Trite but True, Better Safe Than Sorry

Abstract

I recently read that the US Food and Drug Administration (FDA) was proffering an administrative rule to prohibit gay men from donating sperm. Although I found it hard to believe that a law apparently discriminative and overly broad would pass judicial scrutiny, I was intrigued. After all, sexual orientation, same-sex marriage, and homosexual hate crimes are currently vibrant political, ethical, and legal issues. But was the FDA empowered to make such a law dictating private medical practices and laboratories? If so, was this report about gay men being singled out accurate? The Associated Press headline read, “FDA to Implement Gay Sperm Donor Rules.” 11 May 6, 2005. According to the article, the FDA was specifically, “implementing new rules… [barring] any man who has engaged in homosexual sex in the previous five years… from serving as an anonymous sperm donor.” At first, such a ban made medical sense when recognizing unprotected homosexual sex is a risk factor for human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) transmission and the FDA's mandate under the Public Health Act to protect the general health of the public. My second thought reverted to my original disbelief that such a ban was overly exclusive—as I assumed there are gay men in monogamous relationships practicing safe sex who would pose no risk to a recipient. Continuing, I half-heartedly hoped that this article simply exemplified the current trend in media bias and titillation rather than accurately reporting the facts. The article went on to detail critics' accusations against the FDA of “stigmatizing all gay men,” promoting “policy based on bigotry,” and it quoted Leland Trainman, director of a clinic in Alameda, Calif, that solicits gay sperm donors, who claims “[u]nder these rules, a heterosexual man who had unprotected sex with HIV-positive prostitutes would be OK as a donor one year later, but a gay man in a monogamous, safe-sex relationship is not OK unless he's been celibate for five years.” Of course, the former portion of this statement seemed equally as ludicrous as banning donors on the basis of sexual orientation rather than sexual behavior. However, reading on, I discovered that “The FDA is very much aware that [the] strict exclusion policies eliminate some safe donors.” According to the article, the FDA in a reply document to Lambda Legal “felt the broad[er] exclusion was prudent even if it affected gay men who practice safe sex.” Eleanor Nicoll, a spokeswoman for the American Society for Reproductive Medicine (ASRM) concurring with the FDA's exclusionary rule intoned, “With an anonymous sperm donor, you can't be too careful. Our concern is for the health of the recipient, not to let more and more people be sperm donors.” Enlightened by the honest, forthcoming admission by the FDA and comment by the ASRM spokeswoman and vacillating back to believing the old adage, “better safe than sorry,” I pulled the administrative rule that went into effect on May 25, 2005, to clarify the facts and decide: unjustly discriminative or legitimately, medically, reasonable, and responsible. As most of us know, there are 3 branches of the US government: the legislative branch, or Congress, composed of the House of Representatives and the Senate, which make the laws; the executive branch symbolized by the President, which enforces the laws; and the judicial branch or the court system, whose judges interpret the laws. Often administrative agencies such as the FDA, the Central Intelligence Agency (CIA), the Federal Trade Commission (FTC), and the Internal Revenue Service (IRS) are considered the “fourth branch” of our government. Actually, administrative agencies are a creation of the legislative branch via Article I, § 1 and § 8, paragraph 18, of the US Constitution,22 This paragraph is known as the Delegation [of Powers] Doctrine. which states in relevant part, “All legislative Powers herein granted shall be vested in a Congress of the United States… To make all Laws which shall be necessary and proper.” In recent times, the past century or so, administrative agencies were most often created to address impending crises or to redress serious social problems. The establishment of an agency became preferable to Congressional action in certain instances because of its tremendous flexibility, specialized staffing (an agency can hire whom-ever it needs to accomplish its task), developed expertise from continued exposure to a constant problem, ability to tailor its regulatory techniques and decision making procedures to the immediate problem, and wide range of powers including, but not limited to, controlling entry into a field through licensing, imposing penalties, dispensing grants, and adjudicating violations. The FDA specifically gleaned its authority to establish “Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products” from section 361 of the Public Health Service Act33 42 USC 264. (PHS Act). Under the PHS Act with delegation from the Surgeon General and the Secretary of Health and Human Services, “the FDA may make and enforce regulations necessary to prevent the introduction, transmission or spread of communicable diseases between the States or from foreign countries into the States.” Communicable