FDA Ends Across-The-Board Ban On Blood Donations From Gay, Bisexual Men

Exactly a year ago this week, the Food and Drug Administration announced that it was going to eventually change its guidance on blood donations that had barred any man who had been intimate with another male at any time in the previous three decades from donating. Today, the FDA finalized that change, which still requires that all male donors abstain from same-sex intimacy for a year before donating.

Following the outbreak of HIV in the 1980s, the FDA sought to prevent the spread of the virus through blood transfusions by enacting a lifetime deferral for gay and bisexual men — or any male who had been sexually intimate with another man. The agency claims that — between the ban, other restrictions, and improved screening — the rate of HIV transmission through transfusions has dropped from 1 in 2,500 to 1 in 1.47 million.

Last year, then FDA-chief Margaret Hamburg explained that the change to the blood donation guidance came about as the agency endeavored to update its standards to reflect current technology and the relevant “available scientific evidence…including the results of several recently completed scientific studies and recent epidemiologic data.”

“The FDA’s responsibility is to maintain a high level of blood product safety for people whose lives depend on it,” said the FDA’s Acting Commissioner Stephen Ostroff in a statement earlier today. “We have taken great care to ensure this policy revision is backed by sound science and continues to protect our blood supply.”

The one-year deferral treats men who have had sex with men the same as others believed to be at an increased risk for HIV transmission, including recent recipients of blood transfusions and those who have been accidentally exposed to another person’s blood.

It also meshes more closely with deferral timelines in the U.K. and Australia. The FDA says that when Australia updated its policy to shorten the deferral, it saw no change in the risk to the blood supply.

“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,” said Peter Marks, M.D., Ph.D., deputy director of the FDA’s Center for Biologics Evaluation and Research. “Ultimately, the 12-month deferral window is supported by the best available scientific evidence, at this point in time, relevant to the U.S. population. We will continue to actively conduct research in this area and further revise our policies as new data emerge.”

The American Red Cross, the AABB (formerly the American Association of Blood Banks), and America’s Blood Centers have been advocating for the lift on the all-out ban on donations. In a joint statement, the groups say they are pleased with the revised guidance from the FDA.

“The top priority of the blood banking community is the safety of our volunteer blood donors and the recipients of blood,” reads the statement. “While the final FDA guidance describes a pathway for previously deferred donors to give blood, it will take several months for blood centers to update their computer systems, modify processes and procedures, train staff and implement these extensive changes.”

There are those who believe that even a one-year ban is too restrictive. For example, a man in a monogamous relationship with another man in need of blood may not be able to donate — or he may have to lie about his sexuality or his connection to the recipient to be eligible to give his blood.

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