FDA Prescription Drug Importation - Public Meeting April 14, Prescription Drug Importation Public Meeting April 14, 2004 Jim Rittenburg Authentix

FDA Prescription Drug Importation - Public Meeting April 14, Drug Importation Drug counterfeiting is a recognized global problem Incidence of fake drugs in US has been low due to FDA oversight Even with FDA oversight, drug counterfeiting in US is increasing Drug importation will bypass FDA and reduce safety True origin of the drugs will become questionable Drug storage and handling conditions will become questionable The internet already represents a loosely controlled border We do not believe that allowing drug importation is in the best interest of the general population since it will put the drug supply at risk

FDA Prescription Drug Importation - Public Meeting April 14, Ensuring Drug Safety Even the current US drug supply chain requires more vigilance Proven technologies exist today for protecting pharmaceuticals Low impact technologies exist for packaging and dosage form Readily integrated into manufacturing process Relatively low cost Overt and covert technologies will enable inspection by: Consumers, Pharmacists, Healthcare Professionals Pharma Manufacturers and Contracted Inspection Services FDA, Customs, Other Government agencies We believe as part of Good Manufacturing Practice all drug products should be designed to minimize the opportunity for adulterated or counterfeit product to reach the patient.

FDA Prescription Drug Importation - Public Meeting April 14, Field Audit Programs We protect currency with layered security technologies The same approach can work for pharmaceuticals Presence of layered security features enable inspection Overt CovertForensic Point of care PharmacyWholesaler Manufacturer RFID technology and electronic pedigree’s Will eventually complement authentication technologies Unit level tag technology is still many years away Comprehensive domestic and global infrastructure many years away A low level ongoing field audit program will provide an early warning system for flagging counterfeit product

FDA Prescription Drug Importation - Public Meeting April 14, Protecting the product

FDA Prescription Drug Importation - Public Meeting April 14, Overt Covert Forensic Covert Color Shifting Ink Holograms Pen revealable marker Laser Authentication Spectral Fingerprint A Spectral Fingerprint B Forensic Molecular Markers - stable isotope - binding pair Field Visual Field Disposable Field Instrument Laboratory Analysis Field Disposable Overt and Covert Layers Depth of Security Technologies Inspection levels

FDA Prescription Drug Importation - Public Meeting April 14, Overt Technologies Can be used independently or with other technologies such as tamper evident seals and strips Polychromatic – Color Shifting - Security Inks Holograms Combined with covert and forensic technologies, Holograms can provide a high level of protection.

FDA Prescription Drug Importation - Public Meeting April 14, Covert Technologies Pen Revealable Covert Inks Chemically reactive markers within the ink are revealed using appropriate developing reagents. Fixed or variable information can be applied using conventional printing equipment. Phosphors (up/down) -Invisible to Visible -Invisible to Invisible Phosphors collect and store light, then release it only when exposed to light of specific wavelengths. Very high levels of security can be engineered into products using this technology.

FDA Prescription Drug Importation - Public Meeting April 14, Field Test Kit Authenticating the dosage form Markers  Listed in CDER inactive ingredient guide  Simple organic GRAS compounds  Used in CDER approved products  Used at trace levels (ppm to ppb)  Inserted via coatings, inks, excipients, or API Marker Detection  Add tablet to liquid in vial  Shake briefly  Add several drops to test device  Read results: 1 line is authentic 2 lines is counterfeit Inactive ingredients become high security taggants