Day 1 – Tuesday, March 27, 2012
8:15 Registration and Continental Breakfast
9:00 Co-Chairs’ Opening remarks
Andy Rittenberg
Senior Director, Legal
Gilead Sciences (Foster City, CA)
Brien O’Connor
Partner
Ropes & Gray, L.L.P. (Boston, MA)
9:15 Avoiding Individual Accountability: How to Steer Clear of Prosecution and Exclusion Under the responsible Corporate Officer Doctrine
Andy Rittenberg
Senior Director, Legal
Gilead Sciences (Foster City, CA)
Gary Giampetruzzi
Assistant General Counsel
Head of Government Investigations
Pfizer, Inc. (New York, NY)
Mark Mansour
Partner
Akin, Gump, Strauss, Hauer, & Feld, L.L.P. (Washington, DC)
Joseph Savage, Jr.
Partner
Goodwin Procter, L.L.P. (Boston, MA)
Ronald Levine
Partner – Chair, White Collar Defense
Post & Schell, P.C. (Philadelphia, PA)
- Reviewing the criteria under the Park Doctrine defining who is a responsible corporate officer
- What will inform the discretion of the US Attorney’s Office for the exclusion power?
- Understanding the government’s use of a strict liability regime without evidence of intent or knowledge of wrongdoing
- Examining the exclusionary period and what it means in light of the Purdue Pharmaceuticals case
- Analyzing the rationale for the lengthy exclusion period granted by the OIG
- Discussing the appeal sought by the executives
- Examining the attempt to exclude Forest Laboratories CEO Howard Solomon
- Investigating the efficacy of outside counsel in providing guidance on avoiding liability under the Park Doctrine
- Evaluating which actions by officers are most likely to draw scrutiny from the OIG
- The importance of a paper trail
- Understanding and following OIG guidance
- Industry and state codes of conduct
- Decreasing blatant behavior
10:45 Refreshment Break
11:00 Light at the End of the Tunnel? Recent Court Cases and the Saga of Off-Label Promotion Enforcement
Paul Kaufman
Assistant U.S. Attorney
Chief of Civil Healthcare Fraud
U.S. Attorney’s Office, Eastern District of New York (Brooklyn, NY)
Brien O’Connor
Partner
Ropes & Gray, L.L.P. (Boston, MA)
Nicholas Harbist
Partner
Blank Rome, L.L.P. (Princeton, NJ)
Lisa Noller
Partner
Foley & Lardner, L.L.P. (Chicago, IL)
- Discussing the outcome in Sorrell v. IMS Health
- Analyzing the opinion of the court
- What does the Court’s endorsement of First Amendment rights here mean for off-label marketing enforcement?
- The outcome in Sorrell and its implications for U.S. v. Caronia
- Analyzing the claims made in Par Pharmaceuticals, Inc. v. U.S. Food and Drug Administration
- How does the outcome in Sorrell impact Par’s claim?
- Assessing Par’s likelihood of victory
- Identifying activities that invite government scrutiny in off-label promotion
- Training the sales force to respond to professionals’ off-label inquiries appropriately
- Avoiding the impression that off-label discussions by promotional speakers have not been prompted by the company
- Preparing for situations where off-label marketing concerns are tied to kickback accusations
12:15 Networking Lunch
1:45 Analyzing the Broadened Use of the False Claims Act (FCA) and Its Implications for Pharma
Wendy L. Weiss
Assistant U.S. Attorney, Civil Fraud Section
U.S. Attorney’s Office, Central District of California (Los Angeles, CA)
Hope Foster
Member
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. (Washington, DC)
William Escobar
Partner
Kelley Drye & Warren LLP (New York, NY)
Sarah Kelly
Partner
Nutter, McLennen, & Fish, L.L.P. (Boston, MA)
- Responding to the expansion of the False Claim Act’s uses by prosecutors
- The impact of healthcare reform
- The continued use of the FCA in mislabeling cases
- The new utilization of FCA prosecution when foreign facilities fail to follow GMP standards
- Case study: the failure of a GSK facility in Puerto Rico to comply with GMP
- Crafting and implementing an effective whistleblower policy
- Determining whistleblower identity
- Proceeding when the whistleblower remains anonymous
- Evaluating whistleblower credibility in individual cases
- Complying with federal and state law in creating a whistleblower policy
- Evaluating the reputation risk inherent in cases brought under the FCA
- The impact of the 60 day clawback provision in the FCA
- Scrutinize the Court of Appeals for the 1st Circuit’s decision in Hutchison v. Blackstone
- Detailing the new analytical framework utilized by the Court
- Contrasting the Court’s reasoning with those of other circuits
- What does this mean for FCA prosecutions?
