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National Pharma Audioconference

National Pharma Audioconference. Bristol-Myers Squibb 2007 Settlement. Stephen J. Immelt, Esq. November 26, 2007. Overview. Key elements Investigative Approach Relator Issues State Process Corporate Integrity Agreement. Civil Settlement Agreement.

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National Pharma Audioconference

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  1. National Pharma Audioconference Bristol-Myers Squibb 2007 Settlement Stephen J. Immelt, Esq. November 26, 2007

  2. Overview • Key elements • Investigative Approach • Relator Issues • State Process • Corporate Integrity Agreement

  3. Civil Settlement Agreement • Extensive Alleged “Covered Conduct” Released • Apothecon payments to retailers and wholesalers • Former generic subsidiary • Divested in December 2000 • AWP allegations (23 drugs) • Payments to consultants (31 drugs) • FDA promotion allegations (Abilify) • Best Price reporting allegations (Kaiser private label)

  4. Civil Settlement Agreement • No admission of liability • $499 million • Announced $515 million includes agreed to interest (4.5% per annum) from the date of agreement in principle • ~$181 million allocated to states (plus accumulated interest) • Abilify FDCA release

  5. Resolution of Multiple Issues • Working toward a “global” resolution • What can be accomplished in today’s complex enforcement world • Advantages and disadvantages of a “global” approach • Keeping an eye on collateral aspects • States • Private civil litigation

  6. Philosophy and Approach • Establish credibility • Open and regular communication • Complete responses to government concerns • Facing facts • Prompt and complete voluntary disclosure of potential issues • Cooperation directed toward a genuine understanding of the issues • Development of sophisticated financial analysis to guide resolution • Active engagement on the facts, the medicine and the law

  7. Key Role of Compliance • Important demonstration of corporate mindset • Corrective actions prior to awareness of investigative interest • Discontinued certain programs • Developed new policies and procedures • Intensive implementation training • Efforts to address potential promotional concerns • Best-in-class compliance program • Involvement of compliance with investigative process • Open and active engagement

  8. Relator Issues • Eight (8) known related qui tam actions • Many actions include overlapping allegations • Certain actions filed subsequent to BMS’s voluntary disclosure • Scope of Relators’ release • Fees

  9. State Process • State share of Medicaid recovery (~ $181 million) • State sign-off required to resolve those claims • If not resolved, money reverts to BMS • Coordination with assigned NAMFCU Team • Negotiation of state settlement agreement • Roll-out to states • Overlapping AG AWP litigation

  10. Corporate Integrity Agreement • Required element of resolution • Evolving OIG expectations • Importance of having an effective compliance program in place • Pre-existing compliance structure • Pre-existing policies and procedures • Pre-existing extensive training program

  11. Corporate Integrity Agreement • Recognition of BMS internal monitoring capabilities • Internal review of records reflecting the content of detailing sessions, medical information requests, IME, and grants • BMS-run Field Force Monitoring Program • Contemplation that BMS’s internal audit work will substitute for certain required IRO transaction reviews • Only one Medicaid Drug Pricing Systems Review required • Clear map of IRO responsibility

  12. For more information onHogan & Hartson, please visit us at www.hhlaw.com Baltimore Beijing Berlin Boulder Brussels Caracas Colorado Springs Denver Geneva Hong Kong London Los Angeles Miami Moscow Munich New York Northern Virginia Paris Shanghai Tokyo Warsaw Washington, DC

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