1 Press Release, The Nobel Assembly at Karolinska Institutet, The Nobel Prize in Physiology or Medicine 2010 (Oct. 4, 2010),, https://www.nobelprize.org/prizes/medicine/2010/press-release/ [https://perma.cc/CK2M-NNJE].

2 Id.

3 See Genelle Weule, First IVF Baby's 40 ^th Birthday: How a Tiny Girl Changed Science and the World, ABC News (July 24, 2018), https://www.abc.net.au/news/science/2018-07-25/first-ivf-baby-louise-joy-brown-turns-40/10017032 [perma.cc/BK2Y-XAAY].

4 For example, Professor Daniel Carpenter has observed that “the United States still houses the strongest of global pharmaceutical regulators” after being the first such regulator in the world. Daniel P. Carpenter, Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA 42 (2010).

5 See Lewis, Myrisha S., How Subterranean Regulation Hinders Innovation in Assisted Reproductive Technology, 39 Cardozo L. Rev. 1239, 1242-44, 1247-51 (2018)Google Scholar [hereinafter Subterranean Regulation]. While the first child to be born using mitochondrial transfer was purportedly born in Ukraine, because there is no system of regulation in Ukraine, that country is not a subject of the comparative analysis in this Article. See Susan Scutti, Controversial IVF Technique Produces a Baby Girl – and for Some, That's a Problem, CNN (Jan. 18, 2017), https://www.cnn.com/2017/01/18/health/ivf-three-parent-baby-girl-ukraine-bn/index.html [https://perma.cc/DV2J-4CKH]; see also infra Part III (discussing U.S. and U.K. innovation in assisted reproductive technology).

6 Nina Bai, Three-Parent Babies: The Science of Replacing Mitochondrial DNA and What Remains Unknown, UCSF News Center (Jan. 17, 2017), https://www.ucsf.edu/news/2017/01/405486/three-parent-babies-science-replacing-mitochondrial-dna-and-what-remains-unknown [perma.cc/8NCV-UBUU]; Steve Connor, Three-Parent Baby Pioneer: “The Brits Will be Ahead of the World”, The Independent (Jan. 17, 2015) (“‘At least the Brits get it. They will be ahead of the world. It's too bad it's taken so long. It could have been done 15 years ago. I put my toe in the water and got shark bite, so I'm done with it. It's too bad because it cramps creativity, it inhibits medical progress.’”) (quoting Dr. Jamie Grifo, and American researcher whose work on “three-parent in vitro fertilization” was halted by the U.S. Food & Drug Admin.); Mitochondrial Donation Treatment, Human Fertilisation & Embryology Auth., https://www.hfea.gov.uk/treatments/embryo-testing-and-treatments-for-disease/mitochondrial-donation-treatment/ [https://perma.cc/2AR8-MQDE]. “Three-parent in vitro fertilization” is the colloquial term for mitochondrial donation, which is also referred to as mitochondrial transfer, or mitochondrial donation therapy. See Human Fertilisation & Embryology Auth., Scientific Review of the Safety and Efficacy of Methods to Avoid Mitochondrial Disease Through Assisted Conception: 2016 Update 42, 57 (2016), https://www.hfea.gov.uk/media/2611/fourth_scientific_review_mitochondria_2016.pdf.

7 For more on federalism, see Bagley, Nicholas, Federalism and the End of Obamacare, 127 Yale L.J. Forum 1, 2 (2017)Google Scholar; Zick, Timothy, Are the States Sovereign?, 83 Wash. U. L. Q. 229, 255, 292-94 (2005)Google Scholar. For more on newer forms of ART, see Lewis, Myrisha S., Halted Innovation: The Expansion of Federal Jurisdiction Over Medicine and the Human Body, 2018 Utah L. Rev. 1073, 1100 (2018)Google Scholar [hereinafter Halted Innovation]; Subterranean Regulation, supra note 5, at 1241-45, 1248 (“A cell essentially contains three parts: cytoplasm, nucleus, and mitochondria. The nucleus, which is the center of the cell, is surrounded by cytoplasm. Mitochondria are located in the cytoplasm of the cell.” (citations omitted)). Mitochondrial transfer and cytoplasmic transfer, two techniques of assisted reproductive technology, involve the modification of less than .0001 percent of DNA; however, the modification of DNA (even though it is not the “nuclear DNA” that dictates hair color and eye color for example), has led to opposition to the techniques. Mitochondrial transfer is currently being used to prevent the transmission of genetic disease whereas cytoplasmic transfer was used to improve fertility outcomes. Infra Part III.A.

8 Connor, supra note 6; see Wolf, Don P. et al., Mitochondrial Replacement Therapy in Reproductive Medicine, 21 Trends in Molecular Med. 68, 72 (2015)Google Scholar (“In 1998-1999, cytoplasmic transfer, or the augmentation of patient eggs with a small volume (1-5%) of donor cytoplasm was used by several IVF clinics in an effort to overcome repeated IVF failures in selected patients. The procedure essentially involved co-injection of donor cytoplasm with sperm, as an extension of [intracytoplasmic sperm injection]. Several pregnancies were established before the US FDA, for regulatory purposes, insisted that an investigational new drug application be filed before the success or failure of this approach could be determined.”).

9 See Subterranean Regulation, supra note 5, at 1259-62.

10 See id. at 1256, 1259-62 (discussing the “chilling effects” of the FDA's method of regulation on advanced assisted reproductive technologies including cytoplasmic transfer and mitochondrial donation).

11 Id. at 1271-79.

12 See sources cited infra note 117 and accompanying text discussing the work of Dr. John Zhang, a U.S.-based physician, in Mexico; infra notes 195, 199 discussing reproductive and medical tourism.

13 See infra Part III; see also Doctors Given Approval for UK's First ‘Three-Person Babies', BBC News (Feb. 2, 2018), https://www.bbc.com/news/health-42918341 [https://perma.cc/U92N-LTEE].

14 See DuVivier, K.K., The United States as a Democratic Ideal? International Lessons in Referendum Democracy, 79 Temp. L. Rev. 821, 855 n. 245 (2006)Google Scholar; Daniel Kelemen, R., Europe's Other Democratic Deficit: National Authoritarianism in Europe's Democratic Union, 52 Gov't & Opposition 211, 211Google Scholar (“For years, many scholars of European integration have argued that the EU suffers from a democratic deficit, due to the lack of public engagement and political accountability at the EU level and the absence of a common public sphere or common demos characteristic of national democracies.”); id. at 211 n.1; Sieberson, Stephen C., The Proposed European Union Constitution - Will it Eliminate the EU's Democratic Deficit?, 10 Colum. J. Eur. L. 173, 174 (2004)Google Scholar; id. at 195 (“‘Democratic deficit … refers to the legitimacy problems of non-majoritarian institutions, i.e., institutions which by design are not directly accountable to the voters or to their elected representatives.’” (citing Majone, Giandomenico, Europe's ‘Democratic Deficit’: The Question of Standards, 4 Eur. L.J. 5, 15 (1998)Google Scholar).

15 See Follesdal, Andreas & Hix, Simon, Why There is a Democratic Deficit in the EU: A Response to Majone and Moravcsik, 44 J. Common Mkt. Stud. 533, 534 (2006)Google Scholar (“There is no single meaning of the ‘democratic deficit’. Definitions are as varied as the nationality, intellectual positions and preferred solutions of the scholars or commentators who write on the subject. Making a similar observation in the mid-1990s, Joseph Weiler and his colleagues set out what they called a ‘standard version’ of the democratic deficit.”); 534-36 (providing five elements of a “standard version” of the democratic deficit: “First, and foremost, European integration has meant an increase in executive power and a decrease in national parliamentary control… Second, and related to the first element, most analysts of the democratic deficit argue that the European Parliament is too weak…. Third, despite the growing power of the European Parliament, there are no ‘European’ elections…. Fourth, even if the European Parliament's power were increased and genuine European elections were able to be held, another problem is that the EU is simply ‘too distant’ from voters…. Fifth, European integration produces ‘policy drift’ from voters' ideal policy preferences.”); Lindseth, Peter L., Democratic Legitimacy and the Administrative Character of Supranationalism: The Example of the European Community, 99 Colum. L. Rev. 628, 657, 684 (1999)Google Scholar.

16 See Subterranean Regulation, supra note 5, at 1241-45; infra Part III;.

17 See Goodwin, Michele, Prosecuting the Womb, 76 Geo. Wash. L. Rev. 1657, 1693 (2008)Google Scholar; Hecht, Alexander N., The Wild Wild West: Inadequate Regulation of Assisted Reproductive Technology, 1 Hous. J. Health L. & Pol'y 227, 228 (2001)Google Scholar; see also Naomi R. Cahn, Test Tube Families: Why the Fertility Market Needs Legal Regulation vii, 1-10 (2009); Debora L. Spar, The Baby Business: How Money, Science, and Politics Drive the Commerce of Conception 5 (2006); Cahill, Courtney M., The Oedipus Hex: Regulating Family After Marriage Equality, 49 U.C. Davis L. Rev. 183 (2015)Google Scholar; Chan, Naomi R. & Collins, Jennifer M., Eight is Enough, 103 Nw. U. L. Colloquy 501, 507 (2009)Google Scholar; Daar, Judith F., Regulating Reproductive Technologies: Panacea or Paper Tiger?, 34 Hous. L. Rev. 609, 615 (1997)Google Scholar (“[Assisted reproductive technology] is subject to little formal regulation”); Garrison, Marsha, Regulating Reproduction, 76 Geo. Wash. L. Rev. 1623 (2008)Google Scholar; Greely, Hank, Cloning and Government Regulation, 53 Hastings L.J. 1085, 1089–90 (2002)Google Scholar; Lorio, Kathryn V., The Process of Regulating Assisted Reproductive Technologies: What We Can Learn from Our Neighbors-What Translates and What Does Not, 45 Loy. L. Rev. 247, 247 (1999)Google Scholar; Mutcherson, Kimberly M., Blood and Water in a Post-Coital World, 49 Fam. L. Q. 117, 127 (2015)Google Scholar; Noah, Lars, Assisted Reproductive Technologies and the Pitfalls of Unregulated Biomedical Innovation, 55 Fla. L. Rev. 603, 614-15 (2003)Google Scholar; Bernstein, Gaia, Regulating Reproductive Technologies: Timing, Uncertainty, and Donor Anonymity, 90 B.U. L. Rev. 1189, 1196–1205 (2010)Google Scholar; Carbone, June & Gottheim, Paige, Markets, Subsidies, Regulation, and Trust: Building Ethical Understandings into the Market for Fertility Services, 9 J. Gender Race & Just. 509, 511 (2006)Google Scholar (“The regulation of fertility services involves the creation of norms about a new and rapidly growing technology.).

18 See Jost, Timothy S., Health Law and Administrative Law: A Marriage Most Convenient, 49 St. Louis U. L. J. 1, 14-16, 29 (2004)Google Scholar; infra Part I.B.

19 See, e.g., Farber, Daniel A. & O'Connell, Anne J., The Lost World of Administrative Law, 92 Tex. L. Rev. 1137, 1137 (2014)Google Scholar (identifying administrative law's goals as “transparency, rule of law, and reasoned implementation of statutory mandates”); Hammond, Emily & Markell, David L., Administrative Proxies for Judicial Review: Building Legitimacy from the Inside-Out, 37 Harv. Envtl. L. Rev. 313, 316 (2013)Google Scholar (identifying “administrative law values of participation, deliberation, and transparency, which guard against arbitrariness and foster accountability”); Jost, supra note 18, at 1 (referring to the concept of “health-care administrative law”); id. at 9-14; Livermore, Michael A., Political Parties and Presidential Oversight, 67 Ala. L. Rev. 45, 110 (2015)Google Scholar; Rohrschneider, Robert, The Democracy Deficit and Mass Support for an EU-Wide Government, 46 Am. J. of Poli. Sci. 463, 463 (2002)Google Scholar; Seifter, Miriam, Second-Order Participation in Administrative Law, 63 UCLA L. Rev. 1300, 1302 (2016)Google Scholar (“[P]ublic participation is a cornerstone of administrative law.”)

20 Marchant, Gary, Resilience: A New Tool in the Risk Governance Toolbox for Emerging Technologies, 51 U.C. Davis L. Rev. 233, 245 (2017)Google Scholar.

21 See Bignami, Francesca, From Expert Administration to Accountability Network: A New Paradigm for Comparative Administrative Law, 59 Am. J. Comp. L. 859, 860 (2011)Google Scholar (“Comparative administrative law… seeks to uncover the similarities and differences that mark multiple legal systems.”); Rose-Ackerman, Susan, Comparative Administrative Law: Outlining a Field of Study, 28 Windsor Y.B. Access Just. 435, 436 (2010)CrossRefGoogle Scholar. For more on comparative health law, see generally Hoffmann, Diane, Comparative Health Law and Policy: What, If Anything, Can We Learn from Other Countries?, 37 J.L. Med. & Ethics 790 (2009)Google Scholar.

