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New Blood Donation Rules to Loosen Restrictions on Gay and Bisexual Men

A person getting blood from a person.

The Food and Drug Administration plans to revise a longstanding policy that excluded most gay and bisexual men from blood donation, instead adopting an approach that will screen donors depending on their recent sexual activity, agency officials said on Friday.

The move follows years of criticism from L.G.B.T.Q. advocates, who have described the prohibition as unscientific and discriminatory.

Federal officials have long justified the exclusion of gay and bisexual men as a way to keep H.I.V. out of the blood supply. A complete prohibition was put in place in the 1980s. In 2015, the agency allowed gay and bisexual men to donate if they had not had sexual contact with other men for the previous year.

The period was reduced to three months after severe blood shortages during the Covid-19 pandemic.

The F.D.A. said the new guidelines would be more inclusive and were based on a review of a recent study and data from other countries, including Britain and Canada, that took similar approaches. The new draft policy is also intended to shore up U.S. blood stores, which dipped at the outset of the pandemic and remain low.

“Whether it’s for someone involved in a car accident or an individual with a life-threatening illness, blood donation saves lives every day,” Dr. Robert Califf, the F.D.A. commissioner, said on a call with reporters.

“We’re committed to doing the best available science to inform and revise our policies to increase those eligible to donate blood and to maintain appropriate safeguards to protect the recipients of blood products.”

Christopher Hanson, an attorney in South Carolina, has advocated changes in the F.D.A.’s blood donation policies on behalf of an L.G.B.T.Q. health center in Washington, D.C.

He said the agency’s proposal was an important step forward that would enable him — a gay married man — and many others to perform an important public service.

“It’s an entirely powerful experience because you are giving blood to save lives,” said Mr. Hanson, who helped the clinic on a pro bono basis. “Knowing when you’re in a monogamous marriage that you’re being denied that ability, I said to myself, ‘I need to find other ways to help people.’”

The F.D.A. said the new approach would be gender-inclusive — the screening would also apply to women who have sex with gay and bisexual men — and would focus on individual risk, not blanket prohibitions on groups. People seeking to donate blood will be asked about their recent sexual activity and partners, as well as injectable drug use.

Potential donors will be asked whether they have had new sexual partners, or more than one sexual partner, in the past three months. If so, they will also be asked whether they engaged in anal sex. If they report such activity, they will not be permitted to donate at that time.

People who do not report new or multiple partners along with anal sex will be permitted to donate.

In addition, anyone who has tested positive for H.I.V. or who has taken medication to treat an H.I.V. infection will be prohibited from donating, said Dr. Peter Marks, director of the agency’s biologics center.

People taking oral PrEP, to prevent H.I.V. infection, will not be able to donate blood until three months after their last dose. The rationale is that blood centers may not be able to detect an H.I.V. infection in donors taking the drugs, Dr. Marks said. People receiving injectable PrEP will be barred for two years after their last dose.

“Importantly, this approach will not change the testing policies and procedures that are required of blood establishments,” which will still screen all blood donations for H.I.V. and hepatitis C and other conditions, Dr. Marks said.

The proposed guidelines were a step forward, said Tony Morrison, a spokesman for GLAAD, an advocacy organization.

“The fact that time-based deferrals for queer men are being completely eliminated is what we’ve been calling for for a very long time,” he said. “We’re finally elevating science over stigma.”

But the proposed guidelines are still more restrictive than those in some other nations, he noted: “This is progress, but we’re still behind.”

The Human Rights Campaign, an advocacy group, applauded the changes, but said they could be even better tailored to reduce risk to the blood supply and enable more people to give blood. The group said the F.D.A. should focus on data regarding the risks posed by people on PrEP medications.

“This is a really critical step in the right direction,” said Sarah Warbelow, legal director for the group. “We do want to see some additional changes to the policy as it’s been released.”

The F.D.A., in shaping the proposal, reviewed data from a recent study of about 1,600 gay and bisexual men in eight metropolitan areas. Participants in the project, known as the ADVANCE study, answered numerous questions, including about their sexual partners, and donated blood, which was screened for H.I.V.

The proposed changes come as the nation’s blood supply is severely depleted. America’s Blood Centers, an organization that represents blood donation companies, said that the Covid-19 pandemic disrupted the school- and work-based blood drives that were the “backbones of blood donation.”

The result has been “critically low levels” of blood in many areas of the country. The organization estimates that blood transfusions, about a quarter of which are for cancer patients, are needed every two seconds in the United States.

“This is an incredibly important change at a time when we are seeing historic lows in the percentage of Americans that donate blood each year,” said Kate Fry, chief executive of America’s Blood Centers.

A spokesman for Vitalant, a nonprofit blood donation organization, said it worked with the F.D.A. on a study that was central to gathering safety data on the new approach.

“It’s important to note that this change cannot happen overnight,” Nick Gehrig, the spokesman, said in a statement. “Once final, it will take time to update the donor history questionnaire and our computer systems and train our staff, which we intend to complete as quickly as possible.”

The F.D.A. said it would open the current proposal for a 60-day comment period. The agency will review and adjust the proposed policies based on input from various parties, and it will put the new strategy in place as soon as possible, officials said. Ms. Fry, of America’s Blood Centers, said it could take the better part of the year for all the changes to be in place.

Anthony Santella, a public health researcher at Fairfield University in Connecticut who specializes in H.I.V. and sexual health, said the proposed guidelines brought the country closer to having “more equitable policies.”

But, as a gay man, he said that not having the ability to donate blood had made him feel “shunned by the government,” and he was disappointed that the change took so long.

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Tamia Sumpter

Tamia is a driven senior undergraduate Bioengineering student currently enrolled at Clemson University. With a strong foundation in her field, she has honed her skills through hands-on experience in research and development at Eli Lilly & Company. During her time in the ADME department, Tamia contributed significantly by working on siRNAs and their applications in finding In Vitro-In Vivo Correlation (IVIVC). Looking ahead, Tamia has set her sights on a promising career in law. She aspires to specialize in Intellectual Property Law, with a particular focus on serving as in-house counsel for leading medical device or pharmaceutical companies. Her enthusiasm for this role is palpable as she prepares to embark on her legal journey! She is also a proud member of the Omicron Phi chapter of Delta Sigma Theta Sorority, Inc., PEER Mentor for Clemson PEER/WiSE, and currently serves as the President of Clemson Bioengineering Organization (CBO). With her unique blend of scientific knowledge and legal interests, Tamia is poised to make a meaningful impact in the healthcare and life sciences industries.