As Coronavirus Threatens Nation’s Blood Supply, Resolution Expresses Support for FDA to Develop New Guidance Based on Individual Risk Assessment
Washington D.C. – Today, Reps. Katherine Clark (MA-05), Adam Schiff (CA-28) and Carolyn Maloney (NY-12), Alexandria Ocasio-Cortez (NY-14), Chris Pappas (NH-01), Mike Quigley (IL-05), Barbara Lee (CA-13), and Deb Haaland (NM-01), introduced a resolution underscoring the need for policies governing blood and blood product donation to be grounded in science and based on individual risk factors that do not unfairly single out any group of individuals so that all those who can safely donate are able to do so.
“Preventing millions of healthy Americans from giving blood on the basis of their sexual identity is discriminatory, unscientific, and puts lives at risk,” said Congresswoman Clark. “Right now, we’re facing a significant blood shortage in the wake of the coronavirus pandemic. We must take this opportunity to replace exclusionary blood donor referral policies with guidance based on individual risk behavior so that all healthy Americans can support their communities, help us save lives, and prevent delays in essential care.”
“Federal policy for donating blood should be based on science, not based on fear and bias,” said HRC President Alphonso David. “As the global pandemic wears on, we must continue to push the federal government to change this policy, which is not only discriminatory but undermines efforts to support and protect our communities. We appreciate the leadership of Rep. Adam Schiff in introducing this resolution calling for blood donation policies that are equitable, based on science and not unfairly singling out any group.”
“Lambda Legal is pleased to see members of Congress pushing the FDA to further modify blood donation criteria to eliminate discrimination against gay and bisexual men,” said Scott Schoettes, Counsel and HIV Project Director at Lambda Legal. “A shorter deferral period applied to all people engaged in certain risk behaviors, regardless of sexual orientation or gender identity, will create a truly nondiscriminatory policy. Lambda Legal looks forward to the adoption of an individualized risk assessment for every potential blood donor, thereby ensuring a safe and abundant blood supply.”
In April, the Food and Drug Administration announced an updated blood donation deferral policy to allow more healthy gay and bisexual men to donate blood. The new policy lowers the 12-month deferral to a 3-month deferral on blood donations for men who have sex with men (MSM).
The full text of the resolution is below:
H.Res.__: Expressing the sense of the House of Representatives that blood donation policies in the United States should be equitable and based on science.
WHEREAS, In 1983, the United States Food and Drug Administration (FDA), an agency under the United States Department of Health and Human Services (HHS), prohibited the donation of blood by any man who has had sex with another man (MSM) at any time since 1977; and
WHEREAS, In December 2015, based on recommendations from the HHS Advisory Committee on Blood and Tissue Safety and Availability, the FDA promulgated revised regulations to allow an MSM to donate blood only if he has not been sexually active for the past 12 months.
WHEREAS, Despite these steps a double standard remained as the revised policy continued to treat gay and bisexual men differently from others; and
WHEREAS, On April 02, 2020 the FDA issued guidance for immediate implementation to address the urgent and immediate need for blood and blood components.
WHEREAS, The FDA changed the recommended deferral period for MSM donors from 12 months to 3 months; and
WHEREAS, A three-month deferral policy for gay and bisexual men to donate blood remains overly stringent given the scientific evidence, advanced testing methods, and the safety and quality control measures in place within the different FDA-qualified blood donating centers; and
WHEREAS, The Williams Institute of the University of California at Los Angeles School of Law estimates that, based on the population of eligible and likely donors among the MSM community, lifting the federal lifetime deferral policy on blood donation by an MSM could result in as many as 4,200,000 million newly eligible male donors, of which 360,600 would likely donate and generate 615,300 additional pints of blood; and
WHEREAS, The increased uptake of Pre-Exposure Prophylaxis (PrEP), which reduces the likelihood that an HIV-negative individual will acquire HIV, has allowed many more gay and bisexual men to be aware of their HIV-negative status and take steps to effectively eliminate their personal risk of HIV transmission; and
WHEREAS, More than 4,000 blood drives across the United States have been canceled due to the COVID-19 pandemic, resulting in approximately 130,000 fewer donations; and
WHEREAS, Maintaining an adequate blood supply is vital to public health; and
WHEREAS, The American Red Cross estimates that every two seconds, someone in the United States needs blood; and
WHEREAS, The American Medical Association has stated that the ethical ideal for public policy in this area should be to transition away from policy that defers categories of persons based on attributing to all members risks associated with a population and toward policy that defers individual donors on grounds of evidence-based risk assessment; and
WHEREAS, Congress directed the Secretary of HHS to carry out an initiative to improve awareness of the importance and safety of blood donation and the continued need for blood donations during the COVID-19 public health emergency, through passage of the CARES Act; and
WHEREAS, Numerous federal officials, including Surgeon General Dr. Jerome Adams and Department of Health and Human Services Assistant Secretary for Health Dr. Brett Giroir, have publicly encouraged people to donate blood during the COVID-19 pandemic; and
WHEREAS, People who have fully recovered from COVID-19 for at least two weeks are encouraged to consider donating convalescent plasma, which contains antibodies against the virus.
WHEREAS, Convalescent plasma is being evaluated as treatment for patients with serious or immediately life-threatening COVID-19 infections, or those judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease; and
WHEREAS, The FDA is in the process of again reevaluating and considering updating its blood donor deferral policies as new scientific information becomes available, including the feasibility of moving from the existing identity-based deferrals related to group risk behaviors to alternate deferral options, such as the use of individual risk assessments: Now, therefore, be it
Resolved, That it is the sense of the House of Representatives that policies governing blood and blood product donation in the United States should—
- be grounded in science;
- minimize deferral periods;
- be based on individual risk factors;
- not unfairly single out any group of individuals;
- and allow donation by all those who can safely do so.