The Food and Drug Administration has lifted its lifetime ban on accepting blood donations from men who have had sex with men.
“The FDA is changing its recommendation that men who have sex with men (MSM) be indefinitely deferred . . . to 12 months since the last sexual contact with another man,” the administration announced Monday.
This final guidance from the FDA is the culmination of several years of scientific research as well as consultation with external advisory committees and other government agencies.
“We have taken great care to ensure this policy revision is backed by sound science and continues to protect our blood supply,” FDA Acting Commissioner Stephen Ostroff, M.D. said.
The lifetime ban of blood donations from gay and bisexual men was implemented by the FDA in 1983 at the start of the AIDS crisis, when little was known about the spread of the disease.
“The United States government has to stop reacting to HIV like it is the early 1980s,” said Kelsey Louie, CEO for Gay Men’s Health Crisis said. GMHC is the nation’s leading provider of HIV and AIDS care.
“It is time for the FDA to implement a policy that is truly based on science, not blanket bans on certain groups of people,” Louie said.
In 2006, the AABB (formerly known as the American Association of Blood Banks), America’s Blood Centers and the American Red Cross said in a joint statement that the lifetime MSM blood-ban was “medically and scientifically unwarranted” and urged the FDA to modify blood donation policies so they are “comparable with criteria for other groups at increased risk of sexual transmission of transfusion transmitted infections.”
The Human Rights Campaign called the change a “step in the right direction,” but said the new policy, “still falls short of a fully acceptable solution because it continues to stigmatize gay and bisexual men.”
Dr. Peter Marks, deputy director of the FDA’s Center for Biologics Evaluation and Research, said the yearlong celibacy requirement for MSM is supported by scientific evidence relevant to the U.S. population.
“In reviewing our policies to help reduce the risk of HIV transmission through blood products, we rigorously examined several alternative options, including individual risk assessment,” Marks said.
In addition to changing the lifetime ban for homosexual and bisexual men donating blood, the FDA also made recommendations regarding “donor educational materials, donor history questionnaires and accompanying materials, as well as donor requalification and product management procedures,” the release said.
Part of the donor history questionnaire asks that transgender individuals self-identify and self-report for the purpose of blood donation.
