1. Trends: Two Months & Four Settlements That Have Changed Our World
John T. Bentivoglio
Copyright, King & Spalding LLP, 2008

2. Cautionary Notes
All of the factual information discussed regarding the recent settlements is based on publicly available information
None of the information shared today about identifiable companies reflects non-public or “inside” information
Much of the information discussed today is based on settlement documents, complaints, DOJ statements and related materials – caution is appropriate with respect to whether these documents provide a complete, accurate, and/or fair depiction of the conduct of any company or individual
The focus of this presentation is on the settlement requirements – not at the conduct giving rise to the settlements.
Many of the practices and/or requirements in the settlements involve practices the companies adopted prior to the settlements.

3. Key Compliance Standards, Processes
Pfizer
DTC Advertising
Content and use of detailing materials
Compliance with ACCME standards
Financial disclosure by speakers
CME funding
Authorship of manuscripts
Patient testimonials
Detailing practices for multiple products
Prohibition on mentorships
Conduct, disclosure of clinical studies
Medical information letters, MSLs
Reprint practices
Grant review and approval
Samples
Lilly
Promotional activities
Dissemination of medical information
Response to unsolicited requests for information
Reprints
Healthcare economic information
CME and grants
Payments to consultants and speakers
Product samples
Clinical research

4. Key Compliance Standards, Processes
Merck
Clinical trial registry
Written or oral promotional claims (including regarding JV products)
DTC requirements
Presentation of clinical data in marketing, promotional pieces
ACCME compliance, CME practices
DSMB requirements
Authorship of Merck-sponsored articles, manuscripts
Cephalon
Board oversight
Management certifications
Disclosure of HCP payments
Notification to HCPs

5. Pfizer Settlement with State Attorneys General
Summary
$60 million to resolve civil allegations involving promotional practices
Products: Bextra® and Celebrex®
33 States and the District of Columbia
Investigations pursued under state consumer fraud statutes
No admission of liability or wrongdoing of any kind

6. DTC Advertising

7. Dissemination of Study Results

8. Conduct, Funding of Clinical Trials

9. Continuing Medical Education Activities

10. Continuing Medical Education Activities (cont’d)

11. Medical Information, MSLs

12. Marketing Practices, Samples

13. Medical Education Grants

14. Medical Education Grants (cont’d)

15. Lilly Settlement with State Attorneys General
Summary
$62 million to resolve civil allegations involving promotional practices
Product: Zyprexa®
32 States and the District of Columbia
Investigations pursued under state consumer fraud statutes
No admission of liability or wrongdoing of any kind

16. Promotional Slide Kits

17. Dissemination of Medical Information

18. Dissemination of Medical Info (cont’d)

19. Responding to Unsolicited Requests

20. Responding to Unsolicited Requests (cont’d)

21. Payments to HCPs

22. Samples

23. Clinical Studies

24. Cephalon Corporate Integrity Agreement
Summary
$425 million in fines and penalties to resolve off-label promotion allegations
Misdemeanor plea under FDCA
Products: Actiq®, Gabitril®, and Provigil®
5-year CIA

25. Compliance Program Oversight

26. Compliance Program Oversight (cont’d)

27. Management Certifications

28. Management Certifications (cont’d)

29. Reporting of HCP Payments

30. Notification to HCPs

32. We Knew Some of This Was Coming …
NY AG Settlement with GSK Requiring Clinical Trial Disclosure
August 26, 2004

33. HHS OIG Guidance
April 2003

34. More Recently … HHS OIG Testimony on Physician- Industry Relationships
February 27, 2008

35. Important Take-Aways
Recent state settlements have established important benchmarks for pharmaceutical sales, marketing, and medical information practices
Not required as a matter of law
May be viewed as de facto safe harbors (i.e., if you comply with these standards, could be difficult for federal or state agencies to take action)
Definitely should be considered in establishing company policies, procedures and practices
Compliance issues extend beyond sales and marketing -- extending into medical affairs, clinical research
Several trends are powerful -- and unlikely to abate in near term
Disclosure, transparency (payments, clinical studies)
Internal compliance certifications (DPAs, Cephalon)
Requirement to take corrective action
Board, management accountability
These settlements provide insight on possible/likely future requirements … we should use them to bolster current compliance programs

36. Again, please remember my cautionary notes …
Questions?

37. Biography -- John T. Bentivoglio
John Bentivoglio is a partner in the firm’s Washington, D.C., office and serves as Co-Chair of the FDA/Healthcare Group. His practice focuses on assisting pharmaceutical, medical device, and biotechnology manufacturers in three broad areas: FDA and healthcare regulatory counseling, compliance program development and implementation, and representation of companies in civil and criminal investigations by federal and state law enforcement agencies. On the regulatory side, he advises companies on federal and state anti-kickback laws, FDA advertising and promotional rules, drug pricing and reporting, and Medicare reimbursement issues. He has assisted numerous companies in developing, implementing and assessing corporate compliance programs in line with U.S. Sentencing Commission and HHS Office of Inspector General Guidelines, and with state compliance program laws and regulations. And he has represented pharmaceutical and medical device manufacturers in investigations by U.S. Attorney’s Offices in Massachusetts, New York, Maryland, Philadelphia, and California.
From , he served as Associate Deputy Attorney General and Special Counsel for Healthcare Fraud at the U.S. Department of Justice. In these capacities, he advised the Attorney General and Deputy Attorney General on national enforcement initiatives, healthcare investigation and prosecution policies, interagency coordination, and related issues. Earlier in his career, Mr. Bentivoglio served as a professional staff member to the Chairman of the U.S. Senate Committee on the Judiciary, where he handled criminal law and procedure, white-collar crime issues (including healthcare and financial fraud), and international crime and terrorism legislation.