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FDA and DEA Regulation of Opioid Drugs and the Opioid Crisis *In-Person at D.C. Bar*

Date(s):
June 14, 2018
Description:
Credit: 2.0 Credit Hours
 
Description: This course addresses the regulation of opioid drugs and the legal issues involved in combating the current U.S. opioid crisis. Faculty will discuss how the U.S. Food and Drug Administration (FDA) regulates and approves opioid drugs, including drugs intended to counteract addiction. We will also discuss how the U.S. Drug Enforcement Administration (DEA) schedules opioid drugs and develops annual quotas and how the American Medical Association (AMA) and its doctors interact with the regulators at the FDA and DEA. Topics include:
• FDA approval of drugs including opioids with abuse deterrent mechanisms
• FDA's use of Risk Evaluation and Mitigation Strategies (REMS)
      •  Overview of REMS Authority
            • Current Opioid REMS and Planned Expansion
            • Considerations/Challenges with Further REMS Authority for Opioids
                     o Use of methadone, buprenorphine, and other medications to rehabilitate patients addicted to pain                         medications
                     o How DEA scheduling of drugs and quotas affect the availability and use of opioid drugs
      • Controlled Substances Act: Checks & Balances
      •   Drugs of Abuse
      • Diversion Control Division
      • AMA and Physicians’ Interaction with FDA/DEA Regulation of Opioids
      • Physician Prescribing of Opioids and Best Practices
      • Role Addressing Opioid Epidemic
  • Proposed bills, regulations, and guidance to reduce opioid abuse
  • Criminal Activity
• Public Health Epidemic and Impact on Society
• FDA, DEA, and AMA Response
• Other legislative bills under consideration
 
Faculty:
  • Elaine Lippmann, Senior Regulatory Counsel, U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Regulatory Policy
  • James Arnold, Chief, Liaison & Policy, Diversion Control Division, DEA Headquarters
  • Debra A. Cohn, Senior Washington Counsel, American Medical Association
  • Brian J. Malkin, FDA/IP Counsel, Arent Fox
Fee: $89 Community Members; $99 D.C. Bar Members; $109 Government Attorneys; $129 Others
 
Note: Receive a $50 Discount when taken with Legal Ethics, Substance Abuse, and the Opioid Crisis
          Please click here to register: In-Person | Webinar  
          
           
 
 
 
 

 
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D.C. Bar
Debra Cohn,

James Arnold,

Brian Malkin, Arent Fox LLP

Elaine Lippmann,