FDA Proposes Relaxed Blood Donation Restrictions for Gay and Bisexual Men
The U.S. Food and Drug Administration (FDA) is proposing relaxed blood donation restrictions for gay and bisexual men, replacing the decades-old policy set at the start of the AIDS crisis. The new policy would allow men in monogamous relationships to donate blood without having to abstain from sex.
The current donor questionnaire will be revised to ask all prospective donors about new or multiple sexual partners in the past three months. Prospective donors who do not report new or multiple sex partners or anal sex within the past three months would be eligible to donate blood.
The proposed guidance would also eliminate time-based deferrals for men who have sex with other men, instead opting to assess individual HIV risk regardless of gender. Those taking medications to treat or prevent HIV, including PrEP, would not be eligible.
FDA Commissioner Robert M. Califf, M.D. stated, “Blood donations are essential for saving lives, whether it is for a person injured in a car accident or someone suffering from a fatal illness. Ensuring a safe and sufficient supply of blood and blood products in the United States is a major priority for the FDA. We are proposing an individual risk assessment for all individuals, no matter their gender or sexual orientation, as part of our initiative to employ the best practices and science in this realm.”
Sex workers and intravenous drug users, as well as people who have tested positive for HIV or are taking medication to prevent HIV infection, would still be prohibited from donating. Those taking oral medications to prevent HIV infection such as PrEP or PEP would be deferred for three months from their most recent dose, while those receiving injectable PrEP would be subject to a two-month deferral period.
For a period of 60 days, the public can comment on the proposal, after which the FDA will analyze the comments before concluding the draft guidance. The FDA must initiate a 60-day public comment period for the proposal. Once a decision has been made regarding any potential eligibility modifications, the official instructions and documents will be published.
The FDA believes the implementation of the proposed individual risk-based questions will not compromise the safety or availability of the blood supply. The FDA conducted a thorough analysis of relevant information, such as data from other countries with similar HIV epidemiology that have implemented this approach and continued monitoring of the U.S. blood supply, to arrive at these draft recommendations.
0. “FDA to Allow More Gay, Bisexual Men to Donate Blood” The Wall Street Journal, 27 Jan. 2023, https://www.wsj.com/articles/fda-to-allow-more-gay-bisexual-men-to-donate-blood-11674829119
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