Endocrine disruption and the USFDA's Center for Drug Evaluation
and Research
A. Jacobs, P. Brown, J. 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.
*Report from a SCOPE/IUPAC project: Implication of
Endocrine Active Substances for Human and Wildlife (J. Miyamoto and
J.Burger, editors). Other reports are published in this issue,
pp. 1617-2615.
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