22 See Sandy Ong, Singapore Could Become the Second Country to Legalize Mitochondrial Replacement Therapy, Science (Jun. 6, 2018), http://www.sciencemag.org/news/2018/06/singapore-could-become-second-country-legalize-mitochondrial-replacement-therapy [https://perma.cc/BTY2-PMSX]; Scientists Say it's Time to Make ‘3-Parent Baby’ Technology Legal in Canada, CBC Radio (Mar. 26, 2018), https://www.cbc.ca/radio/quirks/march-24-2018-an-alien-looking-skeleton-three-parent-families-in-canada-and-more-1.4588650/scientists-say-it-s-time-to-make-3-parent-baby-technology-legal-in-canada-1.4588671 [https://perma.cc/ZN5R-SZ4C] (providing comment of Health Canada on possible legal changes to accommodate new forms of assisted reproductive technology, “Health Canada is the federal authority responsible for administering and enforcing the Assisted Human Reproduction (AHR) Act. The AHR Act prohibits a person from knowingly altering the genome of a cell of a human being or in vitro embryo such that the alteration is capable of being transmitted to descendants. Genome is defined in the AHR Act as the totality of the deoxyribonucleic acid (DNA) sequence of a particular cell. Since mitochondrial replacement therapy involves the introduction of mitochondrial DNA from a third party and since the introduced DNA is capable of being inherited by the resulting embryo, a person performing this procedure in Canada would be violating a provision of the AHR Act…. After the current regulatory project is complete, the Department will consider the need to amend the Assisted Human Reproduction (AHR) Act to reflect advances in science that have taken place since the Act was first enacted in 2004. This will include revisiting the prohibition in the Act that currently makes it illegal in Canada for a person to conduct mitochondrial replacement therapy (MRT). Health Canada recognizes the promise that the application of this technology, and other technologies that create heritable changes to the genome, may hold. However, further consideration is required, including whether changes to the prohibitions would continue to reflect the values of Canadians, before such changes could be contemplated.”).

23 See Subterranean Regulation, supra note 5, at 1241. This Article focuses on forms of assisted reproductive technology involving genetic modification such as mitochondrial transfer and cytoplasmic transfer, although as will be explained in Parts III and IV, the lessons from this Article, which addresses medical techniques that are accompanied by ethical controversy, could eventually be relevant in similar studies of gene editing technologies. This Article focuses on assisted reproductive technology involving heritable genetic modifications, and while there are some aspects of it that are similar to gene editing (and many that are not), comparative aspects of the regulation of gene editing will be the focus of a subsequent Article.

24 Andrews, Lori B. & Douglass, Lisa, Alternative Reproduction, 65 S. Cal. L. Rev. 623, 631 (1991)Google Scholar; see Frequently Asked Questions: Gynecologic Problems, Am. College of Obstetricians & Gynecologists (Oct. 2017), https://www.acog.org/Patients/FAQs/Treating-Infertility?IsMobileSet=false#assisted [https://perma.cc/V9ZY-R8XC]. For an overview of the mechanics of in vitro fertilization, see Robertson, John A., Embryos, Families, and Procreative Liberty: The Legal Structure of the New Reproduction, 59 S. Cal. L. Rev. 939, 944-52 (1986)Google Scholar.

25 Andrews & Douglass, supra note 24, at 631; see Noah, Lars, Assisted Reproductive Technologies and the Pitfalls of Unregulated Biomedical Innovation, 55 Fla. L. Rev. 603, 608 (2003)Google Scholar (characterizing in vitro fertilization as “represent[ing] the paradigmatic form of ART”).

26 What is Assisted Reproductive Technology?, Ctrs. for Disease Control & Prevention (Feb. 7, 2017), https://www.cdc.gov/art/whatis.html [https://perma.cc/Q5B7-W25L].

27 Id.; see 42 U.S.C. §§ 201, 263a-1-a-7 (2012); Heled, Yaniv, The Regulation of Genetic Aspects of Donated Reproductive Tissue—The Need for Federal Regulation, 11 Columbia Sci. & Tech. L. Rev. 243, 250-51 (discussing the Fertility Clinic Success Rate Act of 1992)Google Scholar; King, Jamie, Predicting Probability: Regulating the Future of Preimplantation Genetic Screening, 2 Yale J. Health Law, Pol'y, & Ethics 101, 153 (2008)Google Scholar (noting that “[o]verall, the CDC has very limited power over ART clinics. [The Fertility Clinic Success Rate Act] specifically states that 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 ART programs.”).

28 See Nat'l Research Council, Scientific and Medical Aspects of Human Reproductive Cloning 61 (2002); Assisted Reproductive Technology, Nat'l Cancer Instit. Dictionary of Genetics Terms, https://www.cancer.gov/publications/dictionaries/genetics-dictionary/def/assisted-reproductive-technology [https://perma.cc/GA6B-9N3L] (“A term used to describe collectively a number of noncoital methods of conception that are used to treat infertility with donor or nondonor eggs and sperm including in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), and zygote intrafallopian transfer (ZIFT). Also called ART.”); Assisted Reproductive Technologies, Soc'y for Assisted Reproductive Tech., https://www.sart.org/topics/topics-index/assisted-reproductive-technologies/ [https://perma.cc/SFT2-V8SC].

29 Nat'l Health Serv., Clinical Commissioning Policy: Assisted Conception, Reference, 2014, : NSC/037, at 5-7, 9, https://www.england.nhs.uk/commissioning/wp-content/uploads/sites/12/2014/11/nsc037.pdf (“Assisted reproduction [:] The collective name for treatments designed to lead to conception by means other than sexual intercourse. Assisted reproduction techniques include intrauterine insemination (IUI), in vitro fertilisation (IVF), intracytoplasmic sperm injection (ICSI) and donor insemination (DI). The term ‘assisted reproduction technology’ (ART) is the term sometimes used to collectively describe these procedures and interventions.”); Explore Fertility Treatments, Human Fertilisation & Embryology Auth. (Nov. 9, 2018), https://www.hfea.gov.uk/treatments/explore-all-treatments [https://perma.cc/KH8M-DN36] (describing intrauterine insemination (IUI), in vitro fertilization, Intracytoplasmic sperm injection (ICSI), fertility drugs, IVF options, surgical sperm extraction, surgery, and surrogacy); Fertility Problems: Assessment and Treatment, Clinical Guideline [CG156], Nat'l Inst. for Health & Care Excellence (Feb. 2013), https://www.nice.org.uk/guidance/cg156/ifp/chapter/assisted-reproduction [https://perma.cc/6CFD-4CYX] (“Assisted reproduction [:] Assisted reproduction is the name given to treatments that can help you get pregnant without you having sexual intercourse. There are a variety of treatments, and what is suitable for you will depend on your own circumstances. The options include: intrauterine insemination (IUI)[;] in vitro fertilisation (IVF)[;] IVF with intracytoplasmic sperm injection (ICSI)[;] the use of donor sperm (donor insemination) or eggs (egg donation)…. Other methods of assisted reproduction called gamete intrafallopian transfer (GIFT) or zygote intrafallopian transfer (ZIFT) are not recommended. Certain forms of assisted reproduction (IUI, IVF, ICSI, donor insemination and egg donation) are regulated by law and their use is controlled by the Human Fertilisation and Embryology Authority”); How We Regulate, Human Fertilisation & Embryology Auth., https://www.hfea.gov.uk/about-us/how-we-regulate/ [https://perma.cc/TF4S-E8BZ].

30 See Subterranean Regulation supra note 5, at 1248-49 (“A cell essentially contains three parts: cytoplasm, nucleus, and mitochondria. The nucleus, which is the center of the cell, is surrounded by cytoplasm. Mitochondria are located in the cytoplasm of the cell.” (citations omitted)); see also Amato, Paula et al., Three-Parent IVF: Gene Replacement for the Prevention of Inherited Mitochondrial Diseases, 101 Fertil. Steril. 31, 32–34 (2014)Google Scholar.

31 For more explanation of how the various techniques of mitochondrial transfer operate, see Reznichenko, A.S. et al., Mitochondrial Transfer: Implications for Assisted Reproductive Technologies, 11 Applied & Translational Genomics 40, 41–44 (2016)Google Scholar; Wang, Tian et al., Polar Body Genome Transfer for Preventing the Transmission of Inherited Mitochondrial Diseases, 157 Cell 1591, 1591 (2014)Google Scholar; Wolf et al., supra note 8, at 69-71.

32 See Nuffield Council on Bioethics, Novel techniques for the prevention of mitochondrial DNA disorders: an ethical review vii, 36 (2014) (“The main difference between [maternal spindle transfer and pronuclear transfer] is that MST uses two unfertilized eggs to reconstruct an egg with healthy mitochondria that can be fertilized; in PNT, two early embryos (zygotes) are used to reconstruct an embryo with healthy mitochondria.”); Mitochondrial Donation Treatment, supra note 6.

33 See Nuffield Council on Bioethics, supra note 32, at 34.

34 Subterranean Regulation, supra note 5, at 1248-50.

35 Id.

36 See Robertson, supra note 24, at 1035-36 (“With adequate peer involvement, more explicit legal controls, such as the national licensing authority suggested in the Warnock Report, need not take root in American soil.”); Rosato, Jennifer L., The Children of Art (Assisted Reproductive Technology): Should the Law Protect Them from Harm?, 2004 Utah L. Rev. 57, 66 (2004)Google Scholar (“The American Society for Reproductive Medicine (‘ASRM’) is the primary professional organization that oversees the field of reproductive medicine, and the Society of Assisted Reproductive Technology (‘SART’), an affiliated organization, specifically covers IVF programs, in addition to other types of ART programs.”(citations omitted)). The Institute of Medicine's recommendation on the eventual use of mitochondrial transfer in the United States were directed at both the FDA and “professional societies.” See The Nat'l Acads. of Sci., Eng'g. & Med., Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations 7, 71, 99 (2016) (“The committee does not suggest an absolute limit on any eventual applicability of MRT to other conditions or diseases, but rather believes FDA and relevant professional societies need to take a cautious approach, with deliberate attention to ethical, social, and policy issues, in considering any uses of MRT beyond the primary indication of preventing transmission of serious mtDNA disease.” (emphasis added)).

37 See Nuffield Council on Bioethics, supra note 32, at 34.

38 See id.

39 See id. at 36; see also Sabrina Tavernies, His Fertility Advance Draws Ire, N.Y. Times (Mar. 18, 2014).

40 See, e.g., Mendelson, Nina, Disclosing “Political” Oversight of Agency Decision Making, 108 Mich L. Rev. 1127, 1130-31 (2010)Google Scholar; Subterranean Regulation, supra note 5, at 1271-74.

41 See Levinson, Sanford, How the United States Constitution Contributes to the Democratic Deficit in America, 55 Drake L. Rev. 859, 860 (2007)Google Scholar; Nettesheim, Martin, Developing a Theory of Democracy for the European Union, 23 Berkely J. Int'l L. 358, 358-59 n.1 (2005)Google Scholar; see also Deacon, Daniel T., Administrative Forbearance, 125 Yale L.J. 1548, 1589 (2016)Google Scholar (“One persistent criticism of the administrative state, and particularly of broad delegations, is that policy is frequently formulated through allegedly less transparent means. Less visible policymaking may lead to less accountable government.” (citations omitted)).

42 See Rovny, Jan, Approaches to the Democratic Deficit in the European Union, 19 Perspectives: Rev. of Central Eur. Affairs 109, 110, 113 (2003)Google Scholar; see also sources cited supra note 19 and accompanying text (identifying the goals of the American administrative state).

43 See Pippa Norris, Democratic Deficit: Critical Citizens Revisited 3, 5 (2011) (“The gap between aspirations and satisfaction is captured here by the concept of democratic deficits. The notion first arose in debates about the legitimacy of the European Union (EU). The core decision-making institutions in the EU have been regarded by some commentators as falling well short of the standards of democratic accountability and transparency that exist at the national level within each of the member states.”); Levinson, supra note 41, at 861-62 (“There is in fact an interesting debate going on about the extent of the democratic deficit in Europe”); id. at 862-64 (discussing the democratic deficit in the context of election law and American federal and state constitutional law); id. at 862 n.4; Young, Ernest A., Protecting Member State Autonomy in the European Union: Some Cautionary Tales from American Federalism, 77 N.Y.U. L. Rev. 1612, 1639 (2002)Google Scholar [hereinafter Protecting Member State Autonomy]; Schwarzschild, Maimon, Complicated-But Not Too Complicated: The Sunset of E.U. Law in the U.K. After Brexit, 39 Cardozo L. Rev. 905, 905 n.2 (2018)Google Scholar; see also Allan, James, Democracy, Liberalism, and Brexit, 39 Cardozo L. Rev. 879, 887-94 (2018)Google Scholar (discussing “democratic deficiencies” in the context of the European Union); Young, Ernest A., What Can Europe Tell Us About the Future of American Federalism?, 49 Ariz. St. L.J. 1109, 1136 (2017)Google Scholar [hereinafter Future of American Federalism]; Peter Millar, What's all this about the EU's ‘Democratic Deficit’?, The Guardian (May 20, 2013), https://www.theguardian.com/commentisfree/2013/may/20/eu-democratic-deficit. [https://perma.cc/QXF7-PVXF].

