Pre-Conference Workshops

Workshop A — FDA 101: A Guide to Agency Structure, Jurisdiction, Regulation, and Applicable Laws

Mar 21, 2023 9:00am – 12:00pm

Speakers

Christopher Mikson
Partner
DLA Piper LLP (Washington, DC)

Day 1 - Wednesday, March 22, 2023

8:15
Co-Chairs’ Opening Remarks
8:30
Exploring New FDA Initiatives
9:15

THE PRE-APPROVAL AND APPROVAL PROCESS

Navigating the Approval Process for Drugs and Biologics
10:15
Morning Break
10:45
Exploring FDA’s Expedited Programs: Applicability and Eligibility
11:45
1:1 Networking Break
12:00
Lunch Break
12:45
Appreciating the Nuances of the Approval Process for Controlled Substances
1:30
Clarifying the Clinical Trial Process for Drugs and Biologics
2:30
Afternoon Break
3:00

IP Overview for Drugs and Biologics: Hatch-Waxman, BPCIA, Trademarks, and More

PART 1: Patents and Related IP Protections and Mechanisms
3:45
PART 2: Hatch-Waxman and BPCIA Fundamentals: Understanding Follow-On Products and the Rules for Generic Entry
4:45
Drugs and Biologics Labeling: Appreciating the Importance of the Final Step of the Approval Process
5:30
Conference Adjourns to Day Two

Day 2 - Thursday, March 23, 2023

8:30
Co-Chairs’ Remarks and Recap of Day One
8:45
cGMPs: Discovering the Unique Role of Current Good Manufacturing Practices (“cGMPs”) in the Post Approval Process
9:45

Advertising, Promotions, and Related First Amendment Concerns

PART 1: Drug and Biologics Advertising and Promotion 101
10:30
Morning Break
11:00
PART 2: Exploring the Subtleties and Safe Zones of Off-Label Communications
11:45
Preparing for the Worse: Adverse Events Monitoring, Pharmacovigilance, Risk Management, and Recalls
12:45
Understanding the Scope of FDA Enforcement Authority and Actions
1:30
Main Conference Ends

Day 1 - Wednesday, March 22, 2023

8:15
Co-Chairs’ Opening Remarks

Stacy Cline Amin
Partner
Morrison Forester (Washington, DC)
(Former Chief Counsel, U.S. FDA)

Kurt R. Karst
Partner
Hyman, Phelps & McNamara, P.C. (Washington, D.C.)

8:30
Exploring New FDA Initiatives

Stacy Cline Amin
Partner
Morrison Forester (Washington, DC)
(Former Chief Counsel, U.S. FDA)

Kurt R. Karst
Partner
Hyman, Phelps & McNamara, P.C. (Washington, D.C.)

This panel will discuss how the Agency—now under the leadership of Dr. Califf will move forward with new initiatives including an evolving response to COVID-19 and examine key priorities.

9:15

THE PRE-APPROVAL AND APPROVAL PROCESS

Navigating the Approval Process for Drugs and Biologics

Kinsey S. Reagan
Partner
Kleinfeld, Kaplan and Becker, LLP (Washington, DC)

Innovator Products: New Drug Applications and Biologic License Applications

The Drug Review Process

  • Reviewing the fundamentals of applications; from submission, through filing and beyond
  • Making sense of PDUFA Goals, fast track, breakthrough status, and other process enhancements
  • Use of administrative appeals

Rx Drugs (Small Molecules)

  • Understanding the difference between “new drugs” and other drugs
  • Examining the research, development, and approval process for new drugs
  • Dissecting the investigational new drug application (IND) vs. the new drug application (NDA)

Biological Products (Large Molecules)

  • What are biological products in relation to traditional drugs?
  • Deciphering the biologics license application (BLA)
  • How do the research, development, and approval process for biological products differ from the process for new drugs?
  • Exploring key similarities and differences between the drug and biological product schemes

NDAs and BLAs

  • Differentiating between 505(b)(1)s, 505(b)(2)s, and BLAs
  • Identifying applications for fixed-dose combination drugs
  • Distinguishing complex molecules regulated through NDAs from small molecules
  • Examining standards for approvals
  • REMS

OTC Products

  • Understanding the concept of “OTC” (OTC-ness)
  • Examining the OTC Review and monographs
    • Differences between approved and monographed OTC drug products
  • Understanding How FDARA and the 21st Century Cures Act are impacting drug approvals through new evidentiary requirements

