May 13, 2015 at 7:58 am EDT | by Lou Chibbaro Jr.
FDA issues draft policy for gay blood donors
Tammy Baldwin, women, gay news, Washington Blade, gay blood donor

Sen. Tammy Baldwin (D-Wis.) called the FDA proposal an important first step in ending what she called an outdated policy. (Washington Blade file photo by Michael Key)

As it announced it would in December, the U.S. Food and Drug Administration issued a “draft guidance” on Tuesday reiterating an earlier proposal recommending that gay and bisexual men abstain from any same-sex sexual relations for one year before being allowed to donate blood.

The proposed guidance would replace the FDA’s longstanding existing policy that permanently bans men who have sex with men from donating blood during their lifetime.

The 24-page draft guidance was to be published in the Federal Register and open for public comment for 60 days before the FDA issues final rules to put the policy in place.

The proposed changes come after LGBT advocacy groups have called on the FDA to allow blood collection organizations like the Red Cross to screen all potential donors based on their individual risk for HIV infection or other blood borne diseases rather than imposing a ban of any time period for people based solely on their sexual orientation.

LGBT advocates have noted that advanced scientific developments since the start of the AIDS epidemic in the early 1980s make blood screening for HIV far more reliable than the screening technology of years past.

“While the new policy is a step in the right direction toward an ideal policy that reflects the best scientific research, it still falls far short of a fully acceptable solution because it continues to stigmatize gay and bisexual men,” said David Stacy, government affairs director for the Human Rights Campaign.

“This policy prevents men from donating life-saving blood based solely on their sexual orientation rather than actual risk to the blood supply,” Stacy said. “It simply cannot be justified in light of the current scientific research and updated blood screening technology.”

U.S. Sen. Tammy Baldwin (D-Wisc.) issued a statement saying she, too, considers the FDA proposal an important first step in ending what she called an outdated policy.

“[B]ut it doesn’t go far enough,” she said. “I look forward to continuing to work with the [Obama] Administration and stakeholders to implement this first phase swiftly so we can soon achieve our ultimate goal of blood donation policies that are based on individual risk factors that don’t unfairly single out one group of individuals and that allow all healthy Americans to donate.”

In addition to the change in policy on blood donations for men who have sex with men, the FDA’s draft guidance document proposes a change for transgender donors. The proposal calls for changing a questionnaire given to all potential donors asking about their sexual and medical histories so that the gender of donors will be “self-identified and self-reported.”

The existing policy calls on potential donors to state on the questionnaire what their birth gender was rather than the gender with which the donor currently identifies.

But the draft guidance adds, “In instances where a donor has asserted a change in gender identification, medical directors may exercise discretion with regard to donor eligibility.”

In support of its decision to retain its proposed one-year period of sexual abstinence for men who have sex with men, the document appears to dispute claims by LGBT advocacy groups that individual risk factors, such as whether gay men are in a monogamous relationship, should be used rather than imposing a one-year sexual abstinence period.

“[T]he available epidemiologic data in published literature do not support the concept that MSM who report mutual monogamy with a partner or who report routine use of safe-sex practices are at low risk for HIV,” the draft guidance says.

“Specifically, the rate of partner infidelity in ostensibly monogamous heterosexual couples and same-sex male couples is estimated to be about 25 percent, and condom use is associated with a 1 to 2 percent failure rate per episode of anal intercourse,” the document says. “In addition, the prevalence of HIV infection is significantly higher in MSM with multiple male partners compared with individuals who have only multiple opposite sex partners.”

LGBT and AIDS activists have said gay and bisexual men who are interested in donating blood, just as their heterosexual counterparts, would willingly remove themselves from the donor pool on a case-by-case basis if, upon being told of individual risk factors, they determine they could be at risk for HIV infection.

“Once the 60-day comment period closes, the Agency will carefully review and consider all comments in finalizing the guidance,” FDA spokesperson Tara Goodin said. “While we are unable to commit to a specific timeline, we consider finalizing the guidance to be a high priority.”

Goodin added, “FDA welcomes and encourages all interested parties to provide input.”

