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Managing the Money Trail in the Research Environment

Managing the Money Trail in the Research Environment. Seth B. Whitelaw Compliance Officer, Global R&D GlaxoSmithKline 14 November 2002. The Business Objective. Obtain the best possible data, in the shortest amount of time. The Challenges.

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Managing the Money Trail in the Research Environment

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  1. Managing the Money Trail in the Research Environment Seth B. Whitelaw Compliance Officer, Global R&D GlaxoSmithKline 14 November 2002

  2. The Business Objective Obtain the best possible data, in the shortest amount of time

  3. The Challenges • Managing the process to avoid compromises in patient safety, data integrity or engaging in commercial bribery • Demonstrating to the public, regulators, shareholders that the concern is understood and being addressed 24/7

  4. Clinical Trial Work IP Advisory Boards Speaking Fees Some Possible IncomeSources for Clinicians

  5. New Developments • TAP Pharmaceuticals Case • OIG Compliance Program Guidance • PhRMA Principles (Heather Stewart) • Post-marketing Studies (Heather Stewart)

  6. TAP Pharmaceuticals • Settlement of $875M • Criminal indictments • Corporate Integrity Agreement (7 years) • Educational Grants • Research Grants • Consulting and advising arrangements

  7. OIG Compliance Program Guidance:Risk Areas • Consultants and advisors • Grants for research and education • Gifts and gratuities • Vendors and other agents

  8. OIG CPG: Risk Areas (cont’d) • Consultants and advisors • Research, data collection, advisory boards, focus groups, speakers • Compensation only for “actual, reasonable and necessary services” not “token arrangements created to disguise otherwise improper payments.” • Manufacturers should “ensure appropriate documentation of the fair market value determination, as well as the performance of the services.”

  9. OIG CPG: Risk Areas (cont’d) • Grants for research and education • Particular risk “where they involve parties in a position to prescribe or order the manufacturer’s product …” • Gifts and gratuities • Must not exceed nominal value and not exceed fair market value for services rendered • Does not take “into account, directly or indirectly, the volume or value of business generated”

  10. OIG CPG: Risk Areas (cont’d) • Vendors and other agents • CO should “ensur[e] that independent contractors and agents … are aware of company’s compliance program …”

  11. OIG CPG: Compliance Activities • Education and training • OIG considers this to be a “must” do • Specific training on risk areas (those in guidance and those identified by other means) for employees associated with relevant activities • New employee and refresher training is important; failure to attend should result in disciplinary action; should be part of employee evaluation

  12. OIG CPG: Compliance Activities (cont’d) • Auditing and Monitoring • Flexibility on frequency and subject of audits; could be prospective or retrospective • Use of “internal or external evaluators who have relevant expertise” • Mechanisms for corrective action • Duty to investigate “reasonable indications of suspected noncompliance”

  13. What Does the Future Hold? • Pressure to achieve the business objective will increase. • The challenges will remain and grow more acute. • The demand for accountability will increase and become global. . The need for compliance programs tailored to the research environment will increase.

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