# Presentation: 773475

## Presentation to the FDA Anti-Counterfeit WorkshopFebruary 8, 2006Potential Role of Electronic Track & Trace in Public Health Emergencies

- Paul Rudolf, MD, JD

## Types of Public Health Emergencies

- As the problem gets worse, the need for visibility and preparedness becomes more urgent:
- Mild Flu Outbreak
- Serious Flu Outbreak
- Pandemic Flu Outbreak
- Avian Flu Outbreak
- Terrorist Attack using Biologic Agents

## “Customs Agents Seize Counterfeit Tamiflu”

- “Customs Agents Seize Counterfeit Tamiflu”
- -AP

- “FDA Fraudulent Avian Flu Therapies Could Harm Consumers or Interfere with Conventional Treatments”
- -Pharmalive

- “Improved Tracking Sought for Flu Shot...thousands of doses unused in New England...jeopardizes the public’s health and illustrates the need for better tracking of vaccine supplies”
- -Boston Globe

- “...the timing of flu vaccine shipments is crucial....”
- -New York Times

- “Phony Bird Flu Drugs Plaguing Internet”
- -Knight Ridder Newspapers

- “...expertise, coordination, disciplineand infrastructure are lacking”		-The Washington Times

- “Counterfeit vaccines endanger China’s flu fight”		-Wall Street Journal

## The need for Electronic Track & Trace is real - NOW

- Recent history indicates:
- Presence of Counterfeit Flu Vaccine
- Presence of Counterfeit Tamiflu
- Public health authorities have said they do not know where all available flu vaccine is
- Admit that improvements in tracking and tracing are needed - now

## Visibility 

- Visibility
- Ability to know, in real time, the location of every medication and product needed to combat a public health emergency
- Current electronic track and trace technology is not able to do this
- Set up to _track _individual items, not _see_ all items
- Requires an additional layer on top of contemplated e-pedigree and authentication solutions
- Requires public-private co-operation
- Stocks of these products will be in government stockpiles and privately held warehouses

## Preparedness

- Ability to distribute needed medications and supplies to areas affected by a public health emergency
- Getting the right medicine to victims in time to make a difference (save lives)
- There is almost certainly going to be a mis-match between the location of medicine and the location of victims
- Must locate and ship product immediately
- Includes the last mile – the most important mile

## Factors affecting availability of medicine

- Ability to rapidly and efficiently distribute medications to the right location at the right time
- Complicating factors:
- Introduction of counterfeit product
- Diversion
- Hoarding
- Shrinkage
- Theft

## Visibility and Preparedness take time to develop

- Technology not yet ready – needs to be encouraged
- Government procurement power more important than regulatory power
- Need for government and non-government partnership
- Stocks will be in government stockpiles and private distribution centers
- Initial implementations needed
- FDA, DOD, DHS are logical entities
- Working with current suppliers (Flu Vaccine, Cipro)
- Need to identify and address technical, business, logistical issues

## Current Environment

- Hurricane Katrina
- Suboptimal distribution of supplies
- Visibility and preparedness were issues
- Public-private cooperation incomplete
- Mismatch of location of supplies and victims
- Would RFID have helped?
- Flu Outbreaks
- Can be extremely localized
- High probability that medication will not be located in affected areas

## FDA can do something now

- Scope of potential actions is large
- Initial step could be to develop a concrete implementation plan with other federal and state government agencies
- Procurement planning and requirements
- Regulatory oversight
- Identify and work with appropriate private partners
- Encourage other agencies to fund (e.g., through purchasing requirements) initial implementations

## Potential for catastrophe if FDA waits

- Takes time to develop technology
- Visibility and preparedness are impossible to initiate during an emergency
- Information on visibility/preparedness is practically priceless during an emergency but costs money to get prior to emergency
- Without prior planning the chance of a public health emergency becoming a catastrophe are greatly increased

## Note on the FDA RFID Timeline

- Mass Serialization still feasible in 2006/2007
- RFID Tagging of Pallets & Cases still feasible in 2006/2007
- RFID at the item level faces significant business/implementation hurdles
- Technology is ready at case level
- Government purchasing power may accelerate adoption of electronic track and trace more quickly than its regulatory oversight authority

## Recommendations	

- FDA should require government agencies, suppliers, and distributors of medications needed to address a public health emergency to ensure complete product visibility and to be prepared to immediately ship product to affected locations
- RFID at the case level; 2D bar codes at the item level
- E-Pedigree and E-Authentication Systems to provide Visibility
- FDA should work with DHS, HHS, DOD, and state governments, via issuance of procurement requirements and appropriate regulatory oversight, to facilitate the development of the track and trace technology necessary to provide visibility and preparedness