FDA must lift its discriminatory policy on blood donors

With the nation’s blood supply at its lowest point in a decade and the American Red Cross declaring its first-ever national blood crisis earlier this month, it’s time for the Food and Drug Administration (FDA) to do something. something the AMA and others have been calling for for years: to remove its discriminatory ban that prevents many gay and bisexual men from becoming blood donors.

The current ban requires gay or bisexual men to abstain from sex for at least three months before they can donate blood. This policy was established in April 2020, when the FDA shortened the deferral period from one year to 90 days in response to a drastic drop in blood donations as the COVID-19 pandemic took hold and thousands of blood drives have been cancelled.

The current three-month deferral period singles out and prohibits blood donors based on their inherent attributes rather than the risk factors they exhibit. For example, a man who has had protected sex with another man in the three months prior to donating blood cannot be a donor, but a man or woman who has had unprotected sex with multiple sex partners opposed during the same period remains eligible.

Related coverage

How the right strategy will drive medicine in 2022 and beyond

The roots of restrictions on gay and bisexual blood donors date back to the HIV/AIDS crisis of the 1980s. In 1985, the FDA established a lifetime ban on donations by men who have sex with men (MSM) which remained in place until 2015, when the one-year deferral came into effect. By shortening that period to 90 days in 2020, the agency said it expected the change to stay in place after the pandemic subsides.

While this is a welcome change, the fact remains that further changes, including the removal of all categorical restrictions on blood donations by MSM, are needed. The lifetime ban was imposed at a time when HIV was misunderstood, and it persisted for decades even as blood-screening technology improved dramatically. Today, every unit of donated blood is rigorously tested for any trace of HIV, syphilis, hepatitis, West Nile virus or other blood-borne diseases.

Evaluate all donors equally

At issue is the need to assess all potential blood donors equally based on their individual risk factors and regardless of their sexual orientation or gender identity. The FDA’s Center for Biologics Evaluation and Research, which develops and regulates standards for the collection of blood and blood products, should continue on the path it has already set by ensuring that the criteria for blood donation are applied equitably across all segments of our population, including the LGBTQ+ community, based on the latest scientific evidence.

The American Red Cross, which provides approximately 40% of the national blood and blood product supply, has stated its belief that blood donor eligibility should not be based on sexual orientation and has pledged to reach this goal. The ongoing ADVANCE (Assessing Donor Variability And New Concepts in Eligibility) study could accelerate this achievement.

This important research can help shape the FDA’s donor eligibility requirements by modifying the donor background questionnaire and determining whether research-based questions that better determine individual risk are equally effective in reducing risk. of HIV in blood donations than the existing 90-day deferral. period. The results should be available later this year.

Related coverage

What physicians need to know about clinical therapies for COVID-19

WADA policy also supports the use of a rational and scientifically based deferral period for human tissue donations. FDA policy now requires a five-year deferral period for MSM seeking to donate human cells, tissues, and cell and tissue products such as corneas. We asked the FDA to change its tissue donation policy to provide the same 90-day deferral period that applies to blood donations by MSM, and to use the ADVANCE study or similar research to adopt a individual donor risk assessment.

In the meantime, as a gallon donor myself, I strongly encourage everyone to meet the pressing need for blood donations by visiting the American Red Cross website and finding a donation site or collection blood near you. Blood cannot be manufactured or stored, and an adequate supply depends solely on the goodwill of donors. The COVID-19 pandemic has cast an uncomfortable light on many long-standing and all-too-often discriminatory policies in our healthcare system, and placed on all of us a new responsibility to work quickly to correct them.

Source link

Comments are closed.