By Landon Gray

The FDA is changing a long-held rule and allows men who have sex with men (MSM) to be blood donors.

The FDA finalized recommendations for the assessment of blood donor eligibility using a set of questions based on individual risk to assess the risk for transfusion-transmitted HIV. The questions will be the same for every donor regardless of sexual orientation, sex or gender. The FDA said blood establishments may move forward with the implementation of these recommendations with revisions to their donor history questionnaires and procedures.

“I do think that it’s time to remove these barriers for groups including MSM that are based on what are now clearly archaic generalizations, which stigmatize without enhancing safety of life-sustaining blood products offered generously by volunteer blood products donors,” said Stuart C. Ray, MD, a professor of medicine and oncology in the Division of Infectious Diseases, the vice chair of medicine for data integrity and analytics, and the assistant dean for research at the Johns Hopkins University School of Medicine, in Baltimore. 

“Individual-based screening questions provide a rationally focused means to assess risk prior to donation. The battery of sophisticated screening assays that are performed on every donation provide an additional layer of security. Post-transfusion surveillance is a major asset for our transfusion medicine system, enabling a process of continuous improvement,” added Dr. Ray, who also sits on the Infectious Disease Special Edition editorial advisory board.

The updated policy is similar to current strategies in countries like the United Kingdom and Canada and is based on the best available scientific evidence, according to the agency. The FDA reviewed data from countries with HIV epidemiology similar to the United States that have implemented a similar approach for the assessment of donor eligibility, surveillance information from the Transfusion-Transmissible Infections Monitoring System, performance characteristics of nucleic acid testing for HIV and the ADVANCE (Assessing Donor Variability and New Concepts in Eligibility) study. The ADVANCE study was funded by the agency.

The new policy was initially proposed in January, and the FDA reviewed and considered all comments submitted to the agency to finalize these recommendations as quickly as possible.

The recommendations eliminate time-based deferrals and screening questions focused on MSM and women who have sex with MSM. All potential blood donors must now answer a series of individually specific risk-based questions to determine eligibility.

To reduce the likelihood of donations made by those with recent HIV infection when HIV may still be detected by nucleic acid testing, prospective donors who report having had a new sexual partner, more than one sexual partner in the past three months and anal sex in the past three months would be deferred.

In addition, people receiving medications to treat or prevent HIV infection—antiretroviral therapy, pre-exposure prophylaxis and post-exposure prophylaxis—will be deferred. Available data show these antivirals, although safe and effective, may result in delayed detection of HIV by currently licensed screening tests for blood donations and may potentially give false-negative results, the agency explained.

HIV cannot be transmitted sexually by individuals with undetectable viral levels. The same rule does not apply to transfusion transmission of HIV. Since a blood transfusion is intravenously administered and involves a large volume of blood compared with sexual contact, the risk for transmitting HIV is present.

“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. The implementation of these recommendations will represent a significant milestone for the agency and the LGBTQI+ community,” said Peter Marks, MD, PhD, the director of the FDA’s Center for Biologics Evaluation and Research. “The FDA is committed to working closely with the blood collection industry to help ensure timely implementation of the new recommendations, and we will continue to monitor the safety of the blood supply once this individual risk-based approach is in place.”

The FDA said it was confident that these new recommendations will not adversely affect safety or availability of the U.S. blood supply.

“As a long-time advocate for using rational, scientifically based blood and tissue donation deferral periods based on a donor’s individual risk, the AMA [American Medica Association] welcomes the FDA’s new guidance that removes outdated categorical restrictions on blood donations from men who have sex with men,” said Jack Resneck Jr., MD, the president of the AMA. “We applaud the FDA for applying the latest scientific evidence to ensure that blood donation criteria are applied more equitably across all segments of our population, including the LGBTQ+ community.”

Dr. Resneck added that although this is a step in the right direction, the AMA urges the FDA to expand its work and reevaluate its donation deferral policies for corneas, human cells ,and other cellular and tissue-based products based on the latest scientific evidence.

Dr. Resneck added this change will continue to protect recipients of blood products from iatrogenic infection while making critically needed products now available and removing unnecessary barriers to donation by generous donors.