Corporate Integrity Agreements (CIAs) serve as intelligible “tea leaves” as the government’s focus on commercial-related activities continues to lead to medical affairs activity scrutiny. Who would have thought that CIAs executed over the past several years related to commercial activities should be construed as putting the pharmaceutical industry on notice that the government would be shifting its focus to include medical and scientific affairs activities? As the rise of recent off-label investigations and subsequent CIAs continue to become public, it is clear from CIA provisions that the government will be heavily scrutinizing medical affairs departmental activities.

Recent trends within the industry provide for a period of unprecedented change. The increase in high-profile government investigations leaves little room for mistakes within the medical and scientific affairs arena, as well as within the pharmaceutical industry in general. As CIA provisions serve as “tea leaves,” all companies within the industry are on notice that proper proactive compliance initiatives across all business units are essential.

This presentation provides attendees with an in-depth look at the government’s enforcement focus on medical affairs activities through settlements and CIA provisions, offers a commercial and medical affairs activity overlap discussion, best practices, and a discussion around off-label marketing and the evolving role of the medical science liaison.

This audio conference covers:

• How and why off-label allegations are leading to medical affairs scrutiny and how recent settlements implicate the medical affairs functions
• Key CIA definitions and requirements, including how they each apply to roles, responsibilities and functions within medical affairs
• Risks associated with medical affairs and commercial activity overlap
• Insight into industry best practices
• The evolving role of the MSL, risks and rewards associated with proactive, reactive and hybrid roles, industry benchmarks and best practices

About the speaker:

Jamie L. Kendall, Esq. leads the legal department of CIS and has national and international law firm experience defending and advising pharmaceutical companies. Jamie has a broad knowledge of key industry-wide compliance risk areas, e.g., anti-bribery, anti-corruption (including financial interactions with Healthcare Professionals), off-label promotion and data privacy, and a keen understanding of how those risks impact pharmaceutical company activities in different functional areas (e.g., R&D, clinical, medical affairs, commercial). Jamie also assesses, develops, and implements training, monitoring and auditing programs as these risk areas continue to evolve.

Prior to joining CIS, Jamie was a senior associate with Morgan, Lewis & Bockius LLP in Philadelphia. Her practicing legal experience included the defense of lawsuits and government investigations involving alleged violations of the Office of Inspector General’s (OIG) guidelines and investigations related to alleged fraud and abuse, anti-kickback statutes and false claims acts. Notable legal representation included: Merck: Vioxx off-label government investigation; Pfizer: average wholesale price (AWP) litigation and government investigations including Corporate Integrity Agreement (CIA) implementations; AstraZeneca: Seroquel off-label government investigation and products liability litigation. Jamie has also assessed whether pharmaceutical company compliance programs, guidelines and regulations limit company exposure and/or would be considered adequate and reasonable to third parties.

Who should attend?

• Clinical Development VPs & Directors
• Clinical Development Managers
• Medical Affairs VPs & Directors
• Medical Affairs Managers
• Specialty Pharma
• Compliance
• R&D
• Legal