44 See Norris, supra note 43, at 5; see also Moravcsik, Andrew, Is There a ‘Democratic Deficit’ in World Politics? A Framework for Analysis, 39 Gov't and Opposition 336, 337 (2004)Google Scholar (noting that the European Union “is widely considered to suffer from a ‘democratic deficit’, the redressing of which was the primary purpose for calling the ongoing constitutional convention and negotiation.”). For more on the democratic deficit in the European Union, see Weiler, J.H.H., The Transformation of Europe, 100 Yale L.J. 2403, 2430, 2466-7, 2469 (1991)Google Scholar.

45 See Harold D. Clarke et al., Brexit 72, 114 (2017); Goodwin, Matthew et al., For and Against Brexit: A Survey Experiment of the Impact of Campaign Effects on Public Attitudes toward EU Membership, British Journal of Political Science, at 1, 5 (2018)Google Scholar; Issacharoff, Samuel, Democracy's Deficits, 85 U. Chi. L. Rev. 485, 493–94 (2018)Google Scholar (“In this sense, the desperate gambit of Prime Minister David Cameron [in using the referendum on the UK's membership in the EU] … well follows the pattern in the European Union of seeking to alter its perceived democratic deficit through greater use of referenda and other tools of direct democracy.” (citations omitted)); Timothy G. Ash, As an English European, This is the Biggest Defeat of my Political Life, The Guardian (Jun. 24, 2016) (discussing “Euroskepticism”).

46 Weiler, supra note 44, at 2465-68 (1991); see Overview, Council of the European Union (Feb. 19, 2019), https://europa.eu/european-union/about-eu/institutions-bodies/council-eu_en [https://perma.cc/34ATRF89]. While there are significant literatures in political science, comparative law, and administrative law that analyze the European Union, this Article only analyzes the European Union in order to illustrate the concept of the democratic deficit, which the Article then uses to examine the regulation of assisted reproductive technology in the United States and United Kingdom.

47 Rovny, supra note 42, at 110, 113; Sieberson, supra note 14, at 195.

48 See Bradley, Curtis A., International Delegations, the Structural Constitution, and Non-Self-Execution, 55 Stan. L. Rev. 1557, 1558 n.3 (2003)Google Scholar; Levinson, supra note 41, at 860 (“The term ‘democratic deficit’ has become a staple in contemporary political analysis.”).

49 See Future of American Federalism, supra note 43, at 1112 (“Finally, the Brexit vote and the parallel rise of Euroskeptic movements in France and other Member States reflects profound popular concerns about the legitimacy of governance at the center. Although the United States has not generally been thought to suffer from the same sort of “democratic deficit” that haunts European discourse, we are experiencing profound frustration with gridlocked and nonresponsive government in Washington, reflected in the precipitous decline in public trust in national governing institutions. We are unlikely to see a ‘Texit’ (or perhaps more likely, a ‘Utexit’ or ‘West Virgexit’) but it is nonetheless time to ask how the eroding legitimacy of national government may affect American federalism.”(citations omitted)); Popovic, Dragoljub, Prevailing of Judicial Activism Over Self-Restraint in the Jurisprudence of the European Court of Human Rights, 42 Creighton L. Rev. 361, 364 (2009)Google Scholar (discussing the democratic deficit in the context of unelected judges in the American judiciary).

50 See sources cited supra note 43 (discussing the democratic deficit in the European Union with an emphasis on the Council of the European Union).

51 Rovny, supra note 42, at 112; see Hickman, Kristin, Unpacking the Force of Law, 66 Vanderbilt L. Rev. 465, 520 (2013)Google Scholar.

52 See infra Part III.B.1.

53 Weiler, supra note 44, at 2465-68; see O'Reilly, James T., Losing Deference in the FDA's Second Century: Judicial Review, Politics, and a Diminished Legacy of Expertise, 93 Cornell L.Rev. 939, 959-60 (2008)Google Scholar (describing the appointment processes for the Secretary of Health and Human Services (appointed by the President to his Cabinet) and the FDA Commissioner and other political appointees at the FDA (who are appointed by the President and confirmed by the Senate).

54 For more on the “democratic deficit” in the context of the United Kingdom and the United States, see Future of American Federalism, supra note 43, at 1112.

55 See Lorio, Kathryn V., The Process of Regulating Assisted Reproductive Technologies: What We Can Learn from Our Neighbors - What Translates and What Does Not, 45 Loy. L. Rev. 247, 248-49 (1999)Google Scholar (“Although no one system, or any combination of systems, may be ideal for the United States to emulate, both understanding and insight may be gained from a comparative analysis.”).

56 While media reports have noted that scientists in China is making headway in the field of mitochondrial transfer, this Article does not focus on the experience of China as it would be difficult to draw lessons from the Chinese experience since the country is known for having a lack of regulation in the area of scientific research. Nevertheless, China's Academy of Sciences has been involved in multiple international germline editing summits. This Article does not explore the issue of whether mitochondrial transfer is “germline editing.” For more on the definition of the germline, see Subterranean Regulation, supra note 5, at 1249-50, 1276-78 (2018). For more on CRISPR-Cas9 gene editing in China, see Dennis Normile, CRISPR Bombshell: Chinese Researcher Claims to Have Created Gene-Edited Twins, Science (Nov. 26, 2018), https://www.sciencemag.org/news/2018/11/crispr-bombshell-chinese-researcher-claims-have-created-gene-edited-twins [https://perma.cc/8RLP-GACW]; Sarah Zhang, Chinese Scientists are Outraged by Reports of Gene-Edited Babies, Science, The Atlantic (Nov. 27, 2018), https://www.theatlantic.com/science/archive/2018/11/china-crispr-babies/576784/ [https://perma.cc/RT2J-62TJ] (“China has spent billions turning itself into a scientific powerhouse, but it still struggles with the perception that its scientists do not take ethics seriously. In 2015, when Chinese scientists raced ahead to use CRISPR to edit genes in human embryos, an international outcry ensued.”).

57 There are of course many similarities and differences between the United States and the United Kingdom, which have been (and continue to be) studied by scholars of comparative law, institutional design, and federalism. This Article only focuses on these similarities and differences as pertinent to the regulation of assisted reproductive technology by the United States and United Kingdom. For background, see Calabresi, Steven G., Does Institutional Design Make A Difference?, 109 Nw. U. L. Rev. 577, 578 (2015)Google Scholar (characterizing the United Kingdom as an “otherwise stable western constitutional democrac[y]”); but see id. at 582-83 (“In important respects, the U.S. federal government is far more powerful than the federal governments of the European Union, Argentina, Brazil, Germany, India, Mexico, Canada, Australia, South Africa, and, since devolution, the United Kingdom.”); see also Laffin, Martin & Thomas, Alys, The United Kingdom: Federalism in Denial?, 29 Publius 89, 90-92, 106 (1999)Google Scholar; Schuck, Peter H., Federalism, 38 Case W. Res. J. Int'l L. 5, 5–6 (2006)Google Scholar; See also Ryan, Erin, Secession and Federalism in the United States: Tools for Managing Regional Conflict in A Pluralist Society, 96 Or. L. Rev. 123, 164 (2017)Google Scholar ()(discussing the United States' “symmetrical federalism” and the United Kingdom's “asymmetrical federalism”);

58 As noted in the preceding footnote, there are of course many differences between lawmaking in the United States and United Kingdom; however, this paragraph (and the Article as a whole) focuses on detailing the aspects of lawmaking in the United States and the United Kingdom that are critical to understanding the regulation of assisted reproductive technology in both countries. Proposed legislation in the United Kingdom is called a “bill”, and an Act is the term applied to a bill that has obtained a majority vote in both the House of Commons and House of Lords and “formal[] agree[ment] by the reigning monarch (known as Royal Assent).” See Bills and Legislation, U.K. Parliament, http://www.parliament.uk/business/bills-and-legislation/ [https://perma.cc/A4HJ-72VJ]; House of Commons, U.K. Parliament, http://www.parliament.uk/business/commons/ [https://perma.cc/HW6A-JUS9] (“[t]he UK public elects 650 Members of Parliament (MPs) to represent their interests and concerns in the House of Commons.”); Members and Their Roles, U.K. Parliament, http://www.parliament.uk/business/lords/whos-in-the-house-of-lords/members-and-their-roles/ [https://perma.cc/UHS8-47VP] (“Members of the House of Lords are appointed by the Queen on the advice of the Prime Minister”); see also Gardbaum, Stephen, Political Parties, Voting Systems, and the Separation of Powers, 65 Am. J. Comp. L. 229, 230 (2017)Google Scholar (“When the same party wins both the White House and Congress, the United States has ‘unified’ government resembling parliamentary systems, notwithstanding the formal separation of the two branches. Only during periods of ‘divided’ government, where different parties control the two branches, does the Framers' conception of institutional checks and balances–of ambition checking ambition–come close to reflecting the reality of American politics.”).

59 See sources cited supra note 58 and accompanying text.

60 What is Secondary Legislation?, U.K. Parliament, http://www.parliament.uk/about/how/laws/delegated/ [https://perma.cc/MS69-VFP2].

61 Because Acts of Parliament are often broad, “[statutory instruments] are used to provide the necessary detail that would be too complex to include in the Act itself.” House of Commons Information Office, Statutory Instruments 2 (2008), https://www.parliament.uk/documents/commons-information-office/l07.pdf.

62 What is Secondary Legislation?, supra note 60; see Commons Debate Statutory Instrument on Mitochondrial Donation, U.K. Parliament (Feb. 3, 2015), http://www.parliament.uk/business/news/2015/february/commons-debate-statutory-instrument-onmitochondrial-donation/ [https://perma.cc/53QC-RXS5]; see Draft Regulations on ‘Three Parent’ IVF Published, Nat'l Health Serv. (Feb. 28, 2014), http://www.nhs.uk/news/2014/02February/Pages/Draft-regulations-on-three-parent-IVF-published.aspx [https://perma.cc/3DMS-A78E].

63 See Commons Debate Statutory Instrument on Mitochondrial Donation, supra note 62; The Human Fertilisation and Embryology (Mitochondrial Donation) Regulations 2015, 2015 No. 572, The Nat'l Archives (Mar. 4, 2015), http://www.legislation.gov.uk/ukdsi/2015/9780111125816/contents [https://perma.cc/GS5L-HUYD].

64 See Peter B. Hutt et al., Food and Drug Law: Cases and Materials 1154 (4th ed. 2014).

65 The Nobel Assembly at Karolinska Institutet, supra note 1.

66 Dep't of Health & Soc. Sec., Report of the Committee of Inquiry into Human Fertilisation and Embryology (1984), https://www.hfea.gov.uk/media/2608/warnock-report-of-the-committee-of-inquiry-into-human-fertilisation-and-embryology-1984.pdf [hereinafter Warnock Report].

67 See Warnock Report, supra note 66. For a chapter-by-chapter summary of the Warnock Report, see Jonathon J. LaTourelle, The Report of the Committee of Inquiry into Human Fertilisation and Embryology (1984), by Mary Warnock and the Committee of Inquiry into Human Fertilisation and Embryology, Embryo Project Encyclopedia (Oct. 2, 2014), https://embryo.asu.edu/pages/report-committee-inquiry-human-fertilisation-and-embryology-1984-mary-warnock-and-committee [https://perma.cc/BV6K-V7BN].).

68 Warnock Report, supra note 66, at 80-86 (providing a “List of Recommendations” related to the clinical use of assisted reproductive technology and research on embryos).

69 Id. at 32. In the United Kingdom, health care is provided by the National Health Service, which was created in 1948. See Blank, Robert H., The United Kingdom: Regulation Through a National Licensing Authority, in Comparative Biomedical Policy: Governing Assisted Reproductive Technologies 121 (2004)Google Scholar. The National Health Service provides free health care for UK residents. See About the NHS, Nat'l Health Serv., (Apr. 13, 2016), http://www.nhs.uk/NHSEngland/thenhs/about/Pages/overview.aspx [https://perma.cc/S3FBLD8E].

70 Warnock Report, supra note 66, at 24-25.

71 Id. at 25.

72 Id.

73 See Warnock, Mary, The Warnock Report, 291 Brit. Med. J. 187, 187-89 (1985)Google Scholar (summarizing the Warnock Report).

