A group of 20 state attorneys general has submitted a letter to the U.S. Department of Health and Human Services calling on the Food & Drug Administration to drop its gender-based restrictions on blood donation, specifically its three-month deferral period for gay and bisexual men.
Submitted as part of a public comment period on HHS’s efforts to maintain an adequate blood supply during the COVID-19 pandemic, the attorneys general argue that the FDA should instead adopt a gender-neutral, behavioral-based risk assessment when determining whether people should refrain from donating blood.
More importantly, they say, eliminating the restrictions on healthy gay and bisexual men would increase the available blood supply at a time when donations have dropped due to social distancing amid the ongoing pandemic.
“An adequate blood supply is critical to the nation’s healthcare. Blood transfusions and blood products are needed for major surgeries, to treat diseases such as sickle cell anemia and some cancers, and to treat victims who have injuries caused by accidents or natural disasters,” the attorneys general write in their letter.
“Every day, the United States needs approximately 36,000 units of red blood cells, nearly 7,000units of platelets, and 10,000 units of plasma,” the letter continues. Yet, they say, “as of April 9, 2020, the American Red Cross, which provides about 40 percent of our nation’s blood and blood components, had less than a five-day blood supply on hand.”
Noting that over 4,000 previously scheduled blood drives have been canceled due to concerns about COVID-19, the attorneys general report that the American Red Cross has admitted that the organization is “actively triaging units, determining which hospitals can and can’t get blood.”
While the FDA recently reduced its deferral period for gay and bisexual men wishing to donate blood from 12 months to three months since their last sexual contact, critics, including LGBTQ advocates, say that the deferral period effectively acts like a ban, and imposes restrictions on gay and bisexual men that are not applied equally to other groups.
The attorneys general note that while the reduction of the deferral period is a step in the right direction, they say it does not go far enough.
“The discriminatory restrictions against blood donations by healthy gay and bisexual Americans have persisted for far too long; the steps you have taken acknowledge current rules are informed more strongly by bias than science,” they write.
Citing a 2014 analysis by the Williams Institute, an LGBTQ think tank at the UCLA School of Law, the attorneys note that lifting the gender-based restrictions would produce over 2 million eligible blood donors, resulting in an estimated 300,000 pints of additional donated blood annually, and potentially saving the lives of more than a million people.
The attorneys general note that the FDA recently approved using plasma from people who have recovered from COVID-19 to develop experimental treatments for the virus.
Lifting the restrictions on gay and bisexual men, they say, would expand the pool of available plasma donors. Additionally, they say, the experiences of other countries — most notably Italy — demonstrates that a behavioral-based risk screening is feasible and does not compromise the safety of the blood supply.
Lastly, they argue, the current FDA policy threatens the principle of Equal Protection under the Fourteenth and Fifth Amendments to the U.S. Constitution, as it is based on the assigned sex of a person at birth, as well as assumptions about the behavior of individuals based on their gender or sexual orientation.
“Any sex-based deferral period targets MSM for a perceived and faulty belief that all MSM engaged in risky behavior that could put blood donations at risk. Internationally, other countries have moved away from this approach because it is not the least restrictive means to maintain a safe blood supply,” they write. “Over the long term, the FDA should look at risk behavior and not sex for determining who should donate blood. Further, a revised policy should identify a date certain by which the FDA will replace a time-based deferral with a risk-based framework and identify any research or data needed to achieve this result. Risk-based assessments should apply
regardless of sex.”
“As Americans stay home to stop the spread of coronavirus, the nation is facing a shortage of blood donations, which provide critical medical support to hospitals and their patients,” California Attorney General Xavier Becerra, who is leading the coalition of attorneys general, said in a statement.
“During this pandemic, it is important to continue to evaluate and modernize blood donation guidance to be inclusive of LGBTQ Americans,” Becerra added. “A risk-based model not only protects the health and safety of our communities — it’s the right thing to do.”
In addition to Becerra, the other attorneys general signing onto the letter represent the states of Colorado, Connecticut, Delaware, Hawaii, Illinois, Iowa, Maine, Massachusetts, Michigan, Minnesota, Nevada, New Jersey, New Mexico, New York, Oregon, Pennsylvania, Vermont, and Virginia, as well as the District of Columbia.
“Our country’s blood supply is dangerously low right now during a public health crisis when it is more critical than ever,” Virginia Attorney General Mark Herring said in a statement. “Easing these restrictions will not only help boost the national blood supply but it will also begin the long overdue process of changing this outdated policy towards non-gender-based risk assessment restrictions on blood donations.”
Editor’s note: This story was updated to include reaction from Virginia Attorney General Mark Herring.
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