An FDA panel heard concerns from professional associations, drug manufacturers, drug distributors, pharmacies and others about one portion of a proposed rule that seeks to make major changes to the National Drug Code (NDC) system. The changes, described in 21 CFR Part 207, would expand the scope of products subject to NDC system requirements to include licensed human cells, tissues, and cellular and tissue-based products (HCT/Ps) as well as give FDA responsibility for assigning all segments of the NDC.
Allene Carr-Greer, MT(ASCP)SBB, deputy director of regulatory affairs at AABB, urged FDA to exempt HCT/Ps from any requirement to use the NDC system. Testifying on behalf of AABB, America’s Blood Centers (ABC), American Red Cross (ARC), American Society for Blood and Marrow Transplantation (ASBMT), Foundation for the Accreditation of Cellular Therapy (FACT), International Council for Commonality in Blood Banking Automation (ICCBBA), International Society for Cellular Therapies (ISCT) and National Marrow Donor Program (NMDP), Carr-Greer told the panel that a requirement to implement the NDC system for these products would create a duplicate tracking system that would not provide increased patient safety but in fact may detract from the current level of patient safety.
Because of the biological nature of HCT/Ps and their unique manufacturing process, she said, a manufacturer must have the ability to attain NDC identifiers within minutes of collection, 24 hours a day, seven days a week. Generally, cellular therapy products will have been infused before an NDC number is populated in any federally maintained database.
Carr-Greer also noted that adverse reactions occurring with the patient after infusion are already required to be reported to FDA via MedWatch Form FDA 3500A. This form recognizes the use of a unique number for product identification and does not require use of the NDC number. This unique product number is often a number assigned using ISBT 128, an international information standard used in the labeling of blood and cellular therapy products. She indicated that all major standard-setting organizations for cellular therapy have committed themselves to the use of ISBT 128 as an industry standard, because the labeling system contains more information than NDC and can afford a better tracking and tracing mechanism of the product, which facilitates a quicker recall, improvements in deviation management, reporting of adverse events and outcome follow-up.
Pat Distler, MS, MT(ASCP)SBB, technical director for ICCBBA Inc., the organization that manages the ISBT 128 standard for use in transfusion and transplantation, echoed Carr-Greer’s comments. She explained that the ISBT 128 label is a four-quadrant label that contains virtually every piece of information needed to track a blood or cellular therapy product internationally, including blood center/cellular therapy center information, a donor statement, a donor identification number, ABO/Rh bar code and text, a product code and product information text, an expiration date code and text. ICCBBA also has worked with AABB and others in the cellular therapy community to standardize the nomenclature used for cellular therapy.
Critics of the NDC portion of the proposed rule indicated in comments before the panel that waiting for FDA to assign NDC codes could create delays in providing consumers with access to new drugs. In addition, the new process, which also requires NDC numbers to be printed on product labels and to have different product codes when manufacturers change or when information changes, could create inefficiencies and add costs to manufacturers’ processes. Heidi Horn, associate director of regulatory affairs at Perrigo Co. — one of the nation’s largest suppliers of store-brand drugs — noted along with several other presenters that manufacturers use lot numbers to trace products, so if traceability is the main reason FDA wants to control NDC code assignment, the agency would be setting up an unnecessary, duplicative system. In terms of adding costs and creating inefficiencies, Horn provided an example of how the new NDC system requirements would quadruple her company’s costs for making a label change — from $90,000 to $360,000.