New FDA blood donor recommendations could ease restrictions on cornea donations from gay, bisexual men

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In May, the FDA finalized recommendations for assessing blood donor eligibility using a set of individual risk-based questions to reduce the risk of transfusion-transmitted HIV, a move many advocates hope ultimately may lead to similar changes for guidelines limiting cornea donations from gay and bisexual men.

Guidelines currently prohibit cornea donations from gay or bisexual men who have had sex with another man in the last 5 years of their life, even if it was a monogamous relationship, while heterosexual individuals who have had sex with an HIV-infected individual as little as 1 year before death are permitted to donate the tissue.

According to the FDA’s recommendations for assessing blood donor eligibility, a set of individual risk-based questions would be sued to reduce the risk of transfusion-transmitted HIV. These questions will be the same for every donor, regardless of sexual orientation, sex or gender. Blood establishments may now implement these recommendations by revising their donor history questionnaires and procedures.

According to the FDA, its updated policy is “based on the best available scientific evidence and is in line with policies in place in countries like the United Kingdom and Canada.” It will potentially expand the number of people eligible to donate blood, while also maintaining the appropriate safeguards to protect the safety of the blood supply.

These final recommendations are consistent with the policy the FDA proposed in January, according to an FDA news release.

Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, noted the FDA has worked diligently to evaluate its policies and ensure it had the scientific evidence to support individual risk assessment for donor eligibility while maintaining appropriate safeguards to protect recipients of blood products.

Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research

“The implementation of these recommendations will represent a significant milestone for the agency and the LGBTQI+ community,” Marks said in a statement. “The FDA is committed to working closely with the blood collection industry to help ensure timely implementation of the new recommendations and we will continue to monitor the safety of the blood supply once this individual risk-based approach is in place.”

The newly updated guidelines are aimed at addressing years-long criticisms that the previous policy was discriminatory and outdated, and posed yet another barrier to bolstering the nation's blood supply. Blood banks already routinely screen donated blood for HIV.

For decades, organizations including the American Medical Association, the American Red Cross and numerous LGBTQ+ advocacy groups have called for a rule change for cornea donations. Organizations, including the American Academy of Ophthalmology and Legalize Gay Eyes, have also been advocating for changes to restrictions banning the donation of cornea tissue from gay and bisexual men.

According to Legalize Gay Eyes, while the United States requires men who have sex with men to be abstinent for 5 years, many other countries around the world have no restrictions whatsoever on gay or bisexual corneal donors. The website noted that countries such as Denmark, Germany, Italy, Spain, South Africa, Mexico, Chile, and Argentina all allow men who have sex with men to donate their corneas if their infectious disease testing is negative. Other countries such as France, the United Kingdom, the Netherlands, Canada, Australia, New Zealand, and Brazil have deferral periods far shorter than 5 years.

According to a 2020 study, federal policy in the United States and Canada which prohibits men who have sex with another man (MSM) from donating corneas led to the disqualification of between 1558 and 3217 cornea donations in 2018 alone, according to research published in JAMA Ophthalmology¹.

“At the time of the policy’s introduction, HIV screening tests were unreliable up to 6 months after viral exposure, so it was argued that a categorical exclusion policy for sexually active MSM donors was necessary to protect corneal transplant recipients,” researchers wrote at that time.

However, in the years since the policy was introduced some three decades ago, HIV testing has become more reliable within 4 to 8 days of viral exposure, while modern virologic testing and a better understanding of the risk of HIV transmission through corneal transplants may mean the 5-year deferral policy is no longer supported by evidence.

This has been a key driver in the recommendations being made by the FDA.

In its news release on its recommendations for blood donations, the FDA noted it eliminates time-based deferrals and screening questions specific to men who have sex with men (MSM) and women who have sex with MSM. Under the final guidance issued today, all prospective blood donors will answer a series of individual, risk-based questions to determine eligibility. All prospective donors who report having a new sexual partner, or more than one sexual partner in the past three months, and anal sex in the past three months, would be deferred to reduce the likelihood of donations by individuals with new or recent HIV infection who may be in the window period for detection of HIV by nucleic acid testing.

