June 4, 2004

Structured Product LabelingStructured Product Labeling

A View from the Working Group

“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.

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A Brief History of SPLA Brief History of SPL

Motivated by internal government recommendations, initiatives and legal mandates, the FDA sought a more sophisticated means for the exchange of the content of labeling

SPL Standard initially developed by a small group within the HL7 Regulated Clinical Research Information Management Technical Committee

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

PhRMA HL7 Task Group formed the SPL Working Group in January to further the work of the initial development team

In May 2004, SPL passed the HL7 Committee Ballot process and is now eligible to be an ANSI standard

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The SPL Working GroupThe SPL Working Group

Health Level 7: Sandy Boyer, Gunther Schadow

FDA: Steve Gitterman, Lisa Stockbridge,

Donavan Duggan Vendors:

Arbortext Data Conversion Laboratory I4i Intrasphere Liquent Thomson

Sponsors: Abbott Astrazeneca Aventis Bayer Boehringer-Ingelheim Bristol-Myers Squibb DEY Ipsen Johnson & Johnson Lilly Merck Pfizer Proctor & Gamble Novartis Roche Wyeth

48 active members, including representatives from HL7, Sponsors, FDA and Vendors

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Team Objectives / AccomplishmentsTeam Objectives / Accomplishments

Raise industry awareness concerning SPL Sponsor industry webcasts and meetings, as appropriate

Detailed review of HL7 model (completed) Sandy Boyer has led the team through a detailed review of HL7 SPL standard, and in

discussions during team meetings Develop a generic XSL Style Sheet (completed)

Robert Wallace led a team in the development of a common presentation of SPL labeling content (IntraSphere hosting)

Author an Implementation Guide (in-process) Chief Editor: Sandy Boyer (HL7) Assistant Editor: Robert Wallace (Lilly) Process Section Lead: Glenda Casper (Wyeth) Technical Section Lead: Keith Thomas (i4i)

Pilot test the SPL exchange with FDA (3Q)

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Goals of SPLGoals of SPL

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

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The Best Things About SPL…The Best Things About SPL…

SPL markup maintains human readability while providing machine processability

SPL allows scalable implementation of document markup SPL is flexible – e.g., doesn’t impose naming or nesting of

sections SPL markup facilitates exchange of product labeling documents

Local tag names can be mapped to SPL “One transformation away from exchange”

SPL facilitates modular handling of document sections

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Benefits to SponsorsBenefits to Sponsors

Efficiency of exchange – submit only those sections or data elements that have changed

Eliminate redundant data collection by use in other submissions (such as drug listing)

Increased efficiency in the internal label management process Catalyst towards the development of XML-based authoring Allows for the potential for more re-usable product content across the

enterprise Separates the format of a label from its content Defines a consistent, predictable means of exchanging labeling content Utilizes a flexible, open standard

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Challenges to SponsorsChallenges to Sponsors

Implementation period for conversion to SPL Pilot testing, validation effort, lack of facilitating software, ability to

budget for the implementation Transition to SPL raises questions

Only labels after cut-over date, conversion of legacy labeling, use during on-going label negotiations

New standard and new technology Synchronization of data and narrative, learning curve with new

technology SPL and the eCTD Global Harmonization of Product Information / Labeling standards

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Prescription for SuccessPrescription for Success

Project Manager / Coordinator Follow the Defined Process Schedule and Coordinate Conference Calls or Face-to-Face

Meetings Reports Back to RCRIM

Industry Subject Matter Experts (Bus. and IT) Vendor Representation (Assist with Tools) FDA Representation HL7 Developer with Subject Matter Knowledge International Health Authority participation

HL7 RCRIM: Organizational DiagramHL7 RCRIM: Organizational Diagram

Data Council

R. Levin (FDA) B. Tardiff (Regeneron)

HL7 - RCRIM TCHL7 - RCRIM TC

L. Quade (Lilly)

PhRMA HL7 Task Group

RCRIM Working Teams (Open Industry Participation)

Stability(PhRMATeam

Working)

Product Label(PhRMA Team

Working)

Additional Teams (as required)

Animal Tox(SEND Team

Working)

ECG Waveform

(Completed)

Protocol Rep. (CDISC Team

Working)

CDISC Members

Software CROs

Consultants

HL7 Members

Pharmaceutical Companies

Software

Consultants

Healthcare(Clinics, Hosp.)

HHS

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A Model for the Future…A Model for the Future…

Work together to ensure the development of standards that will work for all sides within our industry

Involvement from the beginning in standard development

Collaborate on industry priorities with the FDA Data Council

Promote open RFI / RFP process to involve appropriate vendors

Pilot new standards

Leverage open SDO forums as a mechanism for global harmonization

“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)

End of Presentation