74 Gitter, Donna M., Am I My Brother's Keeper? The Use of Preimplantation Genetic Diagnosis to Create A Donor of Transplantable Stem Cells for an Older Sibling Suffering from a Genetic Disorder, 13 Geo. Mason L. Rev. 975, 987 (2006)Google Scholar; Riley, Margaret F. & Merrill, Richard A., Regulating Reproductive Genetics: A Review of American Bioethics Commissions and Comparison to the British Human Fertilisation and Embyology Authority, 6 Colum. Sci. & Tech. L. Rev. 1, 5 (2005)Google Scholar. While an analysis of the United Kingdom's institutions may have required an analysis of European Union institutions and law, the United Kingdom, which has been categorized as “experienc[ing] a rising tide of mistrust about government institutions,” voted in 2016 to exit the European Union. See Norris, supra note 43, at 58. As such, the analysis of the U.K.’s regulatory structure infra largely neglects the European Union's regulatory process as, as of the time that this Article is being written, the U.K. is in the process of exiting the European Union. For more on “Brexit,” see sources cited supra note 45 and accompanying text.

75 Macintosh, Kerry L., Teaching About the Biological Clock: Age-Related Fertility Decline and Sex Education, 22 UCLA Women's L.J. 1, 26 (2015)Google Scholar (citing Robert Edwards & Patrick Steptoe, A Matter of Life: The Story of a Medical Breakthrough 11-15 (1980)).

76 Calandrillo, Steve P. & Deliganis, Chryssa V., In Vitro Fertilization and the Law: How Legal and Regulatory Neglect Compromised A Medical Breakthrough, 57 Ariz. L. Rev. 311, 333 (2015)Google Scholar

77 See Calandrillo & Deliganis, supra note 76, at 333; Subterranean Regulation, supra note 5, at 1240 (“Commentators have described the regulatory environment surrounding assisted reproductive technology [in the United States] as ‘limited,’ ‘minimally regulated,’ and even ‘the Wild Wild West.’ [The article] reveals, however, that one important subset of assisted reproductive technology, the subset that contains forms of assisted reproductive technology that combine in vitro fertilization with the modification of small amounts of DNA … is an exception to this general rule.” (citations omitted)).

78 About Us, Human Fertilisation & Embryology Auth., https://www.hfea.gov.uk/about-us/ [https://perma.cc/B9D2-A36D].

79 Human Fertilisation and Embryology Act, 1990, c. 37, § 5 (Eng.).

80 Human Fertilisation and Embryology Authority Access to Anonymised Data, Human Fertilisation & Embryology Auth. (Nov. 23 2011), https://data.gov.uk/dataset/1bdda00f-d661-4901-bf4c-63900011cb0d/human-fertilisation-and-embryology-authority-access-to-anonymised-data [https://perma.cc/U2HR-C5B2].

81 About Us, supra note 78.

82 Id.

83 See Human Fertilisation & Embryology Auth., Annual Report and Accounts 2012/13 1, 8-9 (2013), http://www.hfea.gov.uk/docs/HFEA_Annual_Report_and_Accounts_2012-13.PDF [hereinafter 2013 Annual Report]; see Human Fertilisation and Embryology Act, 1990, c. 37, §§ 5-10 (Eng.); Calandrillo & Deliganis, supra note 77, at 333; About Us, supra note 78.

84 See 2013 Annual Report, supra note 83, at 8. The “Human Fertilisation and Embryology Act 2008” is generally referred to as “the 2008 Act.”

85 See Heled, supra note 27, at 284-85.

86 Id. at 285; Human Fertilisation & Embryology Auth., Code of Practice 11 (9th ed. 2019), https://www.hfea.gov.uk/media/2793/2019-01-03-code-of-practice-9th-edition-v2.pdf (“One of the ways we help licensed centres comply with the Act is by publishing the Code of Practice. This is because we have a duty under the Act to maintain a document that gives guidance about licensed activities and the people who carry them out. The Code of Practice contains regulatory principles for licensed centres, and guidance notes which provides guidance to help clinics deliver safe, effective and legally compliant treatment and research. Guidance in the Code of Practice also serves as a useful reference for patients, donors, donor-conceived people, researchers and those working in the fertility sector.”) [hereinafter Code of Practice].

87 Code of Practice, supra note 86, at 11-12 (noting that the Code of Practice contains “mandatory requirements[,] …[,]…interpretation of mandatory requirements[,] guidance [and o]ther legislation, professional guidelines and information.”).

88 See Press Release, Dept. of Health, Fertility and Tissue Regulators to be Reviewed Following Consultation, (Jan. 25, 2013) (Eng.),, http://mediacentre.dh.gov.uk/2013/01/25/fertility-and-tissue-regulators-to-be-reviewed-following-consultation/ [https://perma.cc/EH3C-2ZM7].

89 For more information on the roles of the Human Tissue Authority, Care Quality Commission, and Health Research Authority, see id.; Dep't of Health, Government Response to the Consultation on Proposals to Transfer Functions from the Human Fertilisation and Embryology Authority and the Human Tissue Authority 6-8 (2013), https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/212742/Consultation_HFEA_and_HTA_government_response.pdf [hereinafter Government Response].. For public responses to the public consultation related to the continued existence of the HFEA, see Dep't of Health, Consultation on Proposals to Transfer Functions From the Human Fertilisation and Embryology Authority and the Human Tissue Authority: Responses (2013).

90 See Adamson, David, Regulation of Assisted Reproductive Technologies in the United States, 39 Fam. L.Q. 727, 739 (2005)Google Scholar; Craven, Lyndsey et al., Research into Policy: A Brief History of Mitochondrial Donation, 34 Stem Cells 265, 265 (2016)Google Scholar; Drabiak, Katherine, Emerging Governance of Mitochondrial Replacement Therapy: Assessing Coherence Between Scientific Evidence and Policy Outcomes, 20 DePaul J. Health Care L. 1, 20 (2018)Google Scholar; Gitter, supra note 74, at 1008; Moses, Lyria B., Understanding Legal Responses to Technological Change of In Vitro Fertilization, 6 Minn. J.L. Sci. & Tech. 505, 603 (2005)Google Scholar (stating “Restrictions on the freedom of clinicians to determine what is best for each individual patient in the context of multiple embryo transfer is the most common criticism of HFEA by clinics.”); Riley & Merrill, supra note 74, at 53 (“HFEA has frequently been criticized as overly ‘pro-choice.”); Shapo, Helene S., Frozen Pre-Embryos and the Right to Change One's Mind, 12 Duke J. Comp. & Int'l L. 75, 99 (2002)Google Scholar.

91 Human Fertilisation & Embryology Auth., Annual Report & Accounts, Chair and Chief Executive's Foreword 4-5 (2012-2013), http://www.hfea.gov.uk/docs/HFEA_Annual_Report_and_Accounts_2012-13.PDF [hereinafter Chair and Chief Executive's Foreword]; see Government Response, supra note 89.). For more on the public consultation process in the United Kingdom, see UK Cabinet Office, Consultation Principles 2018 (2018). For more on public consultations generally, see Bojan Bugaric, Openness and Transparency in Public Administration: Challenges for Public Law, 22 Wis. Int'l L.J. 483, 502-4 (2004); Edgar, Andrew, Administrative Regulation-Making: Contrasting Parliamentary and Deliberative Legitimacy, 40 Melb. U. L. Rev. 738, 751-52 (2017)Google Scholar. For more on public consultations in the United Kingdom related to assisted reproductive technology, see Shanley, Mary L., Collaboration and Commodification in Assisted Procreation: Reflections on an Open Market and Anonymous Donation in Human Sperm and Eggs, 36 L. & Soc'y Rev. 257, 274 n.35 (2002)Google Scholar; Williams, Benjamin B., Screening for Children: Choice and Chance in the “Wild West” of Reproductive Medicine, 79 Geo. Wash. L. Rev. 1305, 1327 (2011)Google Scholar.

92 See Chair and Chief Executive's Foreword, supra note 91, at 4-5; Government Response, supra note 89.

93 Human Fertilisation & Embryology Auth., Mitochondria Replacement Consultation: Advice to Government 8 (2013), https://www.hfea.gov.uk/media/2618/mitochondria_replacement_consultation_-_advice_for_government.pdf [hereinafter Advice to Government]; see Mahoney, Joan, Genome Mapping and Designer Babies: A Comparative Perspective, 79 UMKC L. Rev. 309, 312 (2010)Google Scholar (discussing the scientific and social motivations for the 2008 Amendment to the 1990 Act).

94 See Chair and Chief Executive's Foreword, supra note 92, at 8; Sabatello, Maya, Posthumously Conceived Children: An International and Human Rights Perspective, 27 J.L. & Health 29, 36 (2014)Google Scholar.

95 Advice to Government, supra note 93, at 7.

96 See James Gallagher, UK Government Backs Three-Parent IVF, BBC News (June 27, 2013), www.bbc.co.uk/news/health-23079276 [https://perma.cc/5KDD-LP3F]; see also Chair and Chief Executive's Foreword, supra note 91 (characterizing support for mitochondrial replacement as “broad”).

97 Sarah Barber & Peter Border, Mitochondrial Donation 13 (2015), https://researchbriefings.files.parliament.uk/documents/SN06833/SN06833.pdf.

98 See Brittany Shoot, 3-parent IVF: Why Isn't it Available in the United States?, The Guardian (Feb. 27, 2015), http://www.theguardian.com/sustainable-business/2015/feb/27/3-parent-ivf-us-mitochondria-dna-babies [https://perma.cc/RHM9-96VA]. For more on lawmaking in the UK, see sources cited supra notes 58-63.

99 See Gallagher, supra note 96.

100 Mendelson, Nina A., Rulemaking, Democracy, and Torrents of E-Mail, 79 Geo. Wash. L. Rev. 1343, 1343-44 (2011)Google Scholar.

101 See Barber & Border, supra note 97, at 1. For the “three scientific reviews” of mitochondrial transfer (and the 2014 addendum to the “further update in 2014”), see generally Human Fertilisation & Embryology Auth., Annex VIII: Scientific Review of the Safety and Efficacy of Methods to Avoid Mitochondrial Disease Through Assisted Conception: Update (2013), https://www.hfea.gov.uk/media/2612/mito-annex_viii-science_review_update.pdf; Human Fertilisation & Embryology Auth., Review of the Safety and Efficacy of Polar Body Transfer to Avoid Mitochondrial Disease Addendum to ‘Third Scientific Review of the Safety and Efficacy of Methods to Avoid Mitochondrial Disease Through Assisted Conception: 2014 update’ (2014), https://www.hfea.gov.uk/media/2610/2014-10-07_-_polar_body_transfer_review_-_final.pdf; Human Fertilisation & Embryology Auth., Scientific Review of the Safety and Efficacy of Methods to Avoid Mitochondrial Disease Through Assisted Conception (2011), https://www.hfea.gov.uk/media/2613/scientific-review-of-the-safety-and-efficacy-of-methods-to-avoid-mitochondrial-disease-through-assisted-conception.pdf; Human Fertilisation & Embryology Auth., Third Scientific Review of the Safety and Efficacy of Methods to Avoid Mitochondrial Disease Through Assisted Conception: 2014 Update, (2014), https://www.hfea.gov.uk/media/2614/third_mitochondrial_replacement_scientific_review.pdf.

102 See Human Fertilisation & Embryology Auth., Scientific Review of the Safety and Efficacy of Methods to Avoid Mitochondrial Disease Through Assisted Conception: 2016 Update 4-5 (2016), https://www.hfea.gov.uk/media/2611/fourth_scientific_review_mitochondria_2016.pdf [hereinafter 2016 Update].

103 See Steve Connor, Chief Medical Officer Urges Lords to Legalise ‘Three-Parent’ IVF, The Independent (Feb. 24, 2015), http://www.independent.co.uk/news/science/chief-medical-officer-urges-lords-to-legalise-three-parent-ivf-10065833.html [https://perma.cc/Q2CM-736D].

104 See Advice to Government, supra note 93.

105 See id. at 10-11.

106 Id. at 11, 22.

107 Id. at 11.

108 Id.

109 Id.

110 See Advice to Government, supra note 93, at 11.

111 Id.

112 See infra note 160 and accompanying text (discussing the National Academy of Science's report completed at the request of the FDA); see also About, Nuffield Council on Bioethics, http://nuffieldbioethics.org/about [https://perma.cc/494C-8ZHS] (“The Nuffield Council on Bioethics is an independent body that examines and reports on ethical issues in biology and medicine. It was established by the Trustees of the Nuffield Foundation in 1991, and since 1994 it has been funded jointly by the Foundation, Wellcome and the Medical Research Council. The Council has achieved an international reputation for advising policy makers and stimulating debate in bioethics.”)

113 Nuffield Council on Bioethics, Novel techniques for the prevention of mitochondrial DNA disorders: an ethical review viii (2012), http://nuffieldbioethics.org/wp-content/uploads/2014/06/Novel_techniques_for_the_prevention_of_mitochondrial_DNA_disorders_compressed.pdf.

114 See Advice to Government, supra note 93 at 10; 2016 Update, supra note 102 at 32; Barber & Border, supra note 97, at 5 (stating “information … to Members of Parliament in support of their parliamentary duties”).

