1. Bert Weinstein, VP, Corporate Compliance Purdue Pharma L.P.
Welcome to the 7th Annual Pharmaceutical Compliance Congress November 8-10, 2006
Bert Weinstein, VP, Corporate Compliance
Purdue Pharma L.P.

2. Overview
Housekeeping Matters
The Pharma Compliance Environment
The False Claims Act
The Deficit Reduction Act
Corporate Integrity Agreements (CIAs)
State Laws
Prescriber Data
New Institutional Policies
The Pharmaceutical Compliance Forum

3. The Pharma Compliance Environment
Negative news coverage regularly focuses on claimed misdeeds, influence, pricing, promotion, meals, gifts
Product liability jury verdicts are a barometer of public sentiment
Federal and state prosecutors, lawmakers, and regulators are highly focused on the pharmaceutical industry
Creative US Attorneys are exploring FCA fraud theories
Fraud on the FDA in obtaining / retaining approval
Fraud on Government payor programs: “This is not the branded product or quality we thought we were buying”

4. The Pharma Compliance Environment
“Pharma enforcement is bigger and broader than any other prior enforcement effort” (Lawrence Freedman, former DOJ, Asst. Dir., Fraud Section)
Compliance is no longer “voluntary” under the Federal Sentencing Guidelines and the OIG Compliance Guidance
Government is moving to mandated compliance programs through laws, cases, and oversight

5. The Pharma Compliance Environment
The False Claims Act
Pharma recoveries in excess of $5.8 Billion since 2001
More than 150 active pharmaceutical industry whistleblower cases
Size and number of recoveries to increase
The Deficit Reduction Act of 2005 (eff. 1/07)
The pharma equivalent of “sowing dragon’s teeth”
Incentivizes state False Claims Acts
Mandates employee handbook coverage of whistleblowing

6. Over $1.5 Billion in pharma settlements in the past 12 months alone!
Date Company Claims Settlement ($M)
10/06 InterMune Off-label promotion $ 37
10/06 Medco Kickbacks, false claims $155
8/06 GSK Inflated AWP $ 70
8/06 S-P BP, kickbacks, off-label promotion $435
12/05 Lilly Off-label promotion $ 36
11/05 King Underpayment of rebates $124
10/05 Serono Kickbacks, off-label promotion $704
$1,561

7. Pharma litigation is big business!
Bottom Line:
Pharma litigation is big business!

8. Compliance with State Laws
Mandated reporting of expenditures related to gifts and advertising, registration of clinical trials, publication of trial results, declarations of compliance programs
California, D.C., Maine, Minnesota, Vermont, West Virginia
Many more proposed - If no state law currently exists, there will likely be one in the future
What’s consistent? They are all different.
Feeling good about your expense reporting capability?

9. Restrictions on Prescriber Data
New Hampshire law (6/30/06) – prohibits reporting of prescriber data
AMA’s Prescriber Data Restriction Program (eff. 7/1/06) – doctor “opt out” program started April 2006 (approx MDs opted out as of 11/1)

10. Institutional Policies
Several institutions have developed new policies prohibiting meals, gifts, access to institutions
and / or providers
Yale Medical Center
Hospital of the University of Pennsylvania
Stanford Medical Center
Kaiser
University of California, Davis?
Access fees, parking fees, make a donation…
Don’t forget gift and meal restrictions at government facilities

11. If you’re a compliance person,
2007 and Beyond?
If you’re a compliance person,
You won’t be bored

12. The Pharmaceutical Compliance Forum
First met in 1999 with 10 compliance officers
Today, over 150 members and over 50 companies
Our mission is to promote compliance, ethics, and industry best practices, and effective compliance and ethics programs
Meetings twice each year
Focused on open dialogue and benchmarking
See us at

13. Special thanks to: PCF co-chairs, planning committee, and members
Our Speakers
The Grantors
And all of you in the audience,
… for participating in this year’s Pharma Congress

14. A few Audience response questions before our first speaker
Finally
A few Audience response questions
before our first speaker