Regulatory science: a special update from the United States Food and Drug Administration - Preclinical issues and status of investigation of botanical drug products in the United States

A recent survey was conducted across the therapeutic divisions within the C DER, U.S. FDA regarding the number of submissions related to botanical drug products over the past ten years. The overall number of botanical submissi ons as expressed in the parenthesis are as follows: 1990 (1), 1991 (4), 199 2 (4), 1993 (5), 1994 (6), 1995 (5), 1996 (13), 1997 (16), 1998 (10). In th e total of 64 counted, 50 of them are submitted in original IND and the res t (14) in pre-IND format. The therapeutic categories are focused on dermato logical and topical (19), anti AIDS/antiviral (12), oncologic (13), neuroph armacologic (8), endocrine and metabolic (3), urologic (2), tobacco (2), an d cardio-renal products (1). The regulatory actions taken on these submissi ons showed that 68% of them are evaluated as safe to proceed for the human trials, while the rest (32%) of submissions required agency's regulatory gu idance. Among the submissions that required further guidance, 81% were defi cient in preclinical pharmacology/toxicology information and the rest (19%) lacks information in other areas (chemistry, clinical protocols). Followin g agency's guidance, 93% of the submissions that were put on hold were allo wed to proceed. In summary, a total of 94% of all the botanical INDs submit ted to the agency were allowed to proceed without additional animal toxicit y studies conducted. In conclusion, this survey indicates that the growing public interest in botanical supplements has prompted more formal evaluatio n of the efficacy/safety claims of these products. (C) 2000 Elsevier Scienc e Ireland Ltd. All rights reserved.