How Subterranean Regulation Hinders Innovation in Assisted Reproductive Technology

Most scholars believe assisted reproductive technology is subject only to minimal regulation, especially by the federal government. This belief I contend, is wrong. In this Article, I examine agency documents, statements by officials, and letters that the U.S. Food and Drug Administration (FDA) has sent to physicians and researchers over the past fifteen years to reveal an overlooked regulatory program. The FDA has been targeting new forms of assisted reproductive technology that involve small genetic modifications (advanced assisted reproductive technologies or AARTs) through regulatory actions that receive little public, media, or scholarly attention.

I term this method of regulation "subterranean regulation." Subterranean regulatory actions chill research as many physicians and researchers halt their research after receiving these letters or stop providing access to AARTs in the United States. The existence of this unconventional and largely unnoticed regulatory practice raises a series of issues including whether the FDA should be regulating advanced assisted reproductive technologies at all. Moreover, a hidden, ad hoc regulatory practice is exactly the wrong kind of process to use when it comes to scientific innovations in fraught ethical areas, which includes not only assisted reproductive technology but also other DNA-modifying technologies such as gene editing (including CRISPR-Cas9). Ultimately, I recommend a regulatory approach that is as close to "minimal regulation" as possible.