The proposal was initially placed on the FDA's regulatory agenda, a semiannual publication of the agency's recent activities and upcoming regulatory priorities, back in 1999 in response to a House committee report identifying weaknesses in the FDA's efforts to protect the nation's blood supply from infectious agents.

Specifically, the proposal would have created enforceable standards mandating a tracking system and notification process for alerting, in cases of contamination or risk of contagion, persons who receive batches of products derived from blood plasma and self-administer the products over time.

The FDA argued at the time that voluntary industry programs for notification were inadequate to ensure the protection of these recipients. "[V]oluntary programs for notifying recipients ... are fairly new," the agency explained. "Thus the success of the voluntary programs cannot yet be fully assessed. However, the success of such voluntary programs will always depend on the continued voluntary support by manufacturers of blood products and the continued vigorous recruitment of patients/recipients to encourage full participation. FDA is concerned that the continued success of patient notification cannot be assured without regulatory standards ... and without a clear mechanism of enforcement in the event a notification program is found deficient."

The FDA dropped the item from its June 28, 2004 agenda, without any explanation.