10:15
Morning Break
10:45
Exploring FDA’s Expedited Programs: Applicability and Eligibility

Matt Hegreness
Partner (FDA Regulatory)
Covington & Burling LLP

  • Distinguishing among the different FDA programs for expedited review, authorization and approval of drug products
  • Evaluating the criteria for eligibility, benefits, and limitations of each program
  • Understanding accelerated approval, surrogate, and intermediate clinical endpoints
  • Assessing the breakthrough therapy, regenerative medicine advance therapy (RMAT), and fast track designation programs
  • Reviewing priority review
  • Factoring expedited programs into your drug development strategy

11:45
1:1 Networking Break
12:00
Lunch Break
12:45
Appreciating the Nuances of the Approval Process for Controlled Substances

Delia Deschaine
Epstein
Becker & Green

  • Defining the term “controlled substance”?
  • Reviewing the scheduling process for both approval as well as postmarketing approval with both the DEA and FDA
  • Discussing the proper steps for companies who incorporate CBD’s into their products
  • What clinical trial lab work is necessary to demonstrate to the proper agencies?
  • Exploring state regulations which exist when working with controlled substances
  • Implementing the manufacturing quotas which exist for these products

1:30
Clarifying the Clinical Trial Process for Drugs and Biologics

Benjamin Zegarelli
Of Counsel
Mintz

  • Overview of clinical trials and how they are used (including different phases)
  • Identifying the different parties involved (sponsors, investigators, CROs, etc.)
  • Understanding human research protection (ICF, IRB)
  • Enforcement
  • Review of the “Right to Try” laws and their requirements during the clinical trials process

2:30
Afternoon Break
3:00

IP Overview for Drugs and Biologics: Hatch-Waxman, BPCIA, Trademarks, and More

PART 1: Patents and Related IP Protections and Mechanisms

Chad Landmon
Partner
Axinn, Veltrop & Harkrider LLP (Hartford, CT)

Patent Protection for Drugs and Biologics

  • Summarizing the patenting process for drugs and biologics
  • Strategies for building patent protection for drugs and biologics
  • Applying for and achieving extension of patent term for time spent in the drug approval process
    • Patent Term Extension (“PTE”)
    • Patent Term Adjustment (“PTA”)
  • Reviewing the 271(e)(1) “safe harbor” provision
  • Distinguishing the patenting process for drugs from that of biologics
  • Identifying the respective roles of the FDA and the PTO in the protection of drugs and biological products

Trademarks

  • Overview of selecting a brand name for a proposed drug product
  • Roles of the USPTO and FDA in the drug naming process
  • Identifying the PTO and FDA clearances necessary for trade name/trademark approval on your product
  • How does the branding process work for your product

3:45
PART 2: Hatch-Waxman and BPCIA Fundamentals: Understanding Follow-On Products and the Rules for Generic Entry

Li Feng, Ph.D.,
Partner
Finnegan, Henderson, Farabow, Garrett & Dunner

Alexander J. Varond
Partner
Goodwin

Jason G. Winchester
Partner
JONES DAY

Drugs

  • Overview of Hatch-Waxman and reforms
    • 30-month stay; patent extensions; ANDA filer exclusivity (180 day)
  • Comparing the NDA, 505(b)(2), and ANDA (Abbreviated New Drug Application) drug approval routes
    • Reviewing fundamentals of applications
  • Exploring the ANDA Paragraph IV Certification, and response to Notice Letters
  • Examining ANDA Standards for approval and the concepts of sameness and bioequivalence
  • Special considerations: local acting drugs, labeling carve outs and other nuances
    • Understanding the role of the Orange Book in the drug approval process
  • Market exclusivities and protection
  • Identifying the different types of exclusivities
    • Regulatory exclusivity (FDA)/ (data) exclusivity
      • NCE (new chemical entity)
    • 5 years data exclusivity
      • Indication (new indication or use)
    • 3 years marketing exclusivity
      • NDF (new dosage formulation)
      • ODE (orphan drug exclusivity)
      • PED (pediatric exclusivity)

Biologics

  • Overview of biosimilar legislation and regulations, i.e., Biologics Price Competition and Innovation Act of 2009 (BPCIA)
  • Understanding the rationale for safety and efficacy concerns surrounding second generation biologics
  • Exploring the concepts of “biosimilarity” or “interchangeability”
  • FDA rulemaking and guidance relative to biosimilars
  • Other points for consideration: substitution, naming, patents, and additional nuances
  • Examining biosimilar exclusivities
  • “Shall we dance” — weighing the pros and cons of participating in the patent dance
  • Deciding when to provide notice of commercial marketing

4:45
Drugs and Biologics Labeling: Appreciating the Importance of the Final Step of the Approval Process

Torrey Cope
Partner
Sidley Austin LLP (Washington, DC)

The labeling of the drug/biologic is the final stage of the approval process. The label controls what you can do post-approval and as such it is the point of transition between the approval process and the post-approval world.

