FDA considers dropping ban on gay and bisexual sperm donors

The US Food and Drug Administration (FDA) is reportedly planning to relax its restrictions on gay and bisexual men from anonymously donating sperm.

The FDA banned men who had been sexually active with other men in the previous five years, from donating sperm anonymously, in 2005 (see BioNews 259). Known sperm donation from this group was permitted however. Many states and fertility clinics had already banned anonymous donations from gay and bisexual men since the 1980s, when there were concerns over how long it could take for HIV infections to become detectable.

'Under the proposal it is drafting, the FDA would eliminate the broad ban and instead adopt more pointed screening questions to assess HIV risk, according to people familiar with the agency's deliberations,' the Wall Street Journal reported.

Under the proposal, anonymous donations will be permitted following new screenings involving questions for donors and two negative tests for HIV, spaced at least six months apart, before vials of sperm are released for use.

The planned change reflects fertility industry standards that existed prior to 2005, when all anonymous sperm donations in the USA used by fertility clinics were frozen and quarantined for six months, after which another HIV test was completed by the donor, before donor sperm could be used.

The effective ban on anonymous sperm donation from sexually active gay and bisexual men had come under further criticism in recent months, following the FDA's changes to blood donation regulations. A new policy introduced in 2023 introduced the same set of eligibility questions to all blood donors, regardless of their sex, gender or sexual orientation.

Last year, a coalition of groups including the American Medical Association and the National Centre for Lesbian Rights wrote to the FDA saying 'the current policy is based on outdated thinking and is contrary to evidence-based science, and serves to perpetuate discrimination and stigma'.

The rule change requires approval from the White House and would come into effect by the end of the year, Wall Street Journal understands.