Docket Management
Docket: 01N-0450 - Prescription Drug User Fee Act (PDUFA); Public Meeting
Comment Number: EC -3

Accepted - Volume 1

Comment Record
Commentor Mr. Karl Schwartz Date/Time 2001-11-21 18:14:02
Organization NHL-info (Lymphoma support)
Category Other

Comments for FDA General
Questions
1. General Comments Q. Should PDUFA allow the use of user fee funding to monitor safety after new drug or biologic approval? A. Yes. Since significant profits can be expected for approved agents, we can anticipate that sponsors will be able to easily pay to monitor safety at this time. Therefore, post-approval appears to be *best* time to obtain user fees. The FDA should consider raising user fee funds collected after approval, and lowering fees *prior* to approval. It is during the investigational phase that drug sponsors need to reduce costs. The cancer patient community is concerned about high costs because it can discourage sponsors from developing and testing agents with therapeutic potential. -Kar Schwartz (patient advocate)




EC -3