Off-Label Liability: Legal and Compliance Issues

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Presentation transcript:

Off-Label Liability: Legal and Compliance Issues

Statutory Provisions Three Theories FDCA § 502(a), 21 U.S.C. § 352(a): A drug shall be deemed to be misbranded if its labeling is false or misleading in any particular FDCA § 502(f)(1), 21 U.S.C. § 352(f)(1): A drug shall be deemed to be misbranded unless its labeling contains adequate directions for use FDCA § 505(a), 21 U.S.C. § 355(a): No new drug may be introduced or delivered for introduction into interstate commerce without a new drug application (NDA) or abbreviated NDA

“Safe Harbors” FDA Policies “Scientific exchange” (21 C.F.R. § 312.7) Example: dissemination of scientific findings in scientific or lay media Responses to unsolicited requests Dissemination in accordance with the CME guidance Dissemination in accordance with reprints guidance

Federal Prosecutors are Pursuing the Dissemination of Off-Label Information as Criminal and Civil Misconduct The following major pharmaceutical manufacturers among others have disclosed that they currently are being or have been investigated for alleged off-label promotion of their drugs: Abbott Labs Johnson & Johnson Amgen Eli Lilly AstraZeneca Novartis Cell Therapeutics Pfizer Forest Sanofi-Aventis Genentech Schering-Plough GlaxoSmithKline Wyeth Intermune There are numerous other drugs under investigation.

Federal Prosecutors are Pursuing the Dissemination of Off-Label Information as Criminal and Civil Misconduct In these cases and investigations, the government has pursued criminal off-label charges that do not require a showing of false or misleading representations or other inherently wrongful conduct Instead, the government focuses on all off-label dissemination, including conduct that FDA generally permits Scientific exchange Responses to unsolicited requests Dissemination of enduring materials Continuing Medical Education

Federal Prosecutors are Pursuing the Dissemination of Off-Label Information as Criminal and Civil Misconduct On-label Off-label Truthful, Non-Misleading Untruthful or Misleading

Federal Prosecutors are Pursuing the Dissemination of Off-Label Information as Criminal and Civil Misconduct Government also pursuing alleged off-label promotion under the civil False Claims Act See United States’ Statement of Interest in United States v. Rost Government’s theory cast into doubt by Supreme Court’s decision in Allison Engine Co. v. United States ex rel. Sanders (June 9, 2008)

A Few Guiding Principles for Compliance FDA is the least of your problems One size does not fit all All information dissemination has risk Consider a portfolio approach to risk Be thoughtful about the risks you take

The Future Clarity from the courts? The future of the reprint guidance and further action by FDA Possible clarity from the Department of Justice? Was the communication truthful and not misleading? Were patients harmed? Was FDA approval pursued and\or secured?