Docket Management
Docket: 02N-0445 - FDA Regulation of Combination Products
Comment Number: EC -4

Accepted - Volume 1

Comment Record
Commentor Dr. Paul Goldfarb Date/Time 2002-11-07 16:51:20
Organization Genetronics, Inc
Category Health Professional

Comments for FDA General
1. General Comments I would appreciate the opportunity to address the meeting on several issues related to drug-device combination review. I am a consultant to Gentronics, a company in the process of review at this time, but my comments will be directed at the process of review and not specifically at the issues of Genetronics' review. - In defining the mode of action I would recommend that the decision should be from the patient's perspective and not that of the agent. In this approach a therapy would have a local, regional, or systemic effect on the patient. Evaluation by the Agency would then be directed at assessing the product in an appropriate manner. In essence, we would then not expect systemic activity to be demonstrated by a product that had only local activity. - If the therapeutic effect is local, does not the benefit that accrues also need to be assessed as a local event? An example would be local disease control as an endpoint. Should not the effect be assessed in comparison to other devices or drugs which have a similar effect? - The issue of clinical benefit needs to be reviewed. I would suggest that a product needs to be shown to be effective i.e. do what is claimed to be done. This claim would follow from a decision of what the effect is as above. The patient with the advice of their physicians defines the issue of clinical benefit. We use many devices to achieve a clinical benefit that is determined by the clinical setting and may not be universal. The role of the Agency is to allow me, as a physician, to be confident that what is claimed is what is going to happen. - There appears to be a dearth of surgeons on review panels, which are involved in these issues. This may influence how assessments are made. I will enclose a copy of my c.v. and be available to present until 2:30 in the afternoon as I will have to return to California that evening.

EC -4