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Pure Appl. Chem., 2003, Vol. 75, No. 11-12, pp. 2605-2607

Endocrine disruption and the USFDA's Center for Drug Evaluation and Research

A. Jacobs, Paul Brown, James Farrelly, J. E. Fisher and D. Morse

U.S.Food and Drug Administration, HFD-540 5600 Fishers Lane, Rockville, MD 20857,USA

Abstract: Drugs may have intended or unintended endocrine effects. Drug evaluation may include both in vitro and in vivo evaluations of toxicity and developmental/reproductive effects. After a signal is identified, human relevance is of utmost concern. An integration "tool" that formalizes a weight-of-evidence approach has been developed to assess concern about reproductive/ developmental toxicity to humans. This approach can be used to assess concern about an endocrine disruption signal. A signal alone does not mean a concern for humans. An effect needs to have biologic relevance, and exposure thresholds for effects may exist. Risk/benefit for a particular drug is a clinical decision and may vary by the drug indication. Risk management for an identified concern could include wording in patient communications, tracking distribution or limited distribution, and patient or pregnancy registries.