Pre-Conference Workshop

Pre-Conference Workshop A: Controlled Substances Boot Camp: Introduction To The Fundamentals

Jan 29, 2018 2:00pm – 5:00pm

Speakers

Ronald W. Chapman, II
Shareholder
Chapman Law Group (Troy, MI)

Dominic Chiapperino
Acting Director Controlled Substance Staff Center for Drug Evaluation and Research
Food and Drug Administration

Robert N. Nicholson
Partner
Nicholson & Eastin LLP (Fort Lauderdale, FL)

Day 1 - Tuesday, January 30, 2018

7:45
Registration and Continental Breakfast
8:45
Co-Chairs’ Opening remarks
9:15
Politics and Policy of Controlled Substances in View of the Opioid Overdose Crisis
11:00
Networking Break
11:30
Reassessing your Responsibilities in Light of the Changing Scope of Suspicious Order Monitoring Requirements
12:30
Networking Luncheon
1:45
Understanding and Comparing State Prescription Drug Monitoring Programs
2:45
Evolution of Abuse-Deterrent Opioid Drug Products
3:45
Networking Break
4:00
Overcoming Challenges for Schedule III Opioids and Non-Opioid Products
4:30
New Chemical Entities (NCEs)
5:00
Conference Adjourns to Day 2

Day 2 - Wednesday, January 31, 2018

12:45
Networking Luncheon for Workshop Participants
7:45
Continental Breakfast
8:15
Co-Chairs’ Welcome and Recap of Day 1
8:30
Diving into the State, County, and City Opioid-Related Investigations
9:30
Update on State and Federal Enforcement Initiatives
11:00
Networking Break
11:15
Cracking the Code on DEA Pharmaceutical Take Back Programs
12:00
Tomorrow’s Headlines: Litigations, Task Forces, and New Technologies

Post-Conference Workshop

Post-Conference Workshop B: Simulated Dea Inspection Exercise: Is Your Facility Ready ?

Jan 31, 2018 2:00pm – 5:00pm

Speakers

Benjamin Mink
Director of Compliance and Security
Miami Luken (Springboro, OH)

Brian Rucker
Former DEA Supervisory Diversion Investigator
Director of Compliance

Independent Pharmacy Cooperative (Phoenix, AZ)

Jack Teitelman
President Titan Group (New York, NY)
Former New York Division Security Special Agent U.S. Dept. of Justice-Drug Enforcement Administration

Day 1 - Tuesday, January 30, 2018

7:45
Registration and Continental Breakfast
8:45
Co-Chairs’ Opening remarks

Larry P. Cote
Former Associate Chief Counsel Diversion and Regulatory Litigation Section Drug Enforcement Administration
Partner, Quarles & Brady LLP

Christina M. Markus
Partner and Deputy Practice Leader, FDA & Life Sciences
King & Spalding (Washington, DC)

9:15
Politics and Policy of Controlled Substances in View of the Opioid Overdose Crisis

James Arnold
Liaison and Policy Section Chief
Drug Enforcement Administration (Springfield, VA)

Michael Klein, Ph.D.
Senior Director Regulatory Affairs Coté Orphan, a Quintiles Company (Silver Spring, MD)
Former Director Controlled Substance Staff Food and Drug Administration’s Center for Drug Evaluation and Research

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

Shruti Kulkarni
Advisor
Center for Lawful Access and Abuse Deterrence Associate

Associate (licensed to practice in Maryland. DC application pending)
DCBA Law & Policy (Washington, DC)

Moderator:

John A. Gilbert Jr.
Director
Hyman, Phelps & McNamara, PC (Washington, DC)

Our nation is in trouble. Preliminary New York Times data shows that between 59,000-65,000 people died from drug overdoses in 2016, and the death toll continues to rise in 2017. This roundtable session will bring together key policy leaders from industry organizations to provide their input as to how our nation got here, current initiatives, recent and pending legislation, DEA notices and FDA Guidances, REMs updates, patient access, and other happenings on the Hill. Our panelists will discuss their best options for the future and for ending the opioid overdose epidemic.

