Editorial — Expanding the base: FDA amending its rules for gay and bisexual blood donors

This policy was first enacted in 1983. In 1985, antibody testing for HIV-1 in donated blood began. By 1992, antibody testing could identify HIV-2 in blood.

So within the first decade of the HIV epidemic, testing for the virus in donated blood advanced significantly. And it has been enhanced even more since then.

However, it wasn’t until 2015 that gay and bisexual men were allowed to donate blood — and only if they attested to having not engaged in same-sex relations for the prior year. Despite testing for HIV being highly effective, this rule retained its discriminatory nature for years.

This was the wrong approach for several reasons. The chief one is that HIV does not limit its targets to same-sex interactions. Anyone who is sexually active — gay, straight or bisexual — may contract the virus and spread it to others.

But straight men were not subjected to this prohibitive rule regardless of their sexual activity. The outbreak of the novel coronavirus pandemic in 2020 forced the U.S. Food and Drug Administration to amend the 2015 rule even further. Blood banks experienced critical shortages, and some action needed to be taken to increase the supply.

The 2020 provision reduced the necessary period for sexual abstinence to three months. This was better than an entire year, but it still defied logic.

The FDA wants to remedy this situation. On Jan. 27, it proposed a rule that would screen for all people who report having a new sexual partner or more than one sexual partner within the past three months; these individuals would be prohibited from donating blood. The rule also would screen for people who report having a new sexual partner or more than one sexual partner and had anal sex in the past three months; they too would be excluded from donating blood.

“Whether it’s for someone involved in a car accident or for an individual with a life-threatening illness, blood donations save lives every day,” FDA Commissioner Dr. Robert M. Califf said in a news release issued Jan. 27 by the health agency. “Maintaining a safe and adequate supply of blood and blood products in the [United States] 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.”

Representatives of the LGBTQ+ community applauded the proposed change.

“Today, the Human Rights Campaign — the nation’s largest lesbian, gay, bisexual, transgender and queer civil rights organization — applauded the Biden administration and the U.S. Food and Drug Administration for taking an important first step toward dismantling antiquated and discriminatory policy preventing men who have sex with men from donating blood,” according to a news release issued Jan 27 by the Human Rights Campaign in response to the FDA’s announcement. “The new policy — which is being reported in news outlets but expected to be officially announced by the administration on Friday morning — moves away from discriminatory policy based on identity and toward a science-based, individualized risk assessment approach.”

This proposed change will be open for comment for 60 days. The FDA will then review all comments before finalizing any new rule so it may be effectively implemented by blood collection organizations, the FDA said.

We commend the FDA for moving forward on this issue. Hopefully, it will lead to more people donating blood and replenish depleted supplies.