ROCKVILLE, Md—Last September, medical oncologist Richard Pazdur, MD, became director of the Division of Oncologic Drug Products at the US Food and Drug Administration. Dr. Pazdur joined the FDA after 12 years on the faculty of the University of Texas M.D. Anderson Cancer Center, where his most recent position was professor of medicine and director of educational programs within the Division of Medicine.
In this interview with Patrick Young, ONI’s Washington Bureau Chief, Dr. Pazdur discusses the FDA’s oncologic drugs approval process and his goals as division director.
ONI: What is the specific mission of your division?
Dr. Pazdur: Basically, it is to review oncology drug products. We interact with investigators and the pharmaceutical industry looking at clinical trial design and clinical data, and discussing with them strategies for eventual drug approval. Our division looks at cytotoxic chemotherapies or hormonal agents for the treatment of cancer. Another division handles biologic products.
ONI: What are your personal goals as director of this division?
Dr. Pazdur: I want to provide the agency with more transparency to the outside world as to its goals and functions. To do that, I want to encourage greater participation of the agency in academic endeavors.
These would include participating with organizations such as the American Association for Cancer Research (AACR), the American Society of Clinical Oncology (ASCO), and the Oncology Nursing Society to inform their membership about FDA practices.
In addition, I want to have a greater dialogue with the cancer advocacy community. This is especially important when we discuss areas of patient benefit that come into play with the oncology drug approval process.
ONI: How would groups like ASCO and AACR get involved?
Dr. Pazdur: I want to interact with them in educational programs. An example of this was a program that we put on at the AACR meeting in San Francisco in March. We held a joint workshop on chemoprevention and endpoints in chemoprevention trials. We are exploring with ASCO the presentation of a program on clinical trial design and one to explain our reasons for approving or not approving specific drugs.
In addition we have talked with ASCO and AACR about publishing, in peer-reviewed journals, review articles generated by the FDA on the drug approval process as well as on specific drugs that have come before our Oncologic Drugs Advisory Committee (ODAC).
ONI: Do you think oncologists are interested in the review process?
Dr. Pazdur: Yes. Most of the people who attend the ODAC meetings are investors, drug company personnel, or others connected to the pharmaceutical industry. But I think most medical oncologists still have an interest in these meetings.
It is important for them to understand the differences between just demonstrating that a drug has activity vs showing that the drug has clinical benefit for the patient. By clinical benefit, I mean patients live longer or symptoms decrease or are prevented by the administration of the particular agent.
The pharmaceutical companies have ample opportunity to publish results of their own clinical trials. We look at our presentations as being somewhat different. Many times, our presentations combine all of the known clinical material—combined clinical trials, looking across clinical trials for trends, for patient benefits, etc—whereas most of the information from a company deals with a specific clinical trial.
We realize that medical oncologists do not rely heavily on the package inserts, or drug labels, even though the FDA spends a great deal of time writing these labels. This is why we would like to use articles in peer-reviewed journals to get our viewpoint across, as well as our concerns and the rationale for specific drug approvals.
ONI: What other goals have you set for yourself as director?
Dr. Pazdur: I would like the ongoing dialogue with the academic community and cooperative groups to include several other important issues, including endpoints in chemoprevention, as mentioned previously, surrogate endpoints, and quality of life.
Measurement of quality of life in clinical trials needs a great deal of research and exploration, because it brings in the patient aspect of the benefit of the drug. The clinical trials community has a poor understanding of how we can use the various tools for measuring quality of life and how drugs may affect quality of life.
We have an ODAC subcommittee assessing quality of life. It is an ongoing dialogue we are going to have this year and perhaps next year. That is a very difficult issue that is not going to be answered by one or two meetings.
ONI: Do you have other areas that you intend to look at with special ODAC subcommittees?
Dr. Pazdur: One of the others is a special pediatrics subcommittee. We have recently outlined a plan for the industry and interested parties to develop new pediatric oncology drugs. We believe the pediatric oncology community has not been well represented in the drug approval process. We want to emphasize the early development of drugs in pediatrics. One of my efforts is to hire more pediatric oncologists to look at these applications.
