FDA Reveals New Guidelines on Blood Ban

FDA Reveals New Guidelines on Gay, Bisexual Blood Ban

Civil rights groups say the FDA's new guidelines are 'unacceptable' for retaining restrictions on blood donations by sexually active gay and bisexual men. And for transgender donors, there's also a change in the works.

By Dawn Ennis

May 12 2015 3:26 PM EDT Updated July 23 2019 7:22 PM EDT

The U.S. Food and Drug Administration today issued a recommendation signaling the first significant change to a 33-year ban on blood donations by gay and bisexual men, but it maintains restrictions that civil rights groups say make it still unacceptable.

If approved, the draft guidelines revising that controversial ban on men who have sex with men will give blood collection centers across the country the green light to accept blood donations from everyone — except for gay or bisexual men, who must affirm they have abstained from sex with other men for one year.

However, sexually active gay and bi guys will still be banned for life.

The modification of what the FDA called an “indefinite deferral,” or ban, for all MSM stopped short of what other countries have done in lifting what the Human Rights Campaign calls a “medically and scientifically unwarranted” policy.

HRC slammed the draft guidance for not going far enough. ”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 HRC government affairs director David Stacy in a statement.

“This policy prevents men from donating lifesaving blood based solely on their sexual orientation rather than actual risk to the blood supply. It simply cannot be justified in light of current scientific research and updated blood screening technology,” Stacy said. “We are committed to working towards an eventual outcome that both minimizes risk to the blood supply and treats gay and bisexual men with the respect they deserve.”

The HRC also noted that the American Red Cross, America's Blood Centers, and the American Association of Blood Banks have denounced the FDA’s current blood ban.

Executive Director and Founder of the National Gay Blood Drive, Ryan James Yezak, said of the proposed change: “We are pleased to see the FDA has issued the draft guidance & we look forward to organizing the National Gay Blood Drive in conjunction with the implementation of the revised policy. We will continue to encourage the FDA to move toward a deferral based upon individual risk assessment.”

But to Congressman Mike Honda of San Jose, Calif., the draft guidance perpetuates what he called “an outdated and bigoted system” that only seems like an improvement. “The FDA’s message is clear: ‘If you can stop being gay, stop being bisexual, for one year, then you can donate blood,’ said Rep. Honda in a statement emailed to The Advocate.

Honda, whose granddaughter is transgender, said, “My message to the FDA is simple: We need a screening policy that focuses on behavior, not orientation.

“While I am glad the FDA finally issued new draft guidance, it falls short of what our country needs—and deserves. The Williams Institute at UCLA estimates this revised policy will continue to exclude over 2 million men whom otherwise would be eligible to donate, depriving our hospitals of nearly 300,000 pints of blood. I will continue to work with my colleagues in Congress, and in my district, to get the FDA to recognize this policy for what it is: an outdated, orientation-based view of gay and bisexual men.”

A reporter attending yesterday’s White House media briefing asked spokesman Josh Earnest why President Obama's outspoken opposition to discrimination wouldn’t “naturally apply to the issue of blood donation from gay and bisexual men?”

Earnest said, “This will be something that is going to be guided by the science. And the President does have a very strong record when it comes to ensuring that we’re not discriminating against people because of who they love, and the President feels strongly about that principle being abided by. He also feels strongly about making sure that we have an effective system that manages the reserve blood supply of the country. And we’re mindful of that, and that’s why we’ve got some of the best scientists in the world at the FDA who are looking at this issue and making sure that we can reach an agreement -- or reach a policy that is in the best interest of the country.”

Ian Thompson, legislative representative for the American Civil Liberties Union, had this to say about the FDA’s draft guidance: “As the ACLU made clear late last year, this inadequate proposal must be seen as part of an ongoing process and not an end point. Deferral decisions should be based on activities presenting an elevated risk, not on the identity of a person or that person’s partner. The reality for the vast majority of gay and bisexual men is that this policy continues to stigmatize their intimate relationships and will indefinitely bar them from donating. In addition, this proposal leaves open the possibility that transgender individuals will continue to be needlessly barred from being able to donate.”

The FDA’s proposal is to rewrite the donor history questionnaire with the following 10 questions to assess risk:

i. A history ever of a positive test for HIV
ii. A history ever of exchanging sex for money or drugs
iii. A history ever of non-prescription injection drug use
iv. A history in the past 12 months of sex with a person with a positive
test for HIV, a history of exchanging sex for money or drugs, or a
history of non-prescription injection drug use,
v. A history in the past 12 months of receiving a transfusion of Whole
Blood or blood components such as packed red blood cells, platelets,
or plasma,
vi. A history in the past 12 months of contact with blood of another
individual through percutaneous inoculation such as a needle stick or
through contact with a donor’s open wound or mucous membranes,
vii. A history in the past 12 months of a tattoo, ear or body piercing,
viii. A history in the past 12 months of syphilis or gonorrhea, or treatment
for syphilis or gonorrhea,
ix. For male donors: a history in the past 12 months of sex with another
man,
x. For female donors: a history in the past 12 months of sex with a man
who has had sex with another man.

About those two last points: although it previously advised blood centers to consider all transgender individuals to be men who had sex with men and to consider that gender assigned at birth overrules legal and medical documentation of gender transition, this new document from the FDA says “in the context of the donor history questionnaire, male or female gender is taken to be self-identified and self-reported. In instances where a donor has asserted a change in gender identification, medical directors may exercise discretion with regard to donor eligibility.”

Of this language, an FDA spokeswoman told The Advocate that while such discretion is allowed, medical personnel should keep in mind that “recent scientific data continue to indicate that males who have changed their gender to female are at high risk of acquiring HIV.” The agency's previous view of transgender people has been denounced by Dana Beyer, MD, a retired eye surgeon, transgender advocate, and political activist in Maryland. She told The Advocate in February that the FDA policy is “indirectly discriminatory, as well as harmful to the proper collection of data.”

The decision by the FDA to lean toward giving blood donor centers discretion is not new and reflects a growing shift by the agency away from federal control to local jurisdictional authority.

That “discretion” led to a trans woman being turned away by one for-profit blood-and-plasma bank in Kent, Wash. Jasmine Kaiser is now pursuing legal action, reports Seattle TV station KPLU. Kaiser says she attempted to give plasma in exchange for money at CSL Plasma Inc., but was told she could not donate because she was assigned "male at birth."

Not only was she turned away, Kaiser claims CSL workers informed her that her name would be placed on a "permanent deferral list," and that the plasma center would inform other blood banks of this status. CSL is facing a similar lawsuit from a transgender individual in Minnesota as well, notes KPLU.

Kaiser filed her suit with attorneys from Seattle women's rights group Legal Voice and the Keller Rohrback law firm, who are arguing that CSL has violated a 2006 Washington law prohibiting discrimination based on a person's gender identity.

CSL has yet to respond to the suit.

The new FDA document will be submitted to the Federal Register, and that will be followed by a period of public comment, where online statements in support and opposed will be collected.

U.S. Sen. Tammy Baldwin of Wisconsin told BuzzFeed she’s encouraged to finally see this proposal but hoped it would evolve into a policy that the report said “moved toward a risk-based system for assessing blood donations, not a black-and-white policy that disqualifies donors based solely on their sexual orientation.”

“I have long fought to end this discriminatory, lifetime ban on blood donations,” Baldwin told BuzzFeed in a statement. “I look forward to seeing the Administration’s plans to achieve this goal and one thing is for sure, I will continue to push the Administration to do the right thing by moving away from this outdated policy that is medically and scientifically unwarranted and toward our ultimate goal of risk-based policies that allow all healthy individuals to donate.”