Docket Management
Docket: 01N-0205 - Applications for FDA Approval to Market a New Drug
Comment Number: EC -3

Accepted - Volume 1

Comment Record
Commentor Mr. Robert Hoefflin Date/Time 2001-06-13 18:40:01
Organization St. Vincent Hospital and HCC
Category Health Professional

Comments for FDA General
5. General Comments I was somewhat disappointed with the news that your agency has postponed review of Eli Lilly & Co.'s application for approval of the only drug to treat sepsis. This is a drug that could save many lives in Intensive Care Units around the Nation and the world. We were involved in clinical trials of this agent at our hospital. The results were very promising, so I find it hard to believe other centers didn't have simailar results. The drug appears to be safe enough when comparing benefits to risks. I would appreciate an explanation of why some drugs are fast-tracked and others are not. This drug would seem to be one that you would put on the fast-track line before some of the me-too's that seem to get marketed rapidly. Thank you for your time and I await a reply.

EC -3