diseases include, but are not solely, those transmitted by viruses, bacteria, fungi, parasites, and transmissible spongiform encephalopathy agents. Thus, the FDA clearly has the appropriate authority to issue an administrative rule with the weight of law, concerning potential disease transmission by sperm donation. Having determined the FDA has the legal authority to regulate circumstances where communicable disease transmission is of legitimate concern, how exactly did they do it? In 1997, the FDA proposed a new comprehensive approach to the regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The proposal consisted of 3 elements: Establishment Registration and Listing for Manufacturers of Human Cellular and Tissue-Based Products,44 Proposed rule, 63 FR 26744, May 14, 1998. Suitability Determination for Donors of Human Cellular and Tissue-Based Products,55 Proposed rule, 64 FR 52696, September 30, 1999. and Current Good Tissue Practice for Manufacturers of Human Cellular and Tissue-Based Products.66 Proposed rule, 66 FR 1508, January 8, 2001. On January 19, 2001, the first of these proposed ruled became final when Human Cells, Tissues and Cellular and Tissue-Based Products; Establishment Registration and Listing was published after appropriate public notice and comment.77 Final rule, 66 FR 5447, January 19, 2001. On May 25, 2005, the second proposed rule became final when Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (second rule) was published.88 Final rule, 69 FR 29786, May 25, 2005. The third proposal has not yet reached its final form. The general purpose of this comprehensive approach to HCT/P regulation is to “improve protection of the public health without imposing unnecessary restrictions on research, development or the availability of new products. Consolidating the regulation of HCT/Ps into one regulatory program is expected to lead to increased consistency and greater efficiency. Together, these planned improvements will increase the safety of HCT/Ps and public confidence in their safety.” 99 Id. The FDA's action to consolidate and streamline the regulation of HCT/Ps is productive and commendable, as is the breadth with which it responded to the public's concerns and comments. But what did the second rule explicitly say about the eligibility of sexually active gay men to donate sperm? Not a thing! In layman's terms, the FDA now requires establishments responsible for making cell and tissue donor-eligibility determinations to decide the eligibility of a potential reproductive cells or tissue donor through screening and testing. The second rule states that an eligible donor must be free from risk factors for and clinical evidence of infection resulting from relevant communicable disease and disease agents as well as those associated with xenotransplantation. Additionally, the testing results for the aforementioned must be negative or nonreactive with limited exceptions.1010 Id. at § 1271.50(b). See also §§ 1271.75, 1271.80, and 1271.85. This requirement immediately raises 2 questions: From what “risk factors and clinical evidence” must an eligible donor [of reproductive cells or tissue] be free? And, with respect to reproductive cells and tissue, what communicable diseases and disease agents are considered “relevant”? i. Diseases and disease agents for which screening and testing is mandated. Practicality answered the second question first, because the answer is found within the second rule itself. Section 1271.75 of the second rule specifically mandates screening and testing for: 1) HIV, 2) hepatitis B virus [HBV], 3) hepatitis C virus [HCV], 4) human transmissible spongiform encephalopathy—including Creutzfeldt-Jacob disease, 5) Treponema pallidum, 6) communicable disease risks associated with xenotransplantation, 7) Chlamydia trachomatis, 1111 Screening and/or testing for Chlamydia trachomatis is not required if the specimen is collected “by a method that ensures freedom from contamination of… infectious disease organisms that may be present in the genitourinary tract.” Id. § 1271.75(c). and 8) Neisseria gonorrhea. 1212 Screening and/or testing for Neisseria gonorrhea is not required if the specimen is collected “by a method that ensures freedom from contamination of… infectious disease organisms that may be present in the genitourinary tract.” Id. § 1271.75(c). While the second rule specified the relevant communicable diseases and disease agents, it is silent as to risk factors and clinical evidence. ii. Guidance for identifying risk factors and clinical evidence of infection. To answer the former question, the second rule refers the reader to “donor-eligibility draft guidance that may be found elsewhere in this Federal Registrar.” Unexplainably, the second rule provides no reference to find this “guidance” in the Federal Registrar. Furthermore, the draft guidance is only that, guidance to help establishments comply with the second rule. It is not binding and has no force of law, but simply “reflects the agency's current thinking.” The draft guidance states in relevant part, “[the] FDA believes that the following conditions and behaviors increase the donor's relevant communicable disease risk… [and] recommend that you determine to be ineligible any potential donor who exhibits one or more of the following conditions or behaviors, 1) men who have had sex with another man in the preceding five years, 2) persons who have injected drugs for a non-medical reason in the preceding five years, including intravenous, intramuscular or subcutaneous injections, 4) persons who have engaged in sex in exchange for money or drugs in the preceding five years and 5) persons who have had sex in the preceding 12 months with any person described in the previous 4 items of this section or with any person known or suspected to have HIV infection, clinically active hepatitis B infection or hepatitis C infection.” 