115 Sabrina Tavernies, His Fertility Advance Draws Ire, N.Y. Times (Mar. 17, 2014).

116 See Zhang, John et al., Live Birth Derived from Oocyte Spindle Transfer to Prevent Mitochondrial Disease, 34 Reprod. Biomedicine Online 361, 361-68 (2017)Google Scholar (discussing the use of mitochondrial donation treatment in a patient with Leigh Syndrome by Dr. John Zhang and other colleagues at the New Hope Fertility Center, which has offices in New York and Mexico).

117 See Subterranean Regulation, supra note 5, at 1250, 1260; see also Charlotte Pritchard, The Girl with Three Biological Parents, BBC News: Mag (Sept. 1, 2014), https://www.bbc.com/news/magazine-28986843 [https://perma.cc/HK49-M74V].

118 Subterranean Regulation supra note 5, at 258. For the full letter, see id. at 1289-91.

119 See Letter from Mary A. Malarkey, Dir., Office of Compliance & Biologics Quality, Ctr. for Biologics Evaluation & Research, U.S. Food & Drug Admin., to John Zhang, CEO, Darwin Life, Inc. & New Hope Fertility Center (Aug. 4, 2017), https://www.fda.gov/media/106739/download [hereinafter FDA Letter]; see also Advisory on Legal Restrictions on the Use of Mitochondrial Replacement Techniques to Introduce Donor Mitochondria into Reproductive Cells Intended for Transfer into a Human Recipient, Cellular & Gene Therapy Products, U.S. Food & Drug Admin. (Mar. 16, 2018), https://www.fda.gov/biologicsbloodvaccines/cellulargenetherapyproducts/ucm570185.htm [https://perma.cc/RW6M-S9EN] (“The clinical use of [mitochondrial replacement therapy] in the United States falls within FDA's regulatory authority.”) [hereinafter MRT Legal Restrictions].

120 See, e.g., FDA Letter, supra note 119; MRT Legal Restrictions, supra note 119.

121 Andrews, Lori B. & Elster, Nanette, Regulating Reproductive Technologies, 21 J. Legal Med. 35, 35–44 (2000)Google Scholar (providing historical overview of ART).

122 See Subterranean Regulation, supra note 5, at 1241 n.1, 1259, 1270; see also Heled, supra note 27, at 247 (noting the “dearth of state law and a total lack of federal law regulating the genetic aspects of [donated reproductive tissue]”); Rosato, supra note 36, at 57, 63 (“Assisted reproductive technology (‘ART’) has been in existence for twenty-five years with very little oversight or regulation.” (citations omitted)).

123 See Subterranean Regulation, supra note 5, at 1270-71 n.136.

124 See 42 U.S.C. § 263a-1 (2012).

125 See id.

126 See Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing, 66 Fed. Reg. 5447, 5452 (Jan. 19, 2001); Tissue and Tissue Product Questions and Answers, U.S. Food & Drug Admin., http://www.fda.gov/BiologicsBloodVaccines/TissueTissueProducts/QuestionsaboutTissues/ucm101559.htm [https://perma.cc/88NS-G2XS].

127 Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing, 66 Fed. Reg. at 5452.

128 Id. at 5457 (“Eight comments asserted that ‘minimal manipulation’ is vague and open to subjective interpretation, and should be eliminated. Two comments asserted that it is difficult to draw a meaningful distinction between tissues that are minimally manipulated and those that are more than minimally manipulated. One of these comments suggested that instead of the minimal manipulation criterion, FDA should propose that tissue products labeled or promoted for tissue replacement, reconstruction, or restoration of function be regulated as tissue. Another comment requested the development of guidance and noted that, in light of future technological advances, a broader definition of minimal manipulation may be more appropriate.”). Overall, the FDA received “28 comments on the proposed rule as it was published in 1998 [and] over 400 comments on the donor-suitability proposed rule; many of these raised issues related to subparts A and B of part 1271.” Id. at 5450. Comments related to the term “minimal manipulation” were addressed with the other comments on Comments on Subpart A: Proposed Section1271.10 and Section 1271.15 (Final Section 1271.10 and Section 1271.20). Id. at 5450, 5453, 5457.

129 See Halted Innovation, supra note 7, at 1100.

130 See id. § 553(b)(3) (“Except when notice or hearing is required by statute, this subsection [requiring notice of proposed rulemaking] does not apply … to interpretive rules, general statements of policy, or rules of agency organization, procedure, or practice”); see also Advisory on Legal Restrictions on the Use of Mitochondrial Replacement Techniques to Introduce Donor Mitochondria into Reproductive Cells Intended for Transfer into a Human Recipient, Cellular & Gene Therapy Products, U.S. Food & Drug Admin. (Mar. 16, 2018), https://www.fda.gov/biologicsbloodvaccines/cellulargenetherapyproducts/ucm570185.htm [https://perma.cc/9STE-Q4LF].

131 See William N. Eskridge Jr., Statutes, Regulation, and Interpretation: Legislation and Administration in the Republic of Statutes 713-16, 838 (2014).

132 Id. at 838; Epstein, Richard A.; The Role of Guidances in Modern Administrative Procedure: The Case for De Novo Review, 8 J. of Leg. Analysis 47, 47–48, 58-83 (2016)Google Scholar (discussing the evolution of the current use of guidance documents by administrative agencies); Franklin, David L., Legislative Rules, Nonlegislative Rules, and the Perils of the Short Cut, 120 Yale L.J. 276, 278, 286-89 (2010)Google Scholar; Seidenfeld, Mark, Substituting Substantive for Procedural Review of Guidance Documents, 90 Tex. L. Rev. 331, 332-8 and 340-4 (2011)Google Scholar.

133 Epstein, supra note 132, at 47.

134 Halted Innovation, supra note 7, at 1098.

135 See e.g. Seidenfeld, Mark, Substituting Substantive for Procedural Review, 90 Tex. L. Rev. 331, 332 and 350-2Google Scholar; Id. at 360-1 (“For interpretive rules, the message from the courts is that the weaker the link between the interpretation and the text of the statute or regulation being interpreted, the less likely a court is to allow the agency to announce the interpretation by guidance document.”); Perez v. Mortgage Bankers Ass'n, 135 S. Ct. 1199, 1208 (2015); Appalachian Power Co. v. EPA, 208 F.3d 1015, 1021 and 1024-5 (2000); General Electric Co. v. EPA, 290 F.3d 377, 380-85 (2002); Nat'l Min. Ass'n v. Sec'y of Labor, 589 F.3d 1368, 1371-73 (2009). For more on the disparate tests used to ascertain whether a document that the agency has classified as a non-legislative rule actually required notice-and-comment because it actually should have been issued as a legislative rule, see e.g. Hickman, Kristin, Unpacking the Force of Law, 66 Vand. L. Rev. 465, 480-84 (2013)Google Scholar; Id. at 503 at n. 205, 513; Franklin, David L., Legislative Rules, Nonlegislative Rules, and the Perils of the Short Cut, 120 Yale L. J. 276, 284 (2010)Google Scholar(discussing the concern that agencies “strategically” use non-legislative documents to avoid the notice-and-comment rulemaking process and the various tests that courts use to ascertain whether a “document promulgated without notice and comment is really a legislative rule and is therefore procedurally invalid,” including the “legal effect test” and the “substantial impact test.”). See also Kelley v. E.P.A., 15 F.3d 1100, 1108 (D.C. Cir. 1994); Appalachian Power Co. v. EPA (“We must still look to whether the interpretation itself carries the force and effect of law,.. or rather whether it spells out a duty fairly encompassed within the regulation that the interpretation purports to construe” citing to Paralyzed Veterans v. D.C. Arena L.P., 117 F. 3d 579, 588 (D.C. Cir. 1997). See also infra note 131.

136 Subterranean Regulation, supra note 5, at 1259-60 (describing the reactions of physician-researchers after receiving letters from the FDA which was to cease their research or medical practice or move it abroad). Beyond the reactions of physicians and researchers after receiving letters from the FDA, examining the agency's letters through the lens of the tests that courts have used to ascertain whether guidance documents should be treated as legislative rules, many aspects of those agency rules lend themselves to arguments that the agency documents explaining the application of the “minimal manipulation rule” should be treated as legislative rules as opposed to non-legislative rules. For example, while the FDA's letters to researchers in 2001 did not specifically state that their specific work was subject to the FDA's regulation, the letter used mandatory language: “The use of such genetically manipulated cells (and/or their derivatives) in humans constitutes a clinical investigation and requires submission of an Investigational New Drug application (IND) to FDA.” Letter from U.S. Food & Drug Admin., to Sponsors/Researchers - Human Cells Used in Therapy Involving the Transfer of Genetic Material by Means Other Than the Union of Gamete Nuclei (May 6, 2009); see e.g. Levin, Ronald M., Rulemaking and the Guidance Exemption, 70 Admin. L. Rev. 263, 294-98 (2018)Google Scholar (discussing courts' analysis of mandatory language in litigation related to whether agency documents are in fact legislative rules despite being labeled otherwise). The reactions of physicians and researchers to the FDA's letters which purport to “advise” addressees of the agency's jurisdiction and requirements indicates that those letters and the agency's interpretations have “the force and effect of law.” See Am. Mining Cong. v. Mine Safety & Health Admin., 995 F.2d 1106, 1108-09 (D.C. Cir. 1993). For those who received the agency's letters in 2001, they stopped providing the technique in the United States. Similarly, in 2017, Dr. John Zhang, who provided the technique in Mexico, to avoid the U.S. regulatory system, later submitted an investigational new drug application so as to offer the technique in the United States in accordance with the FDA's statements of what was required by the statute (as explained through the Human Cellular and Tissue-based Products rule and the agency's subsequent pronouncements in non-legislative documents). See supra note 116 and accompanying text. In sum, the effect of these agency statements regarding its jurisdiction over forms of assisted reproductive technology involving genetic modification is that researchers adhere to the FDA's framework, as explained in guidance documents and either cease offering (and researching) the technique altogether or cease offering the technique in the United States specifically in order to avoid the FDA's jurisdiction. Thus, these agency interpretations carry the “force and effect of law.” See Appalachian Power Co. v. EPA, 208 F.3d 1015, 1024 (2000); but see Perez v. Mortgage Bankers Assoc., 135 S. Ct. 1199, 1207-11 (2015) (explaining that agencies do not have to use notice-and-comment rulemaking when “significantly alter[ing] a prior, definitive interpretation of a regulation” as was previously required by Paralyzed Veterans);). But see McKee, Gwendolyn, Judicial Review of Agency Guidance Document: Rethinking the Finality Doctrine, 60 Admin. L. Rev. 371, 380, 390-97Google Scholar 7(discussing the FDA's statutory disclaimer related to the binding nature of guidance documents and litigation related to guidance documents in the context of the FDA). For post-Perez discussion of various tests still used to interpret whether an agency decision is a legislative or non-legislative rule, see generally Levin, Ronald M., Rulemaking and the Guidance Exemption, 70 Admin. L. Rev. 263 (2018)Google Scholar; Sunstein, Cass R., “Practically Binding”: General Policy Statements and Notice-and-Comment Rulemaking, 68 Admin. L. Rev. 491, 505-088 (2016)Google Scholar.

137 See Subterranean Regulation, supra note 5.

138 See Deacon, supra note 41, at 1591.

139 See Daley, George Q., Missed Opportunities in Embryonic Stem-Cell Research, Perspective, 351 N. Eng. J. Med. 627, 628 (2004)Google Scholar (“Proposed in 1996 by Representative Jay Dickey (R-Ark.) as a rider on the appropriations bill for the Department of Health and Human Services and renewed every year since, the Dickey[-Wicker] Amendment prohibits federal engagement in a field of research pertaining to the nature of the human embryo, its disorders of development, and the derivation of new human embryonic stem-cell lines. Although most embryos created in vitro during fertility procedures are deemed unsuitable for pregnancy and are discarded, federal funds may not be used to ascertain what went wrong.”); FDA Letter, supra note 119 (“Since December 2015, the United States Food and Drug Administration (FDA) has been prohibited by Congress in provisions in annual federal Appropriations Acts from using funds to accept IND submissions for clinical investigations that involve ‘a human embryo … intentionally created or modified to include a heritable genetic modification.”); see also The Consolidated Appropriations Act, 2017, Pub. L. No. 115-31, 131 Stat. 173 (2017). For more on the aforementioned Consolidated Appropriations Act provision, see generally Glenn Cohen, I. & Adashi, Eli Y., The FDA is Prohibited From Going Germline, 353 Science 545 (2016)Google Scholar.

