Controlled Substances – Regulation, Litigation, and Enforcement

Registration and Breakfast

Opening Remarks from the Co-Chairs

Jolie Apicella
Partner
Wiggin & Dana LLP
Former AUSA, Chief of Healthcare Fraud, Eastern District of New York

Gustav Eyler
Partner
Gibson, Dunn, & Crutcher LLP
Former Director of Consumer Protection Branch, U.S. Department of Justice

Cori Rizman
Director, Compliance - Controlled Substances Oversight Region North America
Fresenius-Kabi USA
Former Diversion Group Supervisor, DEA

Fireside Chat with the DOJ

Lisa Miller
Deputy Assistant Attorney General, Fraud and Appellate Sections
U.S. Department of Justice, Criminal Division

Arun Rao
Deputy Assistant Attorney General
U.S. Department of Justice, Civil Division

Moderator:

Anthony J. Nardozzi
Assistant Director
U.S. Department of Justice, Consumer Protection Branch, Civil Division

Reevaluating Controlled Substances Prescribing via Telehealth and Appreciating the Impact of the Expiring PHE

Nathan A. Beaver
Partner
Foley & Lardner LLP

William Chang
Chief Legal Officer, Corporate Secretary
UpStream Healthcare

Scott B. Dahlquist
Opioid Coordinator, Consumer Protection Branch
U.S. Department of Justice

Julie Rapoport Schenker, Esq.
Senior Counsel, Business and Litigation | Office of the General Counsel
University of Maryland Medical System

• Considering the impact of the May 11, 2023, expiration of the PHE on controlled substances prescribing
• Will DEA create an official license for the prescribing of controlled substances via telehealth?
• Operating safely during the interim period of the expired PHE and the implementation of new DEA registrants for telehealth prescribers
• Detailing how the supply chain can prepare now for government’s plans to increase enforcement of telehealth prescribing
• Best practices for operating with differing state and federal requirements

Networking Break

National Opioid Litigation and MDL Settlement Update: Tracking Settlements, Agreements, and the Role of State Attorney Generals

Monica Hanna
Special Counsel
Office of the NY State Attorney General

Jayne Conroy
Shareholder
Simmons Hanly Conroy LLP

Much of the $26 billion opioid settlement agreement announced in early 2022 will be used to fund state and subdivision initiatives for abatement of the opioid epidemic. However, not all lawsuits are settled. In this session, topics of discussion include:

• Lessons learned from the settled lawsuits and mitigation strategies for every link in the supply chain
• Evaluating the arguments concerning unlawful advertising and promotion of the consequences for manufacturers
• Identifying the arguments surrounding diversion and the consequences for distributors and pharmacies
• Update on the $26 billion settlement agreement
• What are the abatement initiatives and how will they be implemented
• Reviewing the lawsuits that have not settled and comparing the different legal arguments
• Analyzing the findings of the Johnson & Johnson Oklahoma trial and the implications for multidistrict litigation
• Making the strategic decision between judge-alone or jury trials

DOJ Keynote: Recent DOJ Civil and Criminal Enforcements

Amanda Liskamm
Director, Consumer Protection Branch
U.S. Department of Justice

Networking Lunch

Responding to Emerging Enforcement Trends – Counterfeit Pills, Precursors, and Amphetamines

Ethan Davis
Partner
King & Spalding LLP

Jonathan Lenzner
Chief of Staff
Federal Bureau of Investigations

Uttam Dhillon
Partner | Chair, Regulatory Defense, Compliance & White Collar Practice Group
Michael Best & Friedrich LLP

Gabriel H. Scannapieco
Assistant Director, Consumer Protection Branch
United States Department of Justice

Moderator:

Gustav Eyler
Partner
Gibson, Dunn, & Crutcher LLP
Former Director of Consumer Protection Branch, U.S. Department of Justice

• Update on expanded efforts to interdict counterfeit pills
• Examining investigative and enforcement approaches aimed at stopping necessary precursor chemicals and equipment from reaching illegal drug manufacturers
• Developing corporate engagement protocols to improve responsible sales, distribution, and reporting
• Enforcement tools, approaches, and considerations related to amphetamine manufacturing, distribution, and dispensing
• Compliance advice for corporate actors associated with or transacting in relevant chemicals, equipment, or drugs

Supply Chain Due Diligence for Manufacturers and Distributors: A Deep Dive into Satisfying DEA Diversion Obligations and Streamlining Suspicious Order Monitoring

Hunter G. DeKoninck
Attorney
Quarles & Brady LLP

Cory Kopitzke
Assistant General Counsel, Regulatory
Cardinal Health

Todd Prough, Ph.D
Controlled Substance Monitoring Program
AmerisourceBergen
Former Head of Pharmaceutical Investigations, DEA

