• Posted January 27, 2023

FDA Could Ease Blood Donation Rules for Gay Men

Longstanding restrictions on blood donations from gay or bisexual men could soon shift towards a more nuanced policy, where such men are asked about sexual partners and practices instead, the U.S. Food and Drug Administration announced Friday.

Specifically, gay men who are in monogamous relationships will no longer be required to abstain from sex for any period of time before donating to the nation's blood supply. Old rules in place since the 1980s had made such demands, out of fears of possible HIV contamination of donated blood.

But pressure from LGBT organizations, improvements in blood screening technologies, as well as the input of blood banks and the American Medical Association, have all pushed the FDA to re-examine its rules.

The draft recommendations around the new policy center on "individual risk-based questions to reduce the risk of transfusion-transmitted HIV," the agency explained in a statement.

"These draft recommendations are based on the FDA's careful review of available information, including data from other countries [such as Canada and the United Kingdom] with similar HIV epidemiology that have instituted this approach, as well as ongoing surveillance of the U.S. blood supply," the agency added.

"Maintaining a safe and adequate supply of blood and blood products in the U.S. is paramount for the FDA, and this proposal for an individual risk assessment, regardless of gender or sexual orientation, will enable us to continue using the best science to do so," FDA commissioner Dr. Robert Califf said in the statement.

The basic tenets of the proposed changes are:

• Elimination of any time-based deferrals for blood donation for men who have sex with men (or any woman who has had sex recently with men in that category).
• Standard questionnaires given to prospective donors will now include questions on new and multiple sexual partners going back three months.
• "Prospective donors who report having a new sexual partner, or more than one sexual partner in the past three months, would then be asked about a history of anal sex in the past three months," the FDA said.
• Any prospective donors who report new or multiple sexual partners in the past three months, as well as having had anal sex, will be deferred from donating blood.

The FDA notes that people who have tested positive in the past for HIV will continue to be barred from donating blood, and "blood establishments would still be required to test all blood donations for evidence of certain transfusion-transmitted infections, including HIV, hepatitis B and hepatitis C."

There was a subset of conditions for donation aimed at people currently uninfected by HIV but who are taking post-exposure prophylaxis (PrEP) to help ward off the sexually transmitted virus. PrEP also greatly reduces levels of HIV in people already infected.

Uninfected people taking PrEP in pill form "would be deferred for three months from their most recent dose," the agency said, and "those taking injectable PrEP to prevent HIV infection would be deferred for two years from their most recent injection."

These rules are in place because of data suggesting that PrEP can "delay detection of HIV [in blood] by licensed screening tests," the FDA explained.

The new rules are open for public comment for 60 days, and "the agency will then review and consider all comments before finalizing this guidance," the FDA said.

Men like 22-year-old Cole Williams applauded the proposed rule changes.

"We shouldn't have to fight this hard to do something as selfless as giving blood,"said Williams, a bisexual nursing student who formed the advocacy group Pride and Plasma, which pushes for changes to the FDA policy.

Speaking to the Washington Post, he said the rules are inherently discriminatory, since "I could have as much unprotected sex with as many women as I wanted, and the FDA would have no problem with that."

The FDA's current rules originated in 1985, when -- concerned about HIV entering the blood supply -- the agency placed a lifetime ban on blood donations for any man who had had sex with men going back to 1977.

In 2015 -- by which time testing of the blood supply had greatly improved -- the agency altered its stance to allow men who have sex with men to donate, but only after a 12-month period of abstinence of sex with men.

In April 2020, as the COVID pandemic triggered shortages in the blood supply, the FDA further shrank the abstinence period to three months.

Eric Kutscher, 32, is a gay man who also helped organize a group lobbying for changes to blood donation rules while a student at Columbia University in 2011.

Reacting to the news of the proposed changes, he told the Post that he understands "how lifesaving this is and I'm excited to be a young, healthy adult man who is able to provide blood to the patients who need it. As soon as I am eligible to donate blood, I will be the first in line."

Stefan Baral, a professor in the department of epidemiology at Johns Hopkins University in Baltimore, said the U.S. blood supply is now very safe, and that blood shortages should be the issue people are focusing on.

"Nobody has been infected through blood transfusion for more than 20 years,"Baral told the Post. "The U.S. has a safe blood supply and the major issue with all of it is that there's not enough of it."

More information

The American Red Cross is appealing for blood donors amidst an ongoing shortage.

SOURCES: U.S. Food and Drug Administration, news release, Jan. 27, 2023; Washington Post