The Food and Drug Administration (FDA) is once again seeking to update policies regarding blood donor eligibility. Over the last decade, our community has seen progress in the FDA’s treatment of gay men and men who have sex with men (MSM) in screening and banning (what they call “deferral”) rules for blood and plasma donations.
In 1985, the FDA imposed a lifetime ban for any male donor who had ever had sex with another man, even once, if sex was after 1977. This policy remained unchanged until 2015 when the lifetime ban was replaced with a one-year donation ban for MSM and those with other disqualifying conditions, such a drug users and sex workers. Then in 2020, the ban was lowered again to only three months.
The current rules went into effect in April 2020, in response to the COVID-19 public health emergency and reported shortages in the blood supply. The policy maintains a time-based deferral for MSM and women who have sex with MSM counting from the last sexual encounter.
This January, the FDA issued draft guidance to assess “donor eligibility using gender-inclusive, individual risk-based questions relevant to HIV risk” for most individuals except for those with other risk factors, and anyone taking medication to treat or prevent HIV infection. This would include anyone taking pre-exposure prophylaxis (PrEP), post-exposure prophylaxis (PEP), and those already diagnosed with HIV taking antiretroviral therapy (ART).
U=U for Sexual Transmission Only
Antiretroviral drugs are safe and effective at reducing the HIV viral load to undetectable levels, but drugs do not fully eliminate the virus from the body. Donated blood from individuals infected with HIV can “potentially still transmit HIV to a transfusion recipient,” according to the FDA.
The risk of HIV transmission from blood transfusion is low, estimated at a “residual risk” of one in 1.47 million, the FDA indicated. It also stated no transmissions of HIV, Hepatitis B or C have been documented through U.S.-licensed plasma-derived products in the past three years.
Importantly, the FDA underscored that “undetectable equals untransmissible for sexual transmission, [but] this does not apply to transfusion transmissions.” Its recommendation maintains a lifetime ban for anyone with a known HIV positive test result or who has ever taken medication to treat HIV.
Rules for HIV Prevention Medication Users
Currently, uniform use of nucleic acid testing for Hepatitis B and C and HIV can all detect these viruses within a three-month period following initial infection. In deciding against extending individual risk-based assessments for individuals on PReP and PEP, the FDA stated that use of said drugs may “delay detection” which may result “in false negative results.”
The FDA acknowledged it considered alternatives to time-based bans. These included “prescreening and qualification” of MSM for donation of pathogen-reduced platelets or plasma or Source Plasma and re-testing donors for HIV after a quarantine hold period. These alternatives, however, were deemed “operationally complex.” Additionally, pathogen reduction devices are currently only approved for platelets and plasma for transfusion. No recommendations were made to review other operational alternatives.
Avoiding other operational alternatives, the FDA is banning blood donations from people currently taking HIV prevention medication. Specifically, a three-month deferral from the last dose for those taking oral medication and a two-year deferral from the last injection for anyone taking the preventative medication by injection.
New Screening Criteria for All Donors
The FDA’s “gender-inclusive, individual risk-based” screening criteria seems to narrowly tailor screening to one factor: Anal sex.
Donors who report a new sexual partner or more than one sexual partner in the last three months are then asked about a history of anal sex in the past three months. A history of anal sex with a new partner or more than one partner in the last three months will result in a three-month donation ban, from the last sexual act.
These criteria, according to the FDA, are expected to reduce the likelihood of donations from individuals with new or recent HIV infection who are within the three-month window period for nucleic acid testing detection.
Other Disqualifying Factors
Unchanged from the FDAs 2020 recommendations is a three-month ban, from the last incident, of the following:
- Exchanging sex for money or drugs.
- Non-prescription injection drug use.
- Contact with another’s blood.
- Receiving a blood transfusion.
- Recent tattoo, unless tattoo was applied by a state regulated entity with sterile needles and non-reused ink.
- Recent piercing, unless pierced using single-use equipment.
- After completing treatment for syphilis or gonorrhea.
Criticism of New Policy
“This latest FDA policy on gay men donating blood continues decades of discrimination not rooted in science,” said San Francisco-based Senate Senator Scott Wiener, a former chair of the Legislative LGBTQ Caucus, via a series of Tweets, also shared on Instagram.
Wiener declares, “The FDA continues to issue non-science-based blood donation policies that effectively ban gay men & other people from donating. This time, FDA is categorically banning people taking PrEP from donating despite the fact that PrEP almost completely eliminates the risk of contracting HIV.”
“So you can have vaginal sex with 300 people. But if you have anal sex with 2 people, you’re banned,” Weiner lampooned the new policy.
Share Your Thoughts
The Federal eRulemaking Portal: https://www.regulations.gov allows for submission of electronic comments on the draft guidance by March 31, 2023, to ensure that the Agency considers comment on this draft guidance before it begins work on the final version of the guidance. Comments should reference Docket No. FDA-2015-D-1211.
