Discriminatory Blood Donation Policies Defy Science – The Regulatory Review

During the COVID-19 pandemic, blood donation deferral policies came under scrutiny due to blood donation shortages nationwide. In addition, the U.S. Food and Drug Administration’s (FDA) call for convalescent plasma—blood collected from individuals who have recovered from COVID-19—brought attention to these policies that prohibit some men from donating plasma under FDA’s policy on donations from men who have sex with men (MSM). 

Advocates have long argued for a shift in FDA’s policy targeting MSM. As a result, FDA decreased the once-permanent ban on blood donations by MSM from a 12-month deferral period to a 3-month deferral period in April 2020. Although FDA’s guidance to establish a 3-month deferral period for MSM was a step in the right direction—bringing the United States closer to standards established by other countries such as the United Kingdom and Canada—it does not reflect the latest science.

The MSM deferral policy assumes that a male donor—here we assume sex assigned at birth, rather than a person’s gender identity—is ineligible to donate blood if he has had sex with another man any time in the prior 3 months. The donor’s sexual behavior is assumed to be “high risk,” and the donor is categorized into one of several delineated “high-risk groups.” 

The problem is that the definition of “high risk” sexual behavior is not tied to the prevailing scientific understanding of HIV transmission. Under the FDA’s current regulatory framework, any type of sex (e.g., oral, anal), in any type of relationship (e.g., monogamous, casual), at any frequency (e.g., number of partners, encounters) counts as “high risk.” In addition, sexual behavior is deemed “high risk” without any consideration of the use of prophylactics (e.g., condoms), including biomedical interventions that can prevent contracting HIV by up to 99 percent (e.g., pre-exposure prophylaxis or PrEP).

In addition to this blunt assessment of what constitutes “high risk” sexual behavior, the revised 3-month deferral period for MSM appears random. There are some good reasons to move to a 3-month deferral period—other countries have done it successfully and all surveillance data from these other countries indicate good results. But the 3-month time frame lacks a scientific basis. 

Nucleic acid testing (NAT), a molecular technique for screening blood donations has existed since the late 1990s and early 2000s. NAT reduces the risk of transfusion transmitted infections, and NAT screening can detect infections well within a 3-month period. The window phase—the period where a person infected with a virus may test negative despite being positive—for HIV, hepatitis B, and hepatitis C is 2.93 days, 10.34 days, and 1.34 days, respectively. 

So how does the sensitivity of screening that is days long, about 10 days at most, turn into a 3-month deferral policy? The answer may be in the policy’s roots. 

When the FDA first implemented a permanent deferral in 1985, there were good reasons for broad regulations to ensure the safety of the blood supply. At the height of the AIDS epidemic, the world was dealing with an unknown virus that spread in unknown ways. Scientists identified the virus in the early 1980s, and the FDA approved the first test to screen blood donations for HIV in 1985. At the time, exercising extreme caution was the wisest course of action.

The story told in 1983—that perpetuating stigma through a discriminatory policy was a necessary cost to ensuring a safe blood supply—is not a story Americans can tell ourselves today. Health professionals never eliminated risk to the blood supply by maintaining the MSM deferral policies because there have always been failures in donor screening and blood screening protocols.  

At the same time, scientific advancements have made screenings more effective. The United States has implemented Transfusion Transmissible Infections Monitoring Systems to monitor the safety of the U.S. blood supply for a variety of different pathogens, including HIV. 

Many of the problems associated with blood donation safety, such as donors failing to understand their own sexual risks, are indications of greater failures in other policy arenas. These problems highlight widespread unwillingness to educate the nation about sex, deliver accurate information on sexual risk, and offer helpful ways to mitigate such risk in a culturally appropriate manner.

The FDA’s approach came at a cost. The deferral policy generated stigma targeting communities disproportionately affected by the HIV and AIDS epidemic. As it relates to blood donation, HIV stigma animates unfounded, ongoing fear of an unsafe blood supply. This stigma has been memorialized in outdated state and federal laws, which continue to criminalize behaviors that are erroneously thought to risk exposing others to HIV through blood donation.

Such laws criminalizing HIV status have not curbed the HIV epidemic and, as the U.S. Centers for Disease Control and Prevention has noted, these HIV-specific laws are largely unsupported by science. Sexual minorities, including gay and bisexual men, communities of color, and those facing intersecting oppressions today stand in the crosshairs of HIV stigma enshrined in law and policy. This is why our nation’s plan to end the HIV epidemic cites stigma as a key barrier to progress.

Although not all members of society will agree with each other on what degree of risk is acceptable, it is important to remember that the U.S. calculus, as it relates to the MSM deferral policy, has been flawed historically. To eliminate all HIV-related risks to blood safety, the U.S. must end the HIV epidemic. HIV stigma and gay-related stigma stand in the way of achieving this goal. 

FDA’s recent shift to a 3-month deferral policy for MSM likely resulted from interest convergence—effective activism by dedicated advocates coupled with the practical realities of a nationwide shortage of blood donations during a global pandemic. This shift demonstrates that the previous restrictions on blood donation were never based on science. Going forward, FDA’s policies must harness truths based on science rather than fear.