Academic journal article Columbia Journal of Law and Social Problems

Regulating Relationships: A Challenge to the Constitutional Authority of the FDA Regulation of Private Sperm Donation

Academic journal article Columbia Journal of Law and Social Problems

Regulating Relationships: A Challenge to the Constitutional Authority of the FDA Regulation of Private Sperm Donation

Article excerpt

This Note challenges the constitutionality of the FDA's current regulation of private sperm donation under 21 C.F.R. § 1271. The FDA currently regulates private sperm donors donating to known couples in the same way that it regulates anonymous sperm donors donating to a sperm bank. This Note argues that the current FDA regulation does not comply with constitutional guarantees secured by the Due Process Clause of the Fifth and Fourteenth Amendments, specifically their protection of individual rights concerning procreation. The Supreme Court has developed a hands-off approach to family planning over the last ninety years, and the FDA is attempting to bypass almost a century of jurisprudence to ensure that those attempting artificial insemination through sperm donation adhere to the medicalized guidelines currently in place. This Note further argues that the FDA regulation, in addition to overstepping the protections of the Constitution, does not adhere to its stated purpose and creates a regulation that is both arbitrary and capricious in application.

I. Introduction

Tanya is a woman in her late thirties desperate to become a mother.1 Financially independent but single, Tanya spent be- tween $60,000-$70,000 on vials of sperm from anonymous sperm donation centers, used by her doctor for artificial insemination.2 After multiple attempts to conceive and no success, Tanya turned to online sperm donation, where she found a suitable donor and began having sexual intercourse with the donor in an attempt to become a mother.3

Beth and Richard are a happily married couple who are desperate to become parents, but Richard is unable to impregnate Beth.4 The couple spent approximately $14,000 on unsuccessful artificial insemination through an anonymous sperm donation center.5 Frustrated both financially and emotionally, Beth and Richard decided to try free online sperm donation, found a donor they trusted, and after months of calls and chats, decided to go through with the sperm donation.6 Using sperm donated just minutes before, Richard used a syringe to inseminate his wife.7

Finally, Krista is in a committed partnership and desperately wants to have a child.8 Financially secure and independent, Krista and her partner have spent upwards of $10,000 on artificial insemination procedures using anonymous sperm donation centers.9 Krista reached out to Trent Arsenault, a man who has provided sperm free of charge to many couples, resulting in the birth of fourteen children.10 Using Trent Arsenault's sperm, Krista became pregnant, but tragically miscarried.11

These three stories all ring familiar: individuals who wish to have children but are prevented for lack of partner or depletion of funds after rounds of failed clinical procedures. Interestingly, only one of the three stories is sanctioned by the federal government. The Food and Drug Administration (FDA) regulates all private sperm donation, and requires costly STD tests and tedious procedural requirements to be administered for every at- tempted sperm donation.12 What this means is that Beth and Richard's donor was probably in violation of FDA regulation 21 C.F.R. § 1271 unless he had documentation of the various medical tests with him at the time of donation, labeled cups, and a meticulously kept medical history.13 The FDA issued Krista's donor, Trent Arsenault, a Cease Manufacture order, and faces potential jail time and a fine of up to $100,000 for producing sperm that was used for artificial insemination14 despite the battery of STD testing he has undergone, documentation of his medical history, and meticulous record of his clean-living lifestyle.15

The FDA does not impose this type of financial strain or criminal penalty on sperm donors who inseminate via sexual intercourse rather than syringe. In a twist of modern legal arbitrariness, only those donors and recipients who choose reproduction without having sex are plagued by unnecessary and intrusive federal regulations. …

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