Unfortunately, although few others had sounded the alarm on the FDA's discriminatory queer tissue ban in the past- we found no other individuals, organizations, or groups who researched the policy in its entirety. We had bits and pieces to collect from those who carried the torch before we picked it up, but for the most part, Pride & Plasma had to go in blind. We used our tried and true method of breaking down policy issues to their smallest pieces, as we did with the FDA's queer blood ban, to start to tackle this almost 3-decade old policy. 

On this page you can see our research, how we went about making an argument, and the evidence we found and built on why the 5-year ban on tissue donations from queer men was discriminatory, unscientific, and unnecessary. 

Our Research

The Briefs

Our Argument

Our Process

  • We focus on research for our initiatives, and the tissue ban is no different. We began by looking at all 27 sources used to justify the policy in 2007, breaking down each one individually. 
  • We followed this by looking at published research- a literature review, the FDA's own approved and licensed testing methods, and global policies. 

Calculating the Impact

  • Research published on the impact of the ban on cornea donation found between 779-1,608 donors were impacted every year. 
  • We also knew that each donor could donate to up to 75 recipients, and that the policy was in place for 29 years (since 1994). 
  • Using these figures, we calculated the total historical impact being
    • 22,591-46,632 donors banned for their sexuality
    • 1,694,325-3,497,400 recipients who could have received a donation
  • However, this only calculates the number of deceased donors- living donors can be subject to the ban as well.

Age & Tissue Donation

  • The FDA's tissue donation eligibility policy is applied to all donors, regardless of age, living status, and more. 
  • However, the age of organ/tissue donors and the age of those participating in high-risk activity for STIs and other transmissible infections are vastly different. The FDA's 2007 justification uses data on the latter. 
  • TLDR: the data used to keep the 5-year ban in place focuses on individuals and demographics vastly different than most tissue donors. The data upholding the ban doesn't apply to the donors subject to the eligibility criteria. 

Global Policies (UK)

  • In September of 2023, the United Kingdom announced that a working group had determined that application of individual risk assessments for blood donors were suitable for screening tissue donors, with the intention of replacing the current blanket deferment with an IRA. 
  • For the 10/31 CTGTAC meeting, we included the findings from the UK working group as evidence for a similar transition in the USA- which was directly in line with our recommendations for the FDA. 

Background

LGBTQ+ Military Service

  • Multiple sources used to justify the 5-year queer tissue ban in the FDA's 2007 updated policy included data from the US military. 
  • However, from the 1940s-1980s, queer individuals were outright banned from serving in the United States Armed Forces. In 1983, President Clinton signed "Don't Ask Don't Tell", which was in place until 2011. 
  • No openly queer men were allowed to serve until 2011- so any data from the military on HIV or HBV did not have queer men in the sample.
  • These sources should not have been used to justify a ban on queer men donating when the research didn't have any queer men in it.