Docket Management
Docket: 01N-0450 - Prescription Drug User Fee Act (PDUFA); Public Meeting
Comment Number: EC -5

Accepted - Volume 2

Comment Record
Commentor Ms. Ann Fonfa Date/Time 2001-12-08 12:23:20
Organization The Annie Appleseed Project
Category Consumer Group

Comments for FDA General
1. General Comments On Monday, December 3, I heard a second oncologist discuss the fact that Xeloda (oral chemotherapy) is best utilized at much lower doses than on the FDA-approved label. This doctor, Daniel Budman (Long Island-based) echoed a talk by Charles Vogel (Florida-based) where it was stated that doctors 'in the know' give their patients less Xeloda per treatment dose. I asked Dr. Budman why the label was not changed. Both he and the representative from Roche (manufacturer) agreed that it would not happen by request of the company since it would cost a lot of (extra) money and take time. It is our understanding that FDA does not initiate these changes itself. Dr. Budman suggested that 'most' oncologists learn about the lowered doses by attending meetings or reading journal articles. As patients, we have to respectfully disagree. We know from past experience that many doctors are not up-to-date on all the issues. There are so many issues these days and changes come regularly. Further, it is completely unfair to the patient population to have doctors 'in the know' use a dose different from FDA-approved levels. This can easily create a two-tiered system, failing patients whose doctors are NOT in-the-know. Please advise what steps FDA will take to correct this imbalance and unfair situation it has helped to create? A summary of Dr. Budman's remarks will shortly be posted on our website, adding to the meeting summaries we offer to patients and healthcare providers at

EC -5