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FDA considers moving to individual risk-based assessments for blood donors

Karma Hassan, CNN

The U.S. Food and Drug Administration said Wednesday it is considering moving its blood donation policy from a comprehensive assessment to a questionnaire that focuses more on individual risks.

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

“The FDA remains committed to collecting scientific data related to the Alternate Donor Deferral Policy that maintains a high level of blood safety,” the statement said. We plan to issue a draft guidance.”

The FDA would not comment on further details, but the Wall Street Journal on Wednesday cited sources familiar with the plan as saying the change would allow more men to have sex with men in monogamous relationships. men will be able to donate blood.

Potential donors who have had a new sexual partner in the past three months are asked if they had anal intercourse during that period. said he would.

Current policy requires men who have sex with men to wait three months after having sexual contact with another man before donating blood.

Until 2020, men who had sex with men had to donate blood one year after having sexual contact with men in the United States. FDA revised these guidelines in 2020in view of the increased need for donations as a result of the Covid-19 pandemic.

“Today’s expiring motion report from the FDA is an important step, but our community and leading medical experts are calling for the FDA to lift all restrictions on qualified LGBTQ potential blood donors. GLAAD, the world’s largest LGBTQ media advocacy group, says: statement.

“LGBTQ leaders and medical experts have been saying for years that bans and restrictions on blood donation by gay and bisexual men are rooted in prejudice, not science,” Ellis said.

Dr. Jack Lesneck Jr., president of the American Medical Association, said in a statement to CNN that the news that the guidelines may change is “encouraging.”

“The AMA relentlessly advocates for the exclusion of public policy that is inconsistent with scientific evidence and best ethical practice. We have urged the use of a science-based deferral period that is applied fairly and consistently to donors according to individual risk,” he said.

In a statement Wednesday, the American Red Cross said, “We do not believe eligibility to donate blood should be determined in any way based on sexual orientation, and we are committed to working with our partners to achieve this goal. There are,’ he said.

The Red Cross, in collaboration with Vitalant and other organizations, has announced that in the FDA-funded ADVANCE study, an individual risk-based blood donation history questionnaire will benefit time-based referrals of homosexual and bisexual blood donors. I asked if it could be replaced.

Nick Gehrig, a spokesperson for Vitalant, a nonprofit network of blood donation centers, told CNN: Male (MSM) eligibility policy while maintaining blood supply safety. We look forward to learning more about what comes next from the FDA in the coming months. “

Britain overturned Similar policy In 2020, men in long-term relationships will be able to donate blood at any time. Other men who have sex with men must abstain from sex for three months before donating in the UK.

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