Evolution of Abuse-Deterrent Opioid Drug Products

January 30, 2018 2:45pm

Michael S. Labson
Partner
Covington & Burling LLP (Washington, DC)

Peter Mathers
Partner
Kleinfeld, Kaplan and Becker, LLP (Washington, DC)

  • Obtaining abuse-deterrent product labeling
    • How to properly promote abuse-resistant properties of drug products
    • Lessons learned from FDA’s decision to remove Opana ER from market
  • FDA-current policy position on abuse-deterrence and plans for the future
    • Comments on real-world outcomes with abuse-deterrent drugs
    • Reviewing relevant citizen petitions
    • Analyzing FDA Guidances related to abuse-deterrent formulations
  • Ensuring placement of abuse-deterrent formulations on formularies for similar price as standard formulations