Basics - Terminology - Deferment - FDA - Current Shortage - Global Trends - Safety - IRA - HIV

5/11/2023 Updated Guidance

  • The queer blood ban was in place from 1985-2015 with a lifetime ban, a 12-month deferral from 2015-2020, and a 3-month ban from 2020-2023. 
  • The previous policy applied to queer men who had any sexual activity with another man
  • The new policy removed the blanket policy as well as the impact on women, and all gendered language. 
  • In the updated guidance, the FDA added a deferral for any donors who have had 2+ anal sexual partners in the past 3 months, and/or those taking PrEP medications

NHS (UK) Reports No Increase in Infection After Transition to IRA

  • The United Kingdom transitioned from a blanket deferment for MSM donors to an individual risk assessment in 2021, prior to the United States (2023). 
  • In the 2023 publication "Safe Supplies 2022", the National Health Service (UK) reported no increase in viral infection risk or decrease in safety following the transition. 
  • This means that the current deferral criteria (Anal sex with 2+ or new partners) likely can be revised in the future, and that we can continue to expand the donor eligibility pool safely once US data is available. 
On 5/11/2023, the FDA released final guidance that ended the blanket MSM deferment policy, the "queer blood ban". Many of our previous posts were created and shared before this, so any components of the breakdown below may no longer be relevant. 

Basics & Overview

  • Since 1985 the FDA has banned queer men from donating blood in some way. These policies of deferment have ranged from a lifetime ban (1985-2015), a required 12 month period of celibacy (2015-2020), or the current 3 month requirement. 
  • This policy is based on outdated science, and was implemented when HIV/AIDS was poorly understood, and when blood centers lacked methods of testing donor samples. This is no longer the case. 
  • Current data does not support the deferral period and instead recommends Individual Risk Assessments- which would made decisions based upon how someone has sex (multiple partners, unprotected) rather than who they have sex with. 
  • The current ban on queer donors is one of many factors exacerbating the current blood crisis, but one of the easiest to correct. 

Terminology Related to the Blood Ban 

  • MSM: Men who have sex with men.
  • Deferment: being turned away for x amount of time
  • Nucleic Acid Testing: the standard testing for HIV, which can detect it's presence in a donation w/in 10-33 days
  • Biologics: vaccines, blood and blood components, and more
  • Queer: Individuals with non-heterosexual sexualities
  • Transmission: the act of spreading or passing a disease

All About Deferment

  • In order to explain why queer men are turned away, we need to explain why any donors are turned away. Deferment qualifications are usually assessed through a survey that asks donors about their actions, tests results, and medical history. 
  • Deferment criteria include: male queer sex, injection drugs, receiving a transfusion, contact with blood products, tattoos or piercings, positive STI tests, and clotting disorders. 
  • These criteria are mandated by the FDA and tissue donation centers are required to follow them, if they are not compliant, they risk losing their right to practice.
  • These criteria are biased and are not effective in preventing potential transmission of HIV. Further, every donation is tested for HIV, negating the importance of the screening.

The FDA's Role in the Blood Ban

  • The FDA is a federal agency tasked with regulating food, drugs, biologics and more. Blood and blood products are classified as biologics. 
  • The FDA sets deferment criteria for blood donation, and was the organization that created and can end the ban on queer men. 
  • Advisory committees that can influence this issue include the Advisory Committee on Blood and Tissue Safety and Availability, and the Blood Products Advisory Committee. 
  • Congress itself cannot force a federal agency to change policy, but representatives can pass a resolution that would carry more weight than just stating their opinion. 

Today's Blood Shortage

  • The United States is currently facing a severe blood crisis, deemed the worst in the decade by The Red Cross. 
  • Facilities are seeing only fractions of the units that they have requested.
  • This requires treatments and procedures to be postponed and patients may be turned away.
  • Although the queer blood ban is not the number one cause of this shortage, the FDA cannot afford to turn away any safe donors, and this is one way to help correct the current crisis.

