The FDA's new plan to adjust plasma donation for gay and bisexual men is 'a step in the right direction' but still isn't enough progress

• The FDA's restrictions on plasma donation prevent certain men who have sex with other men (MSM) from donating.
• These donation restrictions stem from HIV fears during the early '80s and are steeped in unfair bias.

Donating plasma — or the liquid portion of blood that's left when red blood cells, white blood cells, and platelets are removed — can be lifesaving for medical patients who have experienced trauma, burns, and other medical emergencies.

Plasma donations are also crucial for those with diseases including immunodeficiency, hemophilia, and lung diseases, says Dr. Mark Schuster, founding dean and CEO at Kaiser Permanente Bernard J. Tyson School of Medicine.

Despite a need for plasma donors, the Food and Drug Administration (FDA) has restricted donations by men who have sex with men since 1983 due to fears of HIV transmission. The FDA eased this restriction in 2015 and again in 2020 for some men.

Now, the FDA may lift the restrictions in favor of an individualized screening approach, according to news reports. The approach would allow men who haven't had any new partners in three months — but have had sex with an existing male partner — to donate.

Important: Federal restrictions on blood and plasma donation focus on men who have sex with men (MSM). While this predominantly affects gay and bisexual men, not all MSM identify as gay, bisexual, or queer.

"The proposed change to allow men who have sex with men in monogamous relationships to donate blood is certainly a step in the right direction," says Alex Sheldon, interim executive director at GLMA: Health Professionals Advancing LGBTQ+ Equality.

Who can donate plasma?

The FDA sets qualifications for who can donate, and health care organizations follow those, says Schuster.

Schuster, who is gay, has shared his frustration at being unable to donate blood when his son needed a transfusion.

In general, plasma donors must:

• Be 18 years old
• Weigh at least 110 pounds
• Test negative for HIV and hepatitis
• Have no new tattoos or piercings for the past four months

Blood is made from solids (red and white blood cells, and platelets), and liquid (plasma). To donate plasma, blood is collected from the donor's arm. It's sent through a machine that separates the liquid and collects plasma. Red blood cells, white blood cells, and platelets are returned to the donor. The process takes about 90 minutes, Schuster says.

Like whole blood, plasma has different types. People with the AB blood type — or universal donors — are particularly needed for plasma donations, since their plasma can be given to anyone. However, all blood types can donate plasma.

Since only about 5% of the population have AB blood, allowing more donors could potentially increase the pool of donors with AB blood.

Why forbidding MSM from donating plasma is problematic

After donation, all plasma goes through rigorous testing to detect infectious diseases, including hepatitis and HIV. Although HIV disproportionately affects MSM, anyone can contract the virus. These screening tests have improved since the FDA first banned donations from MSM.

"Even though testing capabilities have improved dramatically, the FDA has been slow to change its policy," Schuster says. "The current restrictions feel like they have not kept up with technological advances that have allowed us to test more effectively for HIV."

In addition to better screening, medical professionals now understand much more about how HIV is passed.

"Policies centering the potential donors' sexual orientation or gender identity now ignore the ever-evolving medical evidence surrounding HIV," says Sheldon.

When people have undetectable levels of HIV in their blood, they can't pass the infection to sexual partners even if they are positive for the disease. However, people with undetectable levels could, in theory, pass HIV through plasma donation, Schuster says. "Plasma donation is different because such large volumes are donated from one person to another." The FDA continues to ban donations from anyone who has ever tested positive for HIV.

The FDA is currently researching alternatives to bans on MSM donation via the ADVANCE Study. Data from the study is promising, showing that the likelihood of HIV or other infection passing from MSM donors is extremely low. This may contribute to the policy change that the FDA is considering.

"The FDA believes data from the ADVANCE Study, along with broader blood donation data, will likely support an MSM policy change," says Jessica Merrill, American Red Cross biomedical communications director.

Insider's takeaway

The FDA first banned donations from men who have sex with men in response to the HIV/AIDS crisis. Although the policy has been relaxed, it has not kept up with technological innovations in screening plasma, and an increased understanding of HIV transmission.

"It has been overly restricted," Schuster says.

The news that more MSM may soon be able to donate is encouraging to medical professionals in the LGBTQ+ community. However, the history of a policy that promoted stigma, erasure and exclusionary practices will linger, said Sheldon.

"The FDA may have to make concerted efforts to repair the damaged relationship with the LGBTQ+ community resulting from decades of maintaining a discriminatory policy," they say.