Calabasas, CA (PRWEB) July 31, 2013
The CA E-Pedigree Law will take effect on a staggered basis from January 1, 2015 until July 1, 2017. Enacted to safeguard the state’s prescription drug supply, the law requires all owners and buyers of prescription drugs to append an electronically created and maintained record (or pedigree) to track every sale and purchase as the drug moves through the supply chain from the manufacturer through wholesalers to the pharmacy or physician. Businesses will forfeit revenues in California if they did not comply with the Pedigree Laws in 2015.
Devendra Mishra, Executive Director of BSMA, remarked, “Companies that focus purely on achieving compliance will miss the opportunity to use regulation as a business driver. Although simple E-Pedigree systems are an important first step, significant improvement in the overall supply chain of the biotech industry and public safety would result from a more standardized and automated approach. Such systems with serialization, packaging with printing and vision, data interchanges between trading partners and incorporation of Track and Trace technology, have enormous ROI. BSMA is committed to helping its members in sourcing, procurement, clinical operations, manufacturing, quality assurance, packaging, warehousing, transportation, distribution and regulatory affairs to meet the challenges of complying with the impending law as well as deploying it for greater visibility and accountability.”
A recent research has indicated that “the ability to track and serialize unit level saleable packages (e.g. bottle of 25 pills), not just cases or pallets, can create business value in knowing exactly where their products are purchased can do the following”:
1. “Minimize cost of chargebacks through 100% accurate adjudication. Chargebacks account for 2-15% of gross revenue for a pharmaceutical manufacturer.”
2. “Minimize risk by increasing accuracy in Medicare/Medicaid pricing calculations by fully knowing all fees, rebates, and chargebacks that should be applied to a specific unit sale. Over $4B in fines have been handed down for improperly calculating Medicare/Medicaid pricing.”
3. “Limit liability of having to recall entire lots of product because a (non-serialized) shipment was stolen.”
4. “Achieve visibility for manufacturers in the labyrinth that is the wholesale distribution network to more accurately forecast demand and measure sales and marketing.”
Furthermore, the production of substandard and fake drugs is a vast and under-reported problem, particularly affecting poorer countries. The FDA estimates that fake drugs comprise approximately 10% of the global medicine market. Compounding the problem is the theft and illegal diversion of medical products in the supply chain. Considering the consequent loss of life and the economic incentive for these illegal activities, the justification for Pedigree and Serialization is compelling but it requires the collaboration of all stakeholders of the biopharma industry.
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About BSMA: The Bio Supply Management Alliance (BSMA), which organizes the Conference, was born of the need to create a worldwide community of operations and supply chain management leaders and professionals in the biotech, biopharma, and biomedical device industries. Based in the San Francisco Bay Area, home to more than 400 bio firms, the Alliance provides a forum for collaboration, learning and best practice sharing of practitioners, executives and thought leaders in these uniquely demanding industries.