1. 2006 PHARMACEUTICAL REGULATORY AND COMPLIANCE CONGRESS NOVEMBER 9,2006
Ten Reasons Why Off-Label Promotion Is Still A Compliance Problem
2006 PHARMACEUTICAL REGULATORY AND COMPLIANCE CONGRESS NOVEMBER 9,2006
James G. Sheehan
Associate U.S. Attorney
US Attorney’s Office

2. DISCLAIMER My opinions, not Department of Justice policy
In cases where there has not been a trial or guilty plea, Government has duty to present evidence and carries burden of proof at trial, if defendants elect a trial
Allegations of indictment or complaint are not evidence

3. Let us assume that eventually, Congress, the courts, or the FDA may decide that truthful (intent), accurate (factual), non-misleading(?) communications about off-label uses will be permitted . . .

4. Even though it is not the law now . . .
United States v. Caputo WL (N.D. Ill. 10/21/03)
“This Court believes that permitting defendants to engage in all forms of truthful, non-misleading promotion of off-label uses would severely frustrate the FDA’s ability to evaluate” off-label uses.
Conspiracy count to introduce “misbranded” device into commerce through use of off-label information upheld

5. Ten reasons why off-label communication would still be your compliance problem

6. Who in the company will develop the communication?
10.
Who in the company will develop the communication?

7. Who in the company will oversee the communication process?9.
Who in the company will oversee the communication process?

8. Who in the company will review the communication prior to delivery?8.
Who in the company will review the communication prior to delivery?
Truthful
Not misleading

9. 7.
Who in the company will consider whether the communication is misleading, under all the circumstances ?

10. Who in the company will oversee each person communicating?6.
Who in the company will oversee each person communicating?
ABBOTT and CAREMARK responsibilities for Board and senior management
Marketing and sales managers overseeing successful reps
Internal controls, audit, outside auditor and counsel

11. 5.
Who will have ongoing responsibility for assuring that off-label communication, as a whole, is not misleading or untruthful?
New studies
Adverse events
Funded studies
Clinical registry
Unreported results
Negative evidence about drug - no more hide behind label

12. 4.
Who will have responsibility for writing the “risks” section of SEC filings relating to off-label promotion?

13. Which physicians will receive the off-label communication?3.
Which physicians will receive the off-label communication?
Specialties
Community vs. academic medical centers
Physicians involved in thought leader activities

14. 2.
Is it misleading to promote a drug when you don’t know whether it will work?
Deaths
Incurable diseases
Lack of clinical evidence/support in traditional FDA format
Outcomes research?

15. 1.
Who is the vice-president in charge of going to jail if misleading or untruthful?
In Caputo, the compliance officer is going to prison for seven years.