Pharmaceutical Supply Chain in the U.S. The pharmaceutical supply system is complex and involves multiple organizations that play differing but sometimes overlapping roles in drug distribution and contracting. This complexity results in considerable price variability across different types of consumers. Top 5 Retail pharmacy chains in the U.S. Top 3 Wholesalers in the U.S. Between 1975 and 2000, the number of wholesale distributors in the U.S. declined from approximately 200 to fewer than 50. Top 5 Pharmaceutical manufacturers in the U.S. Source: The Health Strategies Consultancy LLC 3/30/2022 1 Wholesale distribution regulations 1988 Prescription Drug Marketing Act of 1987 (PDMA) • PDMA required that all drug wholesalers be licensed by the states. • PDMA prohibited the sales, trading, or distribution of drug samples, by mail or common carrier, to persons other than those licensed to prescribe them. • PDMA prohibited the reimportation of a drug into the U.S. by anyone except the manufacturer. 2004 Verified-Accredited Wholesale Distributors (VAWD) program • VAWD Oregon required any wholesale distributor located outside the boundaries of Oregon, applying for registration or re-registration, as a Class 1 Wholesaler, after January 1, 2008, must provide extra evidences. • VAWD Indiana requires all wholesalers licensed in their state to become VAWD certified. Pills only flow in the authorized distribution networks Source: Shining Light on the Gray Market 3/30/2022 2 Gray Market Drug Distribution Typical market An example of Fluorouracil (a drug used to treat stomach, breast, and pancreatic cancer) licensed in Maryland licensed in New Jersey Source: Shining Light on the Gray Market Increasing prescription drug shortages leads to the generations of the gray market that improving the drug price 1,000 times higher or more. Also, the “fake” pharmacies acquiring drugs from distributors and selling the high demand drugs into the gray market. Source: Shining Light on the Gray Market 3/30/2022 3 Securing the Pharmaceutical Supply Chain Information infrastructure for tracking and tracing Source: Securing the pharmaceutical supply chain. 3/30/2022 4 Securing the Pharmaceutical Supply Chain Source: reference 5. 3/30/2022 Blockchain Based Solution for Information Storage 5