House Resolution 290

  • Rep Adam Schiff has introduced a resolution (290) which would ask the FDA to utilize deferment policies based on science, risk-assessment, and avoid broad discrimination. 
  • A version of this bill was first introduced in 2020 (116th Congress, Res. 989), which died in committee. This bill had 43 co-sponsors.
  • A second bill was reintroduced in the 117th congress, Res. 290. This bill only has 17 co-sponsors, and has been stuck in committee.  
  • There are 31 representatives who did not re-co-sponsor the new bill. There are 176 members of the LGBTQ caucus, and 75 members of the Medicare 4 All caucus. All of these members should be supportive of this resolution. 
  • This bill guides our action and we are asking supporters to contact their representatives, asking them to co-sponsor and vote for this H.Res 290

Global Trends in MSM Deferment

The MSM deferment policies of various countries are as follows: 
  • ​No Ban: Greece, Israel, Chile, Austria, Costa Rica, Scotland, Slovenia, Hungary, Colombia, Mexico, Italy, Brazil, Iceland, Argentina, Germany, Ukraine
  • Temporary Ban: New Zealand, Australia, France, Belgium, Ireland, Estonia, Denmark, Norway, Hong Kong, Canada
  • Lifetime Ban: Croatia, Malaysia, Trinidad & Tobago, Singapore, China, India

The Safety of Blood Donation

Every potential donor is screened before giving any form of blood products, their responses to the survey and examination may result in deferral. 
  • Hemoglobin: hemoglobin carries oxygen in your blood, if a donor's level is too high/low, it's unsafe for them to donate
  • Vitals: donors can be denied for high/low blood pressure
  • Blood donation is sterile, and there is no risk of contracting blood-borne illnesses. The amount of blood donated is safe to the donor as well. 
  • Every unit donor is screened for multiple diseases including HIV. The risk of contracting HIV from a transfusion is 1 in 1.5 million. 
  • Donating blood is safe, we do not need to turn away queer men in order to maintain that safety. 

Individual Risk Assessment

When talking about the replacement of a blanket deferment (ex. all sexually active queer men are turned away from donating blood), the most popular replacement is an individual risk assessment. An IRA helps to ensure the safety of the blood supply by determining the risk of a potential donor by screening behaviors that lead to a higher likelihood of HIV infection. 
  • Example questions could include Number of partners, safe sex practices, and testing for STDs within the past 3 months (with results). 
  • This ensures that queer men with lower risk, and heterosexual individuals with high risk do not pose a threat to the nation's blood supply- all donors are treated equally. 

Human Immunodeficiency Virus

The HIV epidemic of the 1980s is what caused the FDA to put this deferment policy in place. HIV killed queer men in horrifying numbers, and we still don't have a cure. HIV is a virus that attacks the immune system and impacts an individual's ability to fight infections. 
  • Transmission: HIV can be spread through sexual contact, sharing needles, pregnancy/birth, breastfeeding, or contact with infected blood. It cannot​ be spread through saliva, sweat, air, or sharing food and drinks. 
  • Stages: HIV has 3 stages, active infection, chronic infection, and AIDS (Acquired Immunodeficiency Syndrome).
  • AIDS is diagnosed when an individual's CD4 cell count drops below 200 cells/mm3. A healthy individuals' is 500-1,600 mm3
  • Prevention: get tested, use barrier contraceptions, don't share needles, take PrEP and PEP.
  • Testing: Antibody (23-90 days), Antigen/Antibody (18-45/90 days), Nucleic Acid Testing- used in blood donations (10-33 days). 

The Transfusion-Transmissible Infection Monitoring System

  • The TTIMS is a program that reviews infections from blood transfusions and works to determine why and how an infection occurred. 
  • The Donation Database Coordination Center looks at demographic and testing data from about half of the USA's blood centers to estimate prevalence
  • The Laboratory and Risk Coordination Center looks at risk-factor interviews of donors (primary those with HIV, HBV, and HCV infections)
  • This data is used to determine where we have room to allow more donors and was launched in 2015. Since then it has been used to assess the risk of revisions to eligibility- including the blanket 3-month ban in 2020 and the IRA in 2023. 

Plasma Donation

  • Plasma, the liquid component of blood, is a critical treatment for many different illnesses. 
  • When donating plasma, whole blood is removed from the body, and then platelets and blood cells are returned to your body. 
  • Plasma can then be processed to remove specific proteins and components needed to treat patients
  • ​Plasma can treat clotting factor deficiencies, liver conditions, burns, and more.