Day 1 - Wednesday, September 17, 2014

FDA Regulatory Fundamentals 101 With Ethics Session

Aimed at providing a primer to professionals who have limited or no experience working with FDA on regulatory matters, this workshop will provide you with 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 walk you through the pre-approval, approval, and post-approval process. Get the background you need to flow seamlessly into the conversations at FDA Boot Camp.

Topics to include:

  • FDA Mission
  • FDA Organization
  • History of FDA Laws
  • Acronyms and Terminology
  • Clinical Trials Process
  • Types of New Drug Applications
  • The Review Process
  • The Hatch Waxman Act
  • Legal Barriers to Approval
  • Biological Products
  • The Basics of Device classification and approval
  • Post-marketing issues and enforcement, including recalls

This one hour program will explore ethical issues that may arise in the context of communications with FDA on behalf of clients. The program is based on scenarios involving situations in which FDA requires full disclosure of adverse information and authority.
For example:

  1. In the context of citizen petitions FDA requires certification that the petition includes all information and views on which the petition relies as well as data and information known to the petitioner which is unfavorable to the petitioner. 21 CFR 10.30. The discussion will cover the implications of that certification upon an attorney in light of Rules 1.6, 1.7 and 1.8 of the Rules of Professional Responsibility.
  2. In the context of an Advisory Committee meeting at which counsel is present, Committee members ask whether all data regarding adverse events have been reported to FDA. The discussion will cover the implications of the lawyer’s participation in light of the requirements of Rules 1.3, 3.4, and 4.1.
  3. Your client has retained a former FDA official and tells you that he will be contacting FDA to discuss a pending NDA. The discussion will cover the implications of Rule 1.11.

Day 2 - Thursday, September 18, 2014

Registration and Continental Breakfast
Co-Chairs’ Opening Remarks and Brief Overview of FDA Practice


Kurt R. Karst
Hyman, Phelps & McNamara, P.C.

Daniel A. Kracov
Arnold & Porter LLP

The Nature of the Approval Process


James N. Czaban
Partner and Chair, FDA Practice Group
Wiley Rein LLP

Donald Ware
Foley Hoag LLP

Rx Drugs

  • Understanding the difference between “new drugs” and other drugs
  • Overview of the research, development, and approval process for new drugs
  • The investigational new drug application (IND) — timing, content, and purpose
  • The new drug application (NDA) — timing, content, purpose, and review process
  • Accelerated approval (fast track)
  • Different uses of the REMS process in new drug approvals

Biological Products

  • What are biological products? What does it mean to say that they are also “drugs”?
  • Which “new drugs” require BLAs instead of NDAs?
  • How do the research, development, and approval process for biological products
  • differ from the process for new drugs?
  • The biologics license application (BLA) — timing, content, purpose, and review process
  • Key similarities and differences between the drug and biological product schemes

OTC Products

  • The concept of “OTC” (OTC-ness)
  • The OTC Review — identifying covered drugs and defining a “monograph”
  • OTC versus Rx
  • Overview of how old and new OTC drugs come to market

Morning Coffee Break
Understanding the Clinical Trial Process for Drugs and Biologics


David G. Adams
Venable LLP

Daniel A. Kracov
Arnold & Porter LLP

  • Outlining the phases of clinical trials (I-IV)
  • Regulatory requirements (e.g., informed consent, IRBs, sponsor obligations, investigator obligations, etc.)
  • FDA authority
  • Discussing the roles and obligations surrounding CROs and SMOs
  • Identifying major differences between clinical trials for drugs and biologics
  • Disclosure of clinical trial information
    • FDA Amendments Act of 2007
    • FDAMA § 113
    • PhRMA policies

Drugs and Biologics: Labeling


Alan G. Minsk
Arnall Golden Gregory LLP

The labeling of the drug/biological product is the final stage of the approval process. The labeling affects what you can do post-approval. It is the point of transition between the approval process and post-approval world.

  • Labeling overview: key regulatory requirements, information, and contents
  • Review process for labeling
  • How does the final labeling control the scope of post-market activities?
  • How can and when should the labeling be amended post-market?
  • How is the labeling a defense in products litigation?
  • When can punitive damages may be rewarded with respect to labeling
  • Assessing the impact of labeling on reimbursement

Networking Luncheon
Part 1 – Patents, Trademarks and Other IP Protections and Mechanisms


Jill K. MacAlpine, Ph.D.
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (Washington, DC)

Donna M. Meuth
Associate General Counsel, Intellectual Property
Eisai Inc. (Andover, MA)

Patent Protection for Drugs and Biologics

  • Summarizing the patenting process for drugs and biologics
  • Strategies for building patent protection drugs and biologics
  • Seeking extension of patent term for time spent in the drug approval process (Patent Term Extension, Supplemental Protection Certificates), and/or time spent obtaining a patent at the United States Patent Office (Patent Term Adjustment)
  • 271(e)(1) “safe harbor”
  • Identifying the respective roles of the FDA and the PTO in the patenting of drugs and biological products

Trademarks, Trade Names, and Trade Dress

  • The art and science of selecting a brand name for a proposed drug product
  • Understanding the respective 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
  • Appreciating the use of trade dress as a means of IP protection for drug products

Afternoon refreshment break
Part 2 – Hatch-Waxman and BPCIA Overview


Kurt R. Karst
Hyman, Phelps & McNamara, P.C.

