Compliance and FMV - Seth Whitelaw

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Compliance and FMV - Seth Whitelaw

  1. 1. Seth B. Whitelaw, J.D., LL.M. January 12, 2010
  2. 2. Disclaimer <ul><li>The views expressed in this presentation are solely those of the presenter and do not necessarily represent the position of GlaxoSmithKline. </li></ul>1/12/2011 The State of Clinical Development Costs
  3. 3. <ul><li>The Impact on Clinical Operations </li></ul>1/12/2011 The State of Clinical Development Costs
  4. 4. Opening Considerations <ul><li>Generally </li></ul><ul><ul><li>Not “business as usual” </li></ul></ul><ul><ul><li>Your life is no longer yours – It is governed by the terms of the CIA </li></ul></ul><ul><li>Negotiating </li></ul><ul><ul><li>The words are important </li></ul></ul><ul><ul><li>Lawyers on both sides frequently don’t have the expertise to understand the R&D world </li></ul></ul>1/12/2011 The State of Clinical Development Costs
  5. 5. AstraZeneca CIA – April 2010 <ul><li>$520 M in civil penalties to settle charges of promoting anti-psychotic drug Seroquel for off-label uses </li></ul><ul><li>Impact on R&D </li></ul><ul><ul><li>VP of Medical Affairs and direct reports must sign annual certifications </li></ul></ul><ul><ul><li>Requires annual predetermined plans for consultants post-marketing clinical trials, ISSs, scientific publications and grants </li></ul></ul><ul><ul><ul><li>Compliance must review and approve all plans </li></ul></ul></ul><ul><ul><ul><li>Annual audits required </li></ul></ul></ul><ul><ul><li>Posting of payments to healthcare professionals and institutions </li></ul></ul>1/12/2011 The State of Clinical Development Costs
  6. 6. The (Near)Future <ul><li>CIA’s will continue to impact R&D especially as R&D and Commercial Operations become more closely aligned due to operational necessity </li></ul><ul><ul><li>Allergan (Aug. 2010)& Elan (Dec. 2010) CIA’s </li></ul></ul><ul><ul><li>“ Mind the Gap” </li></ul></ul><ul><ul><li>Next big area will be research fraud – pay attention to results that don’t look right </li></ul></ul><ul><ul><li>Michael Loucks, ex-AUSA in Boston District Office </li></ul></ul>1/12/2011 The State of Clinical Development Costs
  7. 7. <ul><li>Fair Market Value Considerations </li></ul>1/12/2011 The State of Clinical Development Costs
  8. 8. Why Apply FMV Principles to Clinical Services? <ul><li>Good business </li></ul><ul><ul><li>Do you know where & how your money is being spent? </li></ul></ul><ul><ul><li>Are you getting value for the cost? </li></ul></ul><ul><li>Federal Sunshine Act Provisions </li></ul><ul><ul><li>Will “research” encompass payments for clinical services? </li></ul></ul><ul><li>Anti-bribery/Anti-corruption </li></ul><ul><ul><li>FCPA </li></ul></ul><ul><ul><li>UK Bribery Act </li></ul></ul>1/12/2011 The State of Clinical Development Costs

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