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Background

The Food & Drug Administration (FDA) is responsible for recommending policies and making rules regarding the donation of blood and blood products. During the 1980s, when it became clear that transmission of Acquired Immune Deficiency Syndrome (AIDS) happened through blood, the FDA began recommending multiple policies that would decrease the risk of transmission of the AIDS virus through the blood supply. These policies included providing donors with educational materials on risk factors and deferring donors who participated in behaviors that were deemed to increase their risk of contracting the AIDS virus. At the time, testing methodologies and pathogen inactivation procedures for HIV/AIDS had not yet been developed and donor education and deferral were the only ways to decrease risk of transmission.

In September of 1985, the FDA recommended that all blood establishments defer male donors who have had sex with other males (MSM) since 1977 from donating blood. Individuals with MSM contact were deemed high risk given the high rates of HIV infection in that particular population. In 1992, the FDA recommended the continued MSM deferral, as well as a deferral for commercial sex workers and those who have injected illicit drugs. The combined use of donor education, donor deferral policies, and advances in HIV testing led to a significant decrease in transmission of the HIV/AIDS virus from blood transfusion.

Recent advances in both HIV testing and pathogen inactivation procedures led some groups to ask the FDA to revisit the MSM donor deferral policy as some groups viewed the policy as discriminatory. In 2010, after years of public meetings, workshops, and the recommendation of the Advisory Committee on Blood Safety and Availability, an Interagency Blood, Organ, & Tissue Safety Working Group on MSM (BOTS Working Group) was assembled to look at scientific data on the subject. The group, consisting of members of the Centers for Disease Control (CDC), Health Resources Services Administration (HRSA), National Institute of Health, (NIH), HHS Office of Civil Rights, Office of the Assistant Secretary for Health (OASH), and the FDA, decided to review blood donation deferral criteria research and establish a national blood safety monitoring system.

Changing the Policy

In 2014, data from various studies recommended by the BOTS Working Group showed a number of things related to the MSM deferral policy, particularly that evidence from other countries that have changed their MSM deferral policies to a one year deferral experienced no change in risk of exposure. The BOTS Working Group recommended the change to a one year deferral policy. After a meeting reviewing the relevant data, the Advisory Committee on Blood and Tissue Safety (ACBSTA) also recommended the policy change. FDA’s Blood Products Advisory Committee (BPAC) met to review the policy and the potential value of a Transfusion Transmissible Infections Monitoring (TTIMS), a laboratory test to detect recently acquired HIV infections. Many members of BPAC noted that a change to the deferral policy would be acceptable with the concurrent implementation of TTIMS. The FDA stated that it intended to establish such a system in collaboration with the National Heart, Lung, and Blood Institute that will be used to further refine blood safety measures and monitor upcoming potential donor risk factors.

In their December 21, 2015 guidance, the FDA finalized the policy change, stating that evidence supports changing the current system to a one year deferral for MSM donors. This means a donor may not donate blood for one year from the date of MSM contact. The FDA will continue to monitor the safety of the blood supply with the implementation of the TTIM System.

Changes to Persons with Hemophilia Deferral Policy

The December 2015 guidance announced other changes that have a direct impact on those with hemophilia. Prior to this guidance, it was recommended that people with hemophilia, and their sexual partners, be deferred from donating blood based on their risks for HIV infection. However, given the increased safety of both the blood supply and clotting factor, the FDA announced that the sexual partners of those with hemophilia were no longer recommended for deferral. Due to the risk of injury from large needles, the FDA is still recommending the deferral of persons with hemophilia.

HFA Action

In 2014, in conjunction with members of the American Plasma Users Coalition (APLUS), HFA provided comments and testimony about the importance of keeping our nation’s blood supply safe. Through our work with APLUS, HFA will monitor the implementation of the TTIMS system and continue to work with the FDA to ensure that it is implemented in a timely manner and in a way that ensures patient safety is the highest priority.

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