FDA urged to use of risk-based, science-based blood donation policy

Senators Elizabeth Warren (D-Mass) and Tammy Baldwin (D-Wis), Representatives Mike Quigley (D-Ill) and Barbara Lee (D-Calif), and 79 other members of Congress sent a letter to the FDA in response to the agency’s recent draft guidance document, which proposed to change the blood donation policy for men who have sex with men (MSM) from a lifetime ban to a one-year deferral from the donor’s last sexual contact with another man.

The letter requested that the FDA implement the one-year deferral policy in a manner that would ensure the agency’s actions were a “first step” toward a “risk-based” blood donation policy for men who have sex with men. The congressional group also requested that the FDA consider amending the draft guidance (see FDA: lift lifetime ban on blood donation from gay males, Health Law Daily, May 13, 2015) to delink the establishment of the Transfusion Transmissible Infections Monitoring System from the FDA’s draft policy, to clarify the agency’s policy on blood donations from transgender individuals, and to take action to address deficiencies in the Uniform Donor History Questionnaire.

The congressional group recognized the FDA’s efforts to address the current blood donation policy, but raised concerns over the proposed one-year deferral policy perpetuating the stereotype “that all MSM pose a risk to the health of others.” The current blood donation policy bans MSM from donating blood and was put in place during the 1980s. The congressional group noted that organizations such as the Red Cross, America’s Blood Centers, and the American Medical Association all agreed that the ban was no longer scientifically justified in light of modern blood screening technology.

As such, the congressional group stated that the proposed deferral policy was still “discriminatory and not based on science,” which was “unacceptable.”