3:00 Networking and Refreshment Break
3:30 Pharma and the Social Network: Methods for Utilizing Social Media to Promote Pharmaceuticals Under Existing Regulations and Expert Discussion on the Eventual FDA Guidelines
Tamara Joseph
Senior Vice President, General Counsel and Secretary
Cubist Pharmaceuticals, Inc. (Lexington, MA)
John Serio
Partner
Seyfarth Shaw, L.L.P. (Boston, MA)
- Divining the rules that may be propagated on social media marketing
- What will the eventual FDA guidance look like?
- Preparing for the FDA guidance and ensuring flexibility to respond appropriately depending on whether such is restrictive or permissive
- What sort of practices must be employed to ensure statements not made by a company on sponsored sites are not attributed to that company?
- Keeping track of internet marketing to ensure rules are not violated
- Assigning responsibility for monitoring social media
- Creating parameters for responding to off-label and other inquiries in chat rooms, message boards, and other media
- Examining the phrasing and word choice that has triggered government scrutiny in the past
- Utilizing best practices for presenting accurate and balanced information on social media
4:15 Designing and Implementing Effective Compliance Programs to Minimize Litigation and reputation risks
Jennifer M. Razor
Senior Counsel
Abbott Laboratories (Abbott Park, IL)
Jack Tanselle
Managing Director
Healthcare and Life Sciences Disputes, Compliance & Investigations
Navigant (Indianapolis, IN)
Allen P. Waxman
Partner
Kaye Scholer, L.L.P. (New York, NY)
- The essentials of a good compliance program
- Crafting a successful training protocol
- Integrating international laws into corporate compliance policies and training
- Ensuring that managers and supervisors fully understand the compliance system in place
- Developing methodologies for vetting distributors
- Measuring effectiveness of compliance programs
- Navigating the myriad laws governing compliance
- In numerous foreign countries
- Among the states domestically
- Implementing auditing systems to ensure compliance
- Deciding on an auditor
- Auditing procedures associated with a CIA
- Audits of risk areas specifically identified in the compliance program
5:15 Conference Adjourns to Day 2
Day 2 – Wednesday, March 28, 2012
8:00 Continental Breakfast
8:45 Co-Chairs’ Opening Remarks
9:00 Government Spotlight: Identifying Federal and State Enforcement Priorities
Robert O’Neill
U.S. Attorney
U.S. Attorney’s Office Middle District of Florida (Tampa, FL)
Amy Berne
Chief, Civil Division
U.S. Attorney’s Office Northern District of Georgia (Atlanta, GA)
Susan Winkler
Chief, Criminal Health Care Fraud Unit
U.S. Attorney’s Office District of Massachusetts (Boston, MA)
Alex Kriegsman
Assistant U.S. Attorney Civil Division and Health Care Fraud Coordinator
U.S. Attorney’s Office, District of New Jersey(Newark, NJ)
Jack W. Pirozzolo
First Assistant U.S. Attorney
U.S. Attorney’s Office, District of Massachusetts(Boston, MA)
Moderator:
Stephen A. Mansfield
Partner
Akin, Gump, Strauss, Hauer, & Feld, L.L.P. (San Francisco, CA)
Hear from top government officials who are actively involved in the pursuit of fraud and abuse cases as they discuss:
- Examining the latest actions brought by federal prosecutors and agencies
- Investigating the government’s continued interest in holding individuals to account
- Considering the government’s continued emphasis on off-label marketing
- The increase in enforcement activity
- The government’s use of whistleblowers under an expanded FCA
- Analyzing the OIG’s use of detailed statistical analysis in finding fraud
- Insights into the government’s future motives in directing enforcement activity
10:30 Refreshment Break
10:45 Case Study: the Indictment, Prosecution, and Acquittal of Lauren Stevens and What It Means for Corporate Counse
Paula Taylor-Whitfield
Deputy General Counsel
Eli Lilly & Co., Inc. (Indianapolis, IN)
Benton Campbell
Partner
Latham & Watkins, L.L.P. (New York, NY)
Emily Schulman
Partner
Wilmer, Cutler, Pickering, Hale, and Dorr, L.L.P. (Boston, MA)
- Recounting the case
- Ms. Stevens’ first dismissal and re-indictment
- The facts presented to the court
- The prosecution’s arguments against Ms. Stevens
- Her directed acquittal
- Dissecting the opinion of the presiding judge in her case
- What was the judge’s rationale for the directed acquittal?
