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ACI : 2012 : FDA Boot Camp : Workshops

ACI\'s

FDA Boot Camp

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

Tuesday, March 20 to Wednesday, March 21, 2012
Doubletree Suites Times Square, New York, NY
​PRE‐CONFERENCE WORKSHOP
Monday, March 19, 2012 | 1:00 p.m. – 5:00 p.m.
(Registration begins at 12:00 p.m.)

Carmen M. Shepard
Partner
Zuckerman and Spaeder LLP (Washington, DC)

Fundamentals of FDA Regulatory Law

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 preapproval, 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

4:00 Resolving Ethical Challenges Encountered During the Drug Approval Process

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. Th e 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.

Post-Conference Master Classes
Wednesday, March 21, 2012

In depth Hatch-Waxman, BPCIA, and Post-Approval Concerns

These concurrent workshops build on content covered during the main conference relative to Hatch-Waxman, BPCIA, post-approval marketing, and preemption. Th ese detailed master classes will provide enhanced information specific to the intersection of IP and regulatory law, and to litigation and compliance matters, and also help you thoroughly comprehend the complexities and nuances of these areas of regulatory law

Master Class B: Hatch-Waxman and BPCIA: Overview of Biosimilars and Life Cycle Planning for Drugs and Biologics will provide an in-depth overview of biosimilars as well as analyses of bioequivalence and exclusivities and their role in patent and product life cycle management.

Master Class C: Post-Approval Marketing Guidance and Preemption Protocols will address issues that arise post-approval, including advertising, promotion, and off -label promotion and enforcement, as well as preemption fundamentals.
Hatch-Waxman and BPCIA: Overview of Biosimilars and Life Cycle Planning for Drugs and Biologics

1:15 Biosimilars

Erika Lietzan
Partner, Covington & Burling, LLP
(Washington, DC)

• Overview of Title VII of the Patient Protection and Aff ordable
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
− addition of the word “protein” to the PHSA defi nition of biologics
− identifying the “reference” product and proving biosimilarity

• analytical data requirements
• when will clinical data submission be necessary?
• Exploring interchangeability requirements
• Understanding the significance of the methods of making claims in this legislation
− query: if a protein is made by a completely different process

than the reference product, is the patent infringed?
• Examining the effect of this abbreviated approval pathway on innovation
−how will this impact brand name and generic companies

• A look at FDA Rule making and guidance relative to biosimilars
• How will biosimilars fi t in with life cycle strategies?
− targeting R&D efforts
− re-examining prosecution efforts
− anticipating vulnerable patents and litigation

2:30 Bioequivalence and the “Same Active Ingredient” vis-à-vis Patentability

Chad A. Landmon
Partner, Axinn Veltrop & Harkrider LLP
(Hartford, CT & Washington, DC)

• Defining bioequivalence in drugs
• What an ANDA-fi ler must demonstrate for bioequivalence?
− bioequivalence and dosage form

• Disputing bioequivalence
− understanding FDA’s current thinking
− using bioequivalence to your strategic advantage

• How does bioequivalence relate to patents?
− patenting of bioequivalence characteristics extended-release drug products
−bioequivalence v. Doctrine of Equivalents – what is the difference?
−arguments about bioequivalence raised in Paragraph IV patent litigation infringement, copying (non-obviousness)

3:30 Afternoon Refreshment Break

3:45 Marketing Exclusivities (Non-Patent): Challenges, Opportunities, and Current Controversies

Sarah Cooleybeck
Partner, Foley Hoag LLP
(Boston, MA)

There are a number of different modes and methods of exclusivity (nonpatent).
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)

4:45 Master Class B Concludes

C. Post-Approval Marketing Guidance and Preemption Protocols

1:15 Advertising and Promotion

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

Advertising and Promotion Overview

•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
• DDMAC (Division of Drug Marketing, Advertising and Communications)
−what duties and responsibilities are DDMAC charged with?
−what are its enforcement capabilities and jurisdiction?
−DDMAC 2010: a year in review

• forthcoming guidance on internet promotions
• what is happening with FDA regulation of social media
and other internet-related activities?
• Consumer fraud class action litigation
• Off label cases
• Identifying the role of the FTC in the advertising and promotion of drugs
• 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
Special Concerns for DTC Advertising
• How is direct-to-consumer advertising regulated and monitored?
− how is it diff erent from other pharmaceutical advertising?

• 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?

2:30 Regulation and Dissemination of Off-Label Information

Joseph G. Poluka
Partner, Blank & Rome LLP
(Philadelphia, PA)

Michael A.Walsh
Partner, Strasburger & Price, LLP
(Dallas, TX)

•Off -label use what is it and what it isn’t
•Overview of the rules that prohibit unapproved new use/new drug communications
•Overview of the rules that permit dissemination of information on unapproved/new uses?
−Written materials
−Presentations
−Direct communications
−The Internet

• FDA and the practice of medicine; off -label use and the standard of care
• Who enforces the rules?
• Resurgence of First Amendment challenges: Sorrell, DC Court cases, Caronia and Par
• Citizen’s Petition

3:30 Afternoon Refreshment Break

3:45 Preemption Fundamentals

James Beck
Partner, Dechert LLP
(Washington, DC)

• 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

4:45 Master Class C Concludes