American Conference Institute's

FDA Boot Camp

Basic training in core regulatory concepts for life sciences lawyers, business executives and policy analysts

Tuesday, March 19 to Wednesday, March 20, 2013
Doubletree Suites Times Square, New York, NY
Day 1, Tuesday, March 19, 2013

7:35 Registration & Continental Breakfast

8:45 Co-Chairs’ Welcoming Remarks

James Czaban
Partner, Wiley Rein LLP (Washington, DC)

Karen A. Weaver, J.D., R.Ph.
Vice-President & Associate General Counsel, Regulatory
CareFusion Corporation (San Diego, CA)

9:00 The Basics: Understanding and Working with the FDA — Jurisdiction, Functions, Organization, and Operations

James Czaban
Partner, Wiley Rein LLP (Washington, DC)

• FDA Overview
• How the FDA is organized
- Department of Health and Human Services and the Commissioner
- The 5 FDA Centers and the Office of Regulatory Affairs and their functions
• The 3 major centers and their roles
- CDER (Drug)
- CBER (Biologic)
- CDRH (Device)
• Understanding how CDER and CBER intersect
- intersection with CDRH
• Defining the scope of the FDA’s jurisdiction
• Examining how the FDA exercises its jurisdiction:
- rule making
- product decisions
- enforcement
- informal mechanisms
• Reviewing the laws that the FDA enforces
- Food Drug & Cosmetic Act
- Prescription Drug Marketing Act
- Public Health Services Act
- Hatch-Waxman Act
- Follow-On Biologics
- Recalls
- other applicable laws
• Defining drugs, biologics, and medical devices
• Labeling: when is a drug a drug and not a medical device or cosmetic, and the consequences
• Defining combination products
• Working with the FDA
- Administrative Procedures Act
- formal and informal dispute resolution mechanisms
• FDA’s policies and procedures
• Interrelationships with OIG and DOJ
• Recent developments at the FDA
- regulations and guidance
- enforcement initiatives
- personnel
- safety related actions at FDA

10:15 Morning Coffee Break


10:30 The Nature of the Approval Process

James R. Ravitz
Partner, Arent Fox LLP (Washington, DC)

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)
- when you need to file one
- what it needs to contain
- what it entitles you to do
- what you need to report when researching a drug in terms of adverse events
• The new drug application (NDA)
- when you need to file one
- what it needs to contain
- FDA review process and timing
- advisory committees
• 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)
- when you need to file one
- what it needs to contain
- FDA review process and timing
- advisory committees
• Key similarities and differences between the drug and biological product schemes

OTC Products

• The concept of “OTC” (OTC-ness)
• The OTC Review
- which drugs are covered?
- what is a “monograph”?
- what does a monograph contain?
- what if you want to deviate from the monograph (innovate)?
• When is a new drug suitable for OTC?
- when must a drug be Rx only?
- how do you switch a new drug from Rx to OTC?
- can a new drug be Rx in some forms/dosages/etc., and OTC in others?
• Overview of how an OTC drug comes to market
- if it’s a new drug
- if it’s not a new drug

11:45 Understanding the Clinical Trial Process for Drugs and Biologics

Karen A. Weaver, J.D., R.Ph.
Vice-President & Associate General Counsel, Regulatory
CareFusion Corporation (San Diego, CA)

Natalie Zaidman

Senior Corporate Counsel, Pfizer Inc. (New York, NY)

• Overview of the clinical trial process
- phases of testing (I-IV)
- which are mandatory?
- what happens in each phase?
- who conducts the testing?
- special considerations for Phase IV testing
• Regulatory requirements
- informed consent
- IRBs
- sponsor obligations
- investigator obligations
• FDA authority
- inspections
- refusal to accept data
- clinical hold
- disqualifi cation of irb and/or investigator
• Other issues
- CROs
- SMOs
- who reviews the data?
- how do clinical trials for drugs differ from clinical trials
for biologics?
• Disclosure of clinical trial information
- FDA Amendments Act of 2007
- FDAMA § 113
- PhRMA policies

12:45 Networking Luncheon

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

2:00 Part 1 – Overview of Patent and Trademark Issues

Leora Ben-Ami
Partner, Kirkland & Ellis LLP (New York, NY)

IP Protection for Drugs and Biologics

• Summarizing the patenting process for drugs and biologics
• Strategies for building patent protection for 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 USPTO (Patent Term Adjustment)
• 271(e)(1) “safe harbor”
• 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

Trademark Issues

• 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?

