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Families, medical groups and sperm banks are asking the agency to make it easier for gay and bisexual men to be donors

After years of public criticism, the Food and Drug Administration in 2020 relaxed its rules regarding blood donation by men who have sex with men. Now the agency is being asked to consider revising its policy again—this time to facilitate sperm donations by these men.

The FDA requires sperm banks to test all donors for HIV, the virus that causes AIDS, and other pathogens and to quarantine vials for at least six months so that the donors can be retested. In addition to establishing these precautions, the agency has long prohibited donations from men who acknowledge having had a male sex partner within the previous five years.

“The FDA believes that overlapping safeguards in place for anonymous semen donations adequately and appropriately reduce the risk of transmission of communicable diseases,” an agency spokeswoman said.

Professional and advocacy groups are seeking changes to the agency’s policies.

The American Association of Tissue Banks has asked the FDA to apply its updated rule for blood donation to all types of tissue, a term that encompasses corneas and skin as well as sperm. Blood donations are allowed from men who have sex with other men as long as the last such contact occurred at least three months before donation.

The group GLMA: Health Professionals Advancing LGBTQ Equality has said the same standards should apply to all donors, regardless of their sexual orientation or gender identity. The American Medical Association maintains that the FDA should re-evaluate the tissue donor rules, especially since HIV tests can now detect the virus as early as seven days following infection.

Medical organizations aren’t alone in pressing for change.

“We want the FDA to overturn the ban,” said Suzanne Currie, who along with her wife, Caroline, had two children in recent years using sperm donated by a man who had acknowledged having sex with men. “If someone is healthy and passes all the tests, then their sexuality should have nothing to do with donating.”

The executive director of the Sperm Bank of California in Berkeley, which sold the donor’s sperm to the Curries despite the agency’s prohibition, said she, too, felt the time had come for the FDA to change its policy. “I am hopeful that what has happened in blood donation can now happen in sperm donation,” Alice Ruby said, adding that some couples prefer gay or bisexual donors because they believe these men may be more accepting of families that some view as nontraditional.

“If you are worried about how a donor will respond to your two-mom family, you might feel more comfortable using a donor who is also part of the community,” she said.

The FDA spokeswoman declined to comment on the Curries’ situation and a handful of similar ones that have arisen at the Sperm Bank of California. The agency said it would review donor eligibility rules this year. An agency-funded study is evaluating the reliability of a questionnaire designed to gauge a blood donor’s risk of transmitting HIV, the spokeswoman said, adding that the findings—which are expected this year—could also be applicable to sperm donation.

“The FDA has a difficult job balancing different competing priorities,” said Dr. Joshua Sharfstein, a former principal deputy commissioner of the FDA who is now vice dean for public health practice and community engagement at Johns Hopkins Bloomberg School of Public Health. “Trying to work through the thicket of new information can be hard.”

Dr. Jaime Shamonki, chief medical officer of the Los Angeles-based California Cryobank, said previous efforts to get the FDA to change its sperm donor rules failed to gain traction. But many sperm banks have had trouble getting donors during the Covid-19 pandemic as young professional men relocated away from the cities where sperm banks are typically located, she said, adding that California Cryobank currently turns away 13% of applicants because they acknowledge having had a male sex partner during the previous five years. “If you lose a donor, there is nobody else like him,” she said.

It is the very argument Caroline and Suzanne Currie made when they asked the FDA to make an exception to the rules.

The Curries married in 2016 and started reviewing donor profiles a year later at the Sperm Bank of California, ultimately choosing a highly educated man with a passion for CrossFit and an openness to meeting any offspring—and who told the sperm bank that he had had sex with men. Despite the FDA rules, Ms. Ruby said, the bank had a longstanding practice of allowing donations by men—like the Curries’ donor—who were deemed to be at low risk after undergoing screening tests and answering questions about their sexual activity.

By 2020, Caroline and Suzanne had each given birth to a child using his sperm, and had plans to build a large family. Then their fertility doctor dropped a bombshell: If they wanted to have more children, Caroline recalled him saying at the time, they were going to have to find another donor.

The FDA warned Ms. Ruby after a 2019 inspection of the facility that its practice was impermissible and that it would have to alert all families and doctors who bought or used sperm from men who acknowledged having sex with men, she said. The bank sent out hundreds of emails and letters regarding the Curries’ donor and many others, she said, adding that to be in compliance with FDA rules the bank now bars donors who report having a male sex partner.

Caroline recalled sobbing when she got the news from the doctor. “We aren’t going to be able to do this anymore,” she said to Suzanne. “The baby you carried will not be genetically related to any future baby I have.”

The couple decided to petition the FDA for permission to use their already-purchased vials, which remained locked away at their doctor’s fertility clinic. They persuaded a pair of law firms—Arnold & Porter Kaye Scholer in Washington, D.C., and Orrick, Herrington & Sutcliffe in San Francisco—to press their case with the agency on a pro bono basis. They also joined forces with Ms. Ruby, who submitted the donor’s medical records showing that he repeatedly tested negative for HIV and other diseases and that his sperm had led to the births of 13 healthy children, including the Curries.’

The lawyers argued in a letter to the FDA last year that the agency policy interfered with the women’s right to decide when to have children as well as their children’s rights to have future siblings who are biological relatives.

Dr. Mark McClellan, a former FDA commissioner who is now director of the Duke-Margolis Center for Health Policy at Duke University, said he had no knowledge of the Curries’ case, but that “real world evidence can really help in the FDA’s thinking” about whether its policies need changing.

Ms. Ruby said the agency notified her in July that the Curries could use their long-sequestered vials. Since then, she added, the bank has gotten the FDA’s approval for five more families who want to use already-purchased vials from a banned donor.

When the Curries heard about the FDA’s decision, they hugged in celebration. Caroline said she is pregnant again. The couple’s third child is expected in July.