MSL-KOL Engagement: Ensuring Compliance
After its initial function to build rapport with KOLs, the MSL role has evolved from being a support to sales reps to the forefront of pharmaceutical practice. Lode Dewulf, chief medical affairs officer at Brussels-based UCB, reflects on this central transformation in the pharma business. “In many ways, MSLs have developed as a new role over the past two decades as did the Medical Affairs function itself,” he says. “Medical Affairs now has the mandate for all medical activities related to marketed products and also provides input to both clinical development and to commercialisation. Within Medical Affairs, the MSLs are the field-based medical partners for physicians and other healthcare stakeholders.”
Yet with that role has come a responsibility to comply with regulations governing off-label promotion. Once deemed ‘a cost of business’, fines are now ‘big business’: In September 2009, Pfizer paid $2.3 billion to settle charges of improperly promoting four products. The question is, how does the industry ensure, and be seen to ensure, no off-label promotion?
Report Overview
How can MSLs reduce their risk of breaching regulatory requirements when their company’s products are used off-label? MSL-KOL Engagement: Ensuring Compliance examines how MSLs are being used to engage physicians in a way that traditional sales no longer can. Casting a net over the current regulatory environment both in the US and EU, the report addresses the increasingly critical need for MSLs to be compliant with the rules on off-label promotion while also connecting with physicians who may be using a product for “off-label” use. Offering insight into the increased scope of the MSL and the importance of having Standard Operating Procedures in place, the report delves into tracking and reporting, compensation metrics and key enforcement policies.
Scope
Yet with that role has come a responsibility to comply with regulations governing off-label promotion. Once deemed ‘a cost of business’, fines are now ‘big business’: In September 2009, Pfizer paid $2.3 billion to settle charges of improperly promoting four products. The question is, how does the industry ensure, and be seen to ensure, no off-label promotion?
Report Overview
How can MSLs reduce their risk of breaching regulatory requirements when their company’s products are used off-label? MSL-KOL Engagement: Ensuring Compliance examines how MSLs are being used to engage physicians in a way that traditional sales no longer can. Casting a net over the current regulatory environment both in the US and EU, the report addresses the increasingly critical need for MSLs to be compliant with the rules on off-label promotion while also connecting with physicians who may be using a product for “off-label” use. Offering insight into the increased scope of the MSL and the importance of having Standard Operating Procedures in place, the report delves into tracking and reporting, compensation metrics and key enforcement policies.
Scope
- MSLs, their function and how they manage promotion vs education with reports of off-label usage
- Overview of the rules governing MSL activities in the US and EU
- Review of Corporate Integrity Agreements
- Importance of Standard Operating Procedures for MSLs
- MSL training and enforcement policies
- Analysis of tracking and reporting systems as well as compensation metrics
- Expert views from Bristol-Myers Squibb, UCB, Philips Healthcare, Medical Science Liaison World (MSL WORLD), Scientific Advantage, Lener Medical Consulting and Cutting Edge Information
- Insightful case studies examining how high-risk situations are mediated by two leading companies
- Unique and rare insight into the evolution and role of MSLs and how companies manage their risks where off-label promotion is concerned
- Compellingly written analysis of the current state of play in regulations across two continents
- Insightful case studies examining how high-risk situations are mediated by two leading companies
- How is the role of MSLs changing?
- How are other leading companies utilizing and protecting their MSL team?
- How are industry leaders building compliant MSL-KOL relationships?
- How are industry leaders protecting themselves from an external audit?
- How is MSL performance evaluated?
EXECUTIVE SUMMARY
EVOLUTION OF THE MSL ROLE
What do MSLs do?
Education versus promotion
REGULATIONS GOVERNING MSLS
US rules on off-label promotion
EU rules on off-label promotion
OFF-LABEL MARKETING CASES
A growing concern
Off-label prescribing
The clinician's perspective
Off-label strategies
CORPORATE INTEGRITY AGREEMENTS
Increased scope of CIAs
STANDARD OPERATING PROCEDURES
Firewalling
Clarification
What SOPs should address
Globalisation
MSL TRAINING
Frequency of training
TRACKING AND REPORTING SYSTEMS
Technological advances
COMPENSATION AND METRICS
Quantitative metrics
Qualitative metrics
CASE STUDY 1: MID-SIZE PHARMACEUTICAL COMPANY
CASE STUDY 2: MEDICAL DEVICE COMPANY
BOARD CONSIDERATIONS
ENFORCEMENT POLICIES
Enforcement policy in the UK
Enforcement policy in the US
Individual responsibility
ACKNOWLEDGEMENTS
EVOLUTION OF THE MSL ROLE
What do MSLs do?
Education versus promotion
REGULATIONS GOVERNING MSLS
US rules on off-label promotion
EU rules on off-label promotion
OFF-LABEL MARKETING CASES
A growing concern
Off-label prescribing
The clinician's perspective
Off-label strategies
CORPORATE INTEGRITY AGREEMENTS
Increased scope of CIAs
STANDARD OPERATING PROCEDURES
Firewalling
Clarification
What SOPs should address
Globalisation
MSL TRAINING
Frequency of training
TRACKING AND REPORTING SYSTEMS
Technological advances
COMPENSATION AND METRICS
Quantitative metrics
Qualitative metrics
CASE STUDY 1: MID-SIZE PHARMACEUTICAL COMPANY
CASE STUDY 2: MEDICAL DEVICE COMPANY
BOARD CONSIDERATIONS
ENFORCEMENT POLICIES
Enforcement policy in the UK
Enforcement policy in the US
Individual responsibility
ACKNOWLEDGEMENTS
