FDA Making Progress With Blood Safety Monitoring System

Last December, Food and Drug Administration (FDA) Commissioner Margaret A. Hamburg  set forth a recommendation to change the current blood donation policy for men who have sex with men (MSM). The old policy, set forth in the height of the AIDS crisis of the 1980s, barred men who have had sex with men since 1977 from donating blood. The revised policy calls for men who have had sexual contact with another man to refrain from donating blood for one year following that contact.
At the time, HFA delivered a statement before the FDA’s Blood Product Advisory Committee (BPAC) regarding the proposed change. HFA stated that, while we do not support “inherently discriminatory processes,” the FDA must put into place a strict hemovigilance surveillance program to maintain the safety of the blood supply.
On Tuesday, the FDA released a Draft Guidance for Industry document outlining new recommendations regarding blood donor deferrals and reducing the risk of transmission of HIV through blood and blood products. The guidance called for updated donor education materials and revisions to the Donor History Questionnaire (DHQ).
On Wednesday, BPAC heard the recommended revisions to the policy as well as an update on the proposed blood safety monitoring system called the Transfusion-Transmissible Infections Monitoring System (TTIMS).
HFA applauds the FDA for making progress in implementing a surveillance system so vital for patients. TTIMS will provide data to assess changes in blood safety initiatives and provide much-needed information on emerging transmissible infectious diseases. HFA will continue to monitor the progress of TTIMS and ensure the FDA is keeping patient safety at the forefront of policy decisions.