As it announced it would in December, the U.S. Food and Drug Administration issued a “draft guidance” on Tuesday reiterating an earlier proposal recommending that gay and bisexual men abstain from any same-sex sexual relations for one year before being allowed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The 24-page draft guidance was to be published in the Federal Register and open for public comment for 60 days before the FDA issues final rules to put the policy in place.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 issued a statement saying she, too, considers the FDA proposal an important first step in ending what she called an outdated policy.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In addition to the change in policy on blood donations for men who have sex with men, the FDA’s draft guidance document proposes a change for transgender donors.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.”