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FDA's New Ruling & COVID-19

Updated: Nov 27, 2020

As the University Blood Initiative continues to advocate for more accessible, equitable blood donation, we are turning our attention to one of its most infamous, hotly contested barriers. For the next week, we will be discussing the history, impacts, and future of LGBTQ+ blood donor discrimination, from the AIDS epidemic to the COVID-19 pandemic. Since the 1980s, the United States has upheld intense donation restrictions on potential MSM (men who have sex with men), though the lifetime ban has changed to a shorter-term deferral period. Today, we are discussing the FDA’s latest modifications to its ban.

In the spring of 2020, in the throes of the COVID-19 pandemic, the Red Cross admitted that it was running out of blood. Decimating all facets of American life, the novel coronavirus has contributed to a sharp drop in blood donations, destabilizing an already precarious blood supply. We have discussed the pandemic’s impact on the nation’s blood more in-depth as part of our COVID Code Red Campaign, but it has also led to an unexpected bright spot: This past April, in an attempt to bolster the blood supply, the FDA issued revised recommendations for MSM blood donation. To be implemented immediately, the deferral period has been reduced from 12 months since last sexual contact to 3. The new rulings also apply to donors who have recently had tattoos or piercings, which previously required a 12-month delay, as well has former sex workers and injection drug users, who had been indefinitely banned from donation.

The aim of this change is to increase the number of eligible blood donors--or at least, in decreasing deferral periods, to incentivize MSM donors to become eligible for donation--and increase the strugglingly low blood supply. This change is another step away from the antiquated lifetime ban of the 1980s, and puts the US on track with countries such as the UK in terms of progress.

However, the rollout of the updated guidelines has faced continued serious complications. First, it is a temporary stay, an emergency response to the COVID-19 pandemic, and will stay in effect up to 60 days after the country’s restrictions are lifted, however long that may be. After that point, more permanent revised guidelines will take effect, supposedly incorporating feedback from the public--hopefully more lenient than before the crisis, but uncertain. More immediately, there have been numerous reports of donors, eligible under the new guidelines, being turned away from centers that have not yet updated their systems or trained staff to implement them. The change is not as simple as a single FDA document; many blood banks use automated screening programs to register donors, and technology, confusion, and bureaucracy can lead to monthslong delays.

These issues significantly decrease the efficacy of the new guidelines as a stopgap emergency response measure. If willing MSM blood donors, many of whom have survived COVID-19 and want to donate antibody-containing plasma for potential treatment, still cannot give blood, the nation’s ever-shrinking supply suffers, too. NBC news indicated that the FDA was aware of these inevitable delays at the time it issued its ruling; “immediate implementation,” as its document declared, “was intended to mean that blood centers should immediately begin the process of implementation, recognizing that it would take some time.”

The new guidelines for MSM blood donors is a promising sign, but its blanket enforcement retains core problems and criticism of the nation’s original lifetime ban. As previously discussed, the science behind the restrictions is flimsy at best, and the FDA’s willingness to shorten the deferral period indicates at least some recognition. Though blood centers are finally developing the capacity to implement the changes, the restrictions continue to face pushback from LGBTQ+ donors and advocacy groups. Even this shortened version of the ban is archaic. And yet, for now, it stays.




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