- How will the judge’s opinion impact future indictments of officers and counsel?
- The fall-out from Ms. Stevens' criminal charge and eventual acquittal
- Discussing the “chilling effect” this case has had on corporate counsel in the pharmaceutical industry
- Analyzing the case’s impact on future responses to government inquiries by corporations
12:00 Networking Lunch
1:30 Addressing and Overcoming Kickback Allegations in Dealings with Clinicians and Other Healthcare Professionals
Jacqueline Mayhew
Director, Medical Education Group External Medical Communications
Pfizer, Inc. (New York, NY)
Antonia F. Giuliana
Partner
Kelley, Drye, & Warren, L.L.P. (New York, NY)
John W. Jones, Jr.
Partner
Pepper Hamilton, L.L.P. (Philadelphia, PA)
- The lowering of the intent standard in healthcare reform
- The elimination of intent to commit or knowledge of a kickback violation in the PPACA
- The expansion of the FCA to cover kickbacks
- The expected increase in whistleblower qui tam cases on kickbacks under the FCA
- Developing best practices for separating medical and sales functions
- Under what circumstances will educational activities trigger government enforcement?
- Grants and charitable contributions
- Support of associations
- Continuing medical education
- Speaker bureau arrangements
- Clinical trials
- Articles
- The consequences of increased enforcement scrutiny on alleged kickbacks
- Acting appropriately in absence of a de minimus standard to effectuate the anti-kickback statute
2:45 Refreshment Break
3:00 Best Practices for Complying with Corporate Integrity Agreements (CIAs)
Seth Rodner
Senior Vice President General Counsel, and Corporate Secretary
Medicis Pharmaceutical Corporation, Inc. (Scottsdale, AZ)
Jim Vollins
Assistant General Counsel
Talecris Biotherapeutics, Inc. (Research Triangle Park, NC)
Holly Pierson
Partner
Morris, Manning, & Martin, L.L.P. (Atlanta, GA)
- Analyzing the parts of a typical CIA
- Determining the ramifications for multi-violators
- Negotiating a CIA to ensure that your company can comply with all its provisions
- What portions of a CIA will the OIG consider non-negotiable?
- Keeping an eye out for provisions that are difficult or impossible to comply with
- Designing protocols for complying with a CIA
- Adopting a useful framework for a compliance program
- Communicating effectively with the OIG during the pendency of a CIA
- Understanding the key differences between issued CIAs
- Why the differences exist
- Identifying the unique nature of each CIA even when they are similar
4:00 Implementing a Training and Monitoring Program to Minimize the Inherent Risks Accompanying a Sales Force in the Field
Damon Strickland
Advisor, US Ethics & Compliance
Eli Lilly & Co., Inc. (Indianapolis, IN)
Gary Mendelsohn
Asst. Field Director, Corporate Compliance
Astellas US, L.L.C. (Deerfield, IL)
- Determining the effects of continued restriction of sales rep access to healthcare professionals
- Detailing the trend towards limiting sales rep access to doctors and other professionals
- Outlining what are now acceptable contacts
- Monitoring field-based personnel to ensure that the company is not engaging in off-label promotion
- Conducting frequent ride-alongs with sales reps
- Establishing sanctions and disciplinary actions for non-compliance
- Educating the sales force adequately on the compliance risks of drugs they are promoting
- Teaching the sales force how to best interact with a physician who uses a drug for both on and off-label purposes
- e pharmaceutical industry
- Does this new regime pressure reps to violate rules?
- How must pharma companies change to meet their sales targets?
5:00 Conference Concludes
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