Thursday 25 December 2014

FDA to Lift Ban on Blood Donations by Gay Men

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Agency cites data from other countries showing such donations wouldn't compromise blood supply

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WebMD News from HealthDay

By Dennis Thompson

HealthDay Reporter

TUESDAY, Dec. 23, 2014 (HealthDay News) -- Gay and bisexual men 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 men who have sex with men.

The U.S. Food and Drug Administration announced Tuesday its intention to release a new draft guidance in early 2015 that would ultimately open the door to blood donations from gay men.

The FDA is changing its policy based on data from other countries that show allowing such donations would not increase the risk of HIV-tainted blood entering America's blood supply, said Dr. Peter Marks, deputy director of the agency's Center for Biologics Evaluation and Research.

Marks noted that some of the most compelling data comes from Australia, which in 2000 implemented a one-year deferral on blood donations from sexually active gay men.

"These studies documented no adverse effects on the safety of the blood supply with a one-year deferral," Marks said.

Marks estimated that about half of the people now barred from donating blood under the current policy would be able to donate under the new policy.

The change will better align the FDA's donation policy for gay and bisexual men with its policies regarding other people potentially exposed to HIV, the virus that causes AIDS.

There is currently a maximum one-year ban in the United States for blood donations by men who have had sex with an HIV-positive woman or commercial sex workers. The same goes for women who have had sex with HIV-positive men.

However, sexually active gay men in a monogamous relationship will not be allowed to donate blood under the new policy, Marks clarified. The increased HIV risk for gay men rules out donations from even those in monogamous relationships, he said.

"This was considered," Marks said. "A person who presents to donate may be certain that he or she has been monogamous. He or she can't be certain that the same is true for his or her partner. That's true for individuals in relationships with members of the same sex as well as for the opposite sex. So at this point, the scientific evidence does not support self-reported monogamy as a sufficient indicator of reduced HIV risk."



source : FDA to Lift Ban on Blood Donations by Gay Men

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