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Transitioning to Risk-Based Questionnaire: A Nuanced Picture.

On May 11th, 2023, the FDA announced a significant shift in its blood donation policy for gay/bisexual men and women who engage in intercourse with such men. A gender-neutral, individual risk-based questionnaire will replace a time-based deferral. Previously the administration instituted a lifetime ban, named the “men who have had sex with men ban” (MSM Ban). In 2015 the FDA transitioned to a 12-month deferral period from the last sexual contact with another man. During COVID this was decreased to 3 months (MSM Defferals). The decision comes after the initial results of the ADVANCE study were released in April. These results have yet to be peer-reviewed and published.

Click here to read our previous articles for a more comprehensive history of the MSM Ban/ Defferal.

The news represents a step forward in creating a safe blood donation system grounded in science, not prejudice. UBI encourages those newly eligible to consider donating. However, we also believe the LGBTQ+ community is entitled to be presented with all the nuances of this topic. The latest ruling does not eradicate all MSM restrictions nor reverse the emotional trauma suffered over the last 40 years.

Individuals who participate in anal sex with new or multiple partners will still be deferred for 3 months, even with condom use.

Those taking PrEP/PEP medications cannot donate until 3 months after their last oral dose and 2 years after their last injected dose. PrEP stands for pre-exposure prophylaxis and lowers an individual’s risk of contracting HIV before exposure. PEP is short for post-exposure prophylaxis and is used after exposure. Both work by suppressing the replication of HIV. Like all medications, neither is 100% effective. There is still a chance of an individual contracting the virus. Not every blood donation can be tested for blood-borne pathogens. In the advent of a breakthrough case of HIV in someone on PrEP/ PEP, viral loads are low enough to result in false negatives when testing is performed. Hence “undetectable= untransmittable” does not apply in the context of donation as patients receive large quantities of blood.

All decisions made by the FDA must be based on the best data available to remain impartial. Their goal is the safety of patients. But no one is free of bias. Revisitation of certain rules is often delayed or outright ignored, such as the MSM Ban/Defferal all these years. The FDA itself is unlikely to apologize as it would be an admission of prejudice in their rulings.

These continued deferrals cast the specter of stigma which serves to deter individuals from practicing safe sexual practices. In addition, 1.2 million people alone use PrEP based on CDC estimates. Factoring in those who take PREP or engage with multiple sexual partners, it is unlikely the announcement will result in a significant increase in donations. GMHC has issued a comprehensive statement voicing its critiques in response to the FDA’s ruling.

Meaningful advocacy on MSM is still needed. A vital area will be soliciting funding to evaluate the risk associated with PrEP/PEP. UBI intends to participate fully in this work and provide opportunities for members of our community to join us.

Those inspired to donate should be prepared to wait several months for their first appointment. AABB, the organization which accredits blood centers in the United States, must re-write the current questionnaire used by all blood centers. The FDA then must review and approve its usage. Lastly, blood centers must update their systems to accommodate the change, which is incredibly challenging for larger organizations. Keep an eye out for communications from your local blood centers.

Even with the remaining limitations it is heartening to see that the voices of the LGBTQ+ community and the blood donation community brought change. Each and every new donor means another person can receive life-saving care.

Edited by Aditi Tuli


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