December 1, 2003

Dr. Gary Firestein Reappointed Chair Of FDA Arthritis Advisory Committee

Gary S. Firestein, M.D.

Gary S. Firestein, M.D., professor of medicine and chief, Division of Rheumatology, Allergy and Immunology, University of California, San Diego (UCSD) School of Medicine, has been reappointed chair of the Arthritis Advisory Committee of the U.S. Food and Drug Administration for a second term, ending in October 2005. His first term began in May 2002.

A specialist in rheumatoid arthritis and autoimmune diseases, Firestein is also executive director of UCSDs Center for Innovative Therapy, which evaluates innovative therapies for immune-mediated diseases (see, and director of the UCSD Clinical Investigation Institute.

The FDA Arthritis Advisory Committee helps the agency make sound decisions based on good science. Committee members are individuals recognized as experts in their field from many different sectors including medical professionals, scientists and researchers, industry leaders, and consumer representatives and patient representatives.

During his first term as chair of the FDA Arthritis Advisory Committee, Firestein said the group focused on one of the key hurdles facing drug development the need for a clear regulatory roadmap defining the requirements for FDA approval.

While the path for success is now well defined in rheumatoid arthritis, the same is not true for many other diseases, he said. The advisory committee, along with leadership of Dr. Lee Simon at the FDA, has developed guidance documents for drugs in acute pain, chronic pain, systemic lupus erythematosus and fibromyalgia. Additional guidance documents will be worked on for other diseases, including gout and ankylosing spondylitis.

Also during his first term, the FDA Arthritis Advisory Committee approved a number of new agents including anakinra for rheumatoid arthritis, and evaluated several safety issues.

One of the most important safety issues involved liver toxicity of leflunomide, a drug for rheumatoid arthritis, Firestein said. This was a very contentious issue that was raised by a petition from a citizen group to withdraw the drug. However, the committee reviewed the data and considered the toxicity similar to other agents used in rheumatoid arthritis. It was felt that the benefit outweighed the safety issues if patients are appropriately monitored.

Another important safety issue involved lymphoma and infections in rheumatoid arthritis patients who receive drugs called TNF inhibitors. Again, the committee determined that the risk benefit ratio was a critical determinant and that the benefits outweighed potential safety issues.

Firestein received his M.D. degree at Johns Hopkins University School of Medicine. His post-graduate residencies and fellowships were at UCLA Medical Center, UCSD and the La Jolla Cancer Research Institute.

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