FDA Relaxes Blood Donation Restrictions

The U.S. Food and Drug Administration has relaxed restrictions on blood donation by gay and bisexual individuals in new guidelines for blood donation organizations. It has been recommended that donors be screened on the basis of one set of criteria, ending a restrictive policy that applied only to men who have sex with men and their female partners.

The US Food and Drug Administration imposed a lifetime ban on donations from men who have sex with men, but its donation guidelines have been criticized for years. Taking a cue from the UK and Canada, the latest policy now evaluates all prospective donors by the same set of criteria while screening for recent, higher-risk sexual activity.

The Biden administration had been seeking to end the previous set of time-based deferrals and screening questions for people who identified as men who have sex with men and their partners. Risk assessments now apply to all potential donors. Individuals, other than those who report having a new sexual partner or multiple partners and had anal sex in the past three months, will be eligible to donate blood, provided all other eligibility criteria are met.

The new rules come several years after the U.S. health regulator reversed a 1980s guideline which banned men who have sex with men from donating blood, but with the caveat they had to abstain from sex for at least a year before donating. The FDA had first proposed easing the sexual abstinence criteria for blood donation in January. The removal of time-based deferrals also applied to women who have sex with the men who have sex with other men.

The regulator also recommends new time limits for people taking pre-exposure prophylaxis or post-exposure prophylaxis treatments used for HIV prevention to reflect data showing these medications may delay the detection of HIV and result in false negatives. The FDA said the rules aim to reduce the risk of transfusion-transmitted HIV and are similar to those in the UK and Canada.