Senator Baldwin Calls on FDA to Change Discriminatory Blood Donation Policies to Address National Blood Supply Shortage

WASHINGTON, D.C. – Today, U.S. Senator Tammy Baldwin led a group of Senators formally calling on Department of Health and Human Services (HHS) Secretary Becerra and Food and Drug Administration (FDA) Acting Commissioner Woodcock to act on the most up to date science and update its discriminatory blood donor deferral policies for men who have sex with men (MSM). With the Red Cross declaring its first-ever national blood shortage that is posing risks to patient care, with as much as one-quarter of hospital blood needs not currently being met, the FDA can take the long overdue step to remove the discriminatory practice, increasing the eligible blood donor base and helping address the crisis.

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.

“In light of the nation’s urgent blood supply crisis and to ensure that Americans have access to life-saving blood transfusions during the pandemic, we urge you to swiftly update your current blood donor deferral policies in favor of ones that are grounded in science, based on individualized risk factors, and allow all potentially eligible donors to do so free of stigma. We also request a briefing in the next 30 days on the agency’s plan to update its MSM blood donation policies,” the Senators wrote.

 “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.”

This letter is also signed by Senators Elizabeth Warren (D-MA), Ed Markey (D-MA), Bob Casey (D-PA), Tammy Duckworth (D-IL), Richard Blumenthal (D-CT), Sherrod Brown (D-OH), Bernie Sanders (I-VT), Chris Coons (D-DE), Mazie Hirono (D-HI), Maria Cantwell (D-WA), Angus King (I-ME), Cory Booker (D-NJ), Catherine Cortez Masto (D-NV), Patrick Leahy (D-VT), Amy Klobuchar (D-MN), Ron Wyden (D-OR), Jeff Merkley (D-OR), Michael Bennet (D-CO), Tina Smith (D-MN), Martin Heinrich (D-NM) and Alex Padilla (D-CA).

A full version of this letter is available here and below.

Dear Secretary Becerra and Acting Commissioner Woodcock,

We write to express our alarm at the nationwide shortage of blood and blood products, which has placed patient care and safety at risk. For the first time, the nation’s leading blood donation organizations, including the Red Cross, have declared a national blood supply crisis due to the continued impact of the COVID-19 pandemic. We urge the Food and Drug Administration (FDA) to quickly act on the best available science and update 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.

It is critical that all patients have access to the health care services they need during this pandemic, and for many, the availability of blood and blood products is a necessary component of care. Unfortunately, a significant drop in the number of donations during the COVID-19 pandemic has resulted in a serious shortage of available blood. The Red Cross, America’s Blood Centers, and AABB, formerly the American Association of Blood Banks, have declared a nationwide blood supply crisis for the first time, as the nation experiences its worst blood shortfall in over a decade.  In recent weeks, hospitals have had less than a single day’s supply of critical blood products, and these organizations have had to limit distribution to health facilities in need. In fact, the Red Cross has reported that as much as one-quarter of hospital blood needs are not currently being met.

While no single solution can fully solve these challenges, the FDA has the ability to take a simple and science-based step to dramatically increase the donor base and help address this crisis. In fact, the agency responded to our previous correspondence and took an encouraging step in the right direction during the early days of the pandemic, shortening the deferral period for MSM from 12 months down to three months in March of 2020.

However, any policy that continues to categorically single out the LGBTQ+ community is discriminatory and wrong. 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, 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. Instead of the current categorical deferral guidelines, we must adopt evidence-based policies focused on assessment of an individual’s risk, not inaccurate and antiquated stereotypes.

All over the world, other countries have led on this issue by scrapping their discriminatory blood donation policies. In October of last year, Israel removed all restrictions on MSM blood donation.  And just last month, Canada’s blood regulatory agency proposed removing all screening questions focused on gender and sexuality.  The tide is turning, and the data support this change.

In light of the nation’s urgent blood supply crisis and to ensure that Americans have access to life-saving blood transfusions during the pandemic, we urge you to swiftly update your current blood donor deferral policies in favor of ones that are grounded in science, based on individualized risk factors, and allow all potentially eligible donors to do so free of stigma. We also request a briefing in the next 30 days on the agency’s plan to update its MSM blood donation policies.

Thank you for your attention to this important issue.

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