The FDA on Thursday finalized a long-awaited plan to loosen restrictions on blood donation by men who have sex with men. It will update risk-based individual questionnaires to help reduce the risk of transfusion-transmitted HIV.
Screening questions asked of prospective blood donors will still limit people who report having sex with a new partner, more than one partner in the past three months or anal sex in the past three months from giving blood.
The FDA said it “strongly believes” the new policy will not hurt the safety or availability of the nation’s blood supply.
Currently, men who have sex with men must abstain from sex for three months before giving blood. The new policy still limits people who have certain risk factors — such as a history of non-prescription injection drug use, those who have exchanged sex for money or drugs, or those who previously tested HIV-positive from donating.
It also limits blood donation by people who are taking medicine to prevent HIV infection, such as antiretroviral therapy, pre-exposure prophylaxis and post-exposure prophylaxis.
“The FDA has worked diligently to evaluate our policies and ensure we had the scientific evidence to support individual risk assessment for donor eligibility while maintaining appropriate safeguards to protect recipients of blood products,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.
Background: The final guidelines are consistent with the draft policy issued in January, which proposed to ease restrictions on blood donation from certain men who have sex with men.
What’s next: The FDA says blood donation establishments “may now implement” the new policy, but it is unclear how long it will take for donation centers to revise questionnaires and procedures. The agency did not set a deadline for implementing the revised policy.
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