Progress in Complementary and Alternative Medicine: Contribution of the National Institutes of Health and the Food and Drug Administration

Since the creation of the Office of Alternative Medicine (OAM) at the National Institutes of Health (NIH), progress has been made in the evaluation and, where appropriate, the clinical and scientific acceptance of "complementary and alternative" medicine (CAM). This progress is due in part to initiatives jointly conducted by the NIH and the U.S. Food and Drug Administration (FDA). In particular, advances in the evaluation and acceptance of two CAM practices, acupuncture and botanical medicine, have resulted from ongoing cooperation between the two agencies. The legalization of the use of acupuncture needles in 1996 came as a result of a workshop sponsored by the OAM with the participation of the FDA, which explored key regulatory issues. Prompted by similar regulatory issues, as well as by the initiation of NIH-funded research projects, the OAM sponsored an international symposium to examine the evidence for and the role of botanical medicine in the United States. This conference generated a series of workshops sponsored by the Drug Information Association in conjunction with NIH and FDA, which explored the scientific, regulatory, and policy issues of heterogeneous botanical products. These efforts resulted in the initiation of a large randomized multicenter clinical trial (sponsored by the National Institute of Mental Health) of the botanical, St. John's wort, for the treatment of depression, and the formation of internal working groups within the FDA that are drafting a guidance policy for the development of botanicals as drugs in the United States. This document is expected to be available in the near future.