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Counter-terrorism at FDA
Andrea Meyerhoff MD
Director, Office of Counter-terrorism
US Food and Drug Administration
Overview
• FDA mandate in counter-terrorism (CT)
• CT Strategic Plan
• Organization of CT activities
• Scientific issues in CT
FDA mandate:counter-terrorism
• Law Enforcement– To prevent, investigate and respond to
tampering with food and animal feed, blood, radiation-emitting instruments, drugs, vaccines, medical devices
• Public Health– To facilitate the availability of safe and
effective medical countermeasures-drugs, vaccines, medical devices -for individuals exposed to a biological, chemical, or nuclear agent
FDA mandate:counter-terrorism
• Civilian– generally operate in areas of lower risk– special populations, e.g., children, elderly– public health actions in counter-terrorism
likely to follow sentinel event
• Military– potential to operate in areas of highest risk– generally healthy adults– public health actions may precede event
Pre September 11• CT Budget $8.2
million• Bioterrorism:
Adequate supply of drugs, vaccines, biologicals
• CDER & CBER
FDA’s CT activities pre/post September 11, 2001
Post September 11• CT Budget > $159
million• Counter-terrorism:
Full range of FDA products
• Total agency involvement
Counterterrorism Strategic Plan
• Goal 1: Safety and security of regulated products (deterrence, detection, investigation and interdiction)
• Goal 2: Medical countermeasures• Goal 3: Emergency preparedness
and response • Goal 4: Radiation safety
Goal 1: Deterrence, detection,
investigation and interdiction: safety and security of FDA
regulated products
Office of the Commissioner:Office of Crisis Management
• Office of Security Operations, Policy and Planning
• Office of Emergency Operations
• Office of Counter-terrorism
Organization from the outside: CT queries to FDA
• Sources – Industry, academic investigator, foreign
government, other federal agency, state/local governments, concerned private citizen
• Portal of entry FDA– Office of CT, Office of the Commissioner
• Queries– FDA jurisdiction?– Funding?– Where/What in FDA?
Organization from the inside: CT Steering Committee
• 5 Centers– CFSAN (foods and cosmetics)– CVM (veterinary medicine)– CDER (drugs)– CBER (vaccines and other biologics)– CDRH (medical devices and radiation-
emitting instruments)• Office of Regulatory Affairs (field operations)• NCTR (toxicology labs)• Press, congressional, legal, international
affairs, budget, planning and evaluation
FDA scientific issues in Counter-terrorism
New standards development building on regulatory precedent
FDA: Scientific issues in CT
• Medical countermeasures– Drugs and biologics
– Diagnostic devices
• Food security
• Radiation safety
Organism Disease
Variola major Smallpox
Bacillus anthracis Anthrax
Yersinia pestis Plague
C. botulinum toxin Botulism
Francisella tularensis Tularemia
Filo-/Arenaviruses Hem fever
Biological Agents: Category AUS CDC, 1999
Medical countermeasures: drugs and biologics
• Rare diseases: indications with little regulatory precedent
• Efficacy endpoints for animal models
• Availability of non-human primates
• Availability of laboratory space
Medical countermeasures: ciprofloxacin for anthrax
• Accelerated approval – Surrogate= human serum levels Cipro– Reached or exceeded monkey serum levels– Consistently higher than MIC B. anthracis– Associated with improved survival in animals
exposed to aerosolized B. anthracis spores compared with those animals receiving placebo
– Database of human pathology permitting direct comparison with animal model (Sverdlovsk, 1979)
– Database of US industrial exposure
Ciprofloxacin Trough Concentrations - All
0.01
0.1
1
10
100
Cip
ro c
on
c (
mc
g/m
L)
MIC90 B. anthracis (0.06 mcg/mL)
MonkeysMD, PO
250 mg x 1, then 125 mg Q12h
AdultsMD, PO
500 mg Q12h
Challenge (from Friedlander et al 1993)S
urvi
val
TOCEnd of treatmentDays Post-Exposure
0 20 40 60 80 100 120
0.0
0.2
0.4
0.6
0.8
1.0
ControlCipro
Ciprofloxacin safety• Approved 1987, used > 250 million• >1000 patients > 60 days (clinical trials)• Compared with patients Cipro® short
course and active controls• GI most common, generally similar
rates across all 3 groups• Abdominal pain (3.5%), rash (3.9%)
more common > 60 days Cipro® group• No previously unidentified AEs
Medical countermeasures: diagnostic devices
• New range of biological agents to assay• First step in identifying an outbreak or
intentional release of biologic agent• Public health, infrastructure, economic
consequences linked to performance of assays
• Need for sensitivity and specificity standards• Need to validate the assays
Food security: test methods development
• Detection of biological agents in various food matrices
• Questions– Survival of pathogen in matrix?– Can pathogen cause human disease
following oral ingestion?– Relevant inoculum causing clinical
disease?
Radiation safety
• Decades of experience• Expertise in
– radiological public health– population dosimetry studies from medical x-ray– emergency response
• Science credentials and on-the-job training• Need for inventory in training and expertise
Conclusion: FDA counter-terrorism programs
• FDA mandate– Regulated products meet a standard of purity,
safety and effectiveness and are available
• Public health emergency– Rapid availability of regulated products for large-
scale use
• FDA role in counter-terrorism– Availability of pure, safe and effective products
consistent with the legal responsibilities of regulatory agency