Docket Management
Docket: 97D-0318 - Revised Preventive Measures to Reduce Transmission of Creutzfeldt-Jakob Disease (CJD) by Blood
Comment Number: EC -8

Accepted - Volume 3

Comment Record
Commentor Dr. Mary Jo Drew Date/Time 2001-09-21 12:55:28
Organization Henry Ford Hospital Blood Bank
Category Health Professional

Comments for FDA General
1. General Comments The recommendations in the docket rely upon calculated, theoretical risk of vCJD transmission, and have the potential to significantly reduce a blood donor base that is already shrinking for other reasons. Therefore, in the interest of maintaining an adequate blood supply, it would be appropriate for the agency to require an application for a variance from this recommendation in the event that a blood collection firm wishes to implement more stringent geographic donor deferrals (Section IX). Merely stating that firms should conduct pilot programs to assess donor loss, monitor donor loss and develop contingency plans to deal with this loss is not enough to ensure these steps take place. In addition, there is the likelihood of confusion among donors and institutions when multiple sets of deferral criteria exist, all slightly different. This alone may serve to put off donors from donating prior to even coming to the donor center. The situation as it currently stands gives the appearance of uncertainty and disunity in the blood community. The FDA should require firms wishing to implement more stringent donor deferrals to submit and have such plans approved under a variance prior to proceeding with them.

EC -8