FDA Issues New Guidance to Ease Blood Donation Restrictions on Gay Men

The U.S. Food and Drug Administration issued a new guidance that eases restrictions for gay men donating blood.

In the 1980’s, there were strict rules set against gay men donating blood due to the AIDS epidemic and fear of contaminating blood banks with HIV. However, over time, the FDA has been easing those restrictions.

The FDA stated that they are “proposing a change from time-based deferrals to assessing blood donor eligibility using gender-inclusive, individual risk-based questions to reduce the risk of transfusion-transmitted HIV.”

“Whether it’s for someone involved in a car accident, or for an individual with a life-threatening illness, blood donations save lives every day,” noted FDA Commissioner Robert M. Califf, M.D., “Maintaining a safe and adequate supply of blood and blood products in the U.S. is paramount for the FDA, and this proposal for an individual risk assessment, regardless of gender or sexual orientation, will enable us to continue using the best science to do so.”

Time-based deferrals for “men who have sex with men” and the women who have sex with those men will be eliminated with the new guidance. However, an updated questionnaire will ask potential donors if they have had “new or multiple sexual partners in the past three months.” If so, they will be asked about a history of anal sex. If they have had anal sex with new or multiple partners within the three-month timeframe, then they will be deferred.

Gay men who orally take pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP) will also be deferred until three months from their last dose. However, men using the injectiable PrEP will be deferred for two years from their last dose as both medications are known to delay a positive HIV test result.

The guidance will maintain the ban on anyone who is HIV positive, and will continue to test blood donations for “transfusion transmitted” diseases like HIV, hepatitis B, and hepatitis C.

The new guidance is expected to take effect after a 60-day public comment period.

“Our approach to this work has always been, and will continue to be, based on the best available science and data,” added FDA Center for Biologics Evaluation and Research director Peter Marks, M.D., Ph.D., “Over the years, this data-driven process has enabled us to revise our policies thereby increasing those eligible to donate blood while maintaining appropriate safeguards to protect recipients.”

He concluded, “We will continue to follow the best available scientific evidence to maintain an adequate supply of blood and minimize the risk of transmitting infectious diseases and are committed to finalizing this draft guidance as quickly as possible.”


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