In light of the recent Letter to the Editor that I had sent to Pharmaceutical Representative magazine regarding its cover story on potential use of MSLs as part of a flexible sales force, here are what is available from Medical Science Liaison Institute on an in-depth discussion of MSL roles, risks, and “returns on investment”.

“Mitigating Off-Label Risk, OIG Scrutiny of MSL Role”
Introduction 3
Latest Developments in Off-Label Prosecution 3
Mitigating the Risk of Private Lawsuits for Off-Label Uses 4
Role of Office of Inspector General’s (OIG) in Monitoring Off-Label Activity and Promotion 6
Importance of Integrating Federal Trade Commission (FTC) Guidelines into a Corporate Compliance program 7
Dissemination of Off-Label Information within Frameworks of Current Case Laws, FDA Rules, and Company Policies 7
Definition of a Medical Science Liaison (MSL) Role and Evaluation of MSL Risk Tolerance Level 8
Conclusion 11

Expert Webinars: MSL Compliance Primer (2007 with Alan Minsk, 52 Minutes)
Main legal and compliance issues affecting MSL programs
Scientific exchange v. Promotion
FDA Regulations relating to Off-Label Promotion v. Scientific Exchange
Proactive v. Reactive MSL Activities
Early Commercialization v. Scientific Exchange
Off-Label in a Peri-Label Situation
Off-Label issues in Medical Device
Compliance Considerations in Medical Device
How Companies Know They’re in Trouble
What May be Audited in MSL Programs
Former Sales Reps as MSLs and the MSL Mindset
MSL Attitudes Toward Compliance
MSL Metrics in a Compliant Environment
When Do Companies Seek Outside Counsel?
Questions For Prospective Outside Counsel
Alan’s Parting Words of Wisdom

“Medical Science Liaison Roles: Enigma and Dilemma”
Introduction 3
A Medical Science Liaison on National TV 3
Moment of Truth Assessment for MSL Directors 4
Intent of Field-Medical Involvement 4
Reach and Frequency Directives 5
Whose Quota are These, Anyway? 5
Why MSL Roles Remain an Enigma 6
Lack of Guidance Driven by Industry and Governing Bodies 7
How “Safe” is Organizing MSL Programs Under Medical Affairs? 7
MSL Role: Substantive or Symbolic? 9
Expanding MSL Programs: Encouraging or Concerning? 9
A Matter of Culture and Self Examination 11

“Off-Label, Safe Harbors, and MSL Compliance”
Introduction 3
Quest for “Safe Harbor” 3
The FDAMA Effect 4
Where “Safe Harbor” is Not 4
What Effective Compliance Really Requires 6