Speaking Engagement

Avoiding Indictment When the FDCA is Violated

American Conference Institute’s 7th National Forum on Off-Label Communications

14 Jul 2010 10:15 a.m. - 11:30 a.m.

The Union League
140 South Broad St.
Philadelphia, PA 19102

In the last twelve months, several major pharmaceutical and device companies have been assessed record-breaking fines by the government for off-label promotion. Penalties are not stopping at just fines. The states are now going after individuals responsible for corporate compliance programs and drug advertising. Increasingly complex Corporate Integrity Agreements are becoming part of negotiated settlements. In addition, pharmaceutical and medical device companies are becoming extremely vulnerable with their global operations, which are under great scrutiny from federal and state prosecutors, members of Congress, and potential whistleblowers. If your company isn’t up to speed on the latest FDA guidance and interpretation of the rules, yours could be the next company landing in the headlines. To manage off-label risks with confidence and mitigate potential liability, you must be savvy with regard to what conduct is triggering government investigations and litigation, and how you need to adjust your compliance efforts and be ready to defend against any investigation or claim.
American Conference Institute’s 7th National Forum on Off-Label Communications will provide you with the most up-to-date tools for tackling the challenges associated with drug and device promotion. You will hear about successful compliance plans, effective business practices, and winning litigation tactics from leading in-house counsel, compliance and regulatory officers, and expert attorneys who represent the pharmaceutical and device industries. In addition, leading government prosecutors will be on-hand to provide insights on recent government investigations.
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