The Food and Drug Administration reiterated its longstanding policy on its Web site Wednesday, more than a year after the Red Cross and two other blood groups criticized the policy as "medically and scientifically unwarranted."
"I am disappointed, I must confess," said Dr. Celso Bianco, executive vice president of America's Blood Centers, whose members provide nearly half the nation's blood supply.
Before giving blood, all men are asked if they have had sex, even once, with another man since 1977. Those who say they have are permanently banned from donating. The FDA said those men are at increased risk of infection by HIV that can be transmitted to others by blood transfusion.
In March 2006, the Red Cross, the international blood association AABB and America's Blood Centers proposed replacing the lifetime ban with a one-year deferral following male-to-male sexual contact. New and improved tests, which can detect HIV-positive donors within just 10 to 21 days of infection, make the lifetime ban unnecessary, the blood groups told the FDA.
In a document posted Wednesday, the FDA said it would change its policy if given data that show doing so wouldn't pose a "significant and preventable" risk to blood recipients.
"It is a way of saying, 'Whatever was presented to us was not sufficient to make us change our minds,'" Bianco said.
Read the FDA's question and answer page concerning its policy.
The FDA said HIV tests currently in use are highly accurate, but still cannot detect the virus 100 percent of the time. The estimated HIV risk from a unit of blood is currently about one per 2 million in the United States, according to the agency.
Critics of the exclusionary policy said it bars potential healthy donors, despite the increasing need for donated blood, and discriminates against gays. The FDA recognized the policy defers many healthy donors but rejected the suggestion it's discriminatory.
Anyone who's used intravenous drugs or been paid for sex also is permanently barred from donating blood.