The FDA have now revised their blood donor policy to include MSM who have not had sex with men in the past 12 months.
The previous deferral policy, which completely banned men who have sex with men (MSM) from donating blood, has been a source of controversy in the past with gay rights organizations, who have called the policy discriminatory.
An announcement by the Food and Drug Administration (FDA) notes that their decision comes after a thorough review of their policies regarding human immunodeficiency virus (HIV) transmission through blood products.
"The FDA's responsibility is to maintain a high level of blood product safety for people whose lives depend on it," says Dr. Stephen Ostroff, the FDA's acting commissioner. "We have taken great care to ensure this policy revision is backed by sound science and continues to protect our blood supply."
According to the regulatory body, by following the best available science - along with donor education materials, deferral questions and advances in HIV donor testing - they have been able to reduce the HIV transmission rates from blood transfusion from 1 in 2,500 to 1 in 1.47 million.
Study results led to deferral policy revisions
During the past 10 years, the FDA have revisited their donor deferral recommendations several times, particularly as they relate to reducing HIV transmission risk.
- Gay, bisexual and MSM represent around 2% of the US population, yet they are most severely affected by HIV
- In 2010, young gay and bisexual men accounted for 72% of new HIV infections in 13-24-year-olds
- By the end of 2011, 57% of people with HIV in the US were gay and bisexual men.
In 2010, the Advisory Committee for Blood Safety and Availability (ACBSA) found that the deferral policy for MSM needed to be revisited.
As such, studies were conducted to better inform a potential policy change, and in 2014, the FDA, Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) - along with other Public Health Service agencies - assessed the study results.
Then, in November 2014, the results were presented to the relevant committees; after assessing the results, it was recommended that a shorter deferral period was more suitable.
The FDA note that donor screening plays a pivotal role in keeping the US blood supply safe. Donors must be free from any disease that is transmissible by blood transfusion, which is determined by health history and examination.
Additionally, donors are informed about risks and must answer questions relating to their blood safety; donors with a history of intravenous drug abuse are deferred.
FDA will 'continue to conduct research in this area'
Officials from the FDA say their updated recommendations mean that the deferral period for MSM is more in line with that for other men and women who are at increased HIV risk, for example, those who have had a recent blood transfusion or have been accidentally exposed to another person's blood.
The US is not the first country to revise their blood donor recommendations; other countries, such as the UK and Australia, have put in place 12-month deferrals for MSM.
In fact, during Australia's shift to a 12-month deferral for MSM, health officials in the country conducted studies that evaluated over 8 million units of donated blood and found that there was no change in risk to the blood supply with the new deferral system.
The new guidance also suggests that blood establishments make revisions to their donor education materials, questionnaires and accompanying materials, as well as to their product management procedures.
Commenting on their updated deferral policy, Dr. Peter Marks, deputy director of the FDA's Center for Biologics Evaluation and Research, says:
"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. Ultimately, the 12-month deferral window is supported by the best available scientific evidence, at this point in time, relevant to the US population."
He adds that the FDA will "continue to actively conduct research in this area and further revise our policies as new data emerge."
In October of this year, Medical News Today reported on a study that suggested stored blood is safe to use in transfusions after heart surgery.