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New guidelines ease restrictions on gay and bisexual blood donations

The Federal Drug Administration recently unveiled the new proposed guidelines. The 60-day public comment period is now underway.

COLUMBUS, Ohio — New guidelines could make it easier for gay and bisexual men to donate blood. Last Friday, the Federal Drug Administration announced the new proposed rules, which would ease some of the restrictions on certain potential blood donors.

“I do think that it is a step in the right direction,” said Dr. Joseph Gastaldo, OhioHealth infectious disease specialist. “Is it a complete elimination of potential discrimination or traumatizing questions, no, it’s not. But it is progress, and in the setting of gay rights and equity and inclusion, it is a step in the right direction.”

Dr. Gastaldo points out that the current guidelines, while updated, still stem from the HIV epidemic of the 80s and 90s. Since then, technology has changed, improving the ability to screen blood for HIV, hepatitis B and hepatitis C.

“Our current exclusion of gay and bisexual men is not only discriminatory, but you’re excluding a potential part of the population that are quite eager to donate blood,” Dr. Gastaldo said. “There is a national and state shortage of blood products and blood donors. What this FDA guidance really does is eliminates discrimination. High-risk sexual behaviors can happen in any individual, either in a gay or straight man, or a gay or straight woman, or anybody who identifies as transgender. I think the most important thing to do is ask the appropriate screening questions for high-risk sexual behavior to all individuals, not just gay or bisexual men.”

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.

Despite the updated guidance, Dr. Gastaldo does fear the intrusive questions could still act as a barrier to potential donors.

“You’re asking very traumatizing questions, and I think, just for some people, the thought of having to answer those questions, would be enough to keep them away from donating blood,” he said. “Look, we need blood donors in the state of Ohio. We need to improve our blood supply. And this may be a step in that direction to really get more blood donors available for blood donation.”

10TV did reach out to the local chapter of the American Red Cross for comment and more information.

While there is not a shortage right now, the need for blood is ongoing. One in seven patients who enter a hospital will need a blood transfusion, according to the American Red Cross. Anyone who donates in February will receive a $10 Amazon gift card.

The American Red Cross also released the following statement:

"The Red Cross believes blood donation eligibility should not be based on sexual orientation and has long advocated for changes to those policies. The proposed guidance from the FDA is a positive step forward, but we recognize there is still work to be done to make blood donation a more inclusive process. The reality is only three percent of the US population donates blood, and new donors are always needed and welcome to help save lives.”

The 60-day public comment period is now open. That input will be collected before the FDA finalizes a decision on the new guidance.

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