rendering of luminous DNA with gene being removed with forceps.

Mainstreaming Reproductive Genetic Innovation

By Myrisha S. Lewis

Despite religious and ethical objections, assisted reproductive technology (ART), including in vitro fertilization and egg freezing, manages to flourish in the United States, with some states and companies even creating regimes for its insurance coverage. However, reproductive genetic innovation — a term I use to refer to the combination of assisted reproduction with genetic modification or substitution — has yet to receive the same acceptance. Examples of reproductive genetic innovation include mitochondrial transfer, cytoplasmic transfer, and germline gene editing.

Moreover, while many scientists, regulators, and members of the public have called for societal discourse or consensus related to individual reproductive genetic innovation techniques, these calls rarely include an explanation as to how these discourses would be conducted. In a recent article, Normalizing Reproductive Genetic Innovation, I offer four potential avenues for structuring a societal discourse in the U.S. on the topic.

When considering when and how to have a societal discourse, it is worth remembering that many other commonly accepted techniques were quite controversial at their inception, including artificial insemination, in vitro fertilization, organ transplantation, and the still-controversial vaccination. Consensus is not clear on these issues, either nationally or internationally, which is why I emphasize “discourse” instead of “consensus.” Yet, despite controversy, many people avail themselves of medical treatments that others would not, such as prenatal testing, organ donation and transplantation, abortion, and ART in general. Interestingly, the aforementioned commonly accepted medical techniques seemingly entered clinical practice without a societal discourse or consensus. This lack of a broad societal discourse is interesting, as it appears not to be the path forward for reproductive genetic innovation, at least if it is to ever be legal in the United States.

To date, reproductive genetic innovation has been targeted by the U.S. Food and Drug Administration (FDA). For example, physicians and companies offering cytoplasmic and mitochondrial transfer have received Untitled Letters from the FDA. After receiving the letters, these individuals and entities have ceased to provide these techniques in the United States. Reproductive genetic innovation techniques are now included in an FDA Advisory listing techniques that are subject to the agency’s investigational new drug (IND) application requirements. In 2015, Congress included a now-recurring budget rider in appropriations legislation that prevents the FDA from using its funding to consider IND applications involving “heritable genetic modification.” The FDA has interpreted this Congressional budget rider to preclude not only the approval of germline gene editing, but also mitochondrial transfer and cytoplasmic transfer.

Moreover, funding related to ART and germline gene editing has historically been limited by NIH policy. Some certainly laud such a prohibitive regime; others believe such a moratorium should focus on human germline gene editing specifically, and views differ on the extent of its duration (e.g., in perpetuity versus only until certain safety and efficacy concerns are resolved).

To the extent that this discourse already has occurred, it has largely focused on scientific experts, and not the general public. For example, while scientists have continued to meet to discuss the appropriateness of germline gene editing at various international summits, the federal administrative state has yet to facilitate significant public discourse, and a Congressional subcommittee hearing in 2015 similarly fell short.

Even though it is possible that calls for societal discourse are just attempts by opponents to stymie the use of these techniques, after addressing the shortcomings of administrative law mechanisms like notice-and-comment rulemaking in Normalizing Reproductive Genetic Innovation I offer the following possibilities for structuring a societal discourse in the U.S. using administrative law: (1) adapting the U.K.’s public consultation methods used in the leadup to the legalization of mitochondrial transfer to the U.S.’ existing deliberative processes; (2) citizens’ juries, which have been used around the world to consider views of individuals on various issues; (3) Consensus Development Review, a process that was used in the U.S. to classify liver transplantation as “established” instead of experimental, thus clearing the way for insurance coverage; and (4) increased administrative agency and media outreach, as occurred during the COVID-19 vaccination campaign (although this certainly has not led to consensus on vaccination in the United States). One also could consider Australia’s recent incremental approach to the legalization of mitochondrial transfer.

While participatory approaches could have disadvantages, including the overrepresentation of advocacy groups and a failure to include the broader public, any negative participation would, at worst or at best, depending on one’s perspective, preserve the current regulatory environment in the U.S. where traditional ART is widely available but reproductive genetic innovation is not.

When scientists and the public finally do engage in conversation, it is worth reminding the public how similar reproductive genetic innovation is to many other initially controversial medical techniques and approved medical products, including organ transplantation, vaccination, IVF, and somatic gene therapy. Doing so could perhaps foster a productive conversation that can focus on safety, efficacy, and the practice of medicine, instead of sensationalism and science fiction.

Myrisha S. Lewis is an Associate Professor of Law at William & Mary Law School.

The Petrie-Flom Center Staff

The Petrie-Flom Center staff often posts updates, announcements, and guests posts on behalf of others.

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