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Audioconference Agenda

National Pharma Audioconference: Ten Emerging Risk Areas for Drug and Device Companies

  • Wednesday, June 16, 2010
1:00 pm - 2:30 pm (Eastern)
12:00 pm - 1:30 pm (Central)
11:00 am - 12:30 pm (Mountain)
10:00 am - 11:30 am (Pacific)

The Audioconference agenda is set forth in Eastern Daylight Time below:
(See Faculty Materials page for background reading and information)

1:00 pm Introductions
Matthew Hay (Moderator)
1:05 pm Discussion of Emerging Risk Areas
Daniel R. Miller, Esq.
William A. Sarraille, Esq.
  1. New trends in off-label marketing suits:
    1. The overall pace of pharma qui tams and the rise in state qui tams
      Where are the Part D cases?
  2. The rise in medical device qui tams
    1. A review of the Seroquel case
    2. A review of the TOBI case
    3. Wyeth Rapamune suit
  3. Prosecutors target the science behind off-label uses
  4. The growing risks associated with individual prosecutions and certifications
  5. The threat of third-party payor suits in the wake of Pfizer's $142 million jury verdict
  6. How the RICO statute is becoming the latest weapon in the prosecutorial arsenal
  7. Understanding the increasing importance of interactions with payers, pharmacies and others
  8. Assess the potential impact of disclosures under the Sunshine Act
  9. How changes in the False Claims Act may increase corporate exposure
  10. The rising threat of Foreign Corrup Practices Act cases
2:05 pm Questions & Answers
2:30 pm Audioconference Adjournment




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