Dianne Murphy, M'D'

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Dianne Murphy, M.D.
December 4, 2001

• Center for Drug Evaluation and Research
• U.S. Food and Drug Administration

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Counter-TerrorismSurveillance

• French surveiller, watch over sur, over
• a. Exercising surveillance
• n. surveillant
• FDA/CDER n. Aggressive Surveillant

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CDERs Role

• Prospective identification of gaps in therapeutic
  armamentarium
• Assessment of data/studies needed for labeling
• Coordination of therapeutic development
• Facilitation of IND process
• Ensuring appropriate data collection post event

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Examples of Aggressive Surveillance
1. Identification and coordination of therapy
for Anthrax (R) to tetracycline, penicillin
and macrolide 2. Review of all U.S. clinical
cases of pneumonic plague and
recommendations for additional studies. 3.
Development of streamlined IND for NPS 4.
Facilitation of INDs for therapies for
smallpox, neurologic toxins and
radioprotectants. National Pharmaceutical
Stockpile
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Examples Contd
5. Published findings on clarification of
dosing regimen for doxycycline and procaine G
penicillin for treatment of inhalational
anthrax 6. Survey of literature and teratology
registries and publication of information
concerning drugs for use in pregnant and
lactating women. 7. Establishment of pediatric
biopharm working groups to develop standardized,
on site, recipes for delivery of non-pediatric
formulations (tablets and capsules) to children.
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Examples Contd
8. Development of information from internal
documents and literature to provide additional
dosing regimen data for use by physicians 9.
Establishment of FDA/NIH Antibiotic Working
Groups to provide clinical and scientific options
concerning needs for additional product
development using monkey models. 10. Providing
input, feedback, and personnel to work with the
CDC in developing assessment tools for adverse
event and outcome reporting on the 5,000
patients who were placed on a 60 day regimen of
antibiotics post inhalational exposure to anthrax.