140 For more on the “scant” legislative history of the Dickey-Wicker Amendment and the surrounding discussion, see Macintosh, Kerry L., Psychological Essentialism and Opposition to Human Embryonic Stem Cell Research, 18 J. Tech. L. & Pol'y 229, 252-57 (2013)Google Scholar; see also Adashi, Eli Y. & Glenn Cohen, I., Mitochondrial Replacement Therapy: Unmade in the USA, 317 JAMA 555, 574-75Google Scholar (“The congressional record is mum on the identity of the sponsor or sponsors of the ban [‘which comprises Section 749 of the Consolidated Appropriation Act of 2016’], and the precise motives for crafting it remain equally uncertain. The ban's enactment was all but guaranteed by the complete absence of discussion before its passage or at any time thereafter, and by its inclusion in a must-pass omnibus appropriation bill.”); Bigloo, Kiyan, Aggregation of Powers: Stem Cell Research and the Scope of Presidential Power Examined Through the Lens of Executive Order Jurisprudence, 18 Psychol. Pub. Pol'y & L. 519, 522-26 (2012)Google Scholar; Advisory on Legal Restrictions on the Use of Mitochondrial Replacement Techniques to Introduce Donor Mitochondria into Reproductive Cells Intended for Transfer into a Human Recipient, U.S. Food & Drug Admin. (Mar. 16, 2018), https://www.fda.gov/biologicsbloodvaccines/cellulargenetherapyproducts/ucm570185.htm [https://perma.cc/9STE-Q4LF] (“Since December 2015, Congress has included provisions in annual federal appropriations laws that prohibit FDA from accepting applications for clinical research using MRT. Therefore, clinical research using MRT in humans cannot legally proceed in the United States. FDA maintains the authority to investigate and take enforcement action in the event that it becomes aware of noncompliance with the laws and regulations administered by FDA.”).

141 Carbone, June, Negating the Genetic Tie: Does the Law Encourage Unnecessary Risks?, 79 UMKC L. Rev. 333, 354 (2010)Google Scholar.

142 See Annas, George, Resurrection of a Stem-Cell Funding Barrier — Dickey–Wicker in Court, 363 N. Eng. J. Med. 1687, 1687-8 (2010)Google Scholar (“The amendment, known as the Dickey–Wicker amendment, provides that no federal funds can be expended by the National Institutes of Health (NIH) for ‘(1) the creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risks of injury or death.’ It has been added to NIH appropriations bills every subsequent year, just as the Hyde Amendment restricting abortion funding is added.”); Stem Cell Information Home Page, 2016, Nat'l Inst. of Health, https://stemcells.nih.gov/research/newcell_qa.htm [https://perma.cc/5YUZ-DR5W] (“No federal funds may be used, either by an awardee or a sub-recipient, to support research using derivatives of human embryonic stem cell lines (hESCs) that are not listed on the NIH Human Embryonic Stem Cell Registry, with the exception described below.”); see also FDA Letter, supra note 119.

143 See Adashi, Eli Y. & Glenn Cohen, I., Preventing Mitochondrial Diseases: Embryo-Sparing Donor-Independent Options, Opinion, 24 Trends in Molecular Med. 449, 450 at Box 2 (2018)Google Scholar (citing to the “theological, ethical, and safety concerns surrounding mitochondrial transfer”).

144 See Michelle Roberts, First ‘Three Person Baby'Baby' Born Using New Method, BBC News (Sept. 27, 2016), https://www.bbc.com/news/health-37485263 [https://perma.cc/R5Q2-QCZ4].

145 See FDA Letter, supra note 119.

146 Deacon, supra note 41, at 1601; Moses, Lyria B., Understanding Legal Responses to Technological Change: The Example of in Vitro Fertilization, 6 Minn. J.L. Sci. & Tech. 505, 581-82 (2005)Google Scholar.

147 See Carbone, June & Cahn, Naomi, Embryo Fundamentalism, 18 Wm. & Mary Bill Rts. J. 1015, 1017-18 (2010)Google Scholar; Glenn Cohen, I. & Adashi, Eli Y., Embryo Disposition Disputes: Controversies and Case Law, 46 Hastings Ctr. Rep. 13, 15–16 (2016)Google Scholar; Dolgin, Janet L., Embryonic Discourse: Abortion, Stem Cells, and Cloning, 31 Fla. St. U. L. Rev. 101, 104-06, 146 (2003)Google Scholar; Goodwin, Michele, Fetal Protection Laws: Moral Panic and the New Constitutional Battlefront, 102 Cal. L. Rev. 781, 785 (2014)Google Scholar; King, supra note 27, at 323 (“Political debate over embryo creation and destruction often causes people to retreat to their firmly entrenched positions on abortion, which contributes significantly to the regulatory stalemate with respect to ART in the United States.” (citation omitted)); Manian, Maya, Lessons from Personhood's Defeat: Abortion Restrictions and Side Effects on Women's Health, 74 Ohio St. L.J. 75, 77 (2013)Google Scholar; Ziegler, Mary, Beyond Balancing: Rethinking the Law of Embryo Disposition, 68 Am. U. L. Rev. 515, 523-24 (2018)Google Scholar.

148 U.S. Food & Drug Admin., Transcript of Center for Biologics Evaluation and Research, Cellular, Tissue, and Gene Therapies Advisory Committee Meeting #59 13 (2014) [hereinafter Meeting #59 Transcript].

149 Id.; see Subterranean Regulation, supra note 5, at 1271-74.

150 Wolf et al., supra note 8, at 73 (“The FDA has also recognized ethical and social policy issues related to genetic modification of eggs and embryos that will likely affect regulatory decisions.”); NIH Statement on NIH Funding on Research Using Gene-Editing Technologies in Human Embryos, Nat'l Inst. of Health (Apr. 28, 2015), http://www.nih.gov/about-nih/who-we-are/nih-director/statements/statement-nih-funding-research-using-gene-editing-technologies-human-embryos [https://perma.cc/4WK9-L246] (“However, NIH will not fund any use of gene-editing technologies in human embryos. The concept of altering the human germline in embryos for clinical purposes has been debated over many years from many different perspectives, and has been viewed almost universally as a line that should not be crossed.”).

151 See Suter, Sonia M., The “Repugnance” Lens of Gonzales v. Carhart and Other Theories of Reproductive Rights: Evaluating Advanced Reproductive Technologies, 76 Geo. Wash. L. Rev. 1514, 1516 (2008)Google Scholar (discussing the role of states in regulating assisted reproductive technology).

152 See State Laws Related to Insurance Coverage for Infertility Treatment, Nat'l Conference State Legislatures (Apr. 27, 2018), http://www.ncsl.org/research/health/insurance-coverage-for-infertility-laws.aspx#1 [https://perma.cc/Z9TX-XU9U] (providing “state laws that require insurers to either cover or offer coverage for infertility diagnosis and treatment”).

153 La. Rev. Stat. § 22:1036 (2009) (describing “[p]rohibited exclusion of coverage of correctable medical conditions on basis of infertility”); Minn. Stat. § 256B.0625(13)(a) (2018) (stating “[m]edical assistance covers drugs, except for fertility drugs when specifically used to enhance fertility”).

154 See Calandrillo & Deliganis, supra note 76, at 330 (citing Va. Code § 54.1-2971.1).

155 Seifter, Miriam, States as Interest Groups in the Administrative Process, 100 Va. L. Rev. 953, 993–94 (2014)Google Scholar (“Phrased another way, federal agencies can work toward fulfilling their expertise-oriented role by harnessing the information production machine of the federal system–not from abstract arguments regarding principles of federalism, which may well be beyond the administrative ken, but from the specific, diverse experiences and information generated by individual states.” (citations omitted)).

156 See Metzger, Gillian E., Federalism Under Obama, 53 Wm. & Mary L. Rev. 567, 602 (2011)Google Scholar; Weiner, Stephen M., Payment Reform After PPACA: Is Massachusetts Leading the Way Again?, 11 Yale J. Health Pol'y L. & Ethics 33, 33, 33 n.3 (2011)Google Scholar.

157 See Dep't. Veterans Affs., Veterans Health Affairs Directive 1332: Infertility Evaluation and Treatment 1-2 (2017), https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=5431 [https://perma.cc/FDM9-V5G9] (“establish[ing] policies and procedures for providing infertility evaluation and treatment to Veterans enrolled in the Department of Veterans Affairs (VA) healthcare system.”); see generally Falloon, Katie & Rosoff, Philip M., Who Pays? Mandated Insurance Coverage for Assisted Reproductive Technology, 16 Am. Med. Assoc. J. of Ethics 63, 63 (2014)Google Scholar (“Currently, only about a third of states have mandated insurance coverage of infertility treatment, but the vast majority of health insurance plans in other states do not offer coverage; hence, most people pay out of pocket. Furthermore, Medicaid does not pay for ART anywhere in the US” (citations omitted)); Assisted Reproductive Services, TRICARE (Oct. 3, 2018), https://www.tricare.mil/CoveredServices/IsItCovered/AssistedReproductiveServices [https://perma.cc/6VVR-D292] (“To be medically necessary means it is appropriate, reasonable, and adequate for your condition. and combined with natural conception.”).

158 See sources cited infra note 160 and accompanying text (discussing the National Academy of Science's report completed at the request of the FDA).

159 The Nat'l Acads. of Sci., Eng'g & Med., Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations (2016) [hereinafter MRT Report]. For a summary of the 2016 National Academy of Sciences report, see Adashi & Cohen, supra note 143, at 450 Box 2.

160 MRT Report, supra note 159, at ix, 2 (“The proposed investigation and potential clinical use of mitochondrial replacement techniques (MRT) raises a novel collection of ethical, social, and policy issues. At the request of the U.S. Food and Drug Administration (FDA), the National Academies of Sciences, Engineering, and Medicine convened a committee with diverse interdisciplinary expertise and a range of backgrounds to examine and analyze these issues, make recommendations regarding whether and how to go forward with MRT, and elaborate principles for initial clinical investigations involving these novel techniques for avoiding some types of inherited mitochondrial DNA (mtDNA) diseases.”).

161 Id. at xv-xi.

162 See Bierschbach, Richard A. & Bibas, Stephanos, Notice-and-Comment Sentencing, 97 Minn. L. Rev. 1, 20 (2012)Google Scholar; Seifter, supra note 19, at 1308; Criddle, Evan J., When Delegation Begets Domination: Due Process of Administrative Lawmaking, 46 Ga. L. Rev. 117, 123 (2011)Google Scholar; Rose-Ackerman, supra note 21, at 439; Seifter, supra note 19, at 1308.

163 See Marchant, supra note 20, at 256 (“Administrative agencies are required to partake in extensive, procedurally time-consuming activities geared toward public participation and judicial review before setting final rules — a lengthy, time-consuming effort that is not in harmony with the speed of innovation.” (citation omitted)).

164 See Farber & O'Connell, supra note 19, at 1337.

165 See 5 U.S.C. § 553 (2012); see also Sargentich, Thomas O., The Critique of Active Judicial Review of Administrative Agencies: A Reevaluation, 49 Admin. L. Rev. 599, 638 (1997)Google Scholar (highlighting “the transparency of notice-and-comment rulemaking process”); Seifter, supra note 19, at 1308 (“As the thousands of regulations promulgated each year ‘wield[] vast power and touch[] almost every aspect of daily life,’ the notice-and-comment process under section 553 of the Administrative Procedure Act (APA)–the most well-known and heralded form of administrative participation, in which interested persons may comment on proposed rules–has been celebrated as ‘a crucial way to ensure that agency decisions are legitimate, accountable, and just.’” (citations omitted)).

166 See Rose-Ackerman, supra note 21, at 439. For more on the concept of “expertise” in administrative law and the idea that agencies embody subject-specific expertise over the fields that they regulate, see Seifter, supra note 19, at 1325-29.

167 See Rose-Ackerman, supra note 21, at 436.

168 Id.

169 Mendelson, supra note 40, at 1159.

170 See supra Part III.B.

171 See Bierschbach & Bibas, supra note 162, at 20; Mendelson, supra note 40, at 1159.

172 See Bierschbach & Bibas, supra note 162, at 20 (“A central concept [in administrative law] is participation, the idea that citizens should have some input into agency decisions. Public participation, of course, is not the only way to check agency abuses. But it is a crucial way to ensure that agency decisions are legitimate, accountable, and just. [It also] blend[s] democracy with agency expertise and judicial oversight [along with] legitimacy and accountability concerns.”); Mendelson, supra note 40, at 1159.

173 Mendelson, supra note 40, at 1155.

174 See Rescuing Science from politics: Regulation and the Distortion of Scientific research 281-97 (Wendy Wagner & Rena Steinzor, eds. 2016); Criddle, Evan J., Chevron's Consensus, 88 B.U. L. Rev. 1271, 1287-88 (2008)Google Scholar.

175 Mendelson, supra note 40, at 1143.

176 Id. at 1144.

177 See Heinzerling, Lisa, The FDA's Plan B Fiasco: Lessons for Administrative Law, 102 Geo. L. J. 927, 938-39 (2014)Google Scholar (“Twelve years passed between the petition of private citizens and public health and medical organizations to the FDA to approve nonprescription status for levonorgestrel-based emergency contraceptives and a court order that the FDA do so…. Much happened during this time…[T]he FDA passed through two different presidential administrations. Through it all, the FDA remained steadfast on one point: it would not, despite all of the scientific evidence indicating it was the right thing to do, allow unrestricted access to all levonorgestrel-based emergency contraception.”).

