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The US Food and Drug Administration (FDA) has released a draft guidance recommending changes to current policies aimed at reducing the risk of HIV transmission via blood products.
Among the recommended changes is a proposal to alter the policy that prevents men who have sex with men (MSM) from donating blood.
The FDA’s draft guidance is recommending that MSM be allowed to donate blood if they have abstained from sexual contact for 1 year.
If this draft guidance is implemented, the US would follow other countries that have lifted the lifetime ban on MSM blood donors in recent years, such as the UK, Canada, and South Africa.
Human rights groups—such as the Human Rights Campaign, the US’s largest lesbian, gay, bisexual, and transgender civil rights organization—have said the FDA’s proposed policy change is still discriminatory.
“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 Human Rights Campaign Government Affairs Director David Stacy.
“This policy prevents men from donating life-saving 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.”
On the other side of the debate, blood banking groups—including the American Red Cross, America’s Blood Centers, and the American Association of Blood Banks—have voiced their support of a 1-year deferral period for MSM, as data have suggested this group has an increased risk of contracting HIV.
According to the Centers for Disease Control and Prevention, MSM are more severely affected by HIV than any other group in the US.
“This change in policy would align the donor deferral period for MSM with criteria for other activities that may pose a similar risk of transfusion-transmissible infections,” the blood banking groups said in a joint statement.
“We believe the current FDA indefinite blood donation deferral for a man who has [had] sex with another man since 1977 is medically and scientifically unwarranted. The blood banking community strongly supports the use of rational, scientifically based deferral periods that are applied fairly and consistently among blood donors who engage in similar-risk activities.”
The FDA’s draft guidance seems to reflect that idea, as the 1-year deferral period does not only pertain to MSM. It also pertains to individuals who have a history of receiving a transfusion of whole blood or blood components, individuals with a history of syphilis or gonorrhea, and individuals who have had a tattoo or piercing in the last year, among others.
The draft guidance also includes recommendations pertaining to donor education material and donor history questionnaires, donor requalification, product retrieval and quarantine, testing requirements, and other issues.
The full guidance, available here, is open for comment. 
The US Food and Drug Administration (FDA) has released a draft guidance recommending changes to current policies aimed at reducing the risk of HIV transmission via blood products.
Among the recommended changes is a proposal to alter the policy that prevents men who have sex with men (MSM) from donating blood.
The FDA’s draft guidance is recommending that MSM be allowed to donate blood if they have abstained from sexual contact for 1 year.
If this draft guidance is implemented, the US would follow other countries that have lifted the lifetime ban on MSM blood donors in recent years, such as the UK, Canada, and South Africa.
Human rights groups—such as the Human Rights Campaign, the US’s largest lesbian, gay, bisexual, and transgender civil rights organization—have said the FDA’s proposed policy change is still discriminatory.
“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 Human Rights Campaign Government Affairs Director David Stacy.
“This policy prevents men from donating life-saving 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.”
On the other side of the debate, blood banking groups—including the American Red Cross, America’s Blood Centers, and the American Association of Blood Banks—have voiced their support of a 1-year deferral period for MSM, as data have suggested this group has an increased risk of contracting HIV.
According to the Centers for Disease Control and Prevention, MSM are more severely affected by HIV than any other group in the US.
“This change in policy would align the donor deferral period for MSM with criteria for other activities that may pose a similar risk of transfusion-transmissible infections,” the blood banking groups said in a joint statement.
“We believe the current FDA indefinite blood donation deferral for a man who has [had] sex with another man since 1977 is medically and scientifically unwarranted. The blood banking community strongly supports the use of rational, scientifically based deferral periods that are applied fairly and consistently among blood donors who engage in similar-risk activities.”
The FDA’s draft guidance seems to reflect that idea, as the 1-year deferral period does not only pertain to MSM. It also pertains to individuals who have a history of receiving a transfusion of whole blood or blood components, individuals with a history of syphilis or gonorrhea, and individuals who have had a tattoo or piercing in the last year, among others.
The draft guidance also includes recommendations pertaining to donor education material and donor history questionnaires, donor requalification, product retrieval and quarantine, testing requirements, and other issues.
The full guidance, available here, is open for comment.
The US Food and Drug Administration (FDA) has released a draft guidance recommending changes to current policies aimed at reducing the risk of HIV transmission via blood products.
Among the recommended changes is a proposal to alter the policy that prevents men who have sex with men (MSM) from donating blood.
The FDA’s draft guidance is recommending that MSM be allowed to donate blood if they have abstained from sexual contact for 1 year.
If this draft guidance is implemented, the US would follow other countries that have lifted the lifetime ban on MSM blood donors in recent years, such as the UK, Canada, and South Africa.
Human rights groups—such as the Human Rights Campaign, the US’s largest lesbian, gay, bisexual, and transgender civil rights organization—have said the FDA’s proposed policy change is still discriminatory.
“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 Human Rights Campaign Government Affairs Director David Stacy.
“This policy prevents men from donating life-saving 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.”
On the other side of the debate, blood banking groups—including the American Red Cross, America’s Blood Centers, and the American Association of Blood Banks—have voiced their support of a 1-year deferral period for MSM, as data have suggested this group has an increased risk of contracting HIV.
According to the Centers for Disease Control and Prevention, MSM are more severely affected by HIV than any other group in the US.
“This change in policy would align the donor deferral period for MSM with criteria for other activities that may pose a similar risk of transfusion-transmissible infections,” the blood banking groups said in a joint statement.
“We believe the current FDA indefinite blood donation deferral for a man who has [had] sex with another man since 1977 is medically and scientifically unwarranted. The blood banking community strongly supports the use of rational, scientifically based deferral periods that are applied fairly and consistently among blood donors who engage in similar-risk activities.”
The FDA’s draft guidance seems to reflect that idea, as the 1-year deferral period does not only pertain to MSM. It also pertains to individuals who have a history of receiving a transfusion of whole blood or blood components, individuals with a history of syphilis or gonorrhea, and individuals who have had a tattoo or piercing in the last year, among others.
The draft guidance also includes recommendations pertaining to donor education material and donor history questionnaires, donor requalification, product retrieval and quarantine, testing requirements, and other issues.
The full guidance, available here, is open for comment.