WASHINGTON — Eighty U.S. lawmakers on Monday called on the U.S. Department of Health and Human Services to end the Food and Drug Administration’s decades-long ban on blood donations from gay and bisexual men.
U.S. Senators Tammy Baldwin (D-Wis.), Elizabeth Warren (D-Mass.), and Tom Harkin (D-Iowa), and Reps. Mike Quigley (D-Ill.) and Barbara Lee (D-Calif.), led a letter with 75 of their congressional colleagues calling on Secretary of Health and Human Services Sylvia Burwell to replace the lifetime ban on blood donations from men who have sex with men (MSM) with a policy based on individual risk factors.
The ban, first imposed in 1983, dates from the first years of the AIDS epidemic and was intended to protect the U.S. blood supply from exposure to the little-understood disease.
The American Red Cross and the American Association of Blood Banks have since characterized the blood ban as medically and scientifically unwarranted, and the American Medical Association, the largest association of physicians in the U.S., voted last year to oppose the ban, noting that HIV and AIDS testing has become standard practice in blood donations to minimize risk to recipients.
Earlier this month, an FDA advisory panel — the Blood Products Advisory Committee (BPAC) — urged the FDA to exercise caution in making any changes to current policy, saying the impact on the blood supply is difficult to predict.
In their letter, the legislators also expressed concerns with a separate recommendation made in November by the HHS Advisory Committee on Blood & Tissue Safety & Availability (ACBTSA). That committee proposed replacing the lifetime deferral policy with a one-year deferral policy, contingent on the implementation of a blood safety surveillance system, while dismissing a risk-based policy.
The legislators raised concerns about this proposal, writing, “A one-year deferral policy, like a lifetime ban, is a categorical exclusion based solely on the sex of an individual’s sexual partner – not his actual risk of carrying a transfusion-transmittable infection.”
The legislators continued:
“The ACBTSA’s proposed policy change would, in practice, leave that lifetime ban in place for the vast majority of MSM, even those who are healthy and low-risk. Both policies are discriminatory, and both approaches are unacceptable. Low-risk individuals who wish to donate blood and help to save lives should not be categorically excluded because of outdated stereotypes.”
The legislators also urged HHS to consider the work of implementing an infection monitoring system separately from the MSM deferral policy.
“To be clear, a comprehensive surveillance system for our blood supply is a critically important initiative to protect the blood supply from Hepatitis, HIV, and emerging diseases, and is long overdue…Years of HHS inaction on this issue is problematic, but so is the fact that ACBTSA has now suddenly chosen to make such a system a precondition of revising the donation policies specific to MSM.”
The bicameral letter requests additional information from HHS regarding the timeline for reversing the lifetime deferral policy, actions being taken to work towards a risk-based deferral policy, and plans for implementing the long-overdue blood safety surveillance system.