2006 PHARMACEUTICAL REGULATORY AND COMPLIANCE CONGRESS NOVEMBER 9,2006

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Presentation transcript:

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 215-861-8301 Jim.Sheehan@usdoj.gov

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

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 . . .

Even though it is not the law now . . . United States v. Caputo 2003 WL 22431547 (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

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

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

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

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

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

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

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

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

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

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?

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.