Christopher E. Jeffers Ph.D.
Mintz Levin Cohn Ferris Glovsky and Popeo PC


  • Comparing the NDA, 505(b)(2) and ANDA (Abbreviated New Drug Application) drug approval routes
  • ANDA filing: what does the FDA require?
  • Showing bioequivalence in an ANDA
  • ANDA Paragraph IV Certification, and response to Notice Letters
  • The role of the Orange Book in the drug approval process: what is it, why is it Orange, and why is it important?
  • Regulatory Exclusivity (FDA)
    • Categories of regulatory (data) exclusivity — NCE (new chemical entity); new indication; NDF (new dosage formulation); ODE (orphan drug exclusivity); PED (pediatric exclusivity)’ New antibiotic exclusivity
    • overview of Hatch-Waxman and reforms under MMA
    • the role of Orange Book under Hatch-Waxman vis-à-vis the MMA
    • 30-month stay
    • patent extensions
    • ANDA-filer exclusivity (180 day)


  • Identifying products approved/regulated as biologics
  • Overview of biosimilar (FOB) legislation and regulations
  • The rationale for safety and efficacy concerns surrounding second generation biologics Exclusivity for Combination Products

Exclusivity for Combination Products

  • Status and review of Combination Drug Development Incentive Act of 2013 (H.R. 2985)
  • Exploring exclusivities for combination products comprised of two new Orange Book listed drugs, two old drugs, a new and an old, a listed drug and device, and a listed drug and biological product

The Drug Supply Chain Security Act – Summarizing the Act and Its Effecton FDA Practice

Michael Walsh
Principal and International Managing Partner
Midgard Consulting Inc.

  • The executive branch’s strategy and FDA’s pathway for global product supply chain security, safety, and quality
  • Overview of the Drug Supply Chain Security Act (Title II of the Drug Quality and Security Act of 2013)
  • FDA’s Implementation Plan, including timeline for Guidance
  • Identifying the scope of the DSCSA
  • Outlining the specifics:
    • obligations to create a unique product identifier;
    • establishing tracing and monitoring systems;
    • developing detection and response protocols regarding counterfeit materials;
    • understanding notification obligations;
    • evaluating the effect of the act on the recall process; and
    • penalties.

Conference Adjourns to Day Two

Day 3 - Friday, September 19, 2014

Continental Breakfast
Co-Chairs’ Opening Remarks and Recap of Day One
cGMPs: Drugs and Biologics (current Good Manufacturing Practices)


Kirsten Mayer
Ropes & Gray LLP (Boston, MA)

  • Examining cGMPs (current Good Manufacturing Practices)and the scope of their importance in pharmaceutical/biological product commercialization
  • Looking at how cGMPs factor into the scope of the FDA’s authority and history
  • Exploring the scope of the FDA’s cGMP Initiative and how the concept of “risk-based” cGMPs is defined
  • Defining the concept of validation
  • How are laboratory investigations in relation to cGMPs conducted?
  • Defining the term “quality systems”
  • How are cGMPs factoring into products litigation?
  • Evaluating the cost of enforcement actions: what happens to company stock when there is an announcement of an enforcement action?

Adverse Events Monitoring, Pharmacovigilance and Risk Management

Howard L. Dorfman
Senior Vice President and General Counsel
Turing Pharmaceuticals

David L. Rosen
Foley & Lardner LLP

  • 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
  • Risk Evaluation and Minimization Strategies (REMS)
  • Risk evaluation in the approval process
  • Risk minimization tools
  • Enforcement of ADE reporting and REMS requirements
  • Examining the relevance to product liability risks

Morning Coffee Break
Medical Devices: Classifications, the Essentials of the Premarket ReviewProcess, and Post-Market Requirements and Concerns


Jennifer L. Bragg
Skadden, Arps, Slate, Meagher & Flom LLP

Gael Diane Tisack
Cardiovascular Group Vice President of Legal Affairs & Terumo Americas Vice President of Intellectual Property
Terumo Medical Corporation (Ann Arbor, MI)

FDA’s Risk-Based Classification Scheme

  • Understanding the concept of risk-based classification
  • Three main classes of medical devices
  • Device reclassification

The Premarket Review Process

  • Potential changes to 510(k) process and changes to diagnostics
  • 510(k) exemptions for low risk devices and the role of the Investigational Device Exemption (IDE)
  • Understanding the selection of “predicate” devices when 510(k) submissions are made and the consequences of choosing the wrong predicate
  • Premarket approval (PMA) process

Post-Market Requirements and Concerns

  • What is the scope of the Quality System Regulation (QSR)?
  • What are the reporting requirements under the Medical Device Reporting (MDR) and Reports of Corrections and Removals regulations?
  • What other types of post-market requirements can FDA impose on medical devices, e.g., tracking?
  • What claims can device manufacturers make regarding cleared/approved devices, devices with pending 510(k) notices, and investigational devices?
  • What are the consequences of illegal promotion of a device?

