In May 2004, the Food and Drug Administration (FDA) announced a final rule to be published in the Federal Register that would establish eligibility criteria for persons seeking to donate sperm and other human cells and tissues. Concurrently, the FDA issued a draft guidance document that provides recommendations for complying with the requirements, listing men who have had sex with another man in the preceding 5 years (MSMs) as the number one risk factor. The FDA does not, however, make a distinction between MSMs who practice safe sex and those who have unprotected sex, nor does it identify men who have had sex with women - be it with one or many female partners, protected or unprotected - as one of its twenty-nine enumerated risk factors.

The purpose of this article is to highlight several litigation strategies that might be effective in ending discrimination against gay and MSM potential sperm donors. The article does not advocate for one litigation strategy over another, nor does it purport to solve all of the problems involved with each. The overarching goal is to make a potential litigator aware of some of her strategic legal choices, to highlight the advantages and disadvantages of each choice, and to advocate for creative lawyering. The article will discuss claims against the FDA under the Administrative Procedure Act, and it will also analyze claims against individual sperm banks that have adopted the FDA's recommended eligibility requirements under the U.S. and various state constitutions' rights to sexual intimacy and procreation.