Structured Product Labeling A View from the Working

Structured Product Labeling A View from the Working Group June 4, 2004

“Change has a considerable psychological impact on the human mind. To the fearful it is threatening because it means that things may get worse. To the hopeful it is encouraging because things may get better. To the confident it is inspiring because the challenge exists to make things better. ” – King Whitney Jr. 2

A Brief History of SPL 3 v Motivated by internal government recommendations, initiatives and legal mandates, the FDA sought a more sophisticated means for the exchange of the content of labeling v SPL Standard initially developed by a small group within the HL 7 Regulated Clinical Research Information Management Technical Committee v Although originally based upon the Clinical Document Architecture standard, it has come to be known as more of a “sibling” than a “child” of CDA v Ph. RMA HL 7 Task Group formed the SPL Working Group in January to further the work of the initial development team v In May 2004, SPL passed the HL 7 Committee Ballot process and is now eligible to be an ANSI standard

The SPL Working Group 48 active members, including representatives from HL 7, Sponsors, FDA and Vendors v Health Level 7: Ø Sandy Boyer, Gunther Schadow v FDA: Ø Steve Gitterman, Lisa Stockbridge, Donavan Duggan v Vendors: Ø Ø Ø 4 Arbortext Data Conversion Laboratory I 4 i Intrasphere Liquent Thomson v Sponsors: Ø Ø Ø Ø Abbott Astrazeneca Aventis Bayer Boehringer-Ingelheim Bristol-Myers Squibb DEY Ipsen Johnson & Johnson Lilly Merck Pfizer Proctor & Gamble Novartis Roche Wyeth

Team Objectives / Accomplishments v Raise industry awareness concerning SPL Ø Sponsor industry webcasts and meetings, as appropriate v Detailed review of HL 7 model (completed) Ø Sandy Boyer has led the team through a detailed review of HL 7 SPL standard, and in discussions during team meetings v Develop a generic XSL Style Sheet (completed) Ø Robert Wallace led a team in the development of a common presentation of SPL labeling content (Intra. Sphere hosting) v Author an Implementation Guide (in-process) Ø Ø Chief Editor: Sandy Boyer (HL 7) Assistant Editor: Robert Wallace (Lilly) Process Section Lead: Glenda Casper (Wyeth) Technical Section Lead: Keith Thomas (i 4 i) v Pilot test the SPL exchange with FDA (3 Q) 5

Goals of SPL v Human-readable labeling content compatible across systems v Faster dissemination of labeling to improve risk management v More efficient evaluation of labeling changes v More coordinated data collection and storage v Better support for analysis of data v Improved interoperability with other systems v Improved integration of clinical data v Improved access by prescribers and consumers v Support for retention of legacy product labeling 6

The Best Things About SPL… v SPL markup maintains human readability while providing machine processability v SPL allows scalable implementation of document markup v SPL is flexible – e. g. , doesn’t impose naming or nesting of sections v SPL markup facilitates exchange of product labeling documents Ø Local tag names can be mapped to SPL Ø “One transformation away from exchange” v SPL facilitates modular handling of document sections 7

Benefits to Sponsors 8 v Efficiency of exchange – submit only those sections or data elements that have changed v Eliminate redundant data collection by use in other submissions (such as drug listing) v Increased efficiency in the internal label management process v Catalyst towards the development of XML-based authoring v Allows for the potential for more re-usable product content across the enterprise v Separates the format of a label from its content v Defines a consistent, predictable means of exchanging labeling content

Challenges to Sponsors v Implementation period for conversion to SPL Ø Pilot testing, validation effort, lack of facilitating software, ability to budget for the implementation v Transition to SPL raises questions Ø Only labels after cut-over date, conversion of legacy labeling, use during on-going label negotiations v New standard and new technology Ø Synchronization of data and narrative, learning curve with new technology v SPL and the e. CTD v Global Harmonization of Product Information / Labeling standards 9

Prescription for Success v Project Manager / Coordinator Ø Follow the Defined Process Ø Schedule and Coordinate Conference Calls or Face-to -Face Meetings Ø Reports Back to RCRIM v v v 10 Industry Subject Matter Experts (Bus. and IT) Vendor Representation (Assist with Tools) FDA Representation HL 7 Developer with Subject Matter Knowledge International Health Authority participation

HL 7 RCRIM: Organizational Diagram HL 7 - RCRIM TC Data Council R. Levin (FDA) B. Tardiff (Regeneron) L. Quade (Lilly) RCRIM Working Teams (Open Industry Participation) ECG Waveform (Completed) Animal Tox (SEND Team Working) CDISC Members Software Stability (Ph. RMATeam Working) Product Label (Ph. RMA Team Working) Additional Teams (as required) HL 7 Members Ph. RMA HL 7 Task Group Healthcare (Clinics, Hosp. ) CROs Consultants 11 Protocol Rep. (CDISC Team Working) Software Pharmaceutical Companies Consultants HHS

A Model for the Future… v Work together to ensure the development of standards that will work for all sides within our industry v Involvement from the beginning in standard development v Collaborate on industry priorities with the FDA Data Council v Promote open RFI / RFP process to involve appropriate vendors 12 v Pilot new standards

“What we need to do is learn to work in the system, by which I mean that everybody, every team, every platform, every division, every component is there not for individual competitive profit or recognition, but for contribution to the system as a whole on a win-win basis. ” W. Edwards Deming (1900 - 1993) 13

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