Docket Management
Docket: 00N-1637 - Advertising & Promotional Labeling for Drugs & Biologics
Comment Number: EC -1

Accepted - Volume 1

Comment Record
Commentor Mr. Robert Hoffman Date/Time 2000-12-22 11:22:00
Organization Retired
Category Health Professional

Comments for FDA General
1. Is the proposed collection of information necessary for the proper performance of FDA's functions? Will the information have practical utility? Yes- it will have practical utility and it is necessary
2. What is the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used? It should be of no more burden than the old format but should be more helpful to physicians.
3. What are ways to enhance the quality, utility, and clarity of the information to be collected? As a former drug salesman as well as a registered pharmacist I feel that whenever a new side-effect or other warning is added to the drug package-insert the manufacturer should be required to apply a bold-faced (red if possible) notice on all samples,journal advertising,consumer advertising, and stock containers for a period of six months stating New Use Warning Enclosed! This would be seen while , as we know, most physicians do not read the insert since they have used the drug for a long time.
5. General Comments I feel that the first step has been taken toward more safety for patients but the warning should be on samples and stock containers as well as all advertising.

EC -1