FDA Plans to Allow More Gay, Bisexual Men to Donate Blood
Current rules bar blood donations from men who recently had sex with men due to HIV transmission risk .
https://www.wsj.com/articles/fda-to-...od-11669816800
Gay and bisexual men in monogamous relationships would be allowed to donate blood without abstaining from sex under guidelines being drafted by the Food and Drug Administration, people familiar with the plans said.
The change would be a departure from U.S. policy that for many years barred men who have sex with men from donating blood at all. The FDA policy originated in the 1980s during the AIDS epidemic when tests for HIV, the virus that causes AIDS, weren’t considered sensitive enough to protect the blood supply.
The FDA lifted the ban in 2015 but said gay and bisexual men had to abstain from sex for one year before donating. During the pandemic, amid severe blood shortages, federal officials shortened the abstinence requirement to three months.
The FDA plans to issue the new rules in coming months, the people familiar with the plans said. All potential donors would need to complete an individualized risk assessment, the people said. Canada adopted a similar system in September. Canada’s risk assessment is a form that asks uniform questions regardless of gender or sexual orientation about a potential donor’s medical history, travel and sexual activity.
The FDA’s plans come after an agency-funded study of around 1,600 gay and bisexual men examined whether an individualized-risk assessment would be as effective as time deferrals in keeping the blood supply safe. The study, conducted by three of the largest nonprofit blood centers in the U.S.—Vitalant, OneBlood and the American Red Cross—concluded earlier this year.
Participants in the study were asked whether they had more than one sex partner during specific periods of time, the type of sexual activity they engaged in and whether they used condoms, among other questions.
“We have a strong data set,” said Dr. Brian Custer, director of Vitalant Research Institute and principal investigator of the study. “We have highly relevant information to envision what an individual risk-based approach would look like.”
FDA officials are still drafting the new guidance and determining what the questionnaire would contain, the people said. The new risk assessment would likely ask potential donors if they have had any new sexual partners in the past three months, an FDA official said.
People who say they haven’t would be free to donate blood. People who say they have had new sexual partners would be asked if they have had anal intercourse in the past three months. People who say they haven’t would be allowed to donate. People who say they have would likely be asked to wait three months before donating blood, an FDA official said.
Unprotected anal sex presents a higher risk of HIV transmission than other forms of sex, the Centers for Disease Control and Prevention has said. Three months is an adequate wait time, an FDA official said, because an HIV infection would be apparent within that time.
Blood centers such as the American Red Cross test donations for HIV, hepatitis B and C and other viruses. HIV testing over the years has improved. Some tests look for the presence of antibodies to HIV, indicating that a person was exposed to the virus. Other tests measure the amount of virus in the blood.
None of the tests can detect HIV immediately after infection, according to infectious-disease specialists. “With the latest HIV tests, that window is probably no greater than 10 days from the time of exposure,” said Dr. Bruce Walker, an infectious-diseases specialist and director of the Ragon Institute of MGH, MIT and Harvard. He called the risk of HIV transmission during this window “low but it is not negative.” He said he supports allowing men who have sex with men to donate blood.
LGBTQ advocacy groups such as Human Rights Campaign have for years called the U.S. blood policy discriminatory and said that men who have sex with men should be allowed to donate. The American Medical Association and the American Red Cross have also called for the policy to be changed.
“It is a completely outdated policy that doesn’t reflect our current ability to test blood for HIV or the medical science around HIV,” said Sarah Warbelow, legal director for the Human Rights Campaign.
