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U.S. FDA proposes to ease sexual abstinence rule for blood donors


Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly

The U.S. health regulator on Friday proposed new blood donation guidelines for men who have sex with men that are based on individual risk rather than across-the-board requirements, a move it said is in line with other countries and will help ensure the U.S. blood supply.

The U.S. Food and Drug Administration said the rules aim to reduce the risk of transfusion-transmitted HIV and are similar to those in the UK and Canada.

The proposed rule comes several years after the FDA reversed a 1980s guideline, which banned men who have sex with men from donating blood, but said they had to abstain from sex for at least a year before donating.

In 2020, the agency shortened the abstinence period to three months amid a pandemic-driven shortage of blood supply.

The removal of time-based deferrals also applies to women who have sex with the men who have sex with other men, the FDA said.

Under the new proposal, any prospective donor – regardless of gender or sexual orientation – other than those who report having a new sexual partner or multiple partners and having anal sex in the past three months, will be eligible to donate blood, provided all other eligibility criteria are met.

The regulator has also proposed new time limits for people taking pre-exposure prophylaxis or post-exposure prophylaxis treatments used for HIV prevention to reflect data showing that these medications may delay the detection of HIV and result in false negatives.

People taking oral medication would be deferred for three months after the most recent dose and those receiving injections by two years from the last dose.

The FDA will review public comments before finalizing the proposal.