11:00
Networking Break
11:30
Reassessing your Responsibilities in Light of the Changing Scope of Suspicious Order Monitoring Requirements

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

12:30
Networking Luncheon
1:45
Understanding and Comparing State Prescription Drug Monitoring Programs

Erika Marshall
Program Outreach Director
E-FORCSE® Florida Prescription Drug Monitoring Program (Tallahassee, FL)

Brian Rucker
Former DEA Supervisory Diversion Investigator
Director of Compliance

Independent Pharmacy Cooperative (Phoenix, AZ)

  • Corresponding responsibility for pharmacists to identify red flags
    • Role of pharmacies in identifying forged prescriptions
  • Understanding and working with state reporting requirements
  • Shifting to a mandatory requirement for all states
    • Considering Fourth Amendment, data privacy, and HIPAA concerns
    • Determining extent of law enforcement access to data
  • Regulator expectations for pharmacies and physicians
  • Update on state mandatory use requirements for prescription drug monitoring

2:45
Evolution of Abuse-Deterrent Opioid Drug Products

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

3:45
Networking Break
4:00
Overcoming Challenges for Schedule III Opioids and Non-Opioid Products

John A. Gilbert Jr.
Director
Hyman, Phelps & McNamara, PC (Washington, DC)

  • Examining the impact of disparate federal and state regulation of non-opioid drugs
    • Considering state legislative efforts to overcome hurdles for clinical trial execution and patient access
  • Ensuring compliance with special regulations for Buprenorphine, Suboxone, and other schedule III drugs for addiction treatment
  • Updates on cannabis research for use in epilepsy/seizure disorders and rare pediatric disorders
    • Status of pending legislation to reschedule marijuana

4:30
New Chemical Entities (NCEs)

Christina M. Markus
Partner and Deputy Practice Leader, FDA & Life Sciences
King & Spalding (Washington, DC)

  • How and when NCEs are classified under the Controlled Substances Act
  • Escaping automatic scheduling for derivative products
    • Tips for drafting successful rescheduling or de-scheduling petitions
  • Exploring changes in scheduling laws and how to minimize loss of exclusivity during waiting periods

5:00
Conference Adjourns to Day 2

Day 2 - Wednesday, January 31, 2018

12:45
Networking Luncheon for Workshop Participants
7:45
Continental Breakfast
8:15
Co-Chairs’ Welcome and Recap of Day 1
8:30
Diving into the State, County, and City Opioid-Related Investigations

Meredith S. Auten
Partner
Morgan, Lewis & Bockius LLP (Philadelphia, PA)

Ann Callis
Partner
Goldenberg Heller & Antognoli, P.C. (Edwardsville IL)

Benjamin Goetten
Jersey County State’s Attorney
Jersey County State’s Attorney’s Office (Jerseyville, IL)

This session will provide a comprehensive overview of the ongoing state opioid-related enforcement cases. Our panelists will discuss the various causes of action, strategies, parties involved, as well as differences across cases. The panel will include an up-to-date status on the timelines of the cases, any related settlements, a multi-faceted presentation of one rural county’s legal journey in tackling the opioid overdose crisis, and the panelists insights into what lies in the future.

9:30
Update on State and Federal Enforcement Initiatives

James Arnold
Liaison and Policy Section Chief
Drug Enforcement Administration (Springfield, VA)

Thomas Corcoran
Deputy Civil Chief
U.S. Attorney’s Office District of Maryland (Baltimore, MD)

Larry P. Cote
Former Associate Chief Counsel Diversion and Regulatory Litigation Section Drug Enforcement Administration
Partner, Quarles & Brady LLP

Amanda Rocque
Deputy Civil Chief
U.S. Attorney's Office District of Colorado (Denver, CO)

This roundtable panel provides our attendees with the unique opportunity to hear from state and federal government officials as well as enforcement experts as they discuss the ins and outs of the enforcement world including orders to show cause and remedial action plans, when DEA can issue immediate suspension orders, and more.

