Reassessing your Responsibilities in Light of the Changing Scope of Suspicious Order Monitoring Requirements

January 30, 2018 11:30am

Jodi Avergun
Partner, Chair, White Collar Defense and Investigations Practice Group Cadwalader, Wickersham & Taft LLP (Washington, D.C.)
Former Chief of Staff Drug Enforcement Administration Former Chief, Narcotic and Dangerous Drug Section U.S. Department of Justice Partner, Chair, White Collar Defense and Investigations Practice Group

Louis Milione
Senior Managing Director Guidepost Solutions LLC (New York, NY)
Former Assistant Administrator Office of Diversion Control Drug Enforcement Administration

  • Evaluating extent of manufacturer and distributor obligations for suspicious order monitoring
    • Development and implementation of suspicious monitoring programs
      • Must-have controls for internal monitoring and reporting programs
    • Understanding manufacturer responsibilities with respect to chargeback data
      • Reviewing recent DEA settlements addressing scope of duty to report
      • Challenges with manufacturers using hindsight data in monitoring
  • Understanding obligations under strict letter of the law vs. DEA expectations
    • Examining the language and legislative history of 21 C.F.R. 1307.74(b)
    • Analyzing the impact of Masters and its progeny
  • “Know your Customer” Best Practices
  • Predicting notice and comment rulemaking from DEA
  • Considering state requirements for suspicious order monitoring