178 Id.; see Watts, Kathryn A., Controlling Presidential Control, 114 Mich. L. Rev. 683, 708 (2016)Google Scholar (providing the statement of FDA Commissioner Hamburg: “[i]t is our responsibility at FDA to approve drugs that are safe and effective for their intended use based on the scientific evidence”).

179 Heinzerling, supra note 177, at 947-48; Gardiner Harris, Morning After Pill Is Cleared for Wider Sales, N.Y. Times, Aug. 24, 2006, at A1.

180 Cahn, Naomi & Carbone, June, Family Classes: Rethinking Contraceptive Choice, 20 U. Fla. J.L. & Pub. Pol'y 361, 382 (2009)Google Scholar; Watts, supra note 178, at 708; Wood, Alastair J.J. et al., A Sad Day for Science at the FDA, 353 N. Eng. J. Med. 1197, 1197-98 (2005)Google Scholar; see Heinzerling, supra note 177, at 930-58; see also Tummino v. Torti, 603 F. Supp. 2d 519, 523-24, 544-45, 548 (E.D.N.Y. 2009) (“While it may have been rational for the FDA to consider adolescent cognitive development in its evaluation of Plan B as an OTC drug, plaintiffs have presented unrebutted evidence that the FDA's focus on these behavioral concerns stemmed from political pressure rather than permissible health and safety concerns.”).

181 Cahn & Carbone supra note 180, at 381-82; Harris, supra note 179; Watts, supra note 178, at 710-11.

182 See Watts, supra note 178, at 709 (“Not surprisingly, controversy quickly erupted over what the media described as Sebelius's ‘unprecedented’ decision to override the FDA's science-based findings.”); see Wood, Alastair J.J. et al., The Politics of Emergency Contraception, 366 N. Eng. J. Med. 101, 101–102 (2005)Google Scholar (“[W]e called attention to the damage that the FDA was doing—both to its reputation as an impartial regulatory agency that made decisions on the basis of science, insulated from politics, and potentially to women's health.”);.

183 See Sherley v. Sebelius, 689 F.3d 776, 779 (D.C. 2012) (determining whether federal funding should be provided to “research projects directly involving the destruction of a human embryo and projects using embryonic stem cells derived from an earlier destruction”); see also Carbone & Cahn, supra note 180, at 1016 (“The status of embryos, which involves profound religious and philosophical differences and which has become the subject of entrenched political differences over the course of the abortion fight, lies at the heart of these developments.”); Enmon, Jennifer L., Stem Cell Research: Is the Law Preventing Progress?, 2002 Utah L. Rev. 621, 637-42 (2002)Google Scholar (discussing the debate over the personhood of IVF clinics' excess frozen embryos); Suter, Sonia M., In Vitro Gametogenesis: Just Another Way to Have a Baby?, 3 J.L. & Biosciences 87, 116-18 (2016)Google Scholar (discussing the issue of embryo destruction in the context of another form of assisted reproductive technology, in vitro gametogenesis).

184 See Future of American Federalism, supra note 43, at 1112 (“Although the United States has not generally been thought to suffer from the same sort of ‘democratic deficit’ that haunts European discourse, we are experiencing profound frustration with gridlocked and nonresponsive government in Washington, reflected in the precipitous decline in public trust in national governing institutions.”).

185 Seifter, Miriam, Further from the People? The Puzzle of State Administration, 93 N.Y.U. L. Rev. 107, 146-47 (2018)Google Scholar (“[S]cholars, courts, and policymakers … tend to agree that states are closer to the people in some way that matters. In particular, the traditional praise for proximity suggests that it makes state governments more responsive to their constituents' desires or deters abuses of state power, or both.” (citations omitted)); see The President, Executive Order No. 13132, Federalism (Aug. 4, 1999), 64 Fed. Reg. 43,255, 43,255-56 (Section 2. “Fundamental Federalism Principles[:] In formulating and implementing policies that have federalism implications, agencies shall be guided by the following fundamental federalism principles: (a) Federalism is rooted in the belief that issues that are not national in scope or significance are most appropriately addressed by the level of government closest to the people…. (d) The people of the States are free, subject only to restrictions in the Constitution itself or in constitutionally authorized Acts of Congress, to define the moral, political, and legal character of their lives. (e) The Framers recognized that the States possess unique authorities, qualities, and abilities to meet the needs of the people and should function as laboratories of democracy.”).

186 See Gell-Redman, Micah et al., It's All About Race: How State Legislators Respond to Immigrant Constituents, 71 Pol. Res. Q. 517, 527-28 (2018)Google Scholar; Hill, Kim Q. & Leighley, Jan E., The Policy Consequences of Class Bias in State Electorates, 36 Am. J. Pol. Sci. 351, 363 (1992)Google Scholar; but see Seifter, supra note 185, at 146-50.

187 2013 Annual Report, supra note 83, at 4 (“The dialogue, entitled ‘Medical Frontiers: debating mitochondrial replacement’, was carried out over a period of six months, where we took the public temperature on this important and emotive issue. Our consultation showed broad support for mitochondrial replacement being made available to families with serious inherited mitochondrial diseases, provided the techniques are safe enough to use in the clinic and are well regulated.”).

188 See supra Part III.B.1; see also Subterranean Regulation, supra note 5, at 1241-45 (2018) (discussing the FDA's issuance of Untitled Letters to providers of forms of assisted reproductive technology involving genetic modifications).

189 See supra Part III; see also Noah, Lars, Assisted Reproductive Technologies and the Pitfalls of Unregulated Biomedical Innovation, 55 Fla. L. Rev. 603, 617-18 (2003)Google Scholar (“Unlike other medical technologies, ARTs arrive on the scene with little or no rigorous testing of their safety and effectiveness.”).

190 See Paradise, Jordan, U.S. Regulatory Challenges for Gene Editing, 13 SciTech Lawyer 10, 11 (2016)Google Scholar; International Summit on Human Gene Editing, Nat'l Acads. of Sci., Eng'g, & Med., http://nationalacademies.org/gene-editing/Gene-Edit-Summit [https://perma.cc/9JUF-74CX] (“A major component of the National Academy of Sciences and the National Academy of Medicine's Human Gene-Editing Initiative is an international summit that took place December 1-3, 2015, in Washington, D.C. Co-hosted with the Chinese Academy of Sciences and the U.K.'s Royal Society, the summit convened experts from around the world to discuss the scientific, ethical, and governance issues associated with human gene-editing research.”); Second International Summit on Human Gene Editing, Nat'l Acads. of Sci., Eng'g, & Med., http://www.nationalacademies.org/gene-editing/2nd_summit [https://perma.cc/P6C4-KXZ5].

191 See sources cited supra notes 148-50 and accompanying text (discussing the FDA's approach to political and social concerns that “have the potential to affect regulatory decisions.”); see also Nat'l Acads. Of Scis., Eng. & Med., Mitochondrial Replacement Techniques: Ethical, Social, and Policy Considerations 150 (2016). For more on the study approach, see id. at 3, 24; see also Alta Charo, R., Dealing with Dolly: Cloning and the National Bioethics Advisory Commission, 38 Jurimetrics J. 11, 11–14 (1997)Google Scholar (discussing the roles of “public bioethics commissions,” including presidential bioethics commissions); Cathleen Kaveny, M., Rhetoric, Public Reason and Bioethics: The President's Council on Bioethics and Human Cloning, 20 J.L. & Pol. 489, 491-94 (2004)Google Scholar; John P. Holdren, Note on Genome Editing, The White House Office (May 26, 2015), https://obamawhitehouse.archives.gov/blog/2015/05/26/note-genome-editing [https://perma.cc/P4PD-RE7Z] (“The White House fully supports a robust review of the ethical issues associated with using gene-editing technology to alter the human germline. The Administration believes that altering the human germline for clinical purposes is a line that should not be crossed at this time.”).

192 See Rob Stein, Babies With Genes From Three People Could Be Ethical, Panel Says, NPR (Feb. 3, 2016), http://www.npr.org/sections/health-shots/2016/02/03/465319186/babies-with-genes-from-three-people-could-be-ethical-panel-says [https://perma.cc/T4DZ-AXK7] (discussing the National Academies of Sciences, Engineering and Medicine report on cytoplasmic transfer); Statement on NIH Funding of Research Using Gene-Editing Technologies in Human Embryos, Nat'l Inst. of Health (Apr. 29, 2015), https://www.nih.gov/about-nih/who-we-are/nih-director/statements/statement-nih-funding-research-using-gene-editing-technologies-human-embryos [https://perma.cc/7KGM-AHV3] (indicating that the NIH will not fund any use of gene-editing technologies in human embryos.”). While gene editing and mitochondrial transfer are different techniques and research involving mitochondrial transfer is arguably further ahead due to its actual clinical use in the U.K. (and the use of it by U.S. doctors abroad), the social and ethical issues posed by genetic modification exist for both technologies.

193 Ooplasmic/Cytoplasmic Transfer, Ctr. for Genetics & Soc'y, https://www.geneticsandsociety.org/internal-content/ooplasmiccytoplasmic-transfer [https://perma.cc/UBG9-RP22] (defining cytoplasmic transfer as “an experimental fertility technique that involves injecting a small amount of ooplasm from eggs of fertile women into eggs of women whose fertility is compromised. The modified egg is then fertilized with sperm and implanted in the uterus of the woman attempting to achieve pregnancy.”).

194 See Zhang, supra note 116 and accompanying text.

195 See Ikemoto, Lisa C., Reproductive Tourism: Equality Concerns in the Global Market for Fertility Services, 27 J. L. & Inequality 277, 277-79 (2009)Google Scholar (discussing the practice of “reproductive tourism,” and those who travel to access fertility treatments); Mutcherson, Kimberly M., Welcome to the Wild West: Protecting Access to Cross Border Fertility Care in the United States, 22 Cornell J. L. & Pub. Pol'y 349, 349-50 (2012)Google Scholar (discussing “cross border fertility care”).

196 See, e.g., Sachs, Rachel E., Delinking Reimbursement, 102 Minn. L. Rev. 2307, 2309, 2314-21 (2018)Google Scholar (“Although there is not always perfect agreement between the set of FDA-approved drugs and the drugs payers are required to cover, in general there is significant overlap. Particularly for public payers, this robust coverage of prescription drugs is required by federal law. Although private payers are often less constrained, many of them provide similarly comprehensive prescription drug coverage pursuant to federal and state laws.”).

197 See King, supra note 27, at 313 n.142 (discussing access to assisted reproductive technologies, disparities in access to ART, and states that mandate insurance coverage of ART); Falloon & Rosoff, supra note 157, at 63-64 (discussing barriers to access to assisted reproductive technology that exist even with insurance coverage).

198 See Daar, Judith F., Accessing Reproductive Technologies: Invisible Barriers, Indelible Harms, 23 Berkeley J. Gender L. & Just. 18, 22, 31–32, 36-39 (2008)Google Scholar (discussing political, socioeconomic, and racial barriers to accessing assistive reproductive treatment).

199 See Glenn Cohen, I., Circumvention Tourism, 97 Cornell L. Rev. 1309, 1311-12, 1323-26 (2012)Google Scholar (discussing “medical tourism” in the context of assisted reproductive technology, in addition to “circumvention tourism,” a subset of medical tourism).

200 Enmon, supra note 183, at 641-47 (discussing various state statutes affecting embryonic stem cell research).

201 About CIRM, Cal. Inst. for Regenerative Med. (2018), https://www.cirm.ca.gov/ [https://perma.cc/QG7T-F5XH].

202 Frequently Asked Questions About NYSTEM, N.Y. State, https://stemcell.ny.gov/node/191 [https://perma.cc/Y3TX-9LEH]. For more on state stem cell initiatives, see Congressional Research Serv., Stem Cell Research: State Initiatives 2-8 (2006), https://stemcells.nih.gov/staticresources/research/GW-State-Funding.pdf; State Initiatives for Stem Cell Research, Nat'l Inst. of Health, https://stemcells.nih.gov/research/state-research.htm [https://perma.cc/CS82-9FKJ].

203 See Sebelius, 689 F.3d at 780 (discussing the role of Presidents George W. Bush and Barack Obama in providing guidance to the National Institutes of Health on the funding of stem cell research); see also Calandrillo & Deliganis, supra note 77, at 313.

204 See Jeff Lyon, Sanctioned UK Trial of Mitochondrial Transfer Nears, 317 JAMA 462, 463 (2017) (“The HFEA hesitated last summer when major players in the drive to bring MRT to fruition published work that included some qualms. The first article last June in Cell Stem Cell described an in vitro experiment in which Dieter Egli, PhD, and his colleagues at the New York Stem Cell Foundation sought to determine what happens to the minute amount of maternal mtDNA that inevitably hitches a ride when researchers create an embryo with the mother's nDNA and the donor's healthy mtDNA.”).

