Alan BergstromSenior Director, Commercial Regulatory Affairs

CBI Promotional ComplianceOctober 7, 2013

Enhance Promotional Compliance by Improving Internal Review

The content, views, and opinions in this presentation are my own and do not in anyway represent the views or opinions of Daiichi Sankyo, Inc.

3

Agenda

•Process•Reviewers

• Roles and Responsibilities•Collaboration

• Medical Affairs• Marketing

•Training

4

Process

•Do you have an SOP?•Do you have an oversight committee?

• Broad oversight of process• Non-product related material review• 1st line for dispute resolution

•Process Owner• Marketing• Regulatory• Business Operations

•Defined Escalation Process

5

Process

•Expedited Reviews•Innovation

• How do you review truly significant innovative tactics?

6

Reviewers – The Right People

•Roles and Responsibilities• Are they clearly defined?

•Subject Matter Experts

•Solutions oriented, not just preventing risk

•Emotional Intelligence

7

Example – Legal and Regulatory Roles

Legal RegulatoryProvide a broad risk assessment based on all relevant laws and factors known, i.e., specific product liabilitymatters; investigations; engagements with customers, HCPs, medical societies, and 3rd party vendors, etc.• On-label promotion from perspective of FDA, OIG, DOJ and state enforcement actions• False advertising under Lanham Act, applicable state laws, and FTC• Product liability• Anti-Kickback laws and state consumer fraud• Other laws as necessary, i.e., privacy, intellectual property, antitrust, etc.

Provide interpretation and precise application of all FDA regulations, guidance documents, and Office ofPrescription Drug Promotion (OPDP, formerly DDMAC) enforcement actions•FDA requirements for labeling and advertising• FDCA, CFR and FDA Guidance• Not false or misleading• Supported by substantial evidence• Fairly balanced in presentation efficacy and Safety

8

Collaboration with Marketing – Early and Often

•Concept Reviews•Integration into the Brand Team, including Brand Planning

9

Reviewers Not involved…

Brand Brand PlanningPlanning

Concept Concept ExecutionExecution

PRCPRC

Concept reviews traditionally take place here

Review Team not members of the Core Brand Team

RevisionsRevisions Tactical Tactical ExecutionExecution

10

…Fuels the Waste

Brand Brand PlanningPlanning

Concept Concept ExecutionExecution

PRCPRC

Agencies hatch big ideas with few compliance

parameters

Non-starter’ ideas get explored and expanded

RevisionsRevisions Tactical Tactical ExecutionExecution

Agency develops noncompliant campaigns embraced by marketing as differentiating

Overloads review resources with unnecessary reviews

Agency rewrites materials at cost to the company

Lengthy review process slows down marketing execution

11

Collaboration with Medical

•Medical Correctness/Accuracy versus Substantial Evidence•Review of study concepts to support claims•Review of HEOR studies to be used proactively under FDAMA

12

Training

•Regulatory Compliance Training• For Reviewers• For Initiators• For Agencies

•Surveillance and Training on OPDP Letters

13

More Quality, Less WasteQ

ualif

ied

SMEs

as

Rev

iew

Tea

m

Com

plia

nt Id

eas

from

Mar

ketin

g/A

genc

ies

Effective Process

Pinpoint Knowledge

Gaps+

Qualify Thru

Training+

The Ideal

14

Takeaways

•Defined Process

•Defined Roles & Responsibilities

•Compliance Training

•Highly Collaborative

15

Thank You

Questions?