FDA Eyes Relaxing Regulations on Blood Donation Eligibility

02.01.23 | The Boardman Clark I.D.E.A. Group

On January 27, 2023, the federal Food and Drug Administration (FDA) announced proposed changes to the regulations which govern who is eligible to donate blood. Under current regulations, men who have sex with men (MSM) are significantly restricted in their ability to donate blood. Now, the FDA is proposing to eliminate certain barriers to blood donation for MSM and others, subject to certain exceptions. 

For reference, all MSM are currently ineligible to donate blood if they have had sexual contact with another man within the three months immediately prior to donating blood. This is sometimes called a ​“deferral period,” and it applies regardless of whether the proposed donor is actually negative for HIV/AIDS, or if the proposed donor is in a monogamous relationship where both partners are negative for HIV/AIDS.

These restrictions trace back to the HIV/AIDS epidemic which erupted in the 1980s. For context, the World Health Organization (WHO) estimates that since the HIV/AIDS epidemic began, 84.2 million people have been infected with HIV and about 40.1 million people have died worldwide. In the United States, roughly 675,000 people have died since the epidemic began — which is more than died in the entire U.S. Civil War (approximately 620,000). Today, nearly 13,000 people the United States die each year as a result of HIV/AIDS.

Because HIV/AIDS originally disproportionately affected gay men, it was — and still is for some — considered a​“gay disease.” It bears noting, however, that according to federal health officials, nearly a quarter of new U.S. HIV diagnoses in 2020 were the result of heterosexual sexual contact. 

Nonetheless, because it was initially most prevalent among MSM, to mitigate the risk of infected donations, the FDA originally implemented a lifetime ban on blood donations from MSM. In December 2015, the FDA changed the lifetime ban to require MSM to wait for 12 months from their last sexual contact with another man to donate. Then, in April 2020, the FDA shortened it again to a 3‑month deferral period for any man who has had sex with another man during the past 12 months. It should be noted that regulators have not identified any negative impact on the blood supply after these shortened deferral periods went into effect.

Now, under the new proposed guidance, the three-month deferral period would be eliminated, subject to certain exceptions which are described here. In addition, any person who has ever tested positive for HIV would remain ineligible to make blood donations. ​“We feel confident that the safety of the blood supply will be maintained [if the new changes go into effect],” the FDA’s Dr. Peter Marks told reporters. Many in the LGBTQ+ Community have also welcomed the news of the proposed changes, but some still believe that the changes do not go far enough to enfranchise all who wish to make blood donations due to the exceptions which the proposed regulations would implement. 

As noted, these are only proposed changes, and so the three-month deferral period which was implemented in April 2020 remains in effect. Given the immense need for blood donations in the United States, blood centers will surely welcome a new segment of the population potentially becoming eligible to donate a lifesaving resource.