  • Labeling overview: key regulatory requirements, information, and contents
  • Exploring the review process for labeling
  • Incorporating clinical trial data on the label
  • Appreciating the influence of final labeling on the scope of post-market activities
  • Amending labeling post-ingmarket
  • Using labeling as a defense in products liability litigation
  • Exploring label carve outs
  • Discussing the requirements for skinny and narrow labeling

5:30
Conference Adjourns to Day Two

Day 2 - Thursday, March 23, 2023

8:30
Co-Chairs’ Remarks and Recap of Day One

Stacy Cline Amin
Partner
Morrison Forester (Washington, DC)
(Former Chief Counsel, U.S. FDA)

Kurt R. Karst
Partner
Hyman, Phelps & McNamara, P.C. (Washington, D.C.)

8:45
cGMPs: Discovering the Unique Role of Current Good Manufacturing Practices (“cGMPs”) in the Post Approval Process

Cathy L. Burgess
Partner
Alston & Bird LLP

  • Examining cGMPs (current Good Manufacturing Practices) and the scope of their importance in pharmaceutical/biological product commercialization
  • Factoring cGMPs into the scope of the FDA’s authority
  • Exploring the scope of the FDA’s cGMP Initiative and the concept of “risk-based” cGMPs
  • Conducting laboratory investigations in relation to cGMPs
  • Understanding the influence of cGMPs in products liability litigation
  • Evaluating the costs and impact of enforcement actions

9:45

Advertising, Promotions, and Related First Amendment Concerns

PART 1: Drug and Biologics Advertising and Promotion 101

Bryant M. Godfrey
Partner and Co-Chair, Healthcare & Life Sciences and FDA Practice Groups
Foley Hoag LLP (Washington, DC)

  • Overview of laws and regulations controlling the advertising, marketing, and promotion of prescription drugs and biologics
    • 21 CFR Sections 202.1, 352(n), 314.81(b)(3); Section 352(n) of FD&CA
    • Guidance documents
  • Exploring the role of DDMAC (Division of Drug Marketing, Advertising and Communications)
    • What duties and responsibilities is DDMAC charged with?
    • What are its enforcement capabilities and jurisdiction?
  • Identifying the role of the FTC in the advertising and promotion of drugs
    • SEC?
  • Advertising requirements for prescription v. nonprescription products
  • Reviewing the steps which DDMAC takes for the review of launch campaigns and promotional materials
    • Overview of the promotional materials submission and review process
  • What constitutes a launch?
  • What defines an advertisement?
    • What information must a drug advertisement include?
  • Exploring the role of the label in advertising

10:30
Morning Break
11:00
PART 2: Exploring the Subtleties and Safe Zones of Off-Label Communications

Seth A. Mailhot
Partner
Husch Blackwell LLP (New York, NY)

  • Clarifying FDA’s current position on First Amendment and off-label promotion
    • The 21st Century Cures Act
    • FDAMA 114
  • What to expect concerning proposed legislation, rules changes and Citizen Petitions
  • Cases and controversies: state AG actions and private tort claims
  • 11:45
    Preparing for the Worse: Adverse Events Monitoring, Pharmacovigilance, Risk Management, and Recalls

    Linda Pissott Reig
    Shareholder
    Buchanan Ingersoll & Rooney

  • What is pharmacovigilance?
  • How pharmacovigilance uses adverse event reports
    • Direct versus indirect reports
    • Causality assessments
    • Labeling changes
    • Pre-and post-market ADE reporting requirements
    • How regulatory agencies use ADE reports
  • Exploring protocols for Risk Evaluation and Minimization Strategies (REMS)
  • Understanding the role of risk evaluation in the approval process
  • Identifying risk minimization tools
  • Enforcing ADE reporting and REMS requirements
  • Examining the relevance to product liability risks, including innovator and co-promoter liability risks
  • What is the FDA’s recall and oversight authority (overview of 21 CFR Part 7)?
    • Guidance versus regulation
    • Voluntary recalls versus mandatory recalls
    • Market withdrawals and stock recoveries
  • Interaction between recalls and corrective and preventive action
  • 12:45
    Understanding the Scope of FDA Enforcement Authority and Actions

