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FDA Proposes New Guidelines for Blood Donations

Written and medically reviewed by Dorcas Morak, Pharm.D

Updated on March 14th, 2023

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On January 27, 2023, the Food and Drug Administration (FDA) released proposed new blood donor regulations that will cause a shift in blood donation guidance. The proposed guidance will end the current time-based restrictions on blood donations for MSM (men who have sex with men) and women who have sex with MSM. Instead, the FDA recommends that gender-inclusive, individual risk-based inquiries be used to determine blood donor eligibility to lower the risk of transfusion-transmitted Human Immunodeficiency Virus (HIV). Read on to learn more about the proposed guidelines.

Why have gay and bisexual men been restricted from blood donation in the past?

Because of the high prevalence of HIV among gay and bisexual males in the 1980s, they were prohibited from donating blood. In 2015, the lifetime ban was reviewed and changed to a one-year restriction, which was further shortened to three months in 2020 because of a shortfall in blood donations during COVID lockdowns.

What are the new FDA-proposed guidelines for blood donation?

The FDA published draft guidelines to assess individual risk to loosen restrictions on blood donations by MSM and women who have sex with MSM. The proposed regulation has removed the three-month abstinence requirement for gay and bisexual men in monogamous relationships.

What is the new measure to prevent HIV transmission?

The FDA proposes risk-based questions rather than time-based deferrals that will be used to evaluate blood donors to lower the chance of HIV transmission through blood transfusions. Potential donors would be qualified to donate blood if they had no new or multiple sexual partners in the previous three months and satisfied all other eligibility criteria.

What eligibility criteria did not change in the new guidelines? 

The following remained unchanged in the proposed new blood donation guidelines:

  • The deferral period for other HIV risk factors, such as those who have ever traded intercourse for cash or drugs; or have a history of using non-prescription injection drugs.
  • The permanent exclusion of anyone who has ever tested positive for HIV or used any HIV medicine.
  • The requirement that blood banks screen every donation for signs of HIV, hepatitis B, and hepatitis C, as well as other transfusion-transmitted infections.

Have the proposed guidelines been finalized?

The proposed guidelines will be available for public comment for 60 days from the date they were proposed (January 27, 2023) before being finalized.

Why has the FDA proposed lifting the ban on MSM?

The FDA draft policy was based on analyzing data gathered from other nations with comparable HIV epidemiology, such as Canada and the United Kingdom, that have adopted this strategy, as well as ongoing monitoring of the American blood supply. According to the FDA, the suggested modifications reflect an effort to move toward a gender-inclusive, individual risk-based approach to determining blood donor eligibility.

Is there a way for people affected by HIV to save on their medications?

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