FDA plans to move to individual risk-based assessments for blood donors |  CNN

FDA plans to move to individual risk-based assessments for blood donors | CNN


The U.S. Food and Drug Administration is considering shifting its blood donation policy from general assessments to questionnaires that focus more on individual risk, it said Wednesday.

The agency uses data from a donor eligibility study and other blood surveillance information that “will likely support a policy shift to individual risk-based donor screening questions to reduce the risk of HIV transmission.” HIV,” the FDA said in a statement.

“The FDA remains committed to bringing together the scientific evidence related to alternative donor deferral policies that maintain a high level of blood safety,” the statement said. “We expect to release an updated draft guidance in the coming months.”

The FDA would not comment on further details, but The Wall Street Journal reported on Wednesday, citing sources familiar with the plans, that the changes would allow more men who have sex with men in monogamous relationships to give some blood.

Potential donors who have had a new sexual partner in the past three months would be asked whether they had anal intercourse during that time. Those who weren’t would be allowed to donate blood, an FDA official told the Journal.

Current policy requires men who have sex with men to wait three months after sexual contact with other men before they can donate blood.

Until 2020, the United States required men who have sex with men to wait one year after sexual contact with a man before donating blood, but the FDA revised these guidelines in 2020, taking into account an increased need for donations due to the Covid-19 pandemic.

“While today’s reports of an overdue FDA move are an important milestone, our community and leading medical experts will continue to advocate for the FDA to lift all restrictions against qualified LGBTQ blood donor candidates. “, Sarah Kate Ellis, CEO and President of GLAAD, the world’s largest LGBTQ media advocacy organization, said in a statement.

“As LGBTQ leaders and medical experts have been saying for years: bans and restrictions on gay and bisexual men’s blood donations are rooted in stigma, not science,” Ellis said.

American Medical Association President Dr. Jack Resneck Jr. told CNN in a statement that news of the potential change in guidelines is “encouraging.”

β€œThe AMA advocates tirelessly for the elimination of public policies that are inconsistent with scientific evidence and ethical best practices, which is why we have urged the FDA to use rational, scientifically-based deferment periods for the donation of blood, corneas and other tissues that are applied fairly and consistently to donors based on their individual risk,” he said.

The American Red Cross said in a statement Wednesday that it “believes that eligibility for blood donation should not be determined by methods based on sexual orientation and is committed to working with partners to achieve this. objective”.

The Red Cross worked with Vitalant and other organizations on the FDA-funded ADVANCE study to investigate whether an individual risk-based blood donor history questionnaire could replace a time-based benchmark for gay blood donors and bisexual.

Nick Gehrig, spokesperson for Vitalant, a nonprofit network of blood donation centers, told CNN he was “proud to be the principal investigator of the ADVANCE study to provide the FDA with the data needed to consider changes for men who have sex with men (MSM) eligibility policy while keeping the blood supply safe We look forward to hearing more about what comes next from the FDA in the coming months.

The UK reversed a similar policy in 2020, allowing men in a long-term relationship to donate blood at any time. Other men who have sex with men must still abstain from sex for three months before donating in the UK.

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