New FDA blood donation guidelines focus on risks, not sexual orientation
INDIANAPOLIS (WISH) — The U.S. Food and Drug Administration has issued new guidelines to make blood donation more inclusive to the LGBTQ+ community by focusing on donors’ risk behaviors and not their sexual orientation.
The FDA finalized the new risk-based recommendations for blood donation in May, emphasizing that potential donors would be asked the same questions regardless of their sex or sexual orientation.
The guidelines open the door for more gay and bisexual men to give blood, 40 years after they were banned from doing so.
“Assessing a donor by their individual donor history. So it is making blood donation more inclusive and we will be asking questions to all donors – regardless of their gender or sexual orientation,” Penny Schroeder, the vice president of Versiti Blood Center of Indiana, said.
According to the FDA, all potential donors — regardless of sexual orientation, sex, or gender — will be screened with a new questionnaire that evaluates their individual risks for HIV based on sexual behavior, recent partners, and other factors.
Potential donors who report having anal sex with new partners in the last three months will be barred from giving blood until a later date. Another change that will be implemented is based on the use of certain medications that may help patients reduce the risk of HIV.
“(We’ll) ask all donors for different medications (they are taking). So, a donor that is taking PEP or PrEP, if you are taking it orally, you will be deferred for three months. If you are taking it injectable, it is for two years,” Schroeder said.
Schroeder added, “The reason for that (deferral) is the medication does such a great job at suppressing HIV that the testing, there is a window period it can’t pick it up. So that is a medication deferral that will also be implemented at the same time.”
Local blood banks, such as Versiti and the Red Cross, say this is a big step, backed by science; however, it could take some time to implement.
Versiti says it hopes to implement the new guidelines by the end of 2023.
In a statement, the Red Cross said, “The Red Cross is planning to implement FDA’s new final guidance on August 7. The Red Cross is currently working on changes to our regulated processes that will allow those who were previously ineligible to give in the future, in alignment with the new donor criteria.”
The FDA says the new policy reflects the latest scientific evidence and is in line with rules in the U.K. and Canada.
“This change maintains the safety of the blood supply, while also making the process more inclusive. There have been a lot of studies that support this science-based questionnaire and deferral. Other countries have already implemented this. The United Kingdom and Canada have. And have found they have maintained the safety of the blood supply while increasing the inclusivity of the process,” Schroeder said.
Schroeder says there have been several studies that support this science-based questionnaire and deferral. The Advance study and the Transfusion-Transmitted Infectious Monitoring System with the U.S. Department of Health ensure this move is safe.
“I’m a gay man. I grew up in the ’80s and I have never given blood. Never in my life have I given blood because I have never been allowed to give blood,” Alan Witchey, president and CEO of the Damien Center, said. “This is a great opportunity for a whole group of people that have not been able to donate blood to finally donate blood.”
Witchey helps people with HIV and those at risk of getting HIV. He understands how the virus has played a part in the limits of blood donation, and that it’s time for a change.
“These regulations were discriminatory, there is no other way to say it,” Witchey said.
In 2015, the FDA dropped the lifetime ban and replaced it with a one-year abstinence requirement. Then, in 2020, the agency shortened the abstinence period to three months after donations plummeted during the pandemic.
Blood centers and LGBTQ+ advocates say this could be part of the solution to blood shortages. by increasing the pool of donors. However, those involved admit it will take time to educate people about their ability to now donate blood.
In the end, it is a step in bridging the gap in the blood supply and building pride in the process
“I’m very excited. I think it’s long past due,” Witchey said.