FDA Addresses Blood Donations by Men Who Have Sex With Men
Agency cites data from other countries showing such donations don't compromise blood supply
WEDNESDAY, Dec. 24, 2014 (HealthDay News) -- The U.S. Food and Drug Administration announced Tuesday its intention to release a new draft guidance in early 2015 that would ultimately open the door to blood donations from men who have sex with men (MSM).
MSM who have abstained from sex for one year will be allowed to donate blood in the United States, under a new federal policy that would reverse a 31-year ban on donations from MSM.
The FDA is changing its policy based on data from other countries that show allowing such donations would not increase the risk of HIV-infected blood entering America's blood supply, Peter Marks, M.D., Ph.D., deputy director of the agency's Center for Biologics Evaluation and Research, said Tuesday during a news conference. Marks noted that some of the most compelling data come from Australia, which in 2000 implemented a one-year deferral on blood donations from sexually active MSM. "These studies documented no adverse effects on the safety of the blood supply with a one-year deferral," he said.
The FDA also will implement a national blood surveillance system that will help the agency monitor the effect of the policy change and ensure the safety of the blood supply, FDA Commissioner Margaret Hamburg, M.D., said in a statement issued by the agency.