Reforming Blood Donation in the Age of COVID-19

The COVID-19 pandemic has pushed the U.S. Food and Drug Administration (FDA) to modernize regulatory guidance born of an earlier global epidemic: HIV/AIDS.

Previous FDA guidance required that men who had sexual contact with other men (MSM) must defer donating blood for 12 months following their last applicable sexual encounter. In an effort to encourage blood donation, FDA last month reduced this deferral period to three months.

This change in guidance brings the United States into line with the practices of other Western countries, and it better balances the need to address blood donation shortages while preventing the spread of HIV/AIDS and reducing the stigma that MSM face due to their sexual behavior.

To assess the safety of a given blood donor, FDA requires that the physician overseeing a blood donation center determines donor eligibility and that the physician turn away a donor “if the donation could adversely affect the health of the donor or the safety of the blood or blood component.” FDA has also generated guidance on how “blood establishments” should evaluate potential donors and when facilities should “defer” a blood donation.

The guidance aims to reduce the spread of HIV and target individuals considered at high risk for exposure to the disease. Besides regulating MSM, the guidance also applies to other at-risk populations such as sex workers, drug users, individuals who have recently received a tattoo, and recipients of a recent blood transfusion.

Restrictions in this vein began in 1983, when FDA instituted a lifetime ban on blood donation for any man who had sex with another man from 1977 forward. Because HIV testing technology was unreliable at the time, FDA designed the “emergency measure” to keep donors at high risk from contracting HIV out of the transfusion pool.

This “deferral policy” remained unquestioned for more than a decade, until the U.S. Department of Health and Human Services’s Advisory Committee on Blood Safety and Availability recommended research to “develop and validate candidate alternative policies” in 2010. The resulting studies concluded in 2014 and prompted regulators to revisit the deferral policy. A revised guidance issued in 2018 suggested allowing men who had not had sexual contact with another man for a year to donate, and it also lifted the former lifetime ban on blood donation to reflect “current scientific evidence.”

The shooting in Orlando, Florida’s Pulse nightclub in 2016 brought a new wave of attention to the restrictions as members of the LGBTQ+ community were turned away while attempting to donate blood in support and solidarity. FDA evaluated current scientific evidence and began taking public comments on its restrictions on MSM blood donation shortly thereafter.

Released in time to respond to the COVID-19 pandemic, the new 2020 guidance shortens the 12-month deferral period for MSM and other at-risk populations to three months for donating blood or “blood components” such as plasma.

Such changes are supported by studies indicating that the “additional risk” posed by a three-month versus 12-month deferral period for MSM is “very low,” even in a “pessimistic scenario.” In addition, Italian researchers found that relying on individualized risk assessments for blood donors in place of blanket restrictions on MSM blood donation—such as deferral periods—had “no significant impact” on the prevalence of HIV-positive individuals in the donation pool. FDA generally alludes to such studies in its 2020 guidance, but the guidance’s list of references does not appear to include scholarship that specifically establishes the negligible harm posed by reducing the MSM blood donation deferral period from 12 to three months.

The guidance appears conveniently timed to draw upon a new well of donors during a nationwide blood shortage. The American Red Cross attributed its shortage to “an unprecedented number of blood drive cancellations in response to the coronavirus outbreak,” noting that such drives gather more than 80 percent of the blood the organization collects.

Timing aside, the change comes after improvements to blood testing technology, and it brings the United States into line with the three-month deferral periods required for MSM in the United Kingdom and Canada. Some countries such as Italy do not require deferral periods at all and opt to conduct individual risk assessments. Other countries stipulate longer deferral periods, such as France’s four-month and Taiwan’s five-year deferral period.

Since FDA released its new guidance in April, it appears MSM still face barriers to blood donation in the United States. The Washington Blade reported that Children’s National Hospital turned away Aubrey Lay, a gay D.C. native, who attempted to donate in late April despite the fact that he reportedly met the three-month deferral period “because the hospital’s policy has not yet caught up to national standards.” Gay men from across the country report frustrated donation attempts similar to Lay’s.

Calls for further change to FDA’s deferral period scheme continue to brew. The Perelman School of Medicine’s Katharine Bar emphasizes that “screening processes can restrict a lot of higher risk donors, but if they are too broad, they restrict a lot of other donors, also.” She suggests that “the rationale behind banning a whole group of people who are sexually active, regardless of the actual risk they have of being HIV-positive, is questionable.”

The Human Rights Campaign (HRC) encourages FDA revisions to ensure that future risk assessments of prospective donors’ sexual behaviors be evaluated “equally, without regard to sexual orientation or gender identity.” HRC also highlights the importance of basing future improvements to the evaluation of donor suitability “in science” and of federal investment in “new research to study risk behavior.”

It is hard to say whether FDA’s revised guidance will effectively increase the donor pool and decrease the stigma surrounding MSM’s blood donation. It appears that Anthony Fauci—who cut his teeth as “the government’s leading scientist focused on the AIDS epidemic” and eventual ally of AIDS activists—will continue to help guide the U.S. government’s response to the COVID-19 pandemic as a member of the White House Coronavirus Task Force and as Director of the National Institute of Allergy and Infectious Diseases.

As public health officials and the LGBTQ+ community come face-to-face with another disease outbreak within a generation, the public must hope that both groups can work together—as they did under Fauci during the AIDS crisis—to address a harmful disease in a conscientious and scientifically sound manner.