1313 Guidance for Industry, Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products, draft guidance. US Department of Health and Human Services-FDA-Center for Biologics Evaluation and Research May 2004. Available at: http:www.fda.govcberguidelines.htm. This document states it is for comment purposes only. There are a total of 20 conditions and behaviors this guidance suggests be considered. Reported here are only those with topic relevance. The document goes on to detail clinical evidence to consider and to suggest the tests to be used for evaluating the presence of the communicable diseases and disease agents outlined in § 1271.75. Thus, finally, an answer—sort of. Although the second rule on eligibility-determination does not ban gay donors outright—regardless of whether they practice safe sex—the complementary draft guidance does. However, the draft guidance is not a law but only FDA suggestions. To complicate matters even more, there are exceptions to the second rule addressing types of donors and donor-eligibility relevant to determining whether gay men can be sperm donors. There are 3 categories of reproductive donors, subject to 3 different sets of requirements in the second rule. First is the anonymous donor to whom all donor-eligibility requirements of screening and testing apply. Second is the directed reproductive donor whose reproductive cells and tissue may be used with the recipient's consent, even if the donor is found to be ineligible. Lastly, there is the sexually intimate partner of the recipient, whose cells or tissue is to be used, for whom screening and testing are not required. Applying the draft guidance that does explicitly suggest deeming ineligible men who have had sex with another man in the previous 5 years to this trifecta, sexually active gay men would be ineligible to anonymously donate sperm, but a technically ineligible sexually active gay man could be a directed donor. Because screening and testing are not applicable to the sexually intimate partners of recipients, the draft guidance is moot. As I probably should have expected, the Associated Press article was both right and wrong. Yes, the FDA has issued an administrative rule regulating sperm donation, and they have the legal authority to do so. However, it is the accompanying draft guidance, not the second rule, that has the force of law, which declares some sexually active gay men donor-ineligible. And, these ineligible men would only be prohibited from donating sperm anonymously, not from serving as directed donors. By distinguishing between directed reproductive donors who are chosen by a recipient and anonymous donors who have no immediately ascertainable relationship with a recipient, the FDA claims to, and I believe does, “respect the existence of relationships between people who know each other and have made a joint decision for the recipient to conceive a child.” Despite critics' accusations of “stigmatizing all gay men,” promoting “policy based on bigotry,” and lack of scientific evidence to support the policy, the FDA details its collaboration with the Centers for Disease Control (CDC) and its reliance on Guidelines for Preventing Transmission of Human Immunodeficiency Virus Through Transplantation of Human Tissue and Organs1414 Morbidity and Mortality Weekly Report. 1994; 43(R-8). in determining the most accurate and current scientific statistics on the higher prevalence of HIV, HBV, and HCV in homosexual men than in the general public in support of its suggestion to declare ineligible for anonymous sperm donation men who have had sex with another man in the previous 5 years. The FDA also notes that in an effort not to be overly exclusionary, they queried the Center for Biologics Evaluation and Research (CBER) to identify a subset of homosexual men in which the incidences and prevalence of HIV, HBV, and HCV were similar to the population as a whole. The CBER committee responded unanimously that no such data exist.1515 Final rule, 69 FR at 29806. The FDA has passed two thirds of a commonsense, protective regulatory scheme accompanied by fair, tailored, rational, and responsible guidance for inhibiting the transmission of delineated communicable diseases and disease agents, as is its mandate. However, it is only if and when the draft-guidance becomes law that sexually active gay men would be legally prohibited from anonymously donating sperm. If the FDA does codify the draft-guidance, it will protect this generation of reproductive cell and tissue recipients and its future offspring. I believe recipients and their offspring would prefer the FDA be proactive and safe, rather that retroactive and sorry.