| 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 |
| Questions |
|
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.
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