11:00
Networking Break
11:15
Cracking the Code on DEA Pharmaceutical Take Back Programs

Selin Hoboy
Vice President Legislative and Regulatory Affairs
Stericycle Inc. (Lake Forest, IL)

  • Dissecting DEA’s regulations on establishing and maintaining takeback programs
  • Evaluating risks, liabilities, disposal, and cost when establishing pharmacy takeback programs in the face of the opioid overdose crisis
  • Patchwork Effect – Overarching effects of state, county, or local regulations requiring manufacturers or pharmacies to pay for program implementation and/or disposal
  • Ensuring your program is compliant, safe, and environmentally sound

12:00
Tomorrow’s Headlines: Litigations, Task Forces, and New Technologies

Joshua G. Berman
Partner
Clifford Chance US LLP (Washington, DC)

Jason Parish
Shareholder
Buchanan Ingersoll & Rooney PC (Washington, DC)

This session will initiate an open discussion among attendees into topics such as:

  • Preparing for the influx of malpractice, product liability, and wrongful death suits
  • Adjusting to DEA’s new paperless system, and staying compliant
  • Analyzing the status of DOJ’s Opioid Fraud and Detection Unit and other task forces
  • Pending legislation for scheduling of chemically-engineered abusive drugs
  • Discussing current initiatives and their potential for success
  • Using telemedicine and new technologies with lack of or insufficient DEA regulations
  • State and Federal challenges for use of controlled substance dispensing kiosks

Pre-Conference Workshop A: Controlled Substances Boot Camp: Introduction To The Fundamentals

Jan 29, 2018 2:00pm – 5:00pm

Ronald W. Chapman, II
Shareholder
Chapman Law Group (Troy, MI)

Dominic Chiapperino
Acting Director Controlled Substance Staff Center for Drug Evaluation and Research
Food and Drug Administration

Robert N. Nicholson
Partner
Nicholson & Eastin LLP (Fort Lauderdale, FL)

What is it about?

This workshop provides a basic overview of controlled substance regulations and prepares you for the more in-depth discussions that will take place throughout the main conference. This session will set the stage for the main conference by helping attendees thoroughly comprehend the structure of the DEA and FDA while walking through the evergreen and recent challenges that arise when working with controlled substances. Get the background you need to flow seamlessly into the more in-depth discussions that will take place during the main conference.   Topics include:
  • Introduction to the DEA and FDA: agency missions and organizational structures
  • History of controlled substances regulations
  • Intersection between FDA and the DEA: how to work effectively with both agencies
  • Overview of the drug scheduling process and its effects on approval
  • How to de-schedule a drug or move to a different schedule
  • Registration for a DEA number
  • Understanding abuse-deterrence, its current status, and its effect on the approval process
  • Responding to DEA enforcement actions
  • State licensing and the interplay with federal regulations
  • Advertising and promotion of controlled substances

Post-Conference Workshop B: Simulated Dea Inspection Exercise: Is Your Facility Ready ?

Jan 31, 2018 2:00pm – 5:00pm

Benjamin Mink
Director of Compliance and Security
Miami Luken (Springboro, OH)

Brian Rucker
Former DEA Supervisory Diversion Investigator
Director of Compliance

Independent Pharmacy Cooperative (Phoenix, AZ)

Jack Teitelman
President Titan Group (New York, NY)
Former New York Division Security Special Agent U.S. Dept. of Justice-Drug Enforcement Administration

What is it about?

In this exercise, our DEA experts will walk attendees through a mock, unannounced DEA facility inspection and will present tips and best strategies for preparing for, completing a well-supported response, and minimizing/avoiding penalties. Our panelists will explore topics such as:
  • Evaluating internal procedures and how they fit with the ever-changing state and DEA requirements including: Standard Operating Procedure (SOP) Development, Customer Due Diligence/ “Know Your Customer” Activities, and Physical Security Best Practices
  • Examining risk-management, inventory control issues, record-keeping and security issues, to maintain compliance and avoid unforeseen fines and/or federal charges.
  • Identifying potential diversion risks and suggestions for improvement (i.e. dispensing data analysis, 21st century pharmaceutical site evaluations, prescriber due diligence, and information gathering tools/techniques)