groundswell of public interest coupled with an increasing demand for the procedure is likely to stir up legal battles. ^[8]

Academics, journalists, and bloggers alike are fascinated by the ethical, political, and scientific questions surrounding three-party IVF. ^[9] In an age where many people get their news from Facebook and Twitter, three-party IVF lends itself to click-bait titles that are difficult to pass by. ^[10] For example, publishers have written: First 'three person baby' born using new method; 3 biological parents, 1 child, and an international controversy; First child born with THREE PARENTS - medical breakthrough or designer baby nightmare? ^[11] As news sources cover developments in other countries, interest in three-party IVF in the United States will also likely increase. ^[12] Three-party IVF babies have been born in Mexico, Ukraine, and Greece. ^[13] In addition, the United Kingdom legalized three-party IVF to prevent mitochondrial disease, and in 2018, Singapore considered doing the same. ^[14] With its immense promise to prevent genetic disease, treat infertility, and give lesbian women the opportunity to have a child with two genetic mothers, squeamishness about three-parent babies will quickly wear away and be replaced by the outcry that the procedure should be available in the United States. ^[15]

The FDA's jurisdiction to regulate three-party IVF and other comparable techniques, such as cloning and stem cells, has been questioned. ^[16] Despite the fertile ground this question has provided for academics, legal challenges were scarce and one did not arise until 2009. ^[17] In United States v. Regenerative Sciences LLC, ^[18] a company marketing a stem-cell therapy challenged the FDA's asserted authority to regulate the therapy. ^[19] Regenerative acted as a lone, brave wolf and challenged the FDA's jurisdiction to regulate the stem-cell mixture as a drug or a biological product-and lost. ^[20] This case sheds light on the FDA's broad authority to regulate human cells and tissues as drugs or biological products, including three-party IVF. ^[21]

This Note argues the courts should, and likely will, uphold the FDA's jurisdiction over three-party IVF. ^[22] Section II provides a brief overview of three key areas: (1) the basics of three-party IVF, (2) the FDA's regulatory scheme, and (3) a recent United States District Court decision on FDA jurisdiction over a stem-cell procedure. ^[23] Section III establishes that the text of relevant federal legislation provides the FDA jurisdiction to regulate three-party IVF. ^[24] Subsequently, this Note discusses why common objections to FDA jurisdiction over three-party IVF are insufficient. ^[25] In conclusion, the FDA has authority to regulate three-party IVF under the current statutory regime, and careful regulation will protect future children conceived through the technique from unnecessary risks. ^[26]

II. BACKGROUND

A. THE BASICS OF THREE-PARTY IVF: WHAT IT IS, WHAT IT IS FOR, AND THE ASSOCIATED SAFETY AND ETHICAL CONCERNS

1. Three-Party IVF: Scientists Manufacturing Children with Three Genetic Parents

Traditional in vitro fertilization ("IVF") refers to the process by which eggs are harvested from ovaries, fertilized outside the womb, and implanted into the uterus. ^[27] Three-party IVF is the process by which an egg that contains the genetic material of three persons, rather than two, is manufactured, fertilized, and implanted into the uterus. ^[28] After the egg is implanted, the woman's body begins to change, and the single, altered cell eventually becomes a living, breathing human-one with three biological parents. ^[29] These three-parent babies are created using an egg from the intended mother, an additional egg from a donor, and a sperm. ^[30] This feat of science is made possible by transferring the nucleus of the intended mother's egg into an enucleated donor egg either before fertilization or after fertilization at the one-cell zygote stage. ^[31]

At the most basic level, a cell is composed of a cell membrane, cytoplasm, and organelles. ^[32] The cell membrane serves as a permeable wall around the cell, while the cytoplasm inside the cell membrane is home to the cell's organelles. ^[33] Two examples of organelles are the nucleus and the mitochondria. ^[34] The nucleus and the mitochondria contain different deoxyribonucleic acid ("DNA"): nuclear DNA and mitochondrial DNA. ^[35] Humans receive half of their nuclear DNA from their mother, and the other half from their father. ^[36] However, mitochondrial DNA is inherited from the mother because sperm cells do not transfer mitochondria during fertilization. ^[37]

Nuclear DNA is responsible for cell growth and reproduction, as well as animal and plant physical characteristics. ^[38] Scientists currently estimate the human genome consists of approximately 19,000 to 21,000 gene pairs. ^[39] With just thirty-seven gene pairs, mitochondrial DNA comprise only a fraction of a percent of total human DNA, but its role is indispensable to cell function. ^[40] Mitochondrial DNA is responsible for converting food into energy for cells. ^[41] In addition, these thirty-seven gene pairs have an impact on the expression of the nuclear genome. ^[42] For example, a recent study on mice suggested that altering mitochondrial DNA impacted the development of cardiomyopathy caused by a mutation in the nuclear DNA. ^[43] Three-party IVF aims to manufacture and implant an embryo with the nuclear DNA of one woman and the mitochondrial DNA of another woman. ^[44]

2. The Potential Uses of Three-Party IVF: Treating Infertility, Preventing Mitochondrial Disease, and Manufacturing a Child with Two Genetic Mothers

The first successful pregnancies from cytoplasmic transfer, the earliest form of three-party in vitro fertilization ("IVF"), were reported in 1997. ^[45] Cytoplasmic transfer was developed as a treatment for infertility. ^[46] Female fertility is acutely affected by age. ^[47] Researchers suspect that factors in the cytoplasm of an older woman's egg cells can cause abnormalities to develop early in the division process. ^[48] Research shows that transferring even a small amount of the cytoplasm from a healthy, younger woman's egg into an older woman's egg can improve fertility outcomes. ^[49] Because the mitochondria are in the cytoplasm, children born via this technique have some of the mitochondrial deoxyribonucleic acid ("DNA") of the egg donor. ^[50]

Although initially developed to treat infertility, three-party IVF is growing in prominence due to its potential in another area: mitochondrial disease prevention. ^[51] Mitochondrial disease occurs when a person inherits dysfunctional mitochondria. ^[52] Dysfunctional mitochondria can result in a host of mild to severe genetic disorders and, in rare cases, death. ^[53] Three-party IVF has the potential to allow a woman at a high risk for passing on dysfunctional mitochondria to have a child who is biologically related to her and free of mitochondrial disease. ^[54] Three-party IVF prevents the transmission of the mother's damaged mitochondria to the child by substituting the mitochondria of a healthy donor egg. ^[55] Previously, a woman at risk of passing on mitochondrial disease had few options: use an egg donor or adopt-neither of which provide genetic affinity. ^[56] Three-party IVF may be a more popular option than egg donation or adoption because it gives the woman the opportunity to have a healthy child that also shares her nuclear DNA. ^[57]

In addition to the infertile and those with mitochondrial disease, a third demographic with an interest in three-party IVF is lesbian women. ^[58] Children born through three-party IVF have a genetic connection to two women-the woman who provided the nuclear DNA and the woman who provided the mitochondrial DNA. ^[59] Lesbian women may seek three-party IVF for the same reason infertile women and those...