Additionally, under these final recommendations, those taking medications to treat or prevent HIV infection (e.g., antiretroviral therapy (ART), pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP)), will also be deferred. Though these antiretroviral drugs are safe, effective, and an important public health tool, the available data demonstrate that their use may delay detection of HIV by currently licensed screening tests for blood donations, which may potentially give false negative results.

Although HIV is not transmitted sexually by individuals with undetectable viral levels, this does not apply to transfusion transmission of HIV because a blood transfusion is administered intravenously, and a transfusion involves a large volume of blood compared to exposure with sexual contact. As stated in the guidance, individuals should not stop taking their prescribed medications, including PrEP, or PEP, in order to donate blood. The FDA remains committed to evaluating additional data and new technological developments as they become available to inform our donor eligibility recommendations.

The FDA has been evaluating alternatives to time-based deferrals for MSM and helping to facilitate the generation of scientific evidence that would support an individual risk-based-assessment blood donor questionnaire. This scientific information has given the agency a solid foundation to support this new policy. The FDA strongly believes the implementation of an individual risk-based approach will not adversely affect the safety or availability of the U.S. blood supply.

Moreover, the FDA carefully reviewed numerous data sources, including data from countries with similar HIV epidemiology that have implemented an individual risk-based approach for assessing donor eligibility, surveillance information obtained from the Transfusion Transmissible Infections Monitoring System, performance characteristics of nucleic acid testing for HIV and the FDA-funded Assessing Donor Variability And New Concepts in Eligibility (ADVANCE) study. The ADVANCE study examined the rates of HIV risk factors, such as anal sex and rates of HIV infection, as well as the usage of medications to treat or prevent HIV infection, among MSM study participants.

Jack Resneck, Jr., MD, president of the American Medical Association, lauded the news.

Jack Resneck, Jr., MD, president of the American Medical Association.

“As a long-time advocate for using rational, scientifically based blood and tissue donation deferral periods based on a donor’s individual risk, the AMA welcomes the FDA’s new guidance that removes outdated categorical restrictions on blood donations from men who have sex with men (MSM),” he said in a statement. “We applaud the FDA for applying the latest scientific evidence to ensure that blood donation criteria are applied more equitably across all segments of our population, including the LGBTQ+ community.”

Resneck also urged the FDA to continue to make additional changes to its deferral policies, including for cornea donations.

“While this is a huge step in the right direction, we urge the FDA to expand their work by reevaluating its donation deferral policies for corneas, human cells and other cellular and tissue-based products based on the latest scientific evidence—ensuring they are also fairly and consistently applied to donors according to their individual risk,” he said in the statement. “The AMA will continue to relentlessly advocate for eliminating public policies that do not align with scientific evidence and best ethical practices.”

The FDA’s shift in policy also is welcome news to LGBTQ+ organizations, including GLAAD, with Sara Kate Ellis, president and CEO of the organization, expressing support for the move.

Sara Kate Ellis, president and CEO GLAAD

“The FDA's decision to follow science and issue new recommendations for all Americans, regardless of sexual orientation, who selflessly donate blood to help save lives, signals the beginning of the end of a dark and discriminatory past rooted in fear and homophobia,” Ellis said in. statement.

Ellis noted that while the guidance is an important step in the right direction, the deferral period for individuals on PrEP, an FDA-approved drug proven to prevent HIV acquisition, continues to erect barriers to LGBTQ+ blood donors.

Placing potential blood donors taking PrEP in a separate line from every other donor adds unnecessary stigma,” Ellis added. “The bias embedded into this policy may, in fact, cost lives. GLAAD urges the FDA to continue to prioritize science over stigma and treat all donors and all blood equally."

Reference:

1. Puente MA, Patnaik JL, Lynch AM, et al. Asociation of federal regulations in the United States and Canada with potential corneal donation by men who have sex with men. JAMA Ophthalmol. Published online September 24, 2020. doi:10.1001/jamaophthalmol.2020.3630