Baldwin, Gillibrand, Warren Lead 23 Colleagues in Pushing FDA for an Update on Changes to Discriminatory Blood Donation Policies

WASHINGTON, D.C. –Today, U.S. Senators Tammy Baldwin (D-WI), Kirsten Gillibrand (D-NY), and Elizabeth Warren (D-MA) led 23 of their colleagues in calling on Department of Health and Human Services (HHS) Secretary Becerra and Food and Drug Administration (FDA) Commissioner Dr. Robert Califf to provide an update on FDA’s efforts to change their discriminatory blood donor deferral policies for men who have sex with men (MSM). In January, Senator Baldwin led a group of colleagues formally calling on HHS and the FDA to act on the most up to date science and update its discriminatory policy after the Red Cross declared its first-ever national blood shortage.

In addition to decreasing the eligible donor base and depriving patients of needed blood, the current three-month donor deferral blood donation policy for MSM unnecessarily stigmatizes and harms the LGBTQ+ community. The broad consensus among the medical community indicates that the current scientific evidence does not support these discriminatory restrictions, and that a policy focused on individual risk assessment rather than an effective ban on gay and bisexual men would be far more appropriate.

“For nearly 40 years, sexually active MSM have not been allowed to donate blood. This must change,” the senators wrote.

“It is time for the FDA to adopt evidence-based policies focused on assessment of an individual’s risk, not inaccurate and antiquated stereotypes present in the current categorical deferral guidelines," the senators continued.

The letter also signed by Senators Jeff Merkley (D-OR), Bernie Sanders (I-VT), Sherrod Brown (D-OH), Bob Casey (D-PA), Richard Blumenthal (D-CT), Cory Booker (D-NJ), Martin Heinrich (D-NM), Ed Markey (D-MA), Christopher Coons (D-DE), Bob Menendez (D-NJ), Mazie Hirono (D-HI), Catherine Cortez Masto (D-NV), Ben Cardin (D-MD), Ron Wyden (D-OR), Tammy Duckworth (D-IL), Angus King (I-ME), Jacky Rosen (D-NV), Tina Smith (D-MN), Amy Klobuchar (D-MN), Tim Kaine (D-VA), Michael Bennet (D-CO), and Brian Schatz (D-HI).

“Every two seconds, someone in the U.S. needs a blood transfusion to survive. But right now, the FDA continues to use archaic, discriminatory criteria to determine an individual’s eligibility to donate blood based solely on their sexual orientation – not their individual risk factors – which is not rooted in science, limits access to crucial blood products, and stigmatizes one segment of society,” said David Stacy, Government Affairs Director of the Human Rights Campaign. "The FDA instead should focus its considerations for blood donor deferrals based on risky behavior by any potential donor, regardless of one’s sexual orientation. This would both best ensure a safe blood supply and maximize the pool of blood donors. We thank Senator Baldwin and her colleagues for their leadership on this issue.”

Senator Baldwin has been a leader on this issue for years. At the beginning of the COVID-19 pandemic, Senator Baldwin led a letter to the FDA, citing the pandemic spurring a national blood shortage, urging the administration to swiftly change these discriminatory blood donation policies to help save lives. In 2016, Senator Baldwin led a bipartisan group of Senators in calling on the FDA to swiftly move to end the discriminatory blood donation deferral policy for MSM. In December 2014, she led over 75 members of Congress calling on HHS to end the outdated and discriminatory ban, and replace it by instituting a risk-based policy.

The full letter can be found here or below:

Dear Secretary Becerra and Commissioner Califf,

We write to request an update on the Food and Drug Administration’s (FDA) progress in modernizing its outdated and discriminatory blood donor deferral policies for men who have sex with men (MSM), a long overdue step that would dramatically increase the eligible donor base. We applaud the agency’s responsiveness to our concerns in the early days of the pandemic when FDA shortened the deferral period for MSM from 12 months down to three months, however, given the ongoing nationwide shortage of blood and blood products, it is critical that FDA take further action. For nearly 40 years, sexually active MSM have not been allowed to donate blood. This must change.

On March 26, 2020, a group of Senators wrote to the FDA raising concerns with the agency’s discriminatory blood donation deferral policy for men who have sex with men. Soon after, this policy was updated, and FDA shortened the deferral period. However, additional steps are needed to advance science and combat discrimination. We appreciate FDA’s work on the Assessing Donor Variability And New Concepts in Eligibility (ADVANCE) study, which is focused on evaluating alternatives to the blood donor deferral policy for MSM. While no single action can fully address longstanding discrimination, we believe this study will serve as an important first step in making sure that any future donor policy is grounded in science. Given advances in blood screening and safety technology, a time-based policy for gay and bisexual men is not scientifically sound, continues to effectively exclude an entire group of people from the donor base, and does not meet the urgent demands of the moment. And further, with increased uptake of Pre-Exposure Prophylaxis (PrEP), which significantly reduces the likelihood that an HIV-negative individual will acquire HIV, many more gay and bisexual men are aware of their HIV status and are taking steps to eliminate their personal risk.

It is time for the FDA to adopt evidence-based policies focused on assessment of an individual’s risk, not inaccurate and antiquated stereotypes present in the current categorical deferral guidelines. With this shift, there will be a significant need for public outreach and education. As we look towards the completion of the ADVANCE study, we urge FDA to develop a strategic plan in concert with representatives of the LGBTQ+ community that will inform the public of its updated guidelines. Further, we strongly encourage the agency to prioritize outreach and education to blood donation centers to expedite implementation of revisions to the blood donation guidelines.

In the midst of the ongoing blood shortage, it is absolutely essential for FDA to take steps to increase the availability of blood and blood products to prioritize patient care. Following the conclusion of the ADVANCE study, we expect that FDA will utilize this new evidence to work expeditiously and develop an evidence-informed policy based on individualized risk factors that meets the urgent demands of the moment.

The United States remains in a nationwide blood supply crisis for the first time. Now is the time for a new donor deferral policy that allows all potentially eligible donors to contribute free of stigma. Thank you for your attention to this important issue. 

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