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

FDA Counter-terrorism Strategic Plan

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

Goal 2: Medical countermeasures

Goal 3: Emergency preparedness and response

Goal 4: Radiation safety

Organization of FDA Counter-terrorism activities

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