Off-label Promotion: Managing the Regulatory Risks

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Presentation transcript:

Off-label Promotion: Managing the Regulatory Risks Pharma Congress 2003 National Audio conference October 2, 2003 Michael Misocky, R.Ph., J.D.

Off-label Promotion What is it? Know it when you see it! Inconsistent with or contrary to approved product labeling (includes but not limited to indications for use, dosing, special patient populations)

Off-label Promotion When is it not “promotion”? Scientific Exchange (see 21 CFR 312.7) (could include press releases, scientific reprints, and medical education) Unsolicited requests Safe harbors (Independence Criteria for CME and FDAMA Section 401 or 21 CFR Part 99)

Off-Label Promotion What are the regulatory and other risks? FDA Warning or Untitled Letters (could warrant corrective campaign) Mandatory preclearance (of all promotional materials) Dept of Justice Civil or Criminal Proceedings (for misbranding) Class Action Lawsuits False Claims Act (Medicaid Fraud)

Off-label Promotion Managing the risks Get a handle on “all” activities (concerted campaign) Review training materials (similar rigor and scrutiny as promotional materials) Find a safe harbor and dock there First amendment protection for scientific reprint dissemination Mandatory promotional compliance training program