Benefit & Risk Communication The Journey The Journey Speaking - - PowerPoint PPT Presentation

Benefit & Risk Communication The Journey

The Journey

Speaking Today

• Michele Sharp, Director of Regulatory Affairs
• Melissa Barnes, Asst General Counsel
• Paula Garrett, Director of Consumer Marketing

Lilly Vision

Improved Outcomes for Individual Patients

We will make a significant contribution to humanity by improving global health in the 21st century. Starting with the work of our scientists, we will place improved

• utcomes for individual patients at the center of what we do.

We will listen carefully to understand patient needs and work with healthcare partners to provide meaningful benefits to the people who depend on us.

Improved Outcomes & DTC

• Consumer communications play a key role in delivering

better outcomes

• When truthful, accurate, and balanced in the presentation of

benefit and risks, they can

– Raise awareness of diseases and conditions that are often undiagnosed, untreated or under-treated – Enable meaningful discussions among patients and their health professionals – Encourage appropriate use of prescription medications

Start with Patient Labeling

• Foundation of all Consumer Communication

– Assists consumers in understanding benefits and risks of medication – Equips consumers to use medications safely and effectively

• Lilly Recommendations to FDA Risk Communication

Advisory Committee in February ‘09

– Single Document – Standard Format – Prepared by Sponsor – Tested with Consumer – Approved by FDA

Challenge for Consumer Communication

• What does successful communication of benefit and risk

look like?

– How do we know communications achieve the appropriate balance? – How do we know communication is clear, conspicuous and neutral? – Among whom do we measure? – Can we consistently predict any stakeholder response? – Can stakeholders align on measurement principles?

A surprisingly complex issue.

What’s most persuasive?

Advertising that consumers perceive to be most persuasive…

• 1. Spends more time talking about benefits
• 2. Spends more time talking about risks
• 3. Spends equal time talking about benefits and risks

The Lilly Journey

• Consumer communication fundamentals

– Develop and test with consumers – Review with health professionals as appropriate – Iterative process

• Process and methodology improved over time in response

to industry and social input

– Standardized process to understand, reflect consumer perspective – Methodology improvements to understand risk communication and balance of risk and benefit

Questions? Questions?

Please join us on the journey. Please join us on the journey.