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Quigley, Torres, Sorensen lead letter to FDA on updated blood donation guidance
--From a press release

This article shared 3017 times since Thu Mar 30, 2023
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Washington, DC - Today, U.S. Representatives Mike Quigley (IL-05), Ritchie Torres (NY-15), and Eric Sorensen (IL-17) led 23 members in a letter to the Department of Health and Human Services and the Food and Drug Administration (FDA) in support of the FDA's proposed risk-based questionnaire to reduce the risk of HIV transmission by blood and blood products. The letter was submitted to the FDA as a part of the 60-day notice-and-comment period for the draft guidance.

In their letter, the members called on the FDA to reevaluate a key provision in the guidance that could create a significant barrier to donation for many individuals. The provision includes a restriction on blood donation by people taking PrEP—or pre-exposure prophylaxis—a medicine people at risk for HIV take to prevent getting HIV from sex or injection drug use. The members requested that the FDA reevaluate this restriction as additional data and new technological developments become available, while simultaneously prioritizing the safety of the blood supply. The members also encourage the FDA to continue to promote the effectiveness of PrEP and work to discourage stigma surrounding the drug.

For decades, members of the LGBTQI+ community have been barred from donating blood based on discriminatory deferral policies. These policies have reduced the availability of blood and added to an already harmful stigma. January's proposed draft guidance aims to reverse these categorical restrictions and allow for broader eligibility for blood donation.

The Members write, "For too long, the federal government has dictated who can and cannot give blood based on outdated and disproven fears. Instead, we must follow the science and evidence-based data in our blood donation and public information efforts. By making this proposed change, the federal government will begin to break down stigma and increase our capacity to save lives. We encourage the FDA to finalize and implement the draft guidance expeditiously following the public comment period."

A PDF copy of the letter and list of signers is available at and the text of the letter is included below:

The Honorable Xavier Becerra

Secretary, U.S. Department of Health & Human Services

200 Independence Avenue, S.W.

Washington, DC 20201

The Honorable Robert M. Califf

Commissioner, Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

RE: Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions To Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products (Docket Number FDA-2015-D-1211)

Dear Secretary Becerra and Commissioner Califf,

We, the undersigned members of the U.S. House of Representatives, write to express our support for the proposed individual risk-based questionnaire for potential blood donors. Following almost four decades of a discriminatory deferral policy for men who have sex with men (MSM), dating back to the darkest days of the HIV/AIDS Crisis of the '80s and '90s, we acknowledge this important step to create guidance that screens all people for blood donations based on the science of virus transmission rather than a person's sexuality or how they identify.

We commend the impact that this draft guidance would have on advancing the rights of our LGBTQI+ constituents. For too long, many members of the LGBTQI+ community have been barred or deferred from donating blood simply because of who they are and who they have sex with, regardless of the risk of virus transmission. This discrimination, while always harmful, took on additional significance following violence against the community, including the 2016 tragedy at Pulse nightclub in Orlando, FL. At a moment when there was an urgent need for blood donations, many members of the LGBTQI+ community were unable to donate blood to help members of their own community. This draft guidance would reverse the blanket restrictions that have impacted many members of the community.

Further, we commend the FDA on their efforts to base this decision on science and real-word data. This update follows similar blood donation screening changes in the United Kingdom in 2021, France in 2022, and Canada in 2022.[1],[2],[3] It reflects FDA analysis of numerous data sources, including data from the UK and Canada, and the FDA-funded Assessing Donor Variability And New Concepts in Eligibility (ADVANCE) Study. The ADVANCE Study is currently unpublished, and we look forward to working with the FDA as the results of this research become available.

While the framework for the deferral policy is a substantial improvement, we recognize that the draft guidance would still disproportionately prevent some members of the LGBTQI+ community, and especially MSM, from donating blood. We hope that continued analysis of the ADVANCE Study and further research will allow for updates to expand the opportunity for blood donation to more members of the LGBTQI+ community.

We particularly hope that further analysis of the ADVANCE Study, new data, and improvements in testing and pathogen reduction technologies will support changes to the guidance's current deferral for people taking pre-exposure prophylaxis, or PrEP. While the draft guidance removes some long-standing barriers to blood donation, the restriction for those taking PrEP may curb some of the positive impacts of this update. As you know, PrEP is approximately 99 percent effective in preventing HIV transmission through sex.[4] We understand that the deferral for people taking PrEP is based on available data that demonstrates that use of PrEP may delay detection of HIV in screening tests for blood donations.[5],[6] We hope that with additional data and new technological developments, the FDA will be able to amend the scope of this restriction while continuing to ensure the safety of the blood supply. Looking forward, we urge the FDA to continue working together with Congress on developing the next generation of screening and pathogen reduction technologies.

Given this restriction, we also urge the FDA, CDC, and other federal agencies to continue to emphasize the integral role that PrEP plays in the effort to end the HIV epidemic, including throughout the implementation of this new guidance.[7] People who use PrEP are taking steps to safeguard their health and prevent HIV infection. It is our hope that the implementation of this guidance will not stigmatize nor discourage continued use of PrEP.

Lastly, we strongly urge the FDA and HHS to take the necessary steps to educate newly eligible donors, especially members of the LGBTQI+ community, about the new guidance and the importance of blood donation.

For too long, the federal government has dictated who can and cannot give blood based on outdated and disproven fears. Instead, we must follow the science and evidence-based data in our blood donation and public information efforts. By making this proposed change, the federal government will begin to break down stigma and increase our capacity to save lives. We encourage the FDA to finalize and implement the draft guidance expeditiously following the public comment period.

This article shared 3017 times since Thu Mar 30, 2023
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