205 Id. Additionally, just as states have provided funding of stem cell research in the absence of governmental funding, private organizations (including professional organizations) have also provided funding for assisted reproductive technology research. See Am. Soc. for Reproductive Med., American Society for Reproductive Medicine Announces Major Research Initiative-Creation of the ASRM Research Institute, a $10 Million Startup Investment for the Future of Reproductive Medicine, ASRM Bulletin (Jun. 12. 2018), https://www.asrm.org/news-and-publications/news-and-research/press-releases-and-bulletins/american-society-for-reproductive-medicine-announces-major-research-initiative/?_ga=2.228771932.114722499.1545121639-1132316020.1545121639 [https://perma.cc/CAA2-8R5L].

206 See Bierschbach & Bibas, supra note 162, at 23 (“Participation … enhances the soundness of agency decisions by improving the quality and variety of the information an agency considers, whether empirical or related to the public's preferences. It improves accountability by obligating agencies to justify their actions publicly …It increases public trust and educates citizens in government affairs, creating feedback loops between agencies and citizens. And, … it bolsters agency decision-making's democratic pedigree.” (citations omitted)); Marchant, supra note 20, at 256.

207 See Mendelson, Nina, A Presumption Against Agency Preemption, 102 Nw. U. L. Rev. 695, 709 (2008)Google Scholar (“Second, federalism, including a state's enactment of its own laws, also may stimulate citizen participation in self-governance, on the theory that it is easier to participate at a level of government closer to one's home.”); but see Cross, Frank, The Folly of Federalism, 24 Cardozo L. Rev. 1, 1–2 (2002)Google Scholar (suggesting that “federalist” values are really values of localism). While much of the administrative law scholarship focuses on administrative law at the national level, states also have administrative agencies. For more on state participation in the federal administrative law process and the implementation of federal programs, see generally, Seifter, supra note 155. For more on the operation of administrative law at the state level, see Asimow, Michael, Contested Issues in Contested Cases: Adjudication Under the 2010 Model State Administrative Procedure Act, 20 Widener L.J. 707, 707-13 (2011)Google Scholar; Seifter, supra note 185, at 131-48; Asimow, Michael, The Influence of the Federal Administrative Procedure Act on California's New Administrative Procedure Act, 32 Tulsa L. J. 297, 298–303 (1996)Google Scholar; Seifter, supra note 185, at 131-48..

208 See King, supra note 27, at 169-70.

209 See id. at 169 (referring to “the HFEA indications approach”).

210 Gatter, Robert, Faith, Confidence, and Health Care: Fostering Trust in Medicine Through Law, 39 Wake Forest L. Rev. 395, 440 (2004)Google Scholar; Sage, William M. & Hyman, David A., Combating Antimicrobial Resistance: Regulatory Strategies and Institutional Capacity, 84 Tul. L. Rev. 781, 815 (2010)Google Scholar (discussing self-regulation in healthcare); but see Robertson, John A., Assisted Reproductive Technology and the Family, 47 Hastings L.J. 911, 920 (1996)Google Scholar (noting that the American Society for Reproductive Medicine would be amenable to an HFEA-like agency that would license and inspect fertility clinics, whereas the author, Professor John Robertson, is skeptical of the creation of such an agency); Robertson, supra note 24, at 1035-36 (“With adequate peer involvement, more explicit legal controls, such as the national licensing authority suggested in the Warnock Report, need not take root in American soil.”).

211 Datla, Kirti & Revesz, Richard L., Deconstructing Independent Agencies (and Executive Agencies), 98 Cornell L. Rev. 769, 808, 816 (2013)Google Scholar; Devins, Neal, Regulating of Governmental Agencies Through Limitations Riders, 1987 Duke L. J. 456, 461Google Scholar (discussing “appropriations as oversight”).

212 See King, supra note 27, at 173 (detailing the “five main functions” of a proposed “national independent regulatory body … which would include at least two functions that would infringe on the practice of medicine: “1) establish a licensing system for ART clinics; 2) establish procedural guidelines and regulations for ART practice; … 5) in the case that proven risks outweigh the benefits for certain procedures, regulate the use of PGS for certain indications using the novel balancing framework proposed above.”); see also Cahn & Carbone, supra note 180, at 380 (discussing “how politics at the national level can affect access to reproductive rights”).

213 Bierschbach & Bibas, supra note 162, at 20.

214 See HHS Agencies & Offices, U.S. Dep't of Health & Human Servs. (Oct. 27, 2015), https://www.hhs.gov/about/agencies/hhs-agencies-and-offices/index.html [https://perma.cc/S32Y-UK7V] (“HHS has 11 operating divisions, including eight agencies in the U.S. Public Health Service and three human services agencies.”); id. (noting that the FDA is an operating division within the U.S. Department of Health and Human Services).

215 Bagley, Nicholas & Levy, Helen, Essential Health Benefits and the Affordable Care Act: Law and Process, 39 J. Health Pol., Pol'y, & L. 441, 442, 447-49 (2014)Google Scholar.

216 Id. at 445, 449.

217 Id. (“The agency had no obligation to do any of this public outreach. Without informing anyone of its thinking, HHS could simply have issued a notice of proposed rulemaking announcing the benchmark approach. After receiving comments and issuing a final rule, HHS would then have complied with all of the APA's notice-and-comment requirements.”); id. at 456 (noting that “agencies do not have to solicit feedback on guidance documents.”).

218 Cf. Burwell v. Hobby Lobby, 573 U.S. 682 (2014). Thus, while ethical views may not have prevented the inclusion of contraception in minimum essential health benefits at the level of the administrative agency's decision making, the ethical views, which would be religious views in the Hobby Lobby case, of those who would be subsidizing the insurance plans required to have minimum essential health benefits are entitled to a certain amount of exemption or waiver by the federal government.

219 See FDA Grand Rounds, U.S. Food & Drug Admin. (Dec. 20, 2018), https://www.fda.gov/scienceresearch/aboutscienceresearchatfda/ucm486711.htm [https://perma.cc/9LNGWGXH].

220 See supra note 105 and accompanying text (explaining the first strand of the UK's public consultation on mitochondrial transfer).

221 See FDA Grand Rounds, supra note 219.

222 Stein, supra note 192 (“But [Dr.] Sauer said he was disappointed when he learned of the FDA's response. ‘Politics as usual often gets in way of progress,” Sauer said in a subsequent email. While the FDA statement [“prais[ed] the ‘thoughtful work’ of the panel and said the agency would be ‘reviewing’ the recommendations of the 2016 Institute of Medicine Panel] … [since then] … the latest federal budget ‘prevents the FDA from using funds to review applications in which a human embryo is intentionally created or modified to include’ changes that could be passed down to future generations… any such research ‘cannot be performed in the United States’ at this time”].”] … [This] would cause ‘undue delays’ in his research, he added that he hoped it wouldn't permanently ‘necessarily halt the efforts.’”).

223 See FDA Letter, supra note 119 (noting that the FDA had jurisdiction over the mitochondrial replacement techniques used by Dr. John Zhang and also noting that, pursuant to the Consolidated Appropriations Act, the FDA could not use “funds to accept IND submissions for clinical investigations that involve ‘a human embryo … intentionally created or modified to include a heritable genetic modification.’”).

224 See Nielson, Aaron L., Sticky Regulations, 85 U. Chi. L. Rev. 85, 88, 94 (2018)Google Scholar.

225 Evans, Barbara J., The Evolving Ethics Challenge in Genomic Science, 13 SciTech Lawyer 1, 24 (2016)Google Scholar.

226 See supra Part III.

227 Evans, supra note 225.

228 Livermore, Michael, The Perils of Experimentation, 126 Yale L. J. 636, 674 (2017)Google Scholar (“But for new policy domains—for example, when stem cell research first arose as a policy question—experimentation may help clarify the ideological space.”); see id. at 674 n.118 (“Clarifying ideological space may be of value to society, depending on how that information is put to use. Even if the clarification is not socially valuable, it might still be valuable to political actors.”).

229 See Acosta, Nefi D. & Golub, Sidney H., The New Federalism: State Policies Regarding Embryonic Stem Cell Research, J. Law Med. & Ethics 419, 419 (2016)Google Scholar.

230 Meeting #59 Transcript, supra note 148, at 13; see sources cited supra note 111 and accompanying text (providing the fifth strand of the UK's public consultation on mitochondrial donation).

231 See Criddle, Evan J., Fiduciary Administration: Rethinking Popular Representation in Agency Rulemaking, 88 Tex. L. Rev. 441, 478 (2010)Google Scholar (discussing the value of transparency in administrative law); McCuskey, Elizabeth Y., Agency Imprimatur & Health Reform Preemption, 78 Ohio St. L.J. 1059, 1162 (2017)Google Scholar (“The agency imprimatur model has the potential to imbue health law federalism decisions with more transparency and public participation opportunities than judicial preemption decisions afford.”).

232 Mendelson, supra note 40, at 1130-31, 1163-65, 1169.

233 O'Reilly, James T., Losing Deference in the FDA's Second Century: Judicial Review, Politics, and a Diminished Legacy of Expertise, 93 Cornell L.Rev. 939, 964-67 (2008)Google Scholar; Watts, supra note 178, at 732.

234 Heinzerling, supra note 177, at 938.

235 Mendelson, supra note 40, at 1130-31, 1163-65.

236 21 U.S.C. § 393(b)(2) (2012).

237 See Subterranean Regulation supra note 5, at 1257, 1292-93 (providing FDA's view on the regulation of human cloning in the United States); see also, Therapeutic Cloning and Genome Modification, Cellular & Gene Therapy Products, U.S. Food & Drug Admin. (Mar. 16, 2018), https://www.fda.gov/biologicsbloodvaccines/cellulargenetherapyproducts/ucm2007205.htm (“In March 2001, FDA sent a letter to the research community asserting regulatory authority over clinical research using cloning technology to create a human being, and to advise that FDA regulatory process is required in order to initiate these investigations. FDA jurisdiction includes human cells used in therapy involving the transfer of genetic material by means other than the union of gamete nuclei. Examples of such genetic material include, but are not limited to: cell nuclei (for cloning), oocyte nuclei, ooplasm, which contains mitochondria and genetic material contained in a genetic vector, transferred to gametes or other cells. Any clinical research involving these techniques would require an IND.”).

238 Wood et al., supra note 180, at 1197-98 (“The stated reason is that there is uncertainty about the drug's safety in younger women. But the FDA has not pointed to any data support that position, nor has the agency demanded such evidence in the case of other drugs that have been switched to over-the-counter status. All involved acknowledge that Plan B is extraordinarily safe.”).

239 Connor, supra note 6 (noting that FDA employees could not tell him what he needed to do in order to establish safety and that the “animal literature established, as well as you can establish, safety … [as such] … you can never say ‘it's safe’ until you do it.”); see supra note 104 and accompanying text (providing the similar view of the UK's Chief Medical Officer on the use of mitochondrial transfer in humans).

240 Connor, supra note 6.

241 21 U.S.C. § 393(b)(2) (2012).

242 See Drazen, Jeffrey M. et al., The FDA, Politics, and Plan B, 350 N. Eng. J. Med. 1561, 1561-62 (2004)Google Scholar; Wood et al., supra note 180, at 1199.

243 See Drazen et al., supra note 242, at 1561 (20040; Watts, supra note 179, at 708, 726.

244 Heinzerling, supra note 177, at 952.

245 See Advice to Government, supra note 93, at 7.

246 Id. at 15.

247 See infra Part III; see also supra note 101 and accompanying text (citing to the UK's four publications on the science and safety of mitochondrial transfer).

248 See Barry Furrow et al., Health Law: Cases, Materials, and Problems 87 (7th ed. 2013).

249 See Daar, supra note 17, at 615.

250 See id. at 624-26, 646; but see Joslin, Courtney G., Protecting Children(?): Marriage, Gender, and Assisted Reproductive Technology, 83 S. Cal. L. Rev. 1177, 1178-81 (2010)Google Scholar.

251 See Ouellette, Alicia et al., Lessons Across the Pond: Assisted Reproductive Technology in the United Kingdom and the United States, 31 Am. J. L. & Med. 419, 423, 436-37 (2005)Google Scholar.

252 See id. at 423.

253 See, e.g., Mary T. Bergman, Perspectives on Gene Editing, Harvard Gazette (Jan. 9, 2019), https://news.harvard.edu/gazette/story/2019/01/perspectives-on-gene-editing/ [https://perma.cc/3CFZ-336E].

254 Id.

255 Seifter, supra note 185, at 146-47.

256 While states currently license medical providers, another question that might be asked is whether the current demarcation of state and federal jurisdiction should remain as it is, especially in the realm of advanced assisted reproductive technologies. That normative issue is a topic for another paper. See Bagley, supra note 7, at 271 (“Even though regulation of health and safety is ‘primarily, and historically, a matter of local concern,’ there is no question that the Federal Government can set uniform national standards in these areas.”(citations omitted)).

257 See, e.g., King, supra note 27, at 107 (advocating “for the creation of an independent federal entity, the Assisted Reproductive Technology Authority (ARTA)”).

258 Rose-Ackerman, supra note 21, at 442.