FDA issues draft guidance on blood donations from MSM

The FDA has formally recommended a proposal to allow men who have sex with men to donate blood, provided that their most recent sexual contact was at least 1 year ago.

“Since September 1985, FDA has recommended that blood establishments indefinitely defer male donors who have had sex with another male, even one time, since 1977 due to the strong clustering of AIDS illness in the MSM community and the subsequent discovery of high rates of HIV infection in that population,” the FDA wrote in the draft guidance, which the agency announced in November. “Although not making a change would maintain the current level of safety of the blood supply . . . there is evidence that the deferral policy is becoming less effective over time. In addition, the policy is perceived by some as discriminatory.”

The FDA recommends that the indefinite deferral remain intact for commercial sex workers and those who inject drugs.

There will be a 60-day period for public comment on the draft guidance, after which time the agency will look to finalizing its recommendations.

In collaboration with the NIH’s National Heart, Lung and Blood Institute, the FDA has undertaken the creation of a national blood surveillance system that will allow the agency to monitor the effect of this policy change and to ensure the continued safety of the national blood supply.