FDA’s Regulation on Experimental Drugs to Be Topic of UCI Symposium : MEDICAL
A change in regulations approved last spring by the federal Food and Drug Administration to allow physicians to prescribe experimental drugs for seriously ill and dying patients has stirred mixed reactions within the medical community.
Under the revised regulations, physicians can legally prescribe drugs that have not received FDA approval for general distribution if the recipients are in dire medical circumstances and might benefit from the drugs. Previously, such drugs were given only to patients involved in clinical drug study programs.
While the rule change has been applauded for providing a glimmer of hope to victims of cancer, AIDS and other fatal diseases, some critics complain that the extremely high cost of experimental drugs limits their use to wealthy patients.
The ethical and business repercussions of the FDA regulation will be the topic of a national symposium sponsored by the Medical Research and Education Society, a support organization for the California College of Medicine at UC Irvine.
The symposium, scheduled for March 17 and 18 at the Four Seasons Hotel in Newport Beach, requires a $350 registration fee. Although open to the public, it is expected to be attended primarily by physicians, clinical researchers and insurance company representatives.
Among the dozen speakers expected to address the symposium are Steven Bongard, director of the Forum on Drug Development and Regulation of the National Academy of Sciences; Frank A. Duckworth, president of the Food and Drug Law Institute in Washington, and Dr. Robert Oldham, chairman and scientific director of Biotherapeutics Inc., a Franklin, Tenn., company that has pioneered the treatment of cancer with new drugs.
