Prescription Drug Importation Public Meeting April 14, 2004

1. Prescription Drug Importation Public Meeting April 14, 2004 Jim Rittenburg Authentix 610 861 6965 www.authentix.com

2. 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

3. 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.

4. 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 Covert Forensic • Point of care Pharmacy Wholesaler 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

5. Protecting the product

6. Overt and Covert Layers Technologies Depth of Security Inspection levels Color Shifting Ink Holograms Field Visual Overt Field Disposable Pen revealable marker Covert Field Instrument Laser Authentication Covert Field Instrument Spectral Fingerprint A Covert Spectral Fingerprint B Laboratory Analysis Forensic Laboratory Analysis Field Disposable Forensic Molecular Markers - stable isotope - binding pair

7. Overt Technologies • Polychromatic – Color Shifting - Security Inks • Holograms Can be used independently or with other technologies such as tamper evident seals and strips Combined with covert and forensic technologies, Holograms can provide a high level of protection.

8. Covert Technologies • Phosphors (up/down) • Invisible to Visible • Invisible to Invisible • Pen Revealable Covert Inks 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. Chemically reactive markers within the ink are revealed using appropriate developing reagents. Fixed or variable information can be applied using conventional printing equipment.

9. Authenticatingthe 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 Field Test Kit