FDA paves way for more gay and bisexual men to donate blood with new risk-based rules

CNN

The US Food and Drug Administration finalized new rules for blood donations based on risk, which will allow more gay and bisexual males to donate. In the future, all prospective blood donors will be asked to answer the same questions regardless of their sexual orientation or sex.

Many people criticized the FDA's decision to re-examine its policies a few years ago. Gay and bisexual men were banned from donating blood for life. Men who had sex with another man must wait three months before donating blood.

The new policy eliminates deferrals, screening questions and specific questions for men who have had sex exclusively with MSM and women who have only sex exclusively with MSM. The United States now follows other countries, such as Canada and the UK, who have implemented risk-based regulations.

The new questions aim to reduce the risk that HIV (human immunodeficiency) virus will be transmitted through blood donations. The FDA said it made these changes after reviewing data collected from countries with similar HIV rates and who have implemented risk-based blood donation eligibility, information about the accuracy of HIV tests, surveillance information from an infection monitoring system, and individual risk factors from a government funded study.

According to the new rules anyone who reports a new partner, multiple sexual partners, or anal sex that has occurred in the last three months will be asked to wait for at least three more months before donating blood. This will reduce the chances that someone who has a recent or new infection can donate blood during a time period when lab tests would not detect their infection.

Anyone who is taking PrEP or other medications that treat HIV, including those to prevent it, will also be prohibited from donating blood. According to the FDA, HIV cannot be transmitted through sex with people who have undetectable viral levels. However, this does not apply for blood donations. The FDA says that blood transfusions are more risky than sexual contact because they involve a greater volume of fluid and the blood is directly injected into a vein.

The FDA warns that HIV medications or PrEP should not be stopped before donating blood.

The FDA worked hard to review our policies, and to ensure that we had scientific evidence supporting individual risk assessments for donor eligibility. We also maintained appropriate safeguards in order to protect the recipients of blood products. This will be a major milestone for both the FDA and the LGBTQI+ Community, said Dr. Peter Marks of the FDA Center for Biologics Evaluation and Research.

Marks stated that the agency will continue to closely monitor safety of US blood supply once the rules are implemented.