By Doron Dorfman
On May 11, the U.S. Food and Drug Administration (FDA) announced that it is lifting its highly contested blood deferral policy for men who have sex with men (MSM, i.e., gay and bisexual men), colloquially known as the blood ban.
While this decision should be applauded as a step toward equality, the policy remains flawed and needlessly stigmatizing, as it excludes potential donors who use pre-exposure prophylaxis (PrEP), an antiviral regimen that prevents HIV infection from sex.
The new policy uses a behavioral‑individualistic approach to risk, which resembles European policies. Rather than assessing eligibility to donate blood solely on the basis of sexual orientation, potential donors will complete a detailed questionnaire, whereby sexual orientation is just one component of an elaborate risk assessment.
Despite this nuance, the new policy categorically excludes PrEP users. Importantly, PrEP use has been endorsed by federal public health authorities, including the FDA and the Department of Health and Human Services that included PrEP in a strategic plan to end the HIV epidemic by 2030. PrEP has been shown clinically to be 99% successful in preventing HIV infection and has become increasingly popular, specifically in the gay community.
Excluding PrEP users not only significantly cuts down the de facto number of MSM who could actually donate blood, it also penalizes prevention and has the FDA speak in two voices with regard to PrEP: endorsing and incentivizing its use on the one hand, and punishing its users on the other.
This fits a paradigm I describe in recent work, the demedicalization of preventive health care. This approach strips away the benefits of preventive treatment and shifts focus to the patient’s individual behavior, with serious public health ramifications.
For example, since it was first approved by the FDA in 2012, PrEP has been stigmatized as a “party drug” that gives gay users “just an excuse to slut around.”
This stigma around PrEP that connects it to promiscuity found its way into the recent Texas district court decision Braidwood Management Inc. v. Becerra, which enjoined the enforcement of the preventative care mandate under the Affordable Care Act that required dollar-first coverage of PrEP by insurers. The court’s explained: “Providing coverage of PrEP drugs ‘facilitates and encourages homosexual behavior, intravenous drug use, and sexual activity outside of marriage between one man and one woman.’”
Similarly, in an experimental study I conducted before the new FDA blood policy went into place, I found that participants were more reluctant to use blood donated by gay men who use PrEP (compared with the gay men not taking the drug), even after understanding the benefits of PrEP as an effective preventive health measure. Crucially, PrEP users are less likely to have HIV than those who do not take PrEP, as the treatment is so effective. PrEP users are also tested every three months for HIV and STIs to maintain their prescription. Therefore, there is much less of a chance of PrEP users being HIV positive. The participants in my study were thus penalizing those gay men who took care of themselves and exhibited responsible behavior by taking PrEP. The new blood donation policy does the same.
The FDA justifies its policy by appealing to the concern that PrEP “may delay detection of HIV by currently licensed screening tests,” thus causing a false negative: a blood donation that initially seemed to be negative will later turn out to be positive. Nevertheless, a policy solution to this situation is relatively simple and already exists in other countries in the form of a “double testing system.” Under such a system, plasma is tested for HIV and other infectious diseases; if found negative, the plasma is separated, frozen, and kept for four months. Following the quarantine period, the donor will give blood again, and if it is also found negative, the frozen plasma is then approved for transfusion.
Such a solution will achieve three goals: helping fight blood scarcity, which has been at all-time low levels since the early days of the pandemic, destigmatizing PrEP use, which is essential to eradicating HIV, and promoting coherence in FDA policies, thus helping rehabilitate public trust in the federal agency after controversies in recent years.
Doron Dorfman is an Associate Professor of Law at Seton Hall University Law School.
This article was updated to clarify that the double testing system is not specifically focused on PrEP users.
