Last week the Healthcare Distribution Management Association (HDMA), the industry association for the U.S. primary healthcare distributors, published a letter from HDMA President and CEO John M. Gray to the FDA expressing concerns that not all members of the supply chain will be ready to exchange the transaction data mandated by the Drug Supply Chain Security Act (DSCSA) by the January 1 deadline.
The letter expresses concern about the potential that complexities of implementing the law across the entire supply chain…
“…could impair the timely flow of product on January 1, absent additional guidance or enforcement discretion from the Food and Drug Administration (FDA) related to handling of product transactions that are non-compliant.”
“…primary distributors are acutely aware that implementation readiness is not measured by the work of one sector or component, but by the collaborative and coordinated efforts of manufacturers, distributors and dispensers”
“While we believe most trading partners will be ready, there is concern among HDMA member distributors that the supply chain will not be 100 percent compliant with the DSCSA requirements on January 1, due to some legitimate products entering the supply chain without adequate transaction data. To forestall potential disruptions to the pharmaceutical supply chain, we urge the agency to ensure that the overarching priority in implementing this law is that patients continue to receive the products they need.”
Dr. Gray goes on to list the factors contributing to their concerns, including lack of communication or responsiveness by some supply chain members, vendor resources, inability to adequately test data exchanges between all trading partners and questions about the reliability of untested data exchange.
The bottom line,
“In order to prevent potential drug shortages and disruptions in patient access, we urge the agency to be mindful of the status of the supply chain as a whole and exercise discretion in enforcement activities where necessary to ensure patient access to medicines.”
I encourage you to read the entire letter. It is an excellent and surprisingly direct expression of the issue that came to the surface during the Q&A portion of a presentation by Dr. Connie Jung, Acting Associate Director for Policy & Communications, Office of Drug Security, Integrity and Recalls, Office of Compliance, Center for Drug Evaluation and Research at the recent HDMA Traceability Seminar (see “Will The DSCSA Cause Drug Shortages After January 1?”). At that time Dr. Jung did not have a real answer. The topic was not raised on the FDA’s Data Exchange Guidance webinar this afternoon. Will the FDA respond to the HDMA’s latest appeal in time? Stay tuned!