Structured Product Labeling

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Structured Product Labeling

• A View from the Working Group

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

• 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

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Team 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 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

• SPL markup maintains human readability while
  providing machine processability
• SPL allows scalable implementation of document
  markup
• SPL is flexible e.g., doesnt 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 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 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 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

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HL7 RCRIM Organizational Diagram
HL7 - RCRIM TC

R. Levin (FDA)
B. Tardiff (Regeneron)
L. Quade (Lilly)
RCRIM Working Teams (Open Industry Participation)
Product Label (PhRMA Team Working)
Additional Teams (as required)
Stability (PhRMATeam Working)
Animal Tox (SEND Team Working)
ECG Waveform (Completed)
Protocol Rep. (CDISC Team Working)
CDISC Members
HL7 Members
PhRMA HL7 Task Group
Healthcare (Clinics, Hosp.)
Software
CROs
Software
Pharmaceutical Companies
Consultants
HHS
Consultants
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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

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• 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)

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End of Presentation