The Food and Drug Administration on Monday officially lifted its lifetime ban on blood donations from gay and bisexual men, ending a decades-old policy that health organizations have viewed as outdated and advocates have argued unfairly discriminated against individuals based solely on their sexual orientation.
Under the FDA's rule (PDF), men who have sex with men would be deferred from blood donation for 12 months after their last sexual contact. Women who have sex with men would also be banned from giving blood for the same period if they had sexual contact with a man who has had sex with another man within the past year.
“The FDA's responsibility is to maintain a high level of blood product safety for people whose lives depend on it,” acting FDA Commissioner Dr. Stephen Ostroff said in a statement released Monday. “We have taken great care to ensure this policy revision is backed by sound science and continues to protect our blood supply.”
In addition, the guidance states that the gender of blood donors will be “self-identified and self-reported,” with the determination for eligibility up to the discretion of the medical director in cases where a donor has changed gender identity.
The move changes a policy that has been in place since 1985, when the AIDS epidemic in the U.S. was at its height. But a number of health organizations—including the American Medical Association, the American Red Cross, America's Blood Centers and the American Association of Blood Banks—have recommended lifting the indefinite ban for years, finding it unwarranted in light of the improvements made to HIV screening and testing to the nation's blood supply.
Gay-rights activists have argued that a lifetime ban was discriminatory and that it was not supported by scientific evidence. Some feel that even the new policy of a 12-month delay is still unjustified.
“This new policy prevents men from donating life-saving blood based solely on their sexual orientation rather than actual risk to the blood supply,” David Stacy, government affairs director for the advocacy group Human Rights Watch, the country's largest lesbian, gay, bisexual and transgender civil rights organization, said in a statement. “While it's 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.”
According to the FDA, HIV transmission rates from blood transfusions have dropped from 1 in 2,500 during the early days of the epidemic to 1 in 1.47 million currently.
The new guidance maintains a ban on donations from individuals with hemophilia or blood-clotting disorders, but for a different reason. Previously, such donations were prohibited because of concerns about an increased risk of HIV transmission. Now such donations are banned because of the potential harm such donors may suffer from the large needles used in donations.