Docket Management
Docket: 01N-0450 - Prescription Drug User Fee Act (PDUFA); Public Meeting
Comment Number: EC -2

Accepted - Volume 1

Comment Record
Commentor Mr. Karl Schwartz Date/Time 2001-11-21 16:58:30
Organization NHL-info (lymphoma list server)
Category Other

Comments for FDA General
1. General Comments The reauthorization of the Prescription Drug User Fee Act must be achieved. Cancer patients rely on the timely testing and approval of new agents. In the United States alone, we lose ~24,000 individuals *each* year to lymphoma. History tells us that PDUFA has dramatically improved the drug testing and approval system. Advances in biology and molecular science will place even greater stress on the FDA system without PDUFA, or an improved User Fee system. Failing to reauthorize PDUFA will certainly have a negative impact on the survival of millions of Americans. The approval system *must* keep pace with and support the exciting developments in medical science. -Karl Schwartz (Lymphoma patient advocate)

EC -2