A Patchwork of Regulation: Does the FDA have the Authority to Regulate Mitochondrial Transfer, i.e., “Three-Parent Babies”?

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Part 2 of a 3-Part Series on 3-Parent Babies:

I recently wrote why the US should follow Britain’s historic decision to approve mitochondrial transfer, i.e., “three-parent babies,” in order to assist women suffering from mitochondrial diseases. However, the approval process in the US would be very different from that in Britain, mainly due to the chaos surrounding regulation of assisted reproductive technology here in the United States.

Regulation of Assisted Reproductive Technology (ART)

After the birth of Louise Brown, the world’s first IVF baby, the UK recognized the powerful implications of ART, as well as the need for regulation and informed discussion regarding treatments and research in this field. Thus, in 1990 the Human Fertilisation and Embrology Authority (HFEA) was established, making it the first statutory body in the world to monitor, regulate, and inspect all clinics in the UK that provide IVF treatment, artificial insemination, and storage for human eggs, sperm, or embryos. The HFEA also regulates all human embryo research in this field. As such, the HFEA has regulatory authority over mitochondrial transfer.

In comparison, the United States Federal Government does not have jurisdiction over the practice of medicine, and there is no uniform or comprehensive system of regulation over ART, including reproductive genetic testing and treatments such as mitochondrial transfer. Thus, the framework for reproductive technology in the United States is characterized by an assortment of state and federal regulation scattered across various agencies whose jurisdiction is often derived from existing statutes with broad applicability. This, along with professional self-regulation, makes up the patchwork of authority monitoring ART. Included in this mess is the Food and Drug Administration, an agency which has seen fit to declare their jurisdictional authority to regulate mitochondrial transfer in the United States.


ART’s Regulation-free History in the US

In 1980, Virginia approved the first IVF clinic in Norfolk; anti-abortionist protesters were quick to attack this clinic, condemning IVF treatments. Protesters argued that there had not been sufficient and proper study of the scientific, legal, and moral merits – there had, in fact, been over two decades of research on IVF treatments. Fortunately, the protesters failed in their fallacious efforts to stop the Norfolk clinic from utilizing IVF treatments to help countless women become pregnant. However, protestors and other anti-abortionists were successful in lobbying the government to ban federal funding for embryo research. Ironically, according to those opposed to ART advancements, this ban likely did more harm than good.

Without funding from the government, clinics turned to the millions of couples seeking fertility treatment who were more than happy to provide billions of dollars to researchers as the couples pursued fertility treatments in their quest for babies. With this private financing, the burgeoning fertility industry developed in this country without the usual regulation that comes with federal research funds. Competition grew while government oversight remained minimal. Unfortunately, this also opened the door for media sensationalism. With little to no peer review, the media could latch onto advancements in treatment and create sensationalized hype by either referring to it as a “breakthrough for desperate couples,” or they could condone the treatment as “unethical.” The clinics were also guilty of this; sometimes prematurely announcing a “breakthrough” in order to generate business and private funding.

It was in this environment that the first mitochondrial transfer was successfully performed in 1996 in the United States. Following this, with growing concerns regarding advancements in innovative IVF treatments and other assisted reproduction procedures, it is not surprising that the FDA stepped in and began regulating such techniques. On July 6, 2001, the FDA sent warning letters to fertility researchers and “advised practitioners that FDA has jurisdiction over the use of human cells that have received transferred genetic material by means other than union of gamete nuclei.” The FDA explained that any further practice of mitochondrial transfer, or similar treatments, would require an Investigation New Drug submission. According to the FDA, there were concerns that the safety data “were not convincing.” However, after proceeding for so long without much government interference, some clinics questioned the FDA’s authority to regulate such treatments and technology.

FDA Authority

The FDA is empowered by the US Congress to enforce the Federal Food, Drug, and Cosmetic Act, along with other laws including Section 361 of the Public Health Service Act and associated regulations – some of which are not directly related to food or drugs, such as lasers, cellular phones, condoms, sperm donation, etc. The FDA itself admits that “the scope of FDA’s regulatory authority is very broad.

The FDA claims that their authority to regulate mitochondrial transfer and other similar treatments stems from the fact that genetically manipulated embryos constitute a “biological product” and are therefore subject to regulation similar to medical implements and drugs. The FDA defines a “biological product,” or biologics, as medical products that are made from a variety of natural sources including humans, animals, or microorganisms. The FDA further explains that biologics are intended to treat disease and medical conditions, while others are used to prevent or diagnose diseases; biologics can also be living entities, such as cells and tissues.

While some consider this a stretch, claiming it is possibly an overly broad application of the agency’s authority, as of now the FDA seems to be exercising their full authority over this treatment.

IVF Regulated

Concluding Thoughts

In the past two years there have been advisory committee hearings held to discuss potential future clinical trials of mitochondrial manipulation technologies. To date, there has been no formal decision made on the efficacy of various mitochondrial treatments for women, but there has been expressed agreement that with more experimentation and research providing further scientific data, the potential benefits from such treatments could eventually outweigh the concerns.

Ultimately, FDA’s regulation of mitochondrial transfer was the result of a rapidly growing fertility industry that was operating outside the scope of government oversight.  Though questioned by some, the FDA’s action highlights the significant safety, ethical, and policy issues that both society and the government must face as scientific progress in reproductive technologies continues. Whether the agency is correct in their regulation of this treatment or not is up for debate. However, I believe most would agree that some regulatory agency should oversee this and similar treatments. Whatever formal government body assigned to monitor ART – whether it would be like Britain’s HFEA or it continues to be the FDA – it’s power and limitations should be explicitly defined in order to remove the current necessity of  broadly interpreting the applicability of an agency’s statutory authority; otherwise the US will continue to be the “Wild West” of reproductive technology, further delaying the necessary scientific investigation and public debate needed before approval of significant and innovative reproductive treatments.

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