Lou Chibbaro Jr. has reported on the LGBT civil rights movement and the LGBT community for more than 30 years, beginning as a freelance writer and later as a staff reporter and currently as Senior News Reporter for the Washington Blade. He has chronicled LGBT-related developments as they have touched on a wide range of social, religious, and governmental institutions, including the White House, Congress, the U.S. Supreme Court, the military, local and national law enforcement agencies and the Catholic Church. Chibbaro has reported on LGBT issues and LGBT participation in local and national elections since 1976. He has covered the AIDS epidemic since it first surfaced in the early 1980s. Follow Lou

6 Comments
  • If I ever need a transfusion I shall demand that the blood or plasma not come from any homosexual or otherwise sexually confused individual. If they have the right to become a donor I have the right to refuse it. Let us be frank. There is no telling what types of infectious diseases these people carry.

    • Like getting a blood donation from a gay man would turn you gay. It would still have to be tested before it would be allowed to anyone else to use. Use your brain.

    • Robert there is no telling what types of diseases ANY donor, gay or straight carries; this is why the blood is screened. Your implication that “those people ” are inherently flawed or more diseased merely due to their nature– for that matter, your division of the world into ” us and them”– is abhorrent. We are not lepers , nor are all lepers sinners. Poison falls upon the righteous as well as the good, on the upright as well as the fallen. Do not say that we are less than you, for we are all children of God.

  • No, let’s hope he has a change of heart.

  • Give it a rest Singer. You can’t convince me otherwise. Homosexuality is a disease in and of itself.

  • My son, who suffered with a serious congenital heart defect, called Hypoplastic Left Heart Syndrome, was infected with HIV due to a contaminated blood transfusion following open-heart surgery in July 1997 at Mott Children’s Hospital, University of Michigan. Regarding blood donation, the FDA’s proposed action to remove the ban on men who’ve had sex with a man since 1977 and replace the restriction to a one year period may be valid; however, they are missing a much more important and critical risk factor, namely, a donor who has had sex within the previous 12 months with anyone other than his or her spouse. This is the only valid sexual restriction. My perspective comes from my experience wherein subsequent to my son’s blood transfused HIV infection I received a sterilized copy of the HIV-contaminated donor’s medical history taken by the blood center’s nurse in conjunction with the donation. Although the applicable blood center, the American Red Cross (ARC) of Michigan, conducted a “look-back” investigation and purportedly learned what specific HIV-at-risk behavior the donor was engaging in at the time of the donation, the ARC has steadfastly refused to advise me of the HIV-positive donor’s at-risk behavior despite numerous requests. Thus, unless the donor lied during the medical history, I maintain the most likely at-risk behavior, assuming no errors were made in the testing, NAAT (Nucleic Acid Amplification Testing) being in place that time, was heterosexual sex with someone other than the donor’s spouse, excluding sex for drugs or money. If the FDA is serious about limiting risk, they will mandate restricting anyone who has had sex outside of marriage in the previous 12 months.

    As a side note, after my son’s HIV infection and subsequent death I lobbied congress and failed to get attention on the issue of increasing blood safety; however, in that I was in the military (the US Air Force) at the time and the war on terror was resulting in a great increase in blood requirement I decided to demonstrate that with a safe blood donor pool we can increase supply as needed. Consequently I volunteered to serve as the Blood Donation Officer at Andrews Air Force Base (AFB) in Maryland near Washington, DC where I served as a pilot in the Presidential Airlift Wing, the 89th Airlift Wing. With positive motivation and aggressive promotion, with the help of my unit blood collection representatives in each of the approximately thirty organizations (military units—squadron level) at Andrews AFB we went from seeking procurement of blood from the other US military regions around the US to shipping excess blood to the other regions since we began to collect so much more blood at Andrews. The lead phlebotomist, a Navy Petty Officer called me just before more than one of our quarterly blood drives at Andrews and declared, “Major, you’re
    killing me here; you are bringing so many donors at Andrews that I have to mobilize every single blood collection technicians from each military base in and around the entire National Capital Region (within proximity of Washington DC) to support your Andrews AFB blood drives! If any of them are on leave, I’ll have to call them back or I might not be able to support you!” Thus, I proved that even with strict collection restrictions and guidelines if you aggressively promote blood donation you can increase the donor pool when necessary.

    The remainder of my story I chronicle in my book, “The Caleb Years: When God Doesn’t Make Sense,” to encourage others who struggle supporting their children or other family members with extensive medical challenges or other life-stirring adversities. Visit http://www.thecalebyears.com to read
    more about this inspirational and compelling account of hope amidst heartache and betrayal.

    I am available for interviews regarding blood issues, HIV, particularly as it pertains to blood transfused infections, CHD (Congenital heart defects), dealing with grief and struggling with family members’ chronic and serious medical challenges.

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