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U.S. Department of Health and Human Services

Combination Products

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Meetings, Conferences, & Workshops

Presentation on Drug Device Product Regulation

My name is Paul Goldfarb. I am a surgical oncologist in practice for 20 years. I trained at Memorial Sloan Kettering Hospital and am a Clinical Professor at University of California at San Diego. I have been president of the American Cancer Society for the State of California and on the National Board. I have consulted for several medical device and drug companies over the past 15 years.

I appreciate the opportunity to address the meeting on several issues related to drug-device combination review. Presently, I am a consultant to Genetronics, a company that is developing a drug device product to be used in the treatment of cancer, but my comments will be directed at the process of review and not specifically at the issues of Genetronics. I will focus on the management of cancer in the examples I cite.

  • Currently, the mode of action is used to define which Center at the Agency will review a new product. This assessment is directed at defining the active component of a combination product, something that is not always obvious. In defining the “mode of action” I would recommend that a second assessment be made from the patient’s perspective . A drug device product would have a local, regional, or systemic effect on the patient. Evaluation of efficacy, regardless of which Center had jurisdiction, would then be directed at assessing the product in a manner appropriate to its action.
  • If the “therapeutic effect” for the patient is local, then, the benefit that is to be assessed will be at a local level as well. An example would be how we define disease control as an effect of an ablation technology. The effect of a drug device should be evaluated in comparison to other therapies that have a similar therapeutic effect.
  • The issue of “clinical benefit” needs to be reviewed. The patient, with the advice of their physicians, defines what is of clinical benefit to them. This is an individualized process and varies from patient to patient. The role of the Agency should be to demonstrate that a product is “effective” i.e. that the product does what is claimed to be done. As clinicians we look to the FDA to validate the claim and ensure the safety of new products as well as monitor ongoing clinical experience for safety issues after release.
  • Physicians who will use a proposed new drug devise or manage patients with a similar goal of therapy need to involved in assessing new approaches. If a therapy for a cancer has a local effect, it would be appropriate for surgeons who currently operate on these patients to be part of the review.