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An Overview of Medical Radiation
Countermeasures
National REP Conference
April 14, 2005
CDR Michael A. Noska, USPHS
Senior Health Physicist
Center for Devices and Radiological Health
Food and Drug Administration
U.S. Department of Health and Human Services
What this talk is about:
Overview of currently approved medical
countermeasures
Federal programs for countermeasure
development
Mechanisms for emergency use
What this talk is not about:
KI DISTRIBUTION!!!
Off-label uses
Investigational products
FDA Regulatory Review
IND/IDE
NDA/PMA/510K
Accelerated approval
Bioterrorism Act of 2002
– Emergency Authorization
– Animal Rule
Potassium Iodide (KI)
Prophylaxis against uptake of *I
Dosing
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Supplied as 65 or 130 mg tablet
>40 yo, >500 rem: 130 mg/day
18-40, >10 rem: 130 mg/day
3-18 yo, preg/lact: 65 mg/day
1 mo-3 yo: 32 mg/day
Birth to 1 mo: 16 mg/day
Bioterrorism Act
Shelf-life extension
Prussian Blue (Radiogardase™)
Radioeliminator for *Cs and Tl
– Binds and reduces GI re-absorption
Dosing
– Supplied as 500 mg tablet
– Adult: 3 g three times a day for 30 days
– Children 2-12 yo: 1 g three times a day for 30
days
Routes of administration
Side effects: gastric distress
DTPA
Increases rate of elimination of certain
transuranics (Pu, Am, Cm)
Ca and Zn analogs
Dosing
– Supplied as clear sterile liquid for injection
– Adult: 1 g Ca first day + 1 g Ca/Zn following
– Pediatric (<12 yo): 14 mg/kg Ca; 14 mg/kg Ca/Zn
Routes of administration
– IV
– Nebulizer
– RFI for oral
Ancillary topics
Cytokines (Biological response modifiers)
– Neupogen
Strategic National Stockpile (SNS)
Medical Countermeasure
Development
HSC/OSTP RDD/IND Working Group
– Medical Countermeasures Sub-group
DHS/S&T Interagency WG
NIH/NIAID Centers of Excellence
HHS/Project Bioshield Act of 2004 grants
for focused product development
FDA Inter-Center WG on MCM
Contact Information
FDA
www.fda.gov
www.fda.gov/oc/opacom/hottopics/bioterrorism.html
FDA Emergency Operations Center
301-443-1240, 800-759-8352
Mike Noska, CDRH/OCER/DMQRP/RPB
301-594-3527
[email protected]