2:45 Part 2 – Hatch-Waxman and BPCIA Overview

Scott Lassman
Partner, Kleinfeld, Kaplan & Becker LLP (Washington, DC)

Kurt R. Karst
Director, Hyman, Phelps & McNamara, P.C. (Washington, DC)


• Comparing the NDA, 505(b)(2), and ANDA (Abbreviated New Drug Application) drug approval routes
• ANDA filing: what does 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 and why is it Orange?

- listings and de-listings
- use codes
- importance of Orange Book listing
• Regulatory exclusivity (FDA)
- regulatory (data) exclusivity
     • NCE (new chemical entity)
• 5 years marketing exclusivity
• 5 years data exclusivity
     • indication (new indication or use)
• 3 years marketing exclusivity
     • NDF (new dosage formulation)
     • ODE (orphan drug exclusivity)
     • PED (pediatric 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
- 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)
• The rationale for safety and efficacy concerns surrounding second generation biologics

4:00 Afternoon Refreshment Break

4:15 Drugs and Biologics: Labeling

Eric D. Hargan
Shareholder, Greenberg Traurig LLP (Chicago, IL)

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 postapproval 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?
• When should the labeling be amended post-market?
- what is the process for doing so?
• 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

5:15 Conference Adjourns to Day Two

Day Two, Wednesday, March 20, 2013


7:20 Continental Breakfast

8:05 Co-Chairs’ Opening Remarks

8:15 cGMPs: Drugs and Biologics (current Good Manufacturing Practices)

Scott Bass
Partner, Sidley Austin LLP (Washington, DC)

Mary Beth Neraas
Senior Corporate Counsel, Pfi zer Inc. (New York, NY)

• 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?


9:15 Medical Devices: Classifications, the Essentials of the Premarket Review Process, and Post-Market Requirements and Concerns

Seth Mailhot
Special Counsel
Sheppard Mullin Richter Hampton LLP (Washington, DC)

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
- Should Class II medical devices be split in 2 with 510k-heavy and 510k-lite
• 510(k) exemptions for low risk devices and the role of the Investigational Device Exemption (IDE)
• Premarket notification (510(k)) process
- 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?

10:15 Morning Coffee Break

10:30 Adverse Events Monitoring, Pharmacovigilance and Risk Management

Linda Pissott Reig
Partner, Buchannan Ingersoll and Rooney PC (Newark, NJ)

• What is pharmacovigilance?
• How pharmacovigilance uses adverse event reports
- how ADE reports come to a company
     • solicited direct reports
     • unsolicited direct reports
     • indirect reports
- how companies investigate, analyze and use ADE reports
     • causality assessments
     • labeling changes
- requirements for reporting ADEs to regulatory agencies
     • premarket stage
     • post-market stage
- how regulatory agencies use ADE reports
• Examining other tools for pharmacovigilance
• What is risk management?
- the new Risk Evaluation and Minimization Strategies
(REMS) law
- Risk evaluation in the approval process
- Risk minimization tools
- REMS assessments
• Enforcement of ADE reporting and REMS requirements
• Examining the relevance to product liability risks


11:30 Recall Guidance for Drugs, Biologics, and Medical Devices: What You Need to Know

Stephen D. Terman

Olsson Frank Weeda Terman Matz P.C. (Washington, DC)

• What is the FDA’s recall and oversight authority?
- from where does this authority derive?
- 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?
• When should the decision be made to work with the FDA?
- working with the FDA versus working alone?
     • what are the risks and benefits in each course of action?
• Interaction between recalls and corrective and preventive action
• What are the consequences of not instituting a recall?
• FDA seizure and injunction power
• When can product be reintroduced to the market?

12:15 Conference Concludes