Ophthalmologists Seek to Update Old FDA Guidance Excluding Gay Men from Cornea Donation

A tissue donation policy that the US FDA instituted during the AIDS crisis is resulting in viable corneas going unused. Many ophthalmologists say it is time to update the regulation.

FDA guidance published in 1994 recommends that the demographic of men who have had sex with men (MSM) in the past five years be ineligible.

No case of human immunodeficiency virus (HIV) transmission through corneal transplantation has ever been reported. Since corneas are avascular, transmission of HIV through cornea donation is extremely unlikely.

Pediatric ophthalmologist Michael Puente Jr., MD, gave a presentation at the 2020 Eye Bank Association of American (EBAA) annual meeting, sharing his analysis of regulations that prohibit corneal donation by the MSM demographic.

His findings show that modern serologies make long deferral periods antiquated and that the US regulation disproportionately affects gay men in America compared with those in other wealthy countries. In his abstract presentation, Puente said: “Even though our ability to test for HIV and other infectious diseases has advanced tremendously since 1994, this policy remains in place today.”

Puente took his research one step further and set out to determine how many corneas were being rejected. He and his team interviewed every US and Canadian eye bank to see how many corneas were discarded because of MSM status alone. With an impressive response rate of 83.1 percent, the team analyzed the results and determined that, in 2018, approximately 1,600 corneas were excluded due to MSM status.

Globally, there is one cornea available for every 70 corneal transplants that are needed, and the United States is one of the few countries that exports corneas; an increase of 1,600 additional corneas annually would meaningfully impact the corneal transplant landscape and provide more people with sight-saving surgery. Under the current US federal guidance, if a gay man (or his family) chooses organ donation, most likely his solid organs would be donated, but not his corneas. Solid organ donation includes the heart, lungs, liver, pancreas, kidneys, and intestines.

Significant advances in donor screening have occurred since the National Organ Transplant Act (NOTA) was approved in 1984, establishing the framework for the US organ transplant system.

To broaden the donor pool for solid organ donation, deferral periods have been shortened over time. As recently as April 2020, the FDA announced that it was shortening the deferral period for blood donations from 12 months to three months for the MSM demographic.

In early 2020, with support from the Colorado Society of Eye Physicians and Surgeons, Puente submitted a council advisory recommendation to the American Academy of Ophthalmology (AAO) asking that the academy take an official stance on this issue. He presented two potential solutions. One was to shorten the MSM deferral period “from an arbitrary five years to a more scientifically based period of two to three months.” 

In Puente’s EBAA presentation, he suggested that the corneal deferral policy should be shortened to three months, considering the recent change to the blood donation deferral period. The other proposed solution was to follow the lead of other countries such as Italy and Spain where there was “no deferral policy for MSM donors whatsoever, making no distinction between heterosexual and homosexual donors.”

David B. Glasser, MD, secretary for federal affairs, said in the AAO background statement: “The Academy agrees with the council advisory recommendation and the EBAA that the MSM exclusion should be revised.” Glasser noted that the FDA operates on the precautionary principle, an important consideration in how to approach the agency about changing the exclusion.

The AAO council voted in May 2020 to endorse Puente’s proposal to lobby the FDA to change the rule.

The AAO presented options for moving forward. It said that, as long as there is an adequate supply of tissue in the United States, the FDA does not consider in its calculus the availability of tissue in other countries, costs related to increased testing requirements and false positives, or perceived differential treatment of donors based on sexual orientation.

The group said an approach unlikely to succeed, based on the FDA’s risk tolerance, was advocating for elimination of the MSM exclusion for tissue donors based on the availability of adequate serology and nucleic acid testing (NAT) screening.

The AAO said it would recommend support for EBAA’s position requesting a reduction of the MSM exclusionary period to 12 months, consistent with the blood and organ regulations by continuing to coordinate with them. “This has a greater chance of success,” it said.

Glasser wrote the Academy background statement in March, before the FDA shortened the deferral period for MSM blood donors from 12 months to three months (April 2020). Glasser’s statement suggests the AAO recommend the corneal deferral policy be shortened to match the blood deferral policy; with the updated policy, the MSM exclusionary period would be three months.

Tissue donation is regulated in the US across at least three federal organizations.

The FDA manages human cells, tissues, and cellular and tissue-based products (HCT/Ps). The Center for Biologics Evaluation and Research regulates several HCT/Ps under 21 CFR 1271.3(d)(1) and Section 361 of the PHS Act. Sixteen HCT/Ps, including bone, ligaments, tendons, and corneas, are regulated.

The Division of Transplantation (DoT) is the federal agency that oversees the solid organ transplant system in the United States; it is part of the Department of Health and Human Services and operates within the Health Resources and Services Administration's Healthcare Systems Bureau (HSB). DoT provides guidance and resources for medical professionals, organ processing organizations (OPOs), and organ donors.

Since the emergence of HIV in country, the US Public Health Service (PHS) has made recommendations to minimize the risk for potential HIV transmission to organ transplant recipients.

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The AAO posted an update on its website in late August that said: "The Academy is working in collaboration with the Eye Bank Association of America (EBAA) to address the MSM exclusion. AAO and EBAA are going to highlight the request for change via a joint written letter to FDA, with a formal presentation of the request for shortening the exclusionary period to occur at the next opportunity to meet with FDA. A meeting with FDA could occur in late 2020, if able to meet remotely; if not, the next opportunity for a face-to-face meeting will be in early 2021."