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New FDA blood donation pointers ease restrictions for homosexual and bisexual males

With new pointers launched by the U.S. Meals and Drug Administration (FDA), blood donor eligibility now might be primarily based on people’ responses to screening questions — reasonably than group-wide restrictions.

With the earlier pointers, males who’ve intercourse with males (MSM) confronted restrictions when donating blood resulting from considerations about the unfold of HIV from donor to recipient.

With the brand new relaxed guidelines, every donor candidate might be required to reply the identical set of screening questions to find out potential HIV threat “no matter sexual orientation, intercourse or gender.” 

Eligibility then might be decided for every particular person.


“The FDA has labored diligently to guage our insurance policies and guarantee we had the scientific proof to help particular person threat evaluation for donor eligibility whereas sustaining acceptable safeguards to guard recipients of blood merchandise,” stated Dr. Peter Marks, PhD, director of the FDA’s Heart for Biologics Analysis and Analysis in Washington, D.C., in a press launch saying the brand new pointers.

“The implementation of those suggestions will characterize a major milestone for the company and the LGBTQI+ group,” he continued.

“The FDA is dedicated to working intently with the blood assortment trade to assist guarantee well timed implementation of the brand new suggestions and we are going to proceed to observe the protection of the blood provide as soon as this particular person risk-based strategy is in place,” Marks added.

With the beginning of the HIV epidemic within the U.S. within the early 1980s, males who had intercourse with males weren’t permitted to present blood for concern they’d unfold human immunodeficiency virus, the virus that causes AIDS (acquired immunodeficiency syndrome).

The ban continued for greater than 30 years. 


In 2015, in gentle of recent testing and therapy developments, the restrictions relaxed a bit — MSM had been permitted to present blood in the event that they hadn’t had intercourse with a person during the last 12 months.

The subsequent change was in 2020, when the timeframe for abstaining from intercourse with different males was decreased to 3 months.

Potential blood donors might be required to fill out questionnaires to gauge their stage of threat.

Anybody who studies having a brand new sexual accomplice, a number of sexual companions or anal intercourse over the previous few months — no matter sexual orientation — won’t be permitted to donate as a result of probability of current and undetected HIV an infection, per the FDA’s assertion.

Anybody who’s taking medicines to deal with or forestall HIV an infection would even be “deferred” from donating. 

These medicines embody antiretroviral remedy (ART), pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP).

“Although these antiretroviral medication are secure, efficient and an vital public well being software, the out there information reveal that their use might delay detection of HIV by at present licensed screening assessments for blood donations, which can probably give false unfavourable outcomes,” the FDA’s assertion stated.

“The FDA strongly believes the implementation of a person risk-based strategy won’t adversely have an effect on the protection or availability of the U.S. blood provide,” the assertion stated.

The FDA’s new steering relies on its assessment of information from nations which have carried out particular person threat screenings in addition to a number of research measuring threat elements for HIV transmission throughout transfusions.

All donated blood is examined for sure antibodies that will trigger antagonistic reactions within the recipient, per the Facilities for Illness Management and Prevention (CDC).

It’s also examined for hepatitis B and C, HIV, West Nile virus, bacterial contamination and some other pathogens.

“I applaud the FDA’s determination to comply with science and never the biases which have guided earlier blood donation coverage with their new suggestions that apply to all People, no matter sexual orientation,” Dr. David Kilmnick, president of the New York LGBT Community, informed Fox Information Digital.


“Donating blood is a selfless act that helps to avoid wasting lives, and this new ruling is a serious step towards ending the discriminatory coverage on blood donations that was rooted in concern and homophobia,” he additionally stated.

“With our blood provide at a vital scarcity, this ruling couldn’t wait a day longer and can assist to avoid wasting lives.”

Dr. Marc Siegel, a professor of drugs at NYU Langone Medical Heart and a Fox Information medical contributor, suggested warning, nevertheless.

“The difficulty must be primarily based on medical threat, not demographics or political correctness,” he informed Fox Information Digital. “Since you may have a virus and take a look at unfavourable initially after which flip optimistic later, so it isn’t foolproof.”

He added, “My suggestion can be to contemplate permitting it, however solely with serial testing for these frequent ailments.”

This text was initially revealed by Learn the original article here.

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