FDA Calls for Relaxation of Long-Term Organization Donation Restrictions for Gay and Bisexual Men

Feds Ease Organ and Blood Donation Requirements for Gay and Bisexual Men, but Donor Organization Restrictions Remain

Over the past few years, the federal government has made significant adjustments to the rules under which organ and blood donations can be safely made, particularly for men who are sexually involved with another man. the 2020 and 2023 changes reduce the restrictions on this group, which is seen as a progressive step. However, restrictions on donor organizations remain, which has caused concern and frustration among many advocates, legislators and groups.

Donor organization is an all-encompassing term that covers everything from the human eye to skin and ligaments. In particular, advocates working to eliminate barriers to corneal donation say they are frustrated that the U.S. Food and Drug Administration (FDA) has not heeded their call. The groups have been asking the FDA for years to shorten the deferral period from five years to 90 days, which would mean that a man who has sex with another man could donate tissue as long as he does not have sex again within three months of having sex.

Sheryl J. Moore is one of the most vocal advocates for loosening restrictions. She has been an advocate since the death of her 16-year-old son in 2013. Her son AJ's internal organs have been successfully donated to seven people, but his eyes were rejected because of a question posed by a donor network, "Was AJ gay?"

Moore and Colorado physician Michael Puente Jr. have launched a campaign called "Legalize Gay Eyes," which has attracted the attention of national ophthalmology organizations and lawmakers. Puente points out that the current donor guidelines are absurd, considering the advances in HIV detection for potential donors. He emphasized that gays and lesbians can donate an entire heart for transplantation, but not just a heart valve, which is essentially an absolute ban.

These policies were originally set up 30 years ago as a means of preventing the spread of HIV. However, as science has advanced, the rationale for these policies has been questioned. Advocates for changing these policies now argue that they are unnecessary and discriminatory because they focus on specific populations rather than specific behaviors known to increase HIV risk.

Although the FDA Center for Biologics Evaluation and Research has had changes to the tissue guidance on its agenda since 2022, no action has been taken to date. This tardy response has drawn the ire of lawmakers who believe the current deferral policy perpetuates the stigmatization of gay and lesbian people and advocate that risk assessment should be based on individualized risk assessment.

In its response, the FDA said that while the absolute risk of HIV transmission as a result of eye surgery appears to be small, the relative risk remains. The agency emphasized that it regularly reviews donor screening and testing and determines what changes are appropriate based on technology and evolving scientific knowledge.

However, many still want to see more progress and changes to remove unnecessary barriers to gay and bisexual male donor organizations and ensure that all people have the opportunity to save lives through donation.

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