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FDA’s Viewpoint on Approvals Needs to Be Heard: Dr. Pazdur

FDA’s Viewpoint on Approvals Needs to Be Heard: Dr. Pazdur

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.


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