The Food and Drug Administration has formally proposed letting gay and bisexual men donate blood, so long as they've abstained from sex for a year.
The recommendation changes the current guidance, which is that any man who have ever had sex with another man in his entire life should never be able to donate blood. It's a policy that has enraged gay rights groups and that is virtually impossible to enforce.
"No transmissions of HIV, hepatitis B virus, or hepatitis C virus have been documented through U.S.-licensed plasma derived products in the past two decades," the FDA says in its recommendation.
The FDA also handed a victory to transgender people, saying donors may choose how to identify their sex.
The reason for banning donations by men who have sex with other men is simple: they are at much higher risk of becoming infected with HIV, the virus that causes AIDS, as well as other viruses such as hepatitis B and C.
"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 (men who have sex with men) community and the subsequent discovery of high rates of HIV infection in that population," FDA says in its guidance.
Before 1985, people did become infected with HIV from blood transfusions. The Centers for Disease Control and Prevention estimated in 2001 that more than 14,000 people were infected that way.
There are good blood tests that are now used to screen blood donations for HIV and many other viruses, such as hepatitis. The American Red Cross and America's Blood Centers, which collect donations, say the lifetime ban is unnecessary. CDC says the risk of getting HIV from a transfusion is one in 1.5 million.
The tests don't detect a very recent infection, however. To be safe, the FDA wants to stick with the one-year limit. The FDA first said it would change the guidance last December.
"We recommend that donors be provided donor education material before each donation explaining the risk of HIV transmission by blood and blood products, certain behaviors associated with the risk of HIV infection, and the signs and symptoms associated with HIV infection, so that donors can self-defer," FDA says.
"The donor education material should be presented to donors in a manner they will understand, which may include oral, written, or multimedia formats. The donor education material should instruct the donor not to donate when a risk factor for HIV infection or signs or symptoms of HIV infection are present."
FDA says other countries have allowed gay and bisexual men to donate blood with little problem. They include Argentina, Australia, Brazil, Hungary, Japan, Sweden and Britain.
About 7 percent of U.S. men report that they have ever had sex with another man and 4 percent of men have done so in the past five years.
FDA says other groups should still be asked not to donate blood, including prostitutes and injecting drug users.
"Recent data indicate that commercial sex work and injection drug use are behaviors that continue to place individuals both at a relatively high risk of HIV infection and at a relatively high risk of window period transmission of HIV," FDA notes. "Window period" is the short period of time before a test can detect an infection in blood.
The Human Rights Campaign, which has pushed hard to allow gay and bisexual men to donate blood, is still critical of FDA's new policy.
"While the new policy is a step in the right direction toward an ideal policy that reflects the best scientific research, it still falls far short of a fully acceptable solution because it continues to stigmatize gay and bisexual men," said the group's top policy official, David Stacy. "This policy prevents men from donating life-saving blood based solely on their sexual orientation rather than actual risk to the blood supply."
FDA notes this is guidance and not any type of regulation. "Guidances describe the FDA's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited."
The guidance also asks people not to donate blood if they've recently received a transfusion, and it asks women who have had recent sex with a bisexual or gay man to wait a year before donating.