    Jennifer L. Bragg
    Partner
    Skadden LLP (Washington, DC)

  • Enforcement overview—identifying the players and their positions
    • Investigations, enforcement, litigation, and defenses
  • Understanding potential punishments, including civil seizure, injunction, civil money penalties, and criminal prosecutions
  • Exploring FDA compliance and enforcement mechanisms
    • Inspections
      • For cause inspections vs. routine inspections
      • Communication with the FDA during inspections
    • EIRs
    • Form FDA 483 observations
    • Untitled and Warning Letters
      • Related to inspections
      • Resulting from non-inspection data or information
  • Examining enforcement actions related to digital advertising and social media
  • 1:30
    Main Conference Ends

    Workshop A — FDA 101: A Guide to Agency Structure, Jurisdiction, Regulation, and Applicable Laws

    Mar 21, 2023 9:00am – 12:00pm

    Christopher Mikson
    Partner
    DLA Piper LLP (Washington, DC)

    What is it about?

    This workshop provides a basic overview of FDA regulations and will prepare you for the more in-depth discussions that will take place throughout the conference. Topics addressed during this workshop will set the stage for the main conference by helping you thoroughly comprehend the structure of the FDA and obtain a basic understanding of the pre-approval, approval, and post-approval processes. This session also provides a built-in hour of ethics credit.

    Topics of discussion will include:

    • Examining the FDA’s structure, authority, and organization
    • The 3 major FDA centers and their roles
      • – CDER (Drug)
      • – CBER (Biologics)
      • – CDRH (Device)
    • Reviewing major FDA regulations and applicable laws
    • Defining drugs, biologics, and devices
    • Understanding the role of labeling with respect to these definitions
    • Differentiating types of drug applications (INDs, NDAs, and ANDAs)
    • Exploring the clinical trials process
    • Investigating biological products and biosimilars
    • Evaluating post-market dilemmas and enforcement
    • Understanding recalls and withdrawals
    • Examining recent developments at FDA
    • FDA’s policies and procedures
    • Administrative Procedures Act
    • Working with the FDA through formal and informal dispute resolution mechanisms
    • Analyzing ethical dilemmas that may occur throughout various stages of interaction with the FDA, including the approval process related to the disclosure of adverse information

    Workshop B — Medical Devices, Combination Products, and Companion Diagnostics Boot Camp: A Review of FDA Guidelines and Regulations

    Mar 21, 2023 1:30pm – 4:30pm

    Joshua M. Oyster
    Partner
    Ropes & Gray LLP

    What is it about?

    This workshop will provide an introduction and in-depth overview of medical devices, combination products, and companion diagnostics as well as the FDA regulations which govern these products. Topics of discussion will include:

    Medical Devices
    • Reviewing the history of FDA device regulations
    • Examining the basics of device classification and the FDA’s review process
    • Analyzing the clinical trials process for medical devices
    • Assessing strategies to obtain clinical data
    • Determining premarket approvals
    • Exploring the 510(k)-clearance process
    • Discussing key regulatory requirements, information, and concepts

    Combination Products
    • Defining the requirements for combination product classification and approval
    • Selecting the proper regulatory pathway
    • Exploring the Request for designation (RFD) process and the newly created pre-RFD process
    • Determining the role of the Combination Product Policy Council and agencies regulating combination products
    • Examining existing cGMP’s for combination products

    Companion Diagnostics
    • Exploring the regulations of laboratory developed tests (LDTs)
    • Examining the approval process for in vitro diagnostic devices (IVDs) and Next Generation Sequencing (NGS) IVDs
    • Utilizing companion diagnostics via smart technologies

    Workshop C — Hatch-Waxman and BPCIA in the Trenches: Exclusivity and Bioequivalency Working Group

    Mar 23, 2023 2:30pm – 5:30pm

    What is it about?

    This workshop will build upon the content covered during the main conference on the regulatory and IP interplay in the Hatch-Waxman and BPCIA schematics. Our workshop leaders will in a step by-step manner:

    • Deconstruct complex exclusivity disputes
    • Analyze FDA’s and the disputing parties’ various (and sometimes evolving) positions on exclusivity
    • Explore bioequivalency conundrums

    Relevant court decisions will also be analyzed and their practical and future effects discussed. Workshop attendees will have the opportunity to understand how the exclusivity “rules of the road” are applied in a real-world case.