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Pharma Manufacturing Serialization Approval Possible By August W By Gail Dutton, contributing editor ith California's 2015 deadline for serialization looming, Congress is getting serious about crafting a single piece of federal legislation that will prevent a patchwork of legislation crafted by individual states. A bipartisan bill is expected to reach the president's desk in August. If that occurs, individual states' bills regarding serialization or track-and-trace will be preempted by the federal legislation and set aside. California's serialization regulations contain preemption clauses, ensuring they will not compete with federal legislation and recognizing the benefit of a 50-state solution to address counterfeits. Nonetheless, the California Board of Pharmacy formed an e-pedigree committee in May to focus upon implementing California e-pedigree law. As Virginia Herold, executive director, says, "We're moving ahead on implementation. If we're preempted, we're preempted." The Board's goal is to ensure that strong trackand-trace protection is in place in the U.S. While waiting for a federal regulation, Greg Cathcart, CEO of Excellis Health LLC, advises pharmaceutical manufacturers to continue preparing to meet the California requirements. "The California legislation is the most stringent, so if manufacturers meet its requirements, they should meet any other serialization requirements easily." BILLS READY FOR FLOOR VOTE According to Chip Meyers, VP of UPS corporate public affairs, "The House version, H.R. 1919, was passed out of committee May 15." Its goal is to prevent duplicative 44 LifeScienceLeader.com federal and state requirements and "to establish a collaborative, transparent process between the FDA and stakeholders to ensure a reasonable, practical transition to reach unit-level traceability." The current bill requires lot-level traceability as a first step toward unit-level traceability. It establishes national standards for wholesale distributors, while continuing state licensing of wholesale distributors and state fee collection. It also establishes a definition and licensure standards for third-party logistics providers (3PLs) and allows the FDA or the states to collect licensing fees. The Senate version, S.957, left committee May 22 with no amendments. Like the House bill, it calls for licensing of distributors and 3PLs. In this bill, product labeling is specified as "a human- or machine-readable, two-dimensional data matrix bar code on the package or on the case." As Meyers reports, "As the markup concluded, the Drug Supply Chain Security Act was incorporated into S. 959, the Pharmaceutical Compounding Quality and Accountability Act, by unanimous consent. The combined bill was favorably reported out, also by unanimous consent." Because both bills are similar, industry associations say they each are workable, and Congress foresees no difficulty reconciling them. If the bills are approved July 2013 by their respective branches of Congress, they will be reconciled. That version will be voted on again and sent to the president for his signature. At that point, it will become law. The bill that eventually will be approved is intended as a basic framework, allowing the industry and the regulatory communities to build upon what it learns during each phase of implementation. "Lot traceability is a beginning point," according to Elizabeth Gallenagh, VP, government affairs and general counsel, HDMA (Healthcare Distribution Management Association). Whether the final model is track-and-trace or e-pedigree at the unit level is largely a matter of nuance, she adds. The final requirement will create challenges in terms of the enormous amount of data that must be recorded, stored, and passed throughout the supply chain. TIME FRAMES ARE DIFFERENT The bills under consideration significantly delay implementation. Initially, the Senate version of traceability legislation called for unit-level serialization and allowed 10 years before the requirements became mandatory. "The House version allowed more time and did