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FDA eases restrictions on blood donation for gay and bisexual men

FDA eases restrictions on blood donation for gay and bisexual men


The U.S. Food and Drug Administration (FDA) today released draft guidelines to ease blood donation restrictions for gay men (MSM). Previously, the FDA only allowed him to donate blood from her MSM who abstained from having sex with other men for three months. Under the newly proposed guidance, FDA will screen all potential donors with questionnaires that assess HIV risk based on sexual behavior, recent sexual partners, and other relevant factors. is recommended.

Karl Schmidt, executive director of the Institute for HIV+ Hepatitis Policy, applauded this “long-awaited” change. “This is a landmark change, ending a long and painful era of blanket discrimination against gay men. Eligibility to donate blood will no longer be based on sexual orientation. will be individually reviewed to determine if they are eligible to donate,” he said in an email.

Blood donation restrictions for MSM began in response to the AIDS epidemic. In 1985, the FDA enacted a law banning her MSM from donating blood for life. In 2015, the agency dropped this ban and instead required her MSM to abstain from having sex with other men for her year before donating blood. In 2020, this deferral has been shortened to his 90 days. However, LGBTQ rights groups and some medical societies American Medical Association (AMA) has denounced these requirements as discriminatory.

“The current three-month deferral period selects and bans blood donors based on their unique attributes rather than the risk factors they present,” said the former president of the AMA in January 2022. Gerald Harmon, M.D. writes: Before donating blood, he cannot be a donor if he has had sex with another man in the three months, but a man or woman who has had unprotected sex with multiple partners of the opposite sex during the same period is still eligible. “

The newly proposed guidelines remove the 3-month abstinence requirement for MSM. Instead, we will revise the current donor history questionnaire to ask all potential donors about their new and multiple sexual partners in the past 3 months. Those who report having new or multiple sexual partners in the past three months will be asked if they have had anal sex during that period. Anyone who has had a new partner or multiple sexual partners in the past 3 months and reports participating in anal sex will not be allowed to donate until a later date.

Additionally, individuals on pre-exposure prophylaxis (PrEP) defer donating. Those taking oral PrEP will be deferred for 3 months from their most recent dose, and those taking her injectable PrEP will be deferred for 2 years from their most recent injection. Data suggest that these agents may delay detection of the HIV virus in licensed blood donation screening tests, and that their use may lead to false-negative results. .

“While we recognize that the number of individuals eligible to donate may increase once these draft recommendations are finalized, some individuals will still postpone donating blood. The FDA will continue to track the latest data related to PrEP and blood donation to inform these recommendations,” he noted.

Recommendations do not alter donation limits based on other HIV risk factors.People who have had sex or given prescriptions in exchange for money or drugs use of injectable drugs Donations will continue to be prohibited for the past three months. People who have tested positive for HIV or who have taken HIV medications HIV infection Continue to ban blood donation indefinitely.

This proposal is open for public comment for the next 60 days. FDA will then review and finalize the guidance.

“Our approach to this effort has been and will continue to be based on the best available science and data. Over the years, this data-driven process has allowed us to revise our policies. Yes, we maintain appropriate safeguards to protect our recipients,” Marks said. “We remain committed to finalizing this draft guidance as soon as possible, following the best available scientific evidence, to maintain an adequate blood supply and minimize the risk of transmission of infectious diseases. To do.”

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