GMHC, founded in 1982 as Gay Men’s Health Crisis, the world’s first HIV and AIDS services organization, is responding to the U.S. Food and Drug Administration’s (FDA) new, blood donation policy released today.
We are encouraged that the FDA recommends that blood donation centers assess donor eligibility for every donor, regardless of sex or gender, with the same individual risk-based questions for HIV, instead of screening out gay, bisexual, and other men who have sex with men (MSM) based on their identity and requiring them to be celibate for three months to donate blood or blood products, such as plasma.
However, we are concerned that the FDA’s new screening guidelines sends mixed messages about condom and PrEP (pre-exposure prophylaxis) usage for safer sex. This new individual risk assessment would allow MSM to donate blood if they have not had anal sex with a new or multiple partners in the previous three months. However, it prevents PrEP users from donating blood unless they stop using this highly effective medication for HIV prevention. The deferral period for those who use oral PrEP is three months after the last dose and for those using injectable PrEP, it’s two years. (The FDA does not recommend people stop using PrEP only so that they can donate blood.) Additionally, the new guidance defers prospective donors who have anal sex with a new or multiple partners, even if they use condoms.
The following is a statement from Jason Cianciotto, GMHC’s Vice President of Communications and Policy, in response to the new policy:
The FDA’s recommendations to lift the blanket three-month celibacy requirement for gay, bisexual, and other men who have sex with men (MSM) to donate blood and instead implement an individual risk assessment that will allow MSM to donate, as long as they have not had anal sex with a new or multiple partners in the previous three months, is an important step in the right direction.
Since GMHC published the report “A Drive for Change: Reforming U.S. Blood Donation Policies” in 2010, we have been calling on the FDA to implement a screening tool that assesses each prospective donor based on their risk for exposure to HIV within the window period that modern testing cannot detect it. This moves us closer to FDA policy based on science, not stigma, because HIV is not a ‘gay disease.’ There is nothing inherent to sex, gender identity, or sexual orientation that makes people more likely to contract HIV—or any other illness.
Unfortunately, the devil is in the details of this policy, and GMHC has submitted the following concerns and questions to the FDA:
- The FDA states that these recommendations are “nonbinding.” Does this mean that a blood donation center in one location could choose not to implement any of the guidance, while a center in a different location could implement some or all? If this is the case, then prospective blood donors who are MSM could still experience stigma and discrimination depending on where they live and/or what blood donation center they use.
- The new policy states, “The risk of HIV infection is significantly greater for anal sex when compared to other sexual exposures.” GMHC concurs that anal sex without a condom has a higher risk for HIV infection compared to vaginal sex. However, the FDA is not clear about the data it is using to quantify this risk. It simply references a journal article published in 2014. What is the FDA using to assess the relative risk of HIV infection from anal sex without a condom compared to that of vaginal sex without a condom? Is there data more recent than something published nearly a decade ago?
- The FDA indicates in a footnote that its policy does not differentiate whether a condom was used during anal sex. In fact, that is the only instance the word “condom” appears in the entire document. What data on the effectiveness of condoms for HIV prevention is the FDA using as justification to defer condom users?
- The policy recommends deferring any prospective donor “…who has had more than one sexual partner in the past 3 months and who has had anal sex in the past 3 months.” Does this mean that a prospective donor could have vaginal sex without using a condom with any number of partners and not be deferred?
- Regarding the deferral for prospective donors on PrEP (oral or injectable), what data is the FDA using to gauge their relative risk of a false negative on an HIV test? In other words, out of 1,000 people, how many PrEP users could have a negative HIV test yet still transmit HIV in their blood?
- According to the CDC, a nucleic acid test (NAT) can detect HIV 10 to 33 days after exposure. If the window period of an NAT is a maximum of 33 days, why does the FDA recommend a three-month (90-day) deferral? Is it because blood centers are only required to use an HIV antibody test for each blood donation, which has a widow period of up to 90 days? Given the FDA’s goal of preventing HIV infection, why is it not a requirement to test all donated blood with the best available testing technology?
Condoms and PrEP are cornerstones of HIV prevention. Yet, the FDA provides no guidance or information to HIV and AIDS services organizations like GMHC on how to explain to the public why we encourage them to use PrEP and/or condoms to prevent HIV, while, on the other hand, the FDA says that they still cannot donate blood because they present a higher risk for HIV. GMHC will continue to advocate for the FDA to update its blood donation policy so that it does not contribute to HIV stigma and does not undermine condoms and PrEP for prevention.
For more information about GMHC’s work to end the FDA Blood Ban, see: Why Does FDA Ban ‘Gay’ Blood?