FDA issues final guidance on deferral criteria for gay and bisexual men

December 21, 2015 at 1:13 pm

bw-4998

On December 21, 2015 the FDA issued its final guidance on deferral criteria for men who have had sex with men, or MSM.

Under the FDA guidance, there will be a 12-month deferral on MSM donors.

The new policy aligns the MSM deferral period with those for other activities that might pose a similar risk of transfusion-transmissible infections.

BloodworksNW advocated for this change, and applauds the FDA’s decision to change the lifetime deferral. The lifetime ban was implemented in 1983 during the early stages of the AIDS epidemic, when little was known about the cause of HIV, and no quick test was available to determine if someone was infected.

Today the medical community has a thorough knowledge of the epidemiology of AIDS and the workings of HIV. We use several sensitive tests to detect potential infection in all blood donations. These tests will detect a “risky” donation less than two weeks after donor exposure to HIV.

The final FDA guidance today will not result in immediate MSM donations. While the FDA guidance now defines a pathway for previously deferred donors to give blood, we anticipate that it will take several months for all blood centers to update computer systems, modify processes and procedures, train staff, and implement these significant changes. We’ll be working diligently to determine the process for reinstating eligible donors who were deferred under the previous MSM policy.

We will make an announcement when we are ready to implement the new deferral criteria.

Other nations including, Australia, Britain, and Sweden, have already implemented a 12-month deferral period without any adverse impact on the safety of the blood supply.

We are pleased the FDA has recognized that the application of scientific evidence supports eliminating a lifetime ban on gay men to donate blood. With current medical knowledge and reliable and accurate testing, we can with confidence change the deferral period without compromising the safety of the community blood supply.