The Food and Drug Administration is weighing whether to end a total ban on blood donations from gay and bisexual men after seeking information from two advisory panels on how such a change would affect the U.S. blood supply.
“The FDA will consider both committees’ recommendations and input from HHS and our sister agencies as we review” the policy, Jennifer Rodriguez, a spokeswoman for the FDA, said in an e-mail. She was referring to the U.S. Department of Health and Human Services. The FDA’s main concern is making sure the nation’s blood supply is safe, she said.
The U.S. since 1983 has banned men who have had sex with men from donating blood because of the concern that the virus that causes AIDS could be transmitted through blood transfusions. The agency convened advisers yesterday to discuss ways to monitor blood for any increased risk that recipients could become infected with HIV.
There is no timeframe for the agency’s deliberations, which will take into account yesterday’s discussion as well as a vote last month by a separate set of advisers to HHS. Those panelists approved a recommendation that would let men who have had sex with men donate blood after being abstinent for a year.
“It’s going to be politically controversial, I suspect,” said Brooks Jackson, chairman of yesterday’s FDA advisory panel and dean of the University of Minnesota Medical School.
The U.S. has enough blood and the discussion of a change is more a question of the right to donate than a supply need, he said after the meeting.
A potential change in the donation ban highlights the need for the U.S. to create a blood surveillance system that tracks infections transmitted through transfusions, FDA advisers said yesterday. While HHS advisers recommended such a surveillance effort at a meeting in December 2013, the department hasn’t decided to create it.
The risk of getting HIV from a blood transfusion is about 1 per 2 million units of blood transfused, according to the FDA’s website. With HIV cases, there is a 9- to 11-day window when the virus might not be detected in current tests of people who just contracted it.
The American Red Cross, which supplies more than 40 percent of America’s blood supply, supports a one-year deferral. Gay rights advocates at the FDA advisory panel meeting supported the one-year deferral as well, though many said it should be seen as lifting the ban completely.
Any change in the ban is “an important first step of a more comprehensive review,” Scott Schoettes, senior attorney and HIV Project national director at Lamda Legal, a New York- based civil rights organization, said at the meeting.
If a one-year deferral were implemented, an estimated 185,800 additional men would donate 317,000 pints of blood a year, according to a study by the Williams Institute, a research center at the University of California at Los Angeles that examines sexual-orientation and gender-identity law and public policy.