BAKERSFIELD, Calif. (KERO) — If you've ever tried to donate blood you may have gone through the lengthy questionnaire designed to either allow you to donate or be deferred. Now an expansion aims to include more groups in the donation process.
The U.S. Food and Drug Administration is proposing a new method of accepting blood donations that aims to include much of the LGBTQ community that has been left out. Under these new recommendations, singling out donors by sexual orientation will be gone with everyone getting the same questions now.
“Whether it’s for someone involved in a car accident, or for an individual with a life-threatening illness, blood donations save lives every day,” said FDA Commissioner Robert M. Califf, M.D. “Maintaining a safe and adequate supply of blood and blood products in the U.S. is paramount for the FDA, and this proposal for an individual risk assessment, regardless of gender or sexual orientation, will enable us to continue using the best science to do so.”
Currently, gay and bisexual men face hurdles when it comes to donating blood. The newly proposed assessment would eliminate time-based blood donation deferrals for men who have sex with men and women who have sex with bisexual men.
“Our approach to this work has always been, and will continue to be, based on the best available science and data. Over the years, this data-driven process has enabled us to revise our policies thereby increasing those eligible to donate blood while maintaining appropriate safeguards to protect recipients,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “We will continue to follow the best available scientific evidence to maintain an adequate supply of blood and minimize the risk of transmitting infectious diseases and are committed to finalizing this draft guidance as quickly as possible.”
Now everyone will be asked about the number of sexual partners they have had in the past three months and if it's multiple you may be deferred.
“So a lot of these deferral changes that have taken place these last few years have been extremely beneficial as far as making more donors eligible," explained Rachel Nettleton with the Houchin Community Blood Bank. "Once AABB (Association for the Advancement of Blood & Biotherapies) approves it we have a certain time frame where we can make those additional updates no matter what draft guideline is being updated.”
The FDAA’s process of approving this proposal means a 60-day period open for public comment. After that period all comments will be evaluated before finalization and eventually implementation.
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Under the new proposed guidance:
- The time-based deferrals for men who have sex with men (MSM) and women who have sex with MSM would be eliminated.
- The current donor history questionnaire would be revised to ask all prospective donors about new or multiple sexual partners in the past three months.
- Prospective donors who report having a new sexual partner, or more than one sexual partner in the past three months, would then be asked about a history of anal sex in the past three months.
- All prospective donors who report having a new sexual partner or more than one sexual partner and had anal sex in the past three months would be deferred from donation.
- Under this proposal, a prospective donor who does not report having new or multiple sexual partners, and anal sex in the past three months, may be eligible to donate, provided all other eligibility criteria are met.
Other considerations in the guidance include:
- No change in the donor deferral time periods for other HIV risk factors, including for individuals who have exchanged sex for money or drugs or have a history of non-prescription injection drug use.
- Any individual who has ever had a positive test for HIV or who has taken any medication to treat HIV infection would continue to be deferred permanently.
- Blood establishments would still be required to test all blood donations for evidence of certain transfusion-transmitted infections, including HIV, hepatitis B and hepatitis C.
Proposed guidance related to pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP):
- Those taking oral medications to prevent HIV infection such as PrEP or PEP would be deferred for three months from their most recent dose.
- Those taking injectable PrEP to prevent HIV infection would be deferred for two years from their most recent injection.
- Some blood establishments currently have deferral policies related to the use of medications to prevent HIV infections.
- The available data demonstrate that the use of PrEP and PEP may delay detection of HIV by licensed screening tests for blood donations, potentially resulting in false negative results.
