The U.S. Food and Drug Administration (FDA) recently finalized new blood donation guidelines that will make it easier for gay and bisexual men to give blood after decades of restrictions. The new guidelines removed a decades-long requirement that men who have sex with other men must abstain from sex for three months before donating blood in order to help protect blood supplies from HIV.
Now, all potential blood donors will be given a questionnaire to evaluate individual risk for HIV based on factors such as sexual behavior and recent partners. Interested donors who report having had anal sex with new partners in the last three months will not be allowed to donate blood until a future date. The FDA said that the new guidelines are based on changes in scientific evidence and data and offer the benefit of opening the pool of eligible blood donors.
It also stated that, according to the scientific evidence, the new individual risk-based approach will not adversely affect the U.S. blood supply.
“The FDA has worked diligently to evaluate our policies and ensure we had the scientific evidence to support individual risk assessment for donor eligibility while maintaining appropriate safeguards to protect recipients of blood products,” Peter Marks, director of the FDA’s center for biological therapies, said in a statement announcing the new guidelines. “The implementation of these recommendations will represent a significant milestone for the agency and the LGBTQI+ community,” said Marks.
He added that the agency is working with the blood donation industry to support centers with “timely implementation of the new recommendations.” The move was largely touted as a win for the LGBTQ+ community, which, along with allies, has long argued that the FDA’s blood donation guidelines were discriminatory.
“This shift toward individual donor assessments prioritizes the safety of America’s blood supply while treating all donors with the fairness and respect they deserve,” Kate Fry, CEO of America’s Blood Centers, said in a statement.
The president and CEO of GLAAD, Sarah Kate Ellis, also applauded the move. “The FDA’s decision to follow science and issue new recommendations for all Americans, regardless of sexual orientation, who selflessly donate blood to help save lives, signals the beginning of the end of a dark and discriminatory past rooted in fear and homophobia,” Ellis tweeted.
Other groups, such as the American Medical Association and Red Cross, have also long advocated for changes to the FDA’s former guidelines, which span back nearly four decades to the beginning of the AIDS epidemic when gay and bisexual men were completely banned from donating blood.
Despite the new relaxation in the guidelines, some organizations and stakeholders are calling for even greater change and further relaxation of guidelines that prohibit LGBTQ+ individuals from donating blood. One particular area or advancement that LGBTQ+ advocates are calling for is to reduce limitations around blood donation for those individuals who are on PrEP, or pre-exposure prophylaxis — a medication taken to prevent the transmission of HIV. When taken as prescribed, PrEP reduces the risk of getting HIV by 99%, according to the Centers for Disease Control (CDC).
FDA guidelines continue to state that individuals cannot donate blood within three months of their last dose of oral PrEP or within two years of their last PrEP injection. The rationale for maintaining the guideline is to avoid false negative HIV tests given data that suggests that current, licensed blood donation screening tests could delay detection of HIV among those who are taking PrEP. Advocates for eliminating that guideline, however, argue that it perpetuates stigma.
“The agency now runs the risk of casting a shadow on PrEP use and continuing to stigmatize gay and bisexual men — a damaging mistake that this long-awaited change in policy was meant to correct,” Grant Roth, an HIV educator and public health graduate student, wrote in Slate. Roth also argued that the continuation of the PrEP guideline doesn’t seem to make sense given the purpose of PrEP.
“No one is tested for HIV more often than PrEP users, who are screened every three months as part of taking the medication,” he wrote. “The blanket ban excludes a large group of people who have more current information about their HIV status than almost anyone else in the country.”
For its part, the FDA has said that it will continue to evaluate data and technological advancements to update and inform its donor eligibility guidelines.
For more background, see the December 2006 issue of Congressional Digest on “HIV/AIDS in America.”
