The U.S. Food and Drug Administration today announced it is proposing a change to blood donor eligibility by using gender-inclusive, individual risk-based questions to reduce the risk of transfusion-transmitted HIV. In response, North Carolina Department of Health and Human Services Secretary Kody H. Kinsley and State Health Director and Chief Medical Officer Dr. Elizabeth Cuervo Tilson released the following statement:
"We applaud the life-saving decision by the U.S. Food and Drug Administration to adapt its rules for blood donation, joining countries around the world in proposing a set of rules that defers donors for risky behaviors, not for who they are. This decision allows a previously marginalized group of people to participate in one of the most selfless acts that individuals perform, coming together to save lives.
This is the best way to ensure that we have a safe and robust supply of blood. Blood must be donated from another person and cannot be manufactured, and donations help accident victims, people with blood disorders, and cancer patients. Each donation can contribute to saving more than one life.
We still have more to learn about the impact of PrEP – treatment to prevent HIV infection – on blood testing for HIV. PrEP is a critical tool for supporting health and ending the HIV epidemic as we know it, and we appreciate the FDA’s careful and ongoing consideration of this as a factor.
This decision is especially welcome as blood donations continue to be low in the wake of the COVID-19 pandemic, and it is a major step forward for ending stigmatization of gay and bisexual men. We look forward to saving lives together."
Secretary Kinsley also added, "On a personal note, I can’t wait to roll up my sleeve and save lives. When it’s time, I hope you’ll join me."
Secretary Kinsley, Dr. Tilson and health officials from nine other states and the District of Columbia penned a letter to the FDA in March 2022 requesting this policy be lifted. The group pointed out that the specificity of HIV testing now available nearly eliminates risk of the virus in the blood supply. Deferrals from blood donation should be based on risky behavior, not a person’s sexuality, they stated. Read the letter here.
The new FDA rules will go through a 60-day comment period. The FDA will review comments before finalizing guidance.