The Prescription Drug Marketing Act (PDMA) was signed into law by President Ronald Reagan on April 22, 1988. Its purpose is twofold: to ensure that medicinal products purchased by consumers are both effective and safe to use, and to protect U.S. consumers from misbranded, adulterated, counterfeit, under-active, or expired prescription drugs. Prior to the establishment of the PDMA, legislators felt that U.S. consumers were unable to buy prescription drugs with the confidence and certainty that the medications were effective and safe. This was found to be a result of three factors:
- drugs which had previously been exported were being reimported into the U.S. as American Drug Returned
- prescription medication samples were being diverted
prescription drugs were being resold by healthcare organizations in bulk at prices below wholesale prices
The Pedigree Requirements
A prescription drug’s pedigree refers to its statement of origin and lists each sale, purchase or trade, when such transaction took place and the name and addresses of all parties involved in these transactions. Each person or entity who participates in the wholesale distribution of a prescription drug, that is neither the recorded manufacturer nor the authorized distributor of the drug, is required to provide the purchaser with a pedigree for that drug.
The PDMA Alliance
The PDMA Alliance Inc. is an organization that is dedicated to improving, developing and raising awareness of understanding of the PDMA. Among its members are a number of pharmaceutical executives whose businesses can be affected by prescription drug fraud, abuse issues and sample accountability. The alliance works in tandem with the FDA to provide up-to-date information pertaining to federal and state laws.
Contact our experts at Innovatum to find out more about how we can help you meet the challenges of FDA regulated labeling. Our ROBAR Enterprise Labeling Management System includes integration hooks to serialization technologies such as Systech and Seidenader which help to meet ePedigree goals. Contact us today to find out how we can help you meet your ePedigree needs.