Sarah Pechnick
Senior Director
Guidepost Solutions

• Unpacking Suspicious Order Monitoring (SOMS) parameters:
• What exactly constitutes a “suspicious order” (SO) and a “order received under suspicious circumstances” (ORUSC) and what does that mean in practical terms for distributors
• Learning how to design and operate a system to identify SOs and ORUSCs
• What information must you include when you report a suspicious order or ORUSC to DEA?
• Understanding the benefits of an ERP system and knowing the legal and compliance aspects of utilizing technology to fulfill diversion obligations
• Training employees to comply with SOMS requirements
• Best practices for conducting virtual and onsite visits with prospective customers
• Knowing where to search for relevant information and knowing the right questions to ask
• Identifying the common and lesser-known red flags according to industry practice, legislative guidance and case law
• Considering the unique due diligence for international supply chains

Networking Break

Pharmacist Spotlight

What Every Pharmacist and Non-Pharmacist Needs to Know About Proper Administration and Diversion of Prescribed Controlled Substances

Janet Hart
Director, Government Affairs
Rite Aid

Elliot M. Schachner
Assistant U.S. Attorney, Eastern District of New York
U.S. Department of Justice

• Lessons learned from recent pharmacy chain rulings regarding diversion and how to not let this happen to your business
• Developing best practices for communicating with prescribers when the necessity of the prescription is in question
• Protocols for following up with prescriber red flags
• Knowing which red flags to report
• Analyzing guidelines and factors for determining the likelihood of diversion from the patient
• Utilizing the Prescription Drug Monitoring Program as a tool
• Going beyond reporting: can pharmacists refuse to fill prescriptions?
• Incorporating the Model State Pharmacy Act and Model Rules of National Association of Boards of Pharmacy (Model Act) and the PhRMA Code

Ruan v. United States: What Prescribers and Their Lawyers Need to Know

Jay Dewald
Partner | Head of Healthcare Investigations
Norton Rose Fulbright US LLP

Ronald W. Chapman II
Shareholder
Chapman Law Group

In July of 2021, the Supreme Court in Ruan v the United States ruled that the Government must prove the defendant knowingly or intentionally acted in an unauthorized manner to find them guilty of unauthorized distribution of controlled substances. One year later, authorized prescribers need to know how this standard is being applied in practice to adopt their behaviors accordingly. In this session, topics of discussion include:

• Understanding the guidance released by HHS following the Ruan and Khan cases
• Adapting prescribing practices and procedures based on the outcome
• How is Ruan informing DOJ charging decisions, and what that means for your compliance program moving forward

Day One Adjourns

Registration and Breakfast

Opening Remarks from the Co-Chairs

Jolie Apicella
Partner
Wiggin & Dana LLP
Former AUSA, Chief of Healthcare Fraud, Eastern District of New York

Gustav Eyler
Partner
Gibson, Dunn, & Crutcher LLP
Former Director of Consumer Protection Branch, U.S. Department of Justice

Cori Rizman
Director, Compliance - Controlled Substances Oversight Region North America
Fresenius-Kabi USA
Former Diversion Group Supervisor, DEA

FDA Keynote

Dominic Chiapperino, Ph.D.
Director, Controlled Substances Staff
Center for Drug Evaluation and Research, U.S. Food and Drug Administration

Scheduling and Rescheduling Controlled Substances

Delia Ann Deschaine
Partner
Epstein Becker Green

Matthew C. Zorn
Partner
Yetter Coleman LLP

• Reviewing the legal pathways to scheduling and rescheduling: administrative and legislative
  • Assessing the credibility and reliability of the data and evidence used in the scheduling process
    • Strategies for demonstrating a drug has little or no potential for abuse
• Historical review of drugs that have been scheduled legislatively (e.g., gamma-hydroxybutyric acid, a date rape drug)
• Understanding how and when public petitions for administrative scheduling occur (e.g., the 2002 rescheduling of buprenorphine)
• An update on the challenge to DEA’s rescheduling petition denial (Right to Try) in the U.S. Court of Appeal’s 9th circuit
• Considering international treaties in the context of rescheduling

Networking Break

Taking the Bad Trip Out of Psychedelic Medicines: Investing in An Emerging New Paradigm in Therapeutics

Kimberly I. Chew
Partner
Husch Blackwell LLP

Dr. Berra Yazar-Klosinski
Chief Scientific Officer
MAPS Public Benefit Corporation

Psychedelics are increasingly making headlines, especially for the treatment of mental illnesses such as PTSD. Exciting new drug applications involving MDMA, DMT, and psilocybin are making their way through clinical trials and the political and public policy cadence continues to shift towards recognizing the medical value of psychedelics; the DEA is also looking to dramatically boost the production quotas of certain psychedelics, including LSD, psilocyn and mescaline.