Recall Guidance for Drugs, Biologics, and Medical Devices: What You Need to Know


Mark Mansour
Jones Day

  • 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
  • What medical device recalls need to be reported to FDA?
  • When should a company institute a recall? Can new labeling or a new product warning constitute a recall?
  • Working with the FDA versus going it alone
  • Interaction between recalls and corrective and preventive action
  • FDA seizure and injunction power
  • When can product be reintroduced to the market?

Conference Concludes*

* Luncheon will be served for delegates attending the afternoon Master Classes beginning promptly at 12:15

Hatch-Waxman and BPCIA: Overview of Biosimilars and Life Cycle Planning for Drugs and Biologics

  • Overview of Title VII of the Patient Protection and Affordable Care Act (PPACA, P.L. 111-148), i.e., Biologics Price Competition and Innovation Act of 2009 (BPCIA)
  • Biosimilar pathway vs. 505(b)(2) and BLAs
  • Defining “biological” and “biosimilars” under BPCIA
  • Exploring interchangeability requirements
  • Understanding the significance of the methods of making claims in this legislation
  • Examining the effect of this abbreviated approval pathway on innovation
  • A look at FDA Rule making and guidance relative to biosimilars
  • How will biosimilars fit in with life cycle strategies?
    • targeting R&D efforts
    • re-examining prosecution efforts
    • anticipating vulnerable patents and litigation
  • Small molecule patent strategies and their application to biologics
  • Active ingredient claims
  • “Purity” claims (impurity profiles, polymorphs
  • Formulation claims and the Exception Excipient Rule
  • Analytical method claims and the Supreme Court’s Momenta decision
  • Pharmacokinetic / bioequivalence claims
  • Extra hurdles for patenting biologics
  • Enablement
  • Written Description
  • Subject Matter Eligibility
  • Bioequivalence v. biosimilarity
    • What ANDA filers need to show for bioequivalence
    • Exploring bioequivalence in a BCPIA pathway
    • Patent opportunities
    • Relation to doctrine of equivalents and more broadly infringement
      • Role of “copying”
  • What lessons can be applied to biologics from FDA’s rating precedent for 505(b)(2) products?
  • What lessons can be applied to biologics from FDA’s same labeling precedent for small molecules?

There are a number of different modes and methods of exclusivity (non-patent). This session will outline what they are and what challenges, opportunities, and current controversies arise in relation to them, including the role that the FDA plays in regulating these modes of exclusivity. Modes and methods of exclusivity to be discussed include:

  • Orphan Drug Exclusivity (7 years)
  • New Chemical Entity Exclusivity (5 years)
  • New Clinical Study Exclusivity (3 years)
  • Pediatric Exclusivity (6 months)
  • First Generic Applicant Exclusivity (180 days)
  • New Antibiotic Exclusivity

Post-Approval marketing Guidance and preemption protocols

  • Defining express and implied preemption
  • Recognizing the basis for drug and device preemption
  • Uncovering how the presumption against preemption has been applied in drug and device litigation
  • Recognizing the interplay between preemption and the FDA regulatory process
  • Emerging precedents: Riegel v. Medtronic and Wyeth v. Levine
  • Understanding the “parallel requirements” exception to preemption

Advertising and Promotion Overview

  • Overview of laws and regulations controlling the advertising, marketing, and promotion of prescription drugs and biologics
  • Office of Prescription Drug Promotion (OPDP) — duties, responsibilities, and enforcement authority
  • Evaluating the new guidance on internet promotions and use of social media
  • Identifying the role of the FTC in the advertising and promotion of drugs
  • Advertising requirements for prescription versus nonprescription products
  • Overview of the promotional materials submission and review process
  • What constitutes a launch?
  • What information must a drug advertisement include?
  • Exploring the role of the label in advertising and the perils of off-label promotion

Special Concerns for DTC Advertising

  • How is direct-to-consumer advertising regulated and monitored?
  • What information must every DTC ad contain?
  • How do the PhRMA DTC guidelines interplay with current FDA regulation?
  • FDA’s DTC Television User Fee Program
  • Advertising and new media — how is Internet and e-mail advertising regulated?
  • Overview of the FDA’s regulation of off-label promotion
  • How can information on off-label or unapproved uses of drugs and biologics be disseminated?
  • What are the consequences of inappropriate off-label promotion?
  • Survey of recent investigations, penalties, and settlements