Industry Challenges Related to ALP

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Dec 8, 2013 (3 years and 10 months ago)

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Copyright © 2013 Deloitte Development LLC. All rights reserved
Industry Challenges Related to ALP
Regulatory
Environment
Increased FDA enforcement of Company Core Data Sheet compliance, off-label
marketing, label compliance, etc. has resulted in increasing level and frequency fines and
other enforcement action
Constant changes to labeling format and content requirements by FDA
Internal
Preventing advertising and promotional materials from addressing efficacy based on
unsubstantiated evidence and comparative claims, minimizing risk information, and
promoting unapproved uses of company’s product
Supporting a balanced presentation of products’ risk and benefit profile on the company’s
internet and social media portals
Managing compliance is becoming more challenging as companies enter more markets
and rely increasingly on contracted and joint venture partners
External
Competitors & watch-dog groups reporting product materials and promotions which are
expressing off-label claims and usage to the FDA’s Office of Prescription Drug Promotion
Leveraging regulatory and competitive intelligence to inform advertising, labeling and
promotional materials’ strategy
Experience across numerous pharmaceutical, biotech and medical device clients has surfaced three
area of common industry challenges impacting advertising, labeling, and promotion (ALP).
For Discussion Purposes Only – Subject to Deloitte &
Touche
Risk Review
Copyright © 2013 Deloitte Development LLC. All rights reserved
Maintaining a good ALP process requires an understanding of specific regulatory requirements by specific stakeholder
groups.

Understanding the Regulatory Requirements that Impact
the ALP Process
Sources:
1.

Federal Register:
https://www.federalregister.gov/articles/2013/04/19/2013-09175/use-of-certain-symbols-in-labeling

2.

FDA’s Guidance Agenda: New & Revised Draft
Guidances
CDER is Planning to Publish During Calendar Year 2013:
http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/webcontent/ucm314767.pdf

Regulatory Outcomes
Regulatory
Affairs
Medical
Affairs
Legal

Commercial

Commercial
Operations
R&D/
Clinical
Agencies/
Vendors
Compliance
Regulatory Submission in Electronic Format
§

Implications for the promotional review process, from
planning and development through FDA submission
§

Implications for the content management system,
including configuration of the electronic interface to
allow interaction with important vendors (e.g., agencies)
Guidance
Document
expected
in 2013
Safety Considerations for Container & Carton
Labeling Design to Decrease Errors

§

Implications for current product packaging, including the
volume of material re-work for the marketing team
Guidance
Document
Released
in 2013
Incorporating Pediatric Information into Rx
and Biologic Product Labeling
§

Implications for the review process in terms of the
number of materials requiring re-review as well as the
number and volume of revisions required
Guidance
Document
Released
in 2013
Revision to Med Device and Biologic Labeling
to Include Stand-Alone Graphical
Representations of Info or Symbols
§

Implications for the review process in terms of the
number of materials requiring re-review as well as the
number and volume of revisions required
FDA Rule
expected April ‘14
Interaction with Stakeholder Groups via
Social Media
§

Implications for reviewing and adapting current social
media tactics and processes
Guidance
Document
expected in 2014
Recent & Anticipated
Regulatory Documents & Implications
For Discussion Purposes Only – Subject to Deloitte &
Touche
Risk Review
Copyright © 2013 Deloitte Development LLC. All rights reserved
§

Standardized practices that allow for flexibility to adapt to market / industry trends with
respect to promotional review (e.g., digital)
§

Processes that incorporate Six Sigma and ongoing process improvement methodologies
to define and measure process issues
§

A set of metrics that measure workflow as well as effectiveness and quality
What Makes a Great ALP Process?
Best-in-Class Promotional Review requires a core set of operating components to get relevant and compliant
content into the market and manage it throughout its lifecycle
Process
Governance
People
Technology
§

Tools and systems that support content throughout its lifecycle and meet process
challenges (e.g., version control, sign-off and approval, etc.)
§

Flexibility for the tools and systems to meet the demand for the increasing number of
ALP-related submissions to the FDA
O
PERATING
C
OMPONENTS

§

A governance structure that allows for issue resolution and critical interfaces with the rest
of the organization
§

A culture of compliance and understanding of regulatory requirements
§

Defined roles, responsibilities and skills
§

Change management activities to embed roles and responsibilities as well as drive
changes to achieve cultural shifts
S
UCCESS
F
ACTORS

For Discussion Purposes Only – Subject to Deloitte &
Touche
Risk Review
Copyright © 2013 Deloitte Development LLC. All rights reserved
Guiding Principles to Provide an Good ALP Workflow
and Management System
§

Volume capacity
§

Project types
Content Management
§

Standardization
§

Resource planning
§

Key Performance Indicators
§

Measurement and Analytics
P
ROCESS

Planning
Development
Review
Production
Management
Fulfillment
§

Shared ownership
§

Share work environment
C
OLLABORATION

P
ERFORMANCE

S
CALABILITY

G
UIDING

P
RINCIPLES

§

Issue resolution
§

Constant improvement
§

Enforce compliance
G
OVERNANCE

§

Streamlined interfaces
§

Unified system
T
ECHNOLOGY

§

Organizational structure
§

Skills to acquire or train
§

Roles & Responsibilities
P
EOPLE

W
ORKFLOW
&
S
YSTEMS

O
PERATING

C
OMPONENTS

Promotional review workflow and its supporting content management system need to be developed according to guiding
principles and be supported by an operating model that includes process, governance, people and technology
Workflow
System
For Discussion Purposes Only – Subject to Deloitte &
Touche
Risk Review
Copyright © 2012 Deloitte Development LLC. All rights reserved.
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