• Which psychedelics are closest to FDA approval and which remain on the fringes?
• Navigating the difficulty of securing psychedelics for research in order to demonstrate its medical value
• Best practices for applying for a DEA research license
• Partnering with universities and research institutions
• Best practices for comprehensive IND and NDA applications
• Reviewing the other pathways including Special Protocol Assessment, Breakthrough Therapies, Fast Track and Priority Review

Breaking Into the Cannabis Market: Balancing the Profits Against the Risks of Non-Compliance

Jonathan Havens
Partner | Cannabis Law Practice Co-Chair
Saul Ewing LLP

Matthew J. McCarthy
Special Counsel
Duane Morris LLP

Christine Roussel, PharmD, BCOP, BCSCP
Senior Executive Director, Pharmacy, Laboratory and Medical Research
Doylestown Hospital, Member of the Pennsylvania Board of Pharmacy and Medical Marijuana Advisory Board

In October 2022, the Biden Administration announced that it would begin pardoning all prior offences of simple possession of marijuana and asked that DEA and FDA begin the administrative process to review how marijuana is scheduled under federal law. DEA has also proposed to more than double the amount of cannabis that can be legally manufactured for research in 2023. The implications of rescheduling marijuana are massive, and may transform the cannabis market into one that is legal at the federal as well as state level. In this session, topics of discussion include:

• Are designer compounds worth the risk of attracting DEA or FDA interest?

Networking Lunch

Ensuring cGMP Compliance and Quality Standards for Controlled Substances

Francis Godwin
Director, Office of Manufacturing Quality
U.S. Food and Drug Administration

Marian J. Lee
Partner
Gibson, Dunn & Crutcher LLP

Lowell Zeta
Partner
Hogan Lovells US LLP

• Reviewing current Good Manufacturing Practice regulations relative to controlled substances
• Ensuring product integrity through product and facility registration; inspections; chain-of-custody documentation; and technologies to protect against counterfeit, diverted, subpotent, adulterated, misbranded, and expired drugs.
• Knowing the standards for active pharmaceutical ingredients
• Learning the unique considerations for contract manufacturing
• Reviewing the current Chemistry, Manufacturing and Controls regulations
• Synchronizing CMC and GMP
• Considering the draft Quality System Regulation and OMB’s review

Networking Break

Managing the Finer Points of Parallel Investigations: Reconciling the Requirements of the False Claims Act and the Controlled Substances Act

Natalie Waites
Assistant Director, Fraud Section, Civil Division
U.S. Department of Justice

Matthew Feeley
Deputy Chief & Healthcare Fraud Coordinator, USAO SDFL Civil Division
U.S. Department of Justice

Jonathan M. Phillips
Partner
Gibson, Dunn & Crutcher LLP

Charles Graybow
Senior Compliance Counsel
Pfizer

Moderator:

Jolie Apicella
Partner
Wiggin & Dana LLP
Former AUSA, Chief of Healthcare Fraud, Eastern District of New York

Parallel investigations have unique considerations that must be considered when developing your legal, compliance and business strategies. Enforcement trends show that federal authorities target individual actors for criminal sanctions under the Controlled Substances Act, and target corporate entities for civil remedies, frequently under both the False Claims Act and the Controlled Substances Act. Parallel investigations have unique considerations that must be considered when developing your legal strategy. In this session, topics of discussion include:

• Reviewing the CSA civil penalty and FCA framework to understand what actions may give rise to a claim under the Act;
• Understanding CSA civil provisions
• Learning the anatomy of an FCA lawsuit
• Implementing effective and comprehensive FCA compliance measures and outlining best practices to maintain FCA compliance
• Distinguishing between corporate and individual liability and knowing which factors can negatively or positively affect the other
• When is it in the corporation’s interest to self-disclose and cooperate with investigations into individual actors within the corporation?
• What are the privacy and self-incrimination considerations?
• Understanding the new Monaco memo requirements
• Knowing when to hire outside counsel to avoid conflicts of interest

Responding Effectively to DEA Investigations: Tailoring Inspection Strategies for Every Link in the Supply Chain

Joseph J. Bogdan
Founding Lawyer
The Law Offices of Joseph J. Bogdan, LLC

Justin G. Wood
Diversion Program Manager, Washington Division
Drug Enforcement Administration

Moderator:

Cori Rizman
Director, Compliance - Controlled Substances Oversight Region North America
Fresenius-Kabi USA
Former Diversion Group Supervisor, DEA

• Responding to Letters of Admonition within the allotted time frame
• Understanding when to participate in Informal Administrative hearings with DEA
• Knowing when self-disclosure goes too far
• Negotiating suitable terms for a Memorandum of Understanding
• Preparing for an Order to Show Cause
• Learning the legal argument trends that do and do not result in license revocation
• Dealing with license revocation
• Working within